SEO PLR Content Directory Federated States of Micronesia

Wednesday, 13 June 2012

Codeine Phosphate Soluble Tablets

Pronunciation: KOE-deen FOS-fate
Generic Name: Codeine Phosphate
Brand Name: Generic only. No brands available.

Codeine Phosphate Soluble Tablets are used for:

Treating mild to moderate pain.

Codeine Phosphate Soluble Tablets are a narcotic analgesic. It works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Codeine Phosphate Soluble Tablets if:

you are allergic to any ingredient in Codeine Phosphate Soluble Tablets or to any codeine- or morphine-related medicine (eg, oxycodone)

you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Codeine Phosphate Soluble Tablets:

Some medical conditions may interact with Codeine Phosphate Soluble Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures

if you have a history of heart problems, stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), gallbladder problems (eg, gallstones), an enlarged prostate gland or other prostate problems, a blockage of your bladder or bowel, recent abdominal surgery, kidney or liver problems, adrenal gland problems (eg, Addison disease), or an underactive thyroid

if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Codeine Phosphate Soluble Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

HIV protease inhibitors (eg, ritonavir), monoamine oxidase (MAO) inhibitors (eg, phenelzine), other narcotic pain medicines, phenothiazines (eg, chlorpromazine), or tricyclic antidepressants (eg, amitriptyline) because side effects of Codeine Phosphate Soluble Tablets may be increased

Cimetidine or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, and seizures may be increased

Naltrexone or quinidine because effectiveness of Codeine Phosphate Soluble Tablets may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Codeine Phosphate Soluble Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Codeine Phosphate Soluble Tablets:

Use Codeine Phosphate Soluble Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Codeine Phosphate Soluble Tablets must be dissolved in sterile water and filtered through a 0.22 micron filter before use. It is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Codeine Phosphate Soluble Tablets at home, carefully follow the injection procedures taught to you by your health care provider.

If Codeine Phosphate Soluble Tablets contains particles or is discolored after mixing, do not use it.

Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.

If you miss a dose of Codeine Phosphate Soluble Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Codeine Phosphate Soluble Tablets.

Important safety information:

Codeine Phosphate Soluble Tablets may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Codeine Phosphate Soluble Tablets. Using Codeine Phosphate Soluble Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Codeine Phosphate Soluble Tablets. Codeine Phosphate Soluble Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

Some of these products contain sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your pharmacist to determine if the product you are taking contains sulfites.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Codeine Phosphate Soluble Tablets.

Use Codeine Phosphate Soluble Tablets with caution in the ELDERLY because they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: It is unknown if Codeine Phosphate Soluble Tablets can cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Codeine Phosphate Soluble Tablets during pregnancy. Codeine Phosphate Soluble Tablets are excreted in breast milk. Do not breast-feed while taking Codeine Phosphate Soluble Tablets.

When used for long periods of time or at high doses, Codeine Phosphate Soluble Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Codeine Phosphate Soluble Tablets stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Codeine Phosphate Soluble Tablets. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Codeine Phosphate Soluble Tablets, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; pain; rapid heartbeat; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping; and vomiting.

Possible side effects of Codeine Phosphate Soluble Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; flushing; lightheadedness; nausea; sweating; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fast heartbeat; fainting; mental or mood changes; seizures; severe drowsiness or dizziness; slow or shallow breathing; trouble urinating.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Codeine Phosphate side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include cold and clammy skin; coma; confusion; dizziness; excitability; fever; garbled speech; hallucinations; loss of consciousness; mood or mental changes; nausea; rapid breathing; restlessness; ringing in the ears or trouble hearing; seizures; skin rash; slow or shallow breathing; sluggishness; small pupils; sweating; thirst; unusual sleepiness; vision changes; vomiting.

Proper storage of Codeine Phosphate Soluble Tablets:

Codeine Phosphate Soluble Tablets are usually handled and stored by a health care provider. If you are using Codeine Phosphate Soluble Tablets at home, store Codeine Phosphate Soluble Tablets as directed by your pharmacist or health care provider.

