Nurofen Cold and Flu / Nurofen Sinus Relief

1. Name Of The Medicinal Product

Nurofen Cold & Flu

Nurofen Sinus Relief

2. Qualitative And Quantitative Composition

Active ingredients	Quantity
Ibuprofen BP	200mg
Pseudoephedrine Hydrochloride	30mg

3. Pharmaceutical Form

Yellow film coated tablet. Printed in black with an identifying motif.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of symptoms cold and 'flu with associated congestion, including aches and pains, headache, fever, sore throat, blocked nose and sinuses.

4.2 Posology And Method Of Administration

For oral administration and short-term use only.

Adults, the elderly and children over 12 years:

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

Take 1 or 2 tablets with water, up to three times a day as required.

Leave at least 4 hours between doses.

Do not take more than 6 tablets in any 24 hour period.

Not to be given to children under 12 years.

4.3 Contraindications

Hypersensitivity to ibuprofen or any of the excipients in the product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.

Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Severe heart failure, renal failure or hepatic failure (see section 4.4)

Last trimester of pregnancy (see section 4.6)

Patients with serious cardiovascular disease, tachycardia, hypertension, angina pectoris, hyperthyroidism, diabetes, phaeochromocytoma, closed angle glaucoma, prostatic enlargement.

4.4 Special Warnings And Precautions For Use

Undesirable effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to control symptoms (see GI and cardiovascular risks below).

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory:

Bronchospasm may be precipitated in patients suffering from, or with a previous history of, bronchial asthma or allergic disease.

Other NSAIDs:

The use of Nurofen Cold & Flu with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).

SLE and mixed connective tissue disease:

Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8).

Renal:

Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8)

Hepatic:

Hepatic dysfunction (see sections 4.3 and 4.8)

Cardiovascular and cerebrovascular effects:

Caution (discussion with doctor of pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluifd retention, hypertension and oedema have been reported in associated with NSAID therapy.

Clinical trial and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g.

Impaired female fertility:

There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.

Gastrointestinal:

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Dematological:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases with the first month of treatment. Nurofen Cold & Flu should be discontinued at the first appearance of a skin rash, mucosal lesions, or any other signs of hypersensisitivity.

The label will include:

Read the enclosed leaflet before taking this product

Do not take if you:

• Have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding

• Are allergic to ibuprofen or any other ingredient of the product, aspirin or other related painkillers

• Are taking other NSAID painkillers, or aspirin with a daily dose above 75mg

Speak to a pharmacist or your doctor before taking if you:

• Have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

• Are a smoker

• Are pregnant

If symptoms persist, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Ibuprofen (like other NSAIDs) should avoided in combination with:

Aspirin: Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see section 4.4).

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4.).

Ibuprofen should be used with caution in combination with:

Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4).

Antihypertensives and diuretics: NSAIDS may diminish the effects of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Lithium: There is evidence for potential increases in plasma levels of lithium.

Methotrexate: There is a potential for an increase in plasma methotrexate.

Ciclosporin: Increased risk of nephrotoxicity.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effects of mifepristone.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased rish of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Quinolone antibiotics: animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

-Pseudoephedrine may potentiate the effects of other sympathomimetic agents, such as decongestants and appetite suppressants.

-Pseudoephedrine should not be given to patients receiving MAOI therapy or within 14 days of ceasing such treatment.

-The effect of Pseudoephedrine may be diminished by guanethidine, reserpine and methyldopa

-The effect of pseudephedrine may be diminished/enhanced by tricyclic antidepressants.

4.6 Pregnancy And Lactation

Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Nurofen Cold & Flu should, if possible, be avoided during the first 6 months of pregnancy.

During the 3^rd trimester, ibuprofen is contraindicated as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. (see section 4.3).

Although ibuprofen appears in breast milk in very low concentrations, significant amounts of Pseudoephedrine are secreted into breast milk and the use of Nurofen Cold and Flu during lactation should be avoided.

See section 4.4 regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

None expected at recommended doses and duration of therapy.

4.8 Undesirable Effects

Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising of asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and, more rarely, bullous dermatoses (including epidermal necrolysis and erythema multiforme).

The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Hypersensitivity Reactions:

Uncommon: Hypersensitivity reactions with urticaria and pruritus.

Very rare: Severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock).

Exacerbation of asthma and bronchospasm.

Gastrointestinal Disorders:

The most commonly-oberved adverse events are gastrointestinal in nature.

Uncommon: Abdominal pain, dyspepsia and nausea.

Rare: Diarrhoea, flatulence, constipation and vomiting

Very rare: Peptic ulcer, perforation or gastrointestinal hemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis.

Exacerbation of ulcerative colitis and Crohn's disease (See section 4.4)

Nervous System:

Uncommon: Headache

Very rare: Aseptic meningitis – single cases have been reported very rarely.

Renal:

Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.

Hepatic:

Very rare: Liver disorders, especially in long-term treatment.

Haematological

Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.

Dermatological:

Uncommon: Various skin rashes

Very rare: Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multoforme and toxic epidermal necrolysis can occur.

Immune System:

In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea,vomiting, fever or disorientation have been observed.

Cardiovascular and Cerebrovascular:

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke), (see section 4.4).

Side effects of Pseudoephedrine include:

May give rise to dyspepsia, gastro-intestinal intolerance and bleeding, skin rashes, nausea, vomiting, sweating, giddiness, thirst, tachycardia, percorial pain, palpitations, restlessness and insomnia. Less frequently Nurofen Cold and Flu may cause difficulty in micturition, muscle weakness, tremors, anxiety, hallucinations and thrombocytopenia.

4.9 Overdose

In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ibuprofen is a propionic acid derivative, having analgesic, anti-pyretic and anti-inflammatory activity. The drug's therapeutic effects as a non-steroidal anti-inflammatory drug are thought to result from inhibitory activity on prostaglandin synthesis. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken with 8 h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no relevant effect is considered to be likely for occasional use.

5.2 Pharmacokinetic Properties

Ibuprofen is rapidly absorbed from the gastrointestinal tract, peak serum concentrations occurring 1-2 hours after administration. The elimination half- life is approximately two hours.

Ibuprofen is metabolised in the liver to two major inactive metabolites and these together with unchanged ibuprofen are excreted by the kidney either as such or as conjugates. Excretion by the kidney is both rapid and complete.

Ibuprofen is extensively bound to plasma proteins.

Pseudoephedrine is absorbed from the gastrointestinal tract and is largely excreted in the urine unchanged, together with small amounts of a hepatic metabolite. It has an elimination half-life of several hours, which may be reduced by acidifying the urine.

5.3 Preclinical Safety Data

No data is available which is of relevance to the consumer.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tricalcium phosphate 118, microcrystalline cellulose, polyvidone, croscarmellose sodium, magnesium stearate, methylhydroxypropyl cellulose, talc, Opaspray Yellow M-1F-6168 or Mastercote Yellow FA 0156, black printing ink (contains shellac, iron oxide black and propylene glycol).

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store in a dry place.

6.5 Nature And Contents Of Container

A strip pack consisting of a blister tray of white pigmented 250 μm PVC/40 gsm PVDC laminate heat-sealed to lacquered 20 μm aluminium foil containing 12 tablets. One or two trays packed in a cardboard carton (12 or 24 tablets).