General information:

If you have any questions about Codeine Phosphate Soluble Tablets, please talk with your doctor, pharmacist, or other health care provider.

Codeine Phosphate Soluble Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Codeine Phosphate Soluble Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Codeine Phosphate resources

Codeine Phosphate Side Effects (in more detail)
Codeine Phosphate Use in Pregnancy & Breastfeeding
Drug Images
Codeine Phosphate Drug Interactions
Codeine Phosphate Support Group
19 Reviews for Codeine Phosphate - Add your own review/rating

Compare Codeine Phosphate with other medications

Cough
Diarrhea
Pain

Tuesday, 12 June 2012

Nivemycin Tablets 500mg

1. Name Of The Medicinal Product

Nivemycin Tablets 500mg

2. Qualitative And Quantitative Composition

Neomycin sulphate Ph Eur.

an amount equivalent to 550mg of material having a potency of 700 units per mg

3. Pharmaceutical Form

Tablets

4. Clinical Particulars

4.1 Therapeutic Indications

Nivemycin (Neomycin sulphate BP) is indicated for pre-operative sterilisation of the bowel and may be useful in the treatment of impending hepatic coma, including portal systemic encephalopathy.

For oral administration.

4.2 Posology And Method Of Administration

Pre-operative sterilisation of the bowel.

Adults: 2 tablets every hour for 4 hours; then 2 tablets every 4 hours for two or three days before the operation.

Children over 12 years: 2 tablets every 4 hours for 2 or 3 days before the operation.

Children from 6 to 12 years: ½ to 1 tablet every 4 hours for 2 or 3 days before the operation.

For practical reasons, use of the tablets in children under 6 years is not recommended.

In hepatic coma, the adult dose is 4-12 gm/day in divided doses for a period of 5-7 days, whilst for children, 50-100mg/kg/day in divided doses appears appropriate. Chronic hepatic insufficiency may require up to 4 gm/day over an indefinite period.

The elderly dose is the same as for adults.

4.3 Contraindications

Nivemycin should not be given when intestinal obstruction is present.

Hypersensitivity to aminoglycosides.

Infants under 1 year.

Myasthenia gravis

4.4 Special Warnings And Precautions For Use

The absorption of neomycin is poor from the alimentary tract, with about 97% of an orally administered dose being excreted unchanged in the faeces. Impaired G.I. motility however may increase absorption of the drug and it is therefore possible, as with other broad spectrum antibiotics, that prolonged therapy could result in ototoxicity and nephrotoxicity, particularly in patients with a degree of renal failure. In such patients, and in infants and the elderly, it is generally desirable to determine dosage requirements of aminoglycosides by individual monitoring. Some authorities consider that monitoring is also important in obese patients and those with cystic fibrosis.

Impaired hepatic function or auditory function, bacteraemia, fever, and possibly exposure to loud noises have been reported to increase the risk of ototoxicity, while volume depletion or hypotension, liver disease, or female sex have been reported as additional risk factors for nephrotoxicity. Regular assessment of auditory, vestibular and renal function is particularly necessary in patients with additional risk factors.

When used as an adjunct in the management of hepatic coma, care should be taken that administration is of the minimal period necessary, since prolonged exposure to the drug may result in malabsorption.

Neomycin should be used with caution in patients with neuromuscular disorders and parkinsonism.

There is almost complete cross-resistance between neomycin, kanamycin, paromomycin and framycetin. Cross-resistance with gentamicin has also been reported.

Since prolonged therapy may result in the overgrowth of non-sensitive organisms, treatment should not be continued longer than necessary to prevent superinfection due to the overgrowth of non-sensitive organisms.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Neomycin may impair absorption of other drugs including phenoxymethylpenicillin,digoxin, methotrexate and some vitamins. Aminoglycosides exhibit synergistic activity with a number of beta lactams, but aminoglycoside activity was reported to be diminished in a few patients with severe renal impairment.