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 4AQ

8. Marketing Authorisation Number(S)

PL 00063/0375

9. Date Of First Authorisation/Renewal Of The Authorisation

24/11/1993 / 29/04/2009

10. Date Of Revision Of The Text

29/04/2011

carbetapentane and guaifenesin

Generic Name: carbetapentane and guaifenesin (kar BET a PEN tane, and gwye FEN e sin)

Brand names: Allfen C, Allfen CX, Allres-G, BetaVent, Carba-XP, Certuss, exall, Expectuss, Oratuss, Pulmari-GP, Respi-Tann G, Tusso-ZMR, Tusso-ZR, Xpect-AT, Dynex VR, AMBI 1000/5, Duratuss CS

What is carbetapentane and guaifenesin?

Carbetapentane is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen mucus congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of carbetapentane and guaifenesin is used to treat stuffy nose, cough, and chest congestion caused by the common cold or flu.

This medication will not treat a cough that is caused by smoking, asthma, or emphysema.

Carbetapentane and guaifenesin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about carbetapentane and guaifenesin?

You should not use this medication if you are allergic to carbetapentane or guaifenesin. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before you take this medication, tell your doctor if you have asthma or other breathing problems, heart disease, high blood pressure, glaucoma, diabetes, an enlarged prostate, urination problems, or an overactive thyroid.

Tell your doctor about all other medicines you use.

Carbetapentane and guaifenesin may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Do not take carbetapentane and guaifenesin for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

What should I discuss with my health care provider before taking carbetapentane and guaifenesin?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to carbetapentane or guaifenesin.

To make sure you can safely take carbetapentane and guaifenesin, tell your doctor if you have any of these other conditions:

• 
  

  asthma, emphysema, or other breathing problems;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  glaucoma;

  
  


• 
  

  diabetes;

  
  


• 
  

  an enlarged prostate or urination problems; or

  
  


• 
  

  overactive thyroid.

  
  

FDA pregnancy category C. It is not known whether carbetapentane and guaifenesin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. This medication can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take carbetapentane and guaifenesin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medication with a full glass of water. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. You may take carbetapentane and guaifenesin with or without food. Taking it with food or milk may decrease stomach upset.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. Do not take carbetapentane and guaifenesin for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you if you have taken a cough medicine within the past few days.

If you need surgery, tell the surgeon ahead of time if you have taken a cough medicine within the past few days. Store at room temperature away from moisture, heat, and light. Do not allow liquid medicine to freeze.

See also: Carbetapentane and guaifenesin dosage (in more detail)

What happens if I miss a dose?

Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause confusion, agitation, or restless feeling.

What should I avoid while taking carbetapentane and guaifenesin?

Carbetapentane and guaifenesin may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase drowsiness caused by carbetapentane and guaifenesin. Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Cough suppressants and expectorants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains a cough suppressant or expectorant.

Carbetapentane and guaifenesin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  confusion, hallucinations, feeling restless or nervous;

  
  


• 
  

  tremors; or

  
  


• 
  

  extreme weakness.

  
  

Less serious side effects may include:

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  drowsiness, dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  nausea.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Carbetapentane and guaifenesin Dosing Information

Usual Adult Dose for Cough:

Carbetapentane-guaifenesin 10 mg-100 mg/5 mL oral liquid:
5 to 10 mL orally every 4 to 6 hours not to exceed 6 doses daily.

Carbetapentane-guaifenesin 5 mg-1000 mg oral tablet, extended release, Carbetapentane-guaifenesin 60 mg-1000 mg oral tablet, extended release and Carbetapentane-guaifenesin 60 mg-1200 mg oral tablet, extended release: 1 tablet orally every 12 hours not to exceed 2 tablets daily.

Carbetapentane-guaifenesin 7.5 mg-150 mg/5 mL oral syrup:
10 mL orally every 4 to 6 hours not to exceed 6 doses daily.

Carbetapentane-guaifenesin 7.5 mg-200 mg/5 mL oral suspension, extended release:
10 mL orally every 12 hours.

Carbetapentane-guaifenesin 8 mg-200 mg oral capsule:
2 capsules orally every 4 to 6 hours.

Carbetapentane-guaifenesin 20 mg-100 mg/5 mL oral syrup:
10 mL orally every 4 to 6 hours.

Carbetapentane-guaifenesin 20 mg-75 mg/5 mL oral liquid:
5 to 10 mL orally every 4 to 6 hours.

Carbetapentane-guaifenesin 30 mg-400 mg oral capsule, extended release:
1 to 2 capsules orally every 12 hours not to exceed 4 tablets daily.

Carbetapentane-guaifenesin 60 mg-600 mg oral tablet, extended release:
1 to 2 tablets orally every 12 hours not to exceed 4 tablets daily.

Usual Pediatric Dose for Cough:

Carbetapentane-guaifenesin 10 mg-100 mg/5 mL oral liquid:
6 to 11 years: 5 mL orally every 4 to 6 hours not to exceed 6 doses daily.
12 years or older: 5 to 10 mL orally every 4 to 6 hours not to exceed 6 doses daily.

Carbetapentane-guaifenesin 5 mg-1000 mg oral tablet, extended release, and Carbetapentane-guaifenesin 60 mg-1000 mg oral tablet, extended release:
6 to 11 years: 0.5 tablet orally every 12 hours not to exceed 1 tablet daily.
12 years or older: 1 tablet orally every 12 hours not to exceed 2 tablets daily.

Carbetapentane-guaifenesin 7.5 mg-150 mg/5 mL oral syrup:
6 to 11 years: 5 mL orally every 4 to 6 hours not to exceed 6 doses daily.
12 years or older: 10 mL orally every 4 to 6 hours not to exceed 6 doses daily.

Carbetapentane-guaifenesin 7.5 mg-200 mg/5 mL oral suspension, extended release:
2 to 4 years: 2.5 mL orally every 12 hours.
5 to 11 years: 5 mL orally every 12 hours.
12 years or older: 10 mL orally every 12 hours.

Carbetapentane-guaifenesin 8 mg-200 mg oral capsule:
6 to 11 years: 1 capsule orally every 4 to 6 hours.
12 years or older: 2 capsules orally every 4 to 6 hours.


Carbetapentane-guaifenesin 20 mg-100 mg/5 mL oral syrup:
2 to 5 years: 2.5 mL orally every 4 to 6 hours.
6 to 11 years: 5 mL orally every 4 to 6 hours.
12 years or older: 10 mL orally every 4 to 6 hours.

Carbetapentane-guaifenesin 20 mg-75 mg/5 mL oral liquid:
2 to 5 years: 2.5 mL orally every 4 to 6 hours.
6 to 11 years: 5 mL orally every 4 to 6 hours.
12 years or older: 5 to 10 mL orally every 4 to 6 hours.

Carbetapentane-guaifenesin 30 mg-400 mg oral capsule, extended release:
6 to 11 years: 1 capsule orally every 24 hours not to exceed 1 capsule daily.
12 years or older: 1 to 2 capsules orally every 12 hours not to exceed 4 capsules daily.