Care should be taken when considering the use of neomycin concurrently with drugs with a potential to cause nephrotoxicity (including other aminoglycosides, some of the cephalosporins, amphotericin, ciclosporin, capreomycin, polymyxins, platinum compounds, teicoplanin and vancomycin) or ototoxicity (including, loop diuretics, capreomycin, teicoplanin, vancomycin and possibly platinum coumpounds).

The effect of non-depolarising muscle relaxants may be enhanced by aminoglycosides.

Care is required if other drugs with a neuromuscular blocking action, including botulinum toxin, are given concomitantly. Care is required when patients being treated with aminoglycosides are to receive a general anaesthetic or opioids in order to avoid the possible neuromuscular side-effects provoking severe respiratory depression.

The effect of the parasympathomimetic drugs neostigmine and pyridostigmine, may be antagonised by aminoglycosides.

The hypoglycaemic effect of acarbose may be enhanced by neomycin and the severity of gastrointestinal side effects increased.

Aminoglycosides may increase the risk of hypocalcaemia in patients receiving bisphosphonates.

Experience in anticoagulant clinics suggests that INR (International Normalised Ratio) may be altered by antibacterials such as neomycin given for local action on the gut, although studies have failed to demonstrate an interaction with phenindione.

The efficacy of oral contraceptives may be reduced with broad spectrum antibiotics.

Oral typhoid vaccine is inactivated by concomitant antibiotic administration.

4.6 Pregnancy And Lactation

The use of neomycin in pregnancy is not recommended unless the benefits outweigh the potential risks.

There are no reports linking the use of neomycin to congenital defects. However, small amounts of the drug are absorbed when given orally and neomycin and other aminoglycosides may have harmful effects on the foetus following oral absorption during pregnancy.

In some circumstances neomycin may enter the breast milk of lactating mothers. There is little risk of ototoxicity in the infant, but abnormal development of the gut flora may occur. The use of neomycin in lactating mothers is not recommended unless the benefits outweigh the potential risks.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Nausea, vomiting, diarrhoea, increased salivation, stomatitis, nephrotoxicity, ototoxicity, rise in serum levels of hepatic enzymes and bilirubin, blood dyscrasias, haemolytic anaemia, confusion, paraesthesia, disorientation, nystagmus, hypersensitivity reactionsincluding dermatitis, pruritus, drug fever and anaphylaxis.

Cross-sensitivity with other aminoglycosides may occur.

Malabsorption syndrome with steatorrhoea and diarrhoea, which can be severe, may be caused by prolonged oral therapy.

Superinfection may occur, especially with prolonged oral treatment.

Electrolyte disturbances (notably hypomagnesaemia but also hypocalcaemia and hypokalaemia) have occurred with other aminoglycosides.

4.9 Overdose

In overdose, exacerbation of the adverse events reported for neomycin (nausea, diarrhoea, nephrotoxicity, ototoxicity etc.) is expected.

Monitor renal and auditory function. If these are impaired, haemodialysis is indicated. Prolonged assisted ventilation may also be required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Neomycin is an aminoglycoside antibiotic.

Neomycin acts by binding to polysomes, inhibiting protein synthesis and generating errors in the transcription of the genetic code.

5.2 Pharmacokinetic Properties

The absorption of neomycin from the alimentary tract is poor: Only ~ 3% of an oral dose is absorbed, neomycin is rapidly excreted by the kidneys in the unchanged form. The plasma half-life in healthy adults is approximately 2-3 hours. Oral doses of 3 g produce peak plasma concentrations of up to 4 μg/ml.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Plasdone K29-32

Isopropyl alcohol

Calcium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store below 30°C in a dry place – protect from light.

6.5 Nature And Contents Of Container

An amber glass bottle having a tin-plate screw cap with a waxed aluminium-faced pulpboard liner. The ullage is filled with cotton wool.

Pack size: 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Waymade Plc.