Carbetapentane-guaifenesin 60 mg-1200 mg oral tablet, extended release:
12 years or older: 1 tablet orally every 12 hours not to exceed 2 tablets daily.

Carbetapentane-guaifenesin 60 mg-600 mg oral tablet, extended release:
6 to 11 years: 0.5 to 1 tablet orally every 12 hours not to exceed 2 tablets daily.
12 years or older: 1 to 2 tablets orally every 12 hours not to exceed 4 tablets daily.

What other drugs will affect carbetapentane and guaifenesin?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by carbetapentane and guaifenesin.

This list is not complete and other drugs may interact with carbetapentane and guaifenesin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More carbetapentane and guaifenesin resources

• Carbetapentane and guaifenesin Side Effects (in more detail)
• Carbetapentane and guaifenesin Dosage
• Carbetapentane and guaifenesin Use in Pregnancy & Breastfeeding
• Carbetapentane and guaifenesin Drug Interactions
• Carbetapentane and guaifenesin Support Group
• 0 Reviews for Carbetapentane and guaifenesin - Add your own review/rating

Compare carbetapentane and guaifenesin with other medications

• Cough

Where can I get more information?

• Your pharmacist can provide more information about carbetapentane and guaifenesin.

See also: carbetapentane and guaifenesin side effects (in more detail)

Centany Topical

Generic Name: mupirocin (Topical route)

mue-PIR-oh-sin

Commonly used brand name(s)

In the U.S.

• Bactroban


• Centany

Available Dosage Forms:

• Ointment


• Cream

Therapeutic Class: Antibacterial

Uses For Centany

Mupirocin is used to treat bacterial infections. It works by killing bacteria or preventing their growth.

Mupirocin ointment is applied to the skin to treat impetigo. It may also be used for other bacterial skin infections as determined by your doctor.

Mupirocin cream is applied to the skin to treat secondarily infected traumatic skin lesions.

Mupirocin is available in the U.S. only with your doctor's prescription.

Before Using Centany

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Safety and effectiveness of mupirocin cream have not been established in children up to 3 months of age.

Safety and effectiveness of mupirocin ointment have not been established in children up to 2 months of age.

Geriatric

No overall difference in safety and efficacy were observed in patients over 65 years of age.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of mupirocin

This section provides information on the proper use of a number of products that contain mupirocin. It may not be specific to Centany. Please read with care.

Do not use this medicine in the eyes.

To use:

• Before applying this medicine, wash the affected area(s) with soap and water, and dry thoroughly. Then apply a small amount to the affected area(s) and rub in gently.


• After applying this medicine, the treated area(s) may be covered with a gauze dressing if desired.

To help clear up your skin infection completely, keep using mupirocin for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ointment dosage form:
  
  • Impetigo:
    
    • Adults and children 2 months of age and older— Apply three times a day.
    
    
    • Children under 2 months of age — Use and dose must be determined by your doctor.
    
    
  
  

• For cream dosage form:
  
  • Secondarily infected traumatic skin lesions
    
    • Adults and children 3 months of age and older— Apply three times a day, for 10 days.
    
    
    • Children under 3 months of age — Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Centany

If your skin infection does not improve within 3 to 5 days, or if it becomes worse, check with your health care professional.

Centany Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Dry skin


• skin burning, itching, pain, rash, redness, stinging, or swelling


• headache


• nausea

Rare

• Abdominal pain


• dizziness


• secondary wound infection


• sores on mouth and on lips

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Centany Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Centany Topical resources

• Centany Topical Side Effects (in more detail)
• Centany Topical Use in Pregnancy & Breastfeeding
• Centany Topical Support Group
• 0 Reviews for Centany Topical - Add your own review/rating

Compare Centany Topical with other medications

• Nasal Carriage of Staphylococcus aureus
• Skin and Structure Infection

narcotic analgesics and aspirin

Class Name: narcotic analgesics and aspirin (Oral route)

Commonly used brand name(s):

In the U.S.

• Darvon Compound


• Empirin w/Codeine


• Endodan


• Percodan


• Synalgos-DC

Available Dosage Forms:

• Tablet


• Capsule

Uses For This Medicine

Combination medicines containing narcotic analgesics and aspirin are used to relieve pain. A narcotic analgesic and aspirin used together may provide better pain relief than either medicine used alone. In some cases, relief of pain may come at lower doses of each medicine.

Narcotic analgesics act in the central nervous system (CNS) to relieve pain. Many of their side effects are also caused by actions in the CNS. When narcotics are used for a long time, your body may get used to them so that larger amounts are needed to relieve pain. This is called tolerance to the medicine. Also, when narcotics are used for a long time or in large doses, they may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal symptoms when you stop taking the medicine.

Aspirin does not become habit-forming when taken for a long time or in large doses, but it may cause other unwanted effects if too much is taken.

These medicines are available only with your doctor's prescription. In Canada, some strengths of aspirin, codeine, and caffeine combination are available without a prescription.

Before Using This Medicine

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Do not give a medicine containing aspirin to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because aspirin may cause a serious illness called Reye's syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Children who do not have a virus infection may also be more sensitive to the effects of aspirin, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.

The narcotic analgesic in this combination medicine can cause breathing problems, especially in children younger than 2 years of age. These children are usually more sensitive than adults to the effects of narcotic analgesics. Also, unusual excitement or restlessness may be more likely to occur in children receiving these medicines.

Geriatric

Elderly people are especially sensitive to the effects of aspirin and of narcotic analgesics. This may increase the chance of side effects, especially breathing problems caused by narcotic analgesics, during treatment.

Pregnancy

For aspirin—Studies in humans have not shown that aspirin causes birth defects. However, studies in animals have shown that aspirin causes birth defects.

Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn baby. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these effects. However, regular use of aspirin late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn baby. Also, use of aspirin during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn baby.

Too much use of aspirin during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor.

For narcotic analgesics—Although studies on birth defects with narcotic analgesics have not been done in pregnant women, they have not been reported to cause birth defects. However, hydrocodone caused birth defects in animal studies when given in very large doses. Codeine did not cause birth defects in animals, but it caused slower development of bones and other toxic or harmful effects on the fetus. Pentazocine and propoxyphene did not cause birth defects in animals. There is no information about whether dihydrocodeine or oxycodone causes birth defects in animals.

Too much use of a narcotic during pregnancy may cause the fetus to become dependent on the medicine. This may lead to withdrawal side effects in the newborn baby. Also, some of these medicines may cause breathing problems in the newborn baby if taken just before or during delivery.

For caffeine—Studies in humans have not shown that caffeine (contained in some of these combination medicines) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).

Breast Feeding

Most of these combination medicines have not been reported to cause problems in nursing babies.

For aspirin, caffeine, propoxyphene—These medicines do pass into the breast milk.

For codeine and other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine)—Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects. A nursing mother should talk to her doctor if she has any questions about taking codeine or about how this medicine may affect her baby .