Trading as Sovereign Medical

Sovereign House

Miles Gray Road

Basildon

Essex SS14 3FR

8. Marketing Authorisation Number(S)

PL 06464/0710

9. Date Of First Authorisation/Renewal Of The Authorisation

11 January 1999

10. Date Of Revision Of The Text

July 2003

Sunday, 10 June 2012

Feldene Dispersible Tablets

FELDENE (piroxicam) DISPERSIBLE TABLETS

Please read this leaflet

This leaflet tells you about Feldene Dispersible Tablets. Please read it before you start to take your medicine. It will help you. If you do not understand or you want to know more, ask your doctor or pharmacist (chemist). Keep this leaflet, you may want to read it again.

The name of this medicine is Feldene Dispersible Tablets. The active ingredient is piroxicam.

(Pack shot)

What is in your medicine?

Feldene Dispersible Tablets come in two strengths containing either 10mg or 20mg piroxicam. Inactive ingredients: lactose, microcrystalline cellulose, hydroxypropyl cellulose, sodium stearyl fumarate.

The 10mg tablets come in containers of 56. The 20mg tablets come in containers of 28.

Product Licence Holder and Manufacturer

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

What type of medicine is Feldene?

Piroxicam is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This means it will help to relieve pain and reduce swelling affecting joints and muscles.

What is your medicine for?

This medicine is used to relieve some symptoms caused by rheumatoid arthritis, osteoarthritis and ankylosing spondylitis (rheumatism of the spine) such as swelling, stiffness and joint pain. It is also used to treat children with juvenile chronic arthritis (Still's disease). Feldene does not cure arthritis and will help you or your child only as long as you or your child continue to take it.

Feldene is also used to relieve other kinds of pain and to treat other painful conditions such as:- acute attacks of gout, muscle sprains and muscle strains and pain following dental, orthopaedic and minor surgery.

Before you take Feldene

Have you had an allergic reaction to aspirin or other medications used to treat painful joints and muscles? This may have been itching, reddening of the skin or difficulty in breathing.

Have you ever had an allergic reaction to Feldene Dispersible Tablets or any other form of Feldene?

Have you got or ever had peptic (eg stomach) ulcers or other inflammatory bowel disorders (eg Crohn's Disease)?

If the answer to any of these questions is YES - DO NOT TAKE Feldene.

Are you pregnant or trying to become pregnant?

Are you breast feeding?

Do you have kidney disease?

Do you have liver disease?

Do you have high blood pressure or another heart condition?

Do you suffer from asthma or have you in the past?

Are you taking any of the following medicines:-
- anticoagulants such as warfarin to prevent blood clots
- antihypertensives to treat high blood pressure
- methotrexate, which can be given to treat various conditions such as cancers, psoriasis and rheumatoid arthritis
- corticosteroids, which are drugs given to treat a variety of conditions such as allergies and hormone imbalances
- cyclosporin, which is given to help prevent rejection of transplanted organs
- quinolone antibiotics, which are used to treat various infections
- mifepristone, which is used to medically terminate pregnancies
- aspirin or other non-steroidal anti-inflammatory drugs for pain relief
- lithium to treat depression
- diuretics such as hydrochlorothiazide to treat high blood pressure or kidney problems

If the answer to any of these questions if YES - ask your doctor or pharmacist before taking Feldene.

Remember to tell the doctor that you are taking Feldene Dispersible Tablets if you have a blood test or other test or are to have surgery as Feldene may affect the result.

If you are over 65 years old your doctor may wish to see you regularly.

Use of Feldene Dispersible Tablets in children

Feldene Dispersible Tablets may be given to children aged 6 years or over but only for the treatment of juvenile chronic arthritis (Still's disease).

Ask your doctor or pharmacist if you are not sure why your child has been prescribed Feldene.

Dosing instructions

Feldene Dispersible Tablets should only be taken by mouth.

The usual doses of this medicine are given below. Check with your doctor if you are not sure why you have been prescribed this medicine.

For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis

20mg each day. This dose may be decreased to 10mg each day (especially for elderly patients) or increased to 30mg each day. See the label on the pack to find out what dose you should take. (Doses above 20mg daily for more than several days carry an increased risk of effects on the digestive system).