Interactions with Medicines

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Ketorolac

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Anisindione


• Beta Glucan


• Citalopram


• Desirudin


• Desvenlafaxine


• Dicumarol


• Duloxetine


• Eptifibatide


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Ginkgo


• Heparin


• Ketoprofen


• Methotrexate


• Milnacipran


• Nefazodone


• Paroxetine


• Phenindione


• Phenprocoumon


• Reteplase, Recombinant


• Sertraline


• Ticlopidine


• Varicella Virus Vaccine


• Venlafaxine


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol and/or other drug abuse, or history of, or


• Asthma, allergies, and nasal polyps (history of) or


• Brain disease or head injury or


• Colitis or


• Convulsions (seizures), history of, or


• Emphysema or other chronic lung disease or


• Kidney disease or


• Liver disease or


• Underactive thyroid—The chance of serious side effects may be increased.

• Overactive thyroid or


• Stomach ulcer or other stomach problems—Aspirin may make these conditions worse.

• Enlarged prostate or problems with urination or


• Gallbladder disease or gallstones—Narcotic analgesics have side effects that may be dangerous if these medical problems are present.

• Gout—Aspirin can make this condition worse and can also lessen the effects of some medicines used to treat gout.

• Heart disease—Large amounts of aspirin and caffeine (present in some of these combination medicines) can make some kinds of heart disease worse.

• Hemophilia or other bleeding problems or


• Vitamin K deficiency—Aspirin increases the chance of serious bleeding.

Proper Use of This Medicine

Take this medicine with food or a full glass (8 ounces) of water to lessen stomach irritation.

Do not take this medicine if it has a strong vinegar-like odor. This odor means the aspirin in it is breaking down. If you have any questions about this, check with your health care professional.

Take this medicine only as directed by your medical doctor or dentist. Do not take more of it, do not take it more often, and do not take it for a longer time than your medical doctor or dentist ordered. This is especially important for children and elderly patients, who are usually more sensitive to the effects of these medicines. If too much of a narcotic analgesic is taken, it may become habit-forming (causing mental or physical dependence) or lead to medical problems because of an overdose. Also, taking too much aspirin may cause stomach problems or lead to medical problems because of an overdose.

If you think that this medicine is not working as well after you have been taking it for a few weeks, do not increase the dose. Instead, check with your medical doctor or dentist.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For aspirin, caffeine, and dihydrocodeine


• For oral dosage form (capsules):
  
  • For pain:
    
    • Adults—2 capsules every four hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For aspirin and codeine


• For oral dosage form (tablets):
  
  • For pain:
    
    • Adults—1 or 2 tablets every four hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For aspirin, codeine, and caffeine


• For oral dosage form (tablets):
  
  • For pain:
    
    • Adults—1 or 2 tablets every four hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For buffered aspirin, codeine, and caffeine


• For oral dosage form (tablets):
  
  • For pain:
    
    • Adults—1 or 2 tablets every four hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For hydrocodone and aspirin


• For oral dosage form (tablets):
  
  • For pain:
    
    • Adults—1 or 2 tablets every four to six hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For oxycodone and aspirin


• For oral dosage form (tablets):
  
  • For pain:
    
    • Adults—1 or 2 half-strength tablets, or 1 full-strength tablet, every four to six hours as needed.
    
    
    • Children 12 years of age and older—One-half of a half-strength tablet every six hours as needed.
    
    
    • Children 6 to 12 years of age—One-quarter of a half-strength tablet every six hours as needed.
    
    
    • Children up to 6 years of age—Use is not recommended.
    
    
  
  

• For pentazocine and aspirin


• For oral dosage form (tablets):
  
  • For pain:
    
    • Adults—2 tablets three or four times a day as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For propoxyphene and aspirin


• For oral dosage form (capsules):
  
  • For pain:
    
    • Adults—1 capsule every four hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For propoxyphene, aspirin, and caffeine


• For oral dosage forms (capsules or tablets):
  
  • For pain:
    
    • Adults—1 capsule or tablet every four hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Destroy any medicine that you do not need by flushing it down the toilet.

Precautions While Using This Medicine

If you will be taking this medicine for a long time (for example, for several months at a time), your doctor should check your progress at regular visits.

Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. If any contain a narcotic, aspirin, or other salicylates, check with your health care professional. Taking them together with this medicine may cause an overdose.

For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):

• Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual

For nursing mothers taking a codeine-containing medicine or any other narcotic analgesic (dihydrocodeine, hydrocodone, oxycodone, or pentazocine):

• Call your doctor if you become extremely tired and have difficulty caring for your baby.


• Your baby should generally nurse every two to three hours and should not sleep more than four hours at a time.


• Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breast-feeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking aspirin. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.

Taking acetaminophen or certain other medicines together with the aspirin in this combination medicine may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your medical doctor or dentist directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or any of the following medicines together with this combination medicine for more than a few days, unless your medical doctor or dentist has directed you to do so and is following your progress:

• Diclofenac (e.g., Voltaren)


• Diflunisal (e.g., Dolobid)


• Etodolac (e.g., Lodine)


• Fenoprofen (e.g., Nalfon)


• Floctafenine (e.g., Idarac)


• Flurbiprofen, oral (e.g., Ansaid)


• Ibuprofen (e.g., Motrin)


• Indomethacin (e.g., Indocin)


• Ketoprofen (e.g., Orudis)


• Ketorolac (e.g., Toradol)


• Meclofenamate (e.g., Meclomen)


• Mefenamic acid (e.g., Ponstel)


• Nabumetone (e.g., Relafen)


• Naproxen (e.g., Naprosyn)


• Oxaprozin (e.g., Daypro)


• Phenylbutazone (e.g., Butazolidin)


• Piroxicam (e.g., Feldene)


• Sulindac (e.g., Clinoril)


• Tenoxicam (e.g., Mobiflex)


• Tiaprofenic acid (e.g., Surgam)


• Tolmetin (e.g., Tolectin)

This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.

Dizziness, light-headedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your doctor. Lying down for a while may also help some other side effects, such as dizziness or light-headedness.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Do not take this medicine for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems

For patients taking the buffered aspirin, codeine, and caffeine combination (C2 Buffered with Codeine):

• This product contains antacids that can keep many other medicines, especially some medicines used to treat infections, from working properly. This problem can be prevented by not taking the 2 medicines too close together. Ask your pharmacist how long you should wait between taking any other medicine and the buffered aspirin, codeine, and caffeine combination.

For diabetic patients:

• False urine sugar test results may occur if you are regularly taking 8 or more 325-mg or 5 or more 500-mg doses of aspirin a day. Smaller amounts or occasional use of aspirin usually will not affect urine sugar tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

Narcotic analgesics may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If you have been taking this medicine regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. Depending on which of these medicines you have been taking, and the amount you have been taking every day, your doctor may want you to reduce gradually the amount you are taking before stopping completely, to lessen the chance of withdrawal side effects.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or death. Signs of overdose of this medicine include convulsions (seizures); hearing loss; confusion; ringing or buzzing in the ears; severe excitement, nervousness, or restlessness; severe dizziness, severe drowsiness, shortness of breath or troubled breathing, and severe weakness.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following symptoms of overdose occur:

If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:

• Any loss of hearing


• bloody urine


• cold, clammy skin


• confusion (severe)


• convulsions (seizures)


• diarrhea (severe or continuing)


• dizziness or light-headedness (severe)


• drowsiness (severe)


• excitement, nervousness, or restlessness (severe)


• fever


• hallucinations (seeing, hearing, or feeling things that are not there)


• headache (severe or continuing)


• increased sweating


• increased thirst


• low blood pressure


• nausea or vomiting (severe or continuing)


• pinpoint pupils of eyes


• ringing or buzzing in the ears


• shortness of breath or unusually slow or troubled breathing


• stomach pain (severe or continuing)


• uncontrollable flapping movements of the hands (especially in elderly patients)


• weakness (severe)


• Difficulty breathing


• difficulty nursing


• increased sleepiness (more than usual)


• limpness

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

• Bloody or black, tarry stools


• confusion


• dark urine


• fast, slow, or pounding heartbeat


• increased sweating (more common with hydrocodone)


• irregular breathing


• mental depression


• pale stools


• redness or flushing of face (more common with hydrocodone)


• skin rash, hives, or itching


• stomach pain (severe)


• swelling of face


• tightness in chest or wheezing


• trembling or uncontrolled muscle movements


• unusual excitement (especially in children)


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dizziness, light-headedness, or feeling faint


• drowsiness


• heartburn or indigestion


• nausea or vomiting


• stomach pain (mild)

Less common or rare

• Blurred or double vision or other changes in vision


• constipation (more common with long-term use and with codeine)


• difficult, painful, or decreased urination


• dryness of mouth


• false sense of well-being


• frequent urge to urinate


• general feeling of discomfort or illness


• headache


• loss of appetite


• nervousness or restlessness


• nightmares or unusual dreams


• trouble in sleeping


• unusual tiredness


• unusual weakness

Although not all of the side effects listed above have been reported for all of these medicines, they have been reported for at least one of them. However, since all of the narcotic analgesics are very similar, any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on which of these medicines you were taking, the amount of medicine you were using, and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

• Body aches


• diarrhea


• fever, runny nose, or sneezing


• gooseflesh


• increased sweating


• increased yawning


• loss of appetite


• nausea or vomiting


• nervousness, restlessness, or irritability


• shivering or trembling


• stomach cramps


• trouble in sleeping


• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

GI stimulants

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Gastrointestinal stimulants are drugs that increase motility of the gastrointestinal smooth muscle, without acting as a purgative. These drugs have different mechanisms of action but they all work to move the contents of the gastrointestinal tract faster.

Gastrointestinal stimulants are used to treat gastroesophageal reflux disease and other gastrointestinal conditions where gastrointestinal movement is slowed.

See also

Medical conditions associated with GI stimulants:

• Gastroparesis
• GERD
• Indigestion
• Lactation Augmentation
• Migraine
• Nausea/Vomiting
• Nausea/Vomiting, Chemotherapy Induced
• Nausea/Vomiting, Postoperative
• Radiographic Exam
• Small Intestine Intubation

Drug List:

Reglan

Propulsid

Ilopan-Choline

Metozolv-Odt

Cardura XL

Generic Name: doxazosin (dox AY zo sin)

Brand Names: Cardura, Cardura XL

What is Cardura XL (doxazosin)?

Doxazosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Doxazosin relaxes your veins and arteries so that blood can more easily pass through them. It also relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Doxazosin is used to treat hypertension (high blood pressure), or to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

Doxazosin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Cardura XL (doxazosin)?

You should not use this medication if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin). Doxazosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. If you stop taking doxazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using doxazosin before surgery unless your surgeon tells you to.

Tell your doctor about all other medications you use, especially other blood pressure medications including diuretics (water pills).

What should I discuss with my doctor before taking Cardura XL (doxazosin)?

You should not use this medication if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin).

If you have liver disease or a history of prostate cancer, you may need a dose adjustment or special tests to safely take doxazosin.

Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using doxazosin before surgery unless your surgeon tells you to.

FDA pregnancy category C. It is not known whether doxazosin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether doxazosin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Cardura XL (doxazosin)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Doxazosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking doxazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Your blood pressure or prostate will need to be checked often. Visit your doctor regularly.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness or fainting.

What should I avoid while taking Cardura XL (doxazosin)?

Doxazosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of doxazosin.

Cardura XL (doxazosin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  feeling like you might pass out;

  
  


• 
  

  fast or pounding heartbeats, fluttering in your chest;

  
  


• 
  

  trouble breathing;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  penis erection that is painful or lasts 4 hours or longer.

  
  

Less serious side effects may include:

• 
  

  mild dizziness;

  
  


• 
  

  tired feeling, drowsiness;

  
  


• 
  

  headache;

  
  


• 
  

  nausea; or

  
  


• 
  

  runny nose.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cardura XL (doxazosin)?

Tell your doctor about all other medications you use, especially:

• 
  

  sildenafil (Viagra, Revatio)

  
  


• 
  

  tadalafil (Cialis);

  
  


• 
  

  vardenafil (Levitra); or

  
  


• 
  

  other blood pressure medications, including diuretics (water pills).

  
  

This list is not complete and other drugs may interact with doxazosin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cardura XL resources

• Cardura XL Side Effects (in more detail)
• Cardura XL Use in Pregnancy & Breastfeeding
• Cardura XL Drug Interactions
• Cardura XL Support Group
• 1 Review for Cardura XL - Add your own review/rating

• Cardura XL Prescribing Information (FDA)


• Cardura XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardura XL Advanced Consumer (Micromedex) - Includes Dosage Information


• Doxazosin Prescribing Information (FDA)


• Cardura MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardura Prescribing Information (FDA)


• Cardura Monograph (AHFS DI)


• Cardura Consumer Overview

Compare Cardura XL with other medications

• Benign Prostatic Hyperplasia

Where can I get more information?

• Your pharmacist can provide more information about doxazosin.

See also: Cardura XL side effects (in more detail)

Ciclopirox Nail Lacquer

Ciclopirox Topical Solution, 8% (Nail Lacquer)

For use on fingernails and toenails and immediately adjacent skin only

Not for use in eyes

Ciclopirox Nail Lacquer Description

Ciclopirox Topical Solution, 8% (Nail Lacquer) contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.

Each gram of Ciclopirox Topical Solution, 8% (Nail Lacquer) contains 80 mg ciclopirox in a solution base consisting of ethyl acetate, NF; isopropyl alcohol, USP; and butyl monoester of poly[methylvinyl ether/maleic acid] in isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application.

Ciclopirox Topical Solution, 8% (Nail Lacquer) is a clear, colorless to slightly yellowish solution.

The chemical name for ciclopirox is 6-cyclohexyl- 1-hydroxy-4-methyl-2(1H)- pyridone, with the molecular formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:

Ciclopirox Nail Lacquer - Clinical Pharmacology

Microbiology

Mechanism of Action

The mechanism of action of ciclopirox has been investigated using various in vitro and in vivo infection models. One in vitro study suggested that ciclopirox acts by chelation of polyvalent cations (Fe+3 or Al+3) resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. The clinical significance of this observation is not known.

Activity in vitro and ex vivo

In vitro methodologies employing various broth or solid media with and without additional nutrients have been utilized to determine ciclopirox minimum inhibitory concentration (MIC) values for the dermatophytic molds.(1-2) As a consequence, a broad range of MIC values, 1-20 mcg/mL, were obtained for Trichophyton rubrum and Trichophyton mentagrophytes species. Correlation between in vitro MIC results and clinical outcome has yet to be established for ciclopirox.