For juvenile chronic arthritis (Still's disease)

Child's body weight (kg) less than 15

Once daily dose - 5 mg

Child's body weight (kg) 16-25

Once daily dose - 10 mg

Child's body weight (kg) 26-45

Once daily dose - 15 mg

Child's body weight (kg) 46 and above

Once daily dose - 20 mg

See the label on the pack to find what dose you or your child should take.

As your medicine helps to relieve the painful symptoms of arthritis, it is usual for it to be taken for long periods of time.

For acute attacks of gout

40mg each day for 5 to 7 days.

For muscle sprains and strains

40mg each day on the first and second day then 20mg each day for the next 5 to 12 days.

For pain following dental and minor surgery

20mg each day. Doses of 40mg on each of the first and second days, then 20mg each day for the duration of the treatment period may provide a more rapid onset of action.

For pain following orthopaedic surgery

40mg on each of the first and second days, then 20mg each day for the duration of the treatment period.

These are the usual doses. Your doctor may prescribe different doses to these. The label on the pack will tell you what dose you or your child should take and for how long. If you are still not sure ask your doctor or pharmacist.

How to take Feldene Dispersible Tablets

The tablets can be placed in a glass of water, allowed to disperse and then swallowed. If you prefer, you could swallow your tablet whole with a glass of water.

It is best to take your tablet(s) at the same time each day and with food.

What if you take too many tablets?

Too many tablets at once may make you unwell. Contact your doctor or your nearest casualty department at once.

What if you miss a dose?

Do not worry. Take the missed dose as soon as you remember. However, if it is almost time for your next dose, leave out the missed dose and take your next dose at the right time.

YOU WILL FIND MORE ABOUT FELDENE DISPERSIBLE TABLETS ON THE BACK OF THIS LEAFLET

Does this medicine cause undesirable effects?

Feldene Dispersible Tablets may cause undesirable effects. These generally do not cause a problem, however, if any of them are severe you should contact your doctor immediately.

Most common undesirable effects

Effects on digestive system including:

diarrhoea or constipation, wind.

nausea, vomiting, loss of appetite.

sore mouth and/or lips.

stomach ache, indigestion, abdominal pain/discomfort.

stomach (peptic) ulcers.

These effects may sometimes result in bleeding into the digestive system. If you vomit any blood or pass any black or blood stained bowel motions, you should inform your doctor immediately.

The above undesirable effects are more likely to occur if you are taking doses of Feldene Dispersible tablets greater than 20mg daily for more than several days duration.

Other undesirable effects are rare and include:-

swollen ankles and/or feet. These effects may be associated with other medical conditions. See your doctor if these effects occur.

central nervous system effects:- dizziness (vertigo), headache, changes in sleep patterns, depression, nervousness, hallucinations, mood alterations, mental confusion, pins and needles.

serious skin effects (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's Disease) have rarely been reported with Feldene. See your doctor if you have blistering, peeling or burning of the skin.

other skin effects are usually mild: skin rashes; itching, redness, tenderness, thickening or scaling of skin, loosening or splitting of fingernails; hairloss; increased sensitivity of the skin to sunlight; unusual bruising or bleeding; yellow skin or eyes.

changes in kidney function rarely, including interstitial nephritis, nephrotic syndrome, renal failure and renal papillary necrosis.

effects on the liver, which may include jaundice (yellowing of the skin and/or eyes).

abnormalities in blood and other biochemical tests. These effects may result in unusual bruising or bleeding.

other rare undesirable effects: fever; nosebleeds; hearing impairment; ringing in ears; weight increase or decrease; swollen eyes, blurred vision; eye irritation; shortness of breath; fast or pounding heartbeat; feeling unwell; unusual weakness or tiredness without any other symptoms.

These undesirable effects are usually mild but if they cause you discomfort or are long lasting, check with your doctor or pharmacist.