One ex vivo study was conducted evaluating 8% ciclopirox against new and established Trichophyton rubrum and Trichophyton mentagrophytes infections in ovine hoof material.(3) After 10 days of treatment the growth of T. rubrum and T. mentagrophytes in the established infection model was very minimally affected. Elimination of the molds from hoof material was not achieved in either the new or established infection models.

Susceptibility testing for Trichophyton rubrum species

In vitro susceptibility testing methods for determining ciclopirox MIC values against the dermatophytic molds, including Trichophyton rubrum species, have not been standardized or validated. Ciclopirox MIC values will vary depending on the susceptibility testing method employed, composition and pH of media and the utilization of nutritional supplements. Breakpoints to determine whether clinical isolates of Trichophyton rubrum are susceptible or resistant to ciclopirox have not been established.

Resistance

Studies have not been conducted to evaluate drug resistance development in T. rubrum species exposed to 8% ciclopirox topical solution. Studies assessing crossresistance to ciclopirox and other known antifungal agents have not been performed.

Antifungal Drug Interactions

No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis is not recommended.

Pharmacokinetics

As demonstrated in pharmacokinetic studies in animals and man, ciclopirox olamine is rapidly absorbed after oral administration and completely eliminated in all species via feces and urine. Most of the compound is excreted either unchanged or as glucuronide. After oral administration of 10 mg of radiolabeled drug (14C-ciclopirox) to healthy volunteers, approximately 96% of the radioactivity was excreted renally within 12 hours of administration. Ninetyfour percent of the renally excreted radioactivity was in the form of glucuronides. Thus, glucuronidation is the main metabolic pathway of this compound.

Systemic absorption of ciclopirox was determined in 5 patients with dermatophytic onychomycoses, after application of Ciclopirox Topical Solution, 8% (Nail Lacquer) to all 20 digits and adjacent 5 mm of skin once daily for six months. Random serum concentrations and 24 hour urinary excretion of ciclopirox were determined at two weeks and at 1,2, 4 and 6 months after initiation of treatment and 4 weeks post-treatment. In this study, ciclopirox serum levels ranged from 12-80 ng/mL. Based on urinary data, mean absorption of ciclopirox from the dosage form was <5% of the applied dose. One month after cessation of treatment, serum and urine levels of ciclopirox were below the limit of detection.

In two vehicle-controlled trials, patients applied Ciclopirox Topical Solution, 8% (Nail Lacquer) to all toenails and affected fingernails. Out of a total of 66 randomly selected patients on active treatment, 24 had detectable serum ciclopirox concentrations at some point during the dosing interval (range 10.0-24.6 ng/mL). It should be noted that eleven of these 24 patients took concomitant medication containing ciclopirox as ciclopirox olamine (Loprox® Cream, 0.77%).

The penetration of the Ciclopirox Topical Solution, 8% (Nail Lacquer) was evaluated in an in vitro investigation. Radio-labeled ciclopirox applied once to onychomycotic toenails that were avulsed demonstrated penetration up to a depth of approximately 0.4 mm. As expected, nail plate concentrations decreased as a function of nail depth. The clinical significance of these findings in nail plates is unknown. Nail bed concentrations were not determined.

Indications and Usage for Ciclopirox Nail Lacquer

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)

Ciclopirox Topical Solution, 8% (Nail Lacquer) as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Tricho-phyto rubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures.

• No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended.


• Ciclopirox Topical Solution, 8% (Nail Lacquer) should be used only under medical supervision as described above.


• The effectiveness and safety of Ciclopirox Topical Solution, 8% (Nail Lacquer) in the following populations has not been studied.The clinical trials with use of Ciclopirox Topical Solution, 8% (Nail Lacquer) excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded.


• The safety and efficacy of using Ciclopirox Topical Solution, 8% (Nail Lacquer) daily for greater than 48 weeks have not been established.

Clinical Trials Data

The results of use of Ciclopirox Topical Solution, 8% (Nail Lacquer) in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the US. In these studies, patients with onchomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% (Nail Lacquer) in conjunction with monthly removal of the unattached, infected toenail by the investigator. Ciclopirox Topical Solution, 8% (Nail Lacquer) was applied for 48 weeks. At baseline, patients had 20-65% involvement of the target great toenail plate. Statistical significance was demonstrated in one of two studies for the endpoint “complete cure” (clear nail and negative mycology), and in two studies for the endpoint “almost clear” (<10% nail involvement and negative mycology) at the end of study. These results are presented below.

* Clear nail and negative mycology **≤10% nail involvement and negative mycology *** Negative KOH and negative culture
At Week 48 (plus Last Observation Carried Forward) for the Intent-to-Treat (ITT) Population
	Study 312		Study 313
	Active	Vehicle	Active	Vehicle
Complete Cure*	6/110 (5.5%)	1/109 (0.9%)	10/118 (8.5%)	0/117 (0%)
Almost Clear**	7/107 (6.5%)	1/108 (0.9%)	14/116 (12%)	1/115 (0%)
Negative Mycology Alone***	30/105 (29%)	12/106 (11%)	41/115 (36%)	10/114 (9%)

The summary of reported patient outcomes for the ITT population at 12 weeks following the end of treatment are presented below. Note that post-treatment efficacy assessments were scheduled only for patients who achieved a complete cure.

* Four patients (from studies 312 and 313) who were completely cured did not have post-treatment Week 12 planimetry data.
Post-treatment Week 12 Data for Patients Who Achieved Complete Cure at Week 48
	Study 312		Study 313
	Active	Vehicle	Active	Vehicle
Number of Treated Patients	112	111	119	118
Complete Cure at Week 48	6	1	10	0
Post-treatment Week 12 Outcomes:
Patients Missing All Week 12 Assessments	2	0	2	0
Patients with Week 12 Assessments	4	1	8	0
Complete Cure	3	1	4	0
Almost Clear	2*	1	1*	0
Negative Mycology	3	1	5	0

Contraindications

Ciclopirox Topical Solution, 8% (Nail Lacquer) is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings

Ciclopirox Topical Solution, 8% (Nail Lacquer) is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only.

Precautions

General

If a reaction suggesting sensitivity or chemical irritation should occur with the use of Ciclopirox Topical Solution, 8% (Nail Lacquer) treatment should be discontinued and appropriate therapy instituted. So far there is no relevant clinical experience with patients with insulin dependent diabetes or who have diabetic neuropathy. The risk of removal of the unattached, infected nail, by the health care professional and trimming by the patient should be carefully considered before prescribing to patients with a history of insulin dependent diabetes mellitus or diabetic neuropathy.

Information for patients

Patients should have detailed instruction regarding the use of Ciclopirox Topical Solution, 8% (Nail Lacquer) as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product.

The patient should be told to:

1. Use Ciclopirox Topical Solution, 8% (Nail Lacquer) as directed by a health care professional. Avoid contact with eyes and mucous membranes. Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided. Ciclopirox Topical Solution, 8% (Nail Lacquer) is for external use only.


2. Ciclopirox Topical Solution, 8% (Nail Lacquer) should be applied evenly over the entire nail plate and 5 mm of surrounding skin. If possible, Ciclopirox. Topical Solution, 8% (Nail Lacquer) should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis). Contact with the surrounding skin may produce mild, transient irritation (redness).


3. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional is needed with the use of this medication. Inform a health care professional if you have diabetes or problems with numbness in your toes or fingers for consideration of the appropriate nail management program.


4. Inform a health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing).


5. Up to 48 weeks of daily applications with Ciclopirox Topical Solution, 8% (Nail Lacquer) and professional removal of the unattached, infected nail, as frequently as monthly, are considered the full treatment needed to achieve a clear or almost clear nail (defined as 10% or less residual nail involvement).


6. Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.


7. A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a completely clear or almost clear toenail.


8. Do not use the medication for any disorder other than that for which it is prescribed.


9. Do not use nail polish or other nail cosmetic products on the treated nails.


10. Avoid use near heat or open flame, because product is flammable.

Carcinogenesis, mutagenesis, impairment of fertility

No carcinogenicity study was conducted with Ciclopirox Topical Solution, 8% (Nail Lacquer) formulation. A carcinogenicity study of ciclopirox (1% and 5% solutions in polyethylene glycol 400) in female mice dosed topically twice per week for 50 weeks followed by a 6-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application sites.

In human systemic tolerability studies following daily application (~340 mg of Ciclopirox Topical Solution, 8% (Nail Lacquer)) in subjects with distal subungual onychomycosis, the average maximal serum level of ciclopirox was 31±28 ng/mL after two months of once daily applications. This level was 159 times lower than the lowest toxic dose and 115 times lower than the highest nontoxic dose in rats and dogs fed 7.7 and 23.1 mg ciclopirox (as ciclopirox olamine)/kg/day.

The following in vitro genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblasts, with and without metabolic activation (positive); gene mutation assay in HGPRT-test with V79 Chinese hamster lung fibroblasts (negative); unscheduled DNA synthesis in human A549 cells (negative); and BALB/c3T3 cell transformation assay (negative). In an in vivo Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at 5,000 mg/kg.

The following in vitro genotoxicity tests were conducted with Ciclopirox Topical Solution, 8% (Nail Lacquer): Ames Salmonella test (negative); unscheduled DNA synthesis in the rat hepatocytes (negative); cell transformation assay in BALB/c3T3 cell assay (positive). The positive response of the lacquer formulation in the BALB/c3T3 test was attributed to its butyl monoester of poly[methylvinyl ether/maleic acid] resin component (Gantrez® ES-435), which also tested positive in this test. The cell transformation assay may have been confounded because of the filmforming nature of the resin. Gantrez® ES-435 tested nonmutagenic in both the in vitro mouse lymphoma forward mutation assay with or without activation and unscheduled DNA synthesis assay in rat hepatocytes.

Oral reproduction studies in rats at doses up to 3.85 mg ciclopirox (as ciclopirox olamine)/kg/day [equivalent to approximately 1.4 times the potential exposure at the maximum recommended human topical dose (MRHTD)] did not reveal any specific effects on fertility or other reproductive parameters. MRHTD (mg/m2) is based on the assumption of 100% systemic absorption of 27.12 mg ciclopirox (~340 mg Ciclopirox Topical Solution, 8% (Nail Lacquer)) that will cover all the fingernails and toenails including 5 mm proximal and lateral fold area plus onycholysis to a maximal extent of 50%.

Pregnancy

Teratogenic effects

Pregnancy Category B

Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg, respectively, of ciclopirox as ciclopirox olamine/kg/day (14, 8, 17, and 28 times MRHTD), or in rats and rabbits receiving topical doses of up to 92.4 and 77 mg/kg/day, respectively (33 and 55 times MRHTD), did not indicate any significant fetal malformations.

There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. Ciclopirox Topical Solution, 8% (Nail Lacquer) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers

It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when Ciclopirox Topical Solution, 8% (Nail Lacquer) is administered to a nursing woman.

Pediatric use

Based on the safety profile in adults, Ciclopirox Topical Solution, 8% (Nail Lacquer) is considered safe for use in children twelve years and older. No clinical trials have been conducted in the pediatric population.

Geriatric use

Clinical studies of Ciclopirox Topical Solution, 8% (Nail Lacquer) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In the vehicle-controlled clinical trials conducted in the US, 9% (30/327) of patients treated with Ciclopirox Topical Solution, 8% (Nail Lacquer) and 7% (23/328) of patients treated with vehicle reported treatment-emergent adverse events (TEAE) considered by the investigator to be causally related to the test material. The incidence of these adverse events, within each body system, was similar between the treatment groups except for Skin and Appendages: 8% (27/327) and 4% (14/328) of subjects in the ciclopirox and vehicle groups reported at least one adverse event, respectively. The most common were rash-related adverse events: periungual erythema and erythema of the proximal nail fold were reported more frequently in patients treated with Ciclopirox Topical Solution, 8% (Nail Lacquer) (5% [16/327]) than in patients treated with vehicle (1% [3/328]). Other TEAEs thought to be causally related included nail disorders such as shape change, irritation, ingrown toenail, and discoloration.

The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the Ciclopirox Topical Solution, 8% (Nail Lacquer) group and 2% [7/328] in the vehicle group). Moreover, application site reactions and/or burning of the skin occurred in 1% of patients in 1% of patients treated with Ciclopirox Topical Solution, 8% (Nail Lacquer) (3/327) and vehicle (4/328).

A 21-Day Cumulative Irritancy study was conducted under conditions of semi-occlusion. Mild reactions were seen in 46% of patients with Ciclopirox Topical Solution, 8% (Nail Lacquer) 32% with the vehicle and 2% with the negative control, but all were reactions of mild transient erythema. There was no evidence of allergic contact sensitization for either the Ciclopirox Topical Solution, 8% (Nail Lacquer) or the vehicle base. In a separate study of the photosensitization potential of Ciclopirox Topical Solution, 8% (Nail Lacquer) in a maximized test design that included the occluded application of sodium lauryl sulfate, no photoallergic reactions were noted. In four subjects localized allergic contact reactions were observed. In the vehicle-controlled studies, one patient treated with Ciclopirox Topical Solution, 8% (Nail Lacquer) discontinued treatment due to a rash, localized to the palm (causal relation to test material undetermined).

Use of Ciclopirox Topical Solution, 8% (Nail Lacquer) for 48 additional weeks was evaluated in an open-label extension study conducted in patients previously treated in the vehicle- controlled studies. Three percent (9/281) of subjects treated with Ciclopirox Topical Solution, 8% (Nail Lacquer) experienced at least one TEAE that the investigator thought was causally related to the test material. Mild rash in the form of periungual erythema (1% [2/281]) and nail disorders (1% [4/281]) were the most frequently reported. Four patients discontinued because of TEAEs. Two of the four had events considered to be related to test material: one patient’s great toenail “broke away” and another had an elevated creatine phosphokinase level on Day 1 (after 48 weeks of treatment with vehicle in the previous vehicle-controlled study).

Ciclopirox Nail Lacquer Dosage and Administration

Ciclopirox Topical Solution, 8% (Nail Lacquer) should be used as a component of a comprehensive management program for onychomycosis. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy. Careful consideration of the appropriate nail management program should be given to patients with diabetes (see PRECAUTIONS).

Nail Care By Health Care Professionals

Removal of the unattached, infected nail, as frequently as monthly, trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in treatment of nail disorders.

Nail Care By Patient

Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after Ciclopirox Topical Solution, 8% (Nail Lacquer) is removed with alcohol. Ciclopirox Topical Solution, 8% (Nail Lacquer) should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. Ciclopirox Topical Solution, 8% (Nail Lacquer) should be applied evenly over the entire nail plate.

If possible, Ciclopirox Topical Solution, 8% (Nail Lacquer) should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis).

Ciclopirox Topical Solution, 8% (Nail Lacquer) should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every seven days. This cycle should be repeated throughout the duration of therapy.

How is Ciclopirox Nail Lacquer Supplied

Ciclopirox Topical Solution, 8% (Nail Lacquer) is supplied in 3.3 mL (NDC 50383-419-03) and 6.6 mL (NDC 50383-419-06) glass bottles with screw caps which are fitted with brushes.

Protect from light (e.g., store the bottle in the carton after every use).

Ciclopirox Topical Solution, 8% (Nail Lacquer) should be stored at room temperature between 59° and 86° F (15° and 30° C).

CAUTION: Flammable. Keep away from heat and flame.

 

Rx ONLY

Information for Patients

Patients should have detailed instruction regarding the use of Ciclopirox Topical Solution, 8% (Nail Lacquer) as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product.

The patient should be told to:

1. Use Ciclopirox Topical Solution, 8% (Nail Lacquer) as directed by a health care professional. Avoid contact with eyes and mucous membranes. Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided. Ciclopirox Topical Solution, 8% (Nail Lacquer) is for external use only.


2. Ciclopirox Topical Solution, 8% (Nail Lacquer) should be applied evenly over the entire nail plate and 5 mm of surrounding skin. If possible, Ciclopirox. Topical Solution, 8% (Nail Lacquer) should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis). Contact with the surrounding skin may produce mild, transient irritation (redness).


3. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional is needed with the use of this medication. Inform a health care professional if you have diabetes or problems with numbness in your toes or fingers for consideration of the appropriate nail management program.


4. Inform a health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing).


5. Up to 48 weeks of daily applications with Ciclopirox Topical Solution, 8% (Nail Lacquer) and professional removal of the unattached, infected nail, as frequently as monthly, are considered the full treatment needed to achieve a clear or almost clear nail (defined as 10% or less residual nail involvement).


6. Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.


7. A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a completely clear or almost clear toenail.


8. Do not use the medication for any disorder other than that for which it is prescribed.


9. Do not use nail polish or other nail cosmetic products on the treated nails.


10. Avoid use near heat or open flame, because product is flammable.

REFERENCES

1. Dittmar W., Lohaus G. 1973. HOE296, A new antimycotic compound with a broad antimicrobial spectrum. Arzneim- Forsch./Drug Res. 23:670-674.

2. Niewerth et al., 1998. Antimicrobial susceptibility testing of dermatophytes: Comparison of the agar macrodilution and broth micro dilution tests. Chemotherapy. 44:31-35.

3. Yang et al., 1997. A new simulation model for studying in vitro topical penetration of antifungal drugs into hard keratin. J. Mycol. Med. 7:195-98.

Gantrez is a registered trademark of GAF Corporation

Manufactured by

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 419:01 4/09

MG #21742

PATIENT INFORMATION AND INSTRUCTIONS

Patients should have detailed instructions regarding the use of Ciclopirox Topical Solution, 8% (Nail Lacquer) as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product. Discuss your treatment plan with your health care professional for regular removal of the unattached, infected nail.

Call your doctor for medical advice about side effects. You may report side effects to Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088.

Before using this medication, tell your doctor if you:

• Are pregnant or nursing


• Are an insulin dependent diabetic or have diabetic neuropathy


• Have a history of immunosuppression


• Are immunocompromised (e.g., received an organ transplant, etc.)


• Require medication to control epilepsy


• Use or require topical corticosteroids on a repeated monthly basis


• Use steroid inhalers on a regular basis

Patient Information:

• Use Ciclopirox Topical Solution, 8% (Nail Lacquer) as directed by your health care professional.


• Ciclopirox Topical Solution, 8% (Nail Lacquer) is for external use only.


• Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided.


• Avoid contact with the eyes and mucous membranes


• Removal of the unattached, infected nail, as frequently as monthly, by your health care professional is needed with use of this medication to obtain maximal benefit with use of this product. If you have diabetes or problems with numbness in your toes or fingers, talk to your health care provider before trimming your nails or removing any nail material.


• Inform your health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing).


• Up to 48 weeks of daily applications with Ciclopirox Topical Solution, 8% (Nail Lacquer) and professional removal, as frequently as monthly, of the unattached, infected nail are considered the full treatment time to achieve a clear or almost clear nail (defined as 10% or less residual nail involvement). Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.


• A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a clear or almost clear toenail.


• Do not use nail polish or other nail cosmetic products on the treated nails.


• Avoid use near heat or open flame, because product is flammable.

Patient Instruction

1. Before starting treatment, remove any loose nail or nail material using nail clippers or nail files. If you have diabetes or problems with numbness in your toes or fingers, talk to your health care provider before trimming your nails or removing any nail material.

2. Apply Ciclopirox Topical Solution, 8% (Nail Lacquer) once daily (preferably at bedtime) to all affected nails with the applicator brush provided. Apply the lacquer evenly over the entire nail. Where possible, nail lacquer should also be applied to the underside of the nail and to the skin beneath it. Allow lacquer to dry (approximately 30 seconds) before putting on socks or stockings. After applying medication, wait 8 hours before taking a bath or shower.

3. Apply Ciclopirox Topical Solution, 8% (Nail Lacquer) daily over the previous coat.

4. Once a week, remove the Ciclopirox Topical Solution, 8% (Nail Lacquer) with alcohol. Remove as much as possible of the damaged nail using scissors, nail clippers, or nail files.

5. Repeat process (steps 2 through 4).

Please Note:

1. To prevent screw cap from sticking to the bottle, do not allow solution to get into the bottle threads.

2. To prevent the solution from drying out, bottle should be closed tightly after every use.

3. To protect from light, replace bottle into carton after each use.

Manufactured by

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 419:01 4/09

MG #21741

PRINCIPAL DISPLAY PANEL

NDC 50383-419-06

Ciclopirox Topical Solution, 8% (Nail Lacquer)

FOR DERMATOLOGIC USE ONLY

NOT FOR USE IN EYES

6.6 mL

Rx only

CICLOPIROX  ciclopirox  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50383-419 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CICLOPIROX (CICLOPIROX) CICLOPIROX 71.3 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength ETHYL ACETATE   ISOPROPYL ALCOHOL   MALEIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50383-419-06 1  In 1 CARTON contains a BOTTLE 1 6.6 mL In 1 BOTTLE This package is contained within the CARTON (50383-419-06) 2 50383-419-03 1  In 1 CARTON contains a BOTTLE 2 3.3 mL In 1 BOTTLE This package is contained within the CARTON (50383-419-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078270	09/18/2007

Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Revised: 11/2011Hi-Tech Pharmacal Co., Inc.

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