Allergic reactions

A few patients are allergic to medicines. An allergic reaction may be sudden wheeziness and/or difficulty in breathing after taking the medicine. Also skin rash, reddening of the skin, itching all over the body or fever. If you think you are allergic to Feldene Dispersible check with your doctor immediately.

Check with your doctor or pharmacist if you become unwell or have any other discomfort you do not understand.

Look after your medicine

This treatment is for YOU. Do not give it to others. It may not suit them.

Do not take this medicine after the date stamped on the pack.

Where to keep your medicine

Store below 30°C.

Keep all medicines out of the reach of children

Date on which this leaflet was last revised - August 2002

Further information

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The information in this leaflet is about Feldene Dispersible Tablets only.

Ref (UK): FE 3_0

Friday, 8 June 2012

Clotrimazole

Class: Azoles
VA Class: DE102
Chemical Name: 1-[(2-chlorophenyl)diphenylmethyl]-1H-imidazole
CAS Number: 23593-75-1
Brands: Fungoid Solution, Gyne-Lotrimin, Lotrimin, Lotrisone, Mycelex

Introduction

Antifungal; azole (imidazole derivative).

Uses for Clotrimazole

Dermatophytoses

Treatment of tinea corporis (body ringworm), tinea cruris (jock itch), and tinea pedis (athlete’s foot) caused by Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, or T. rubrum.¹⁰⁰ ¹²⁶ ¹²⁹ Can be used for self-medication of these conditions.¹⁰⁰

Treatment (in fixed combination with betamethasone dipropionate) of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis caused by E. floccosum, T. mentagrophytes, or T. rubrum.¹³⁰ ¹⁵⁶

Topical antifungals usually effective for treatment of uncomplicated tinea corporis or tinea cruris.¹⁴³ ¹⁴⁴ ¹⁴⁷ ¹⁴⁸ ¹⁴⁹ An oral antifungal may be necessary when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, infection is chronic or does not respond to topical therapy, or patient is immunocompromised because of coexisting disease or concomitant therapy.¹⁴³ ¹⁴⁴ ¹⁴⁷ ¹⁴⁸ ¹⁴⁹

Topical antifungals usually effective for treatment of uncomplicated tinea pedis.¹⁴³ ¹⁴⁴ ¹⁴⁸ An oral antifungal may be necessary for treatment of hyperkeratotic areas on the palms and soles, for chronic moccasin-type (dry-type) tinea pedis, and for tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).¹⁴³ ¹⁴⁴ ¹⁴⁸

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).¹⁰⁰ ¹²⁶ ¹²⁹

Topical antifungals generally effective;¹⁴⁵ ¹⁴⁶ ¹⁴⁸ an oral antifungal (with or without a topical antifungal) may be necessary in patients who have extensive or severe infections or have failed to respond to or have frequent relapses with topical therapy.¹⁴⁵ ¹⁴⁶ ¹⁴⁸

Cutaneous Candidiasis

Treatment of cutaneous candidiasis.¹²⁶ ¹²⁹

Oropharyngeal Candidiasis

Treatment of oropharyngeal candidiasis confirmed by potassium hydroxide microscopic mounts and/or culture.¹²¹ ¹²⁵ ¹²⁸ ^c

A drug of choice for the treatment of uncomplicated oropharyngeal candidiasis in HIV-infected patients;¹²¹ ¹²³ ¹²⁸ ^c ineffective for the treatment of esophageal candidiasis in HIV-infected patients.¹²⁰ ¹²¹ ^c

Prophylaxis to reduce the incidence of oropharyngeal candidiasis in immunocompromised patients receiving immunosuppressive therapy (e.g., corticosteroids, antineoplastic agents, radiation therapy) for leukemia, solid tumor, or renal transplantation.¹²⁵ Efficacy and safety in patients with immunosuppression resulting from primary immunodeficiency or other causes not established.¹²⁵

Not recommended for prophylaxis against oropharyngeal candidiasis in HIV-infected patients.¹²² ^c

Vulvovaginal Candidiasis

Treatment of uncomplicated vulvovaginal candidiasis (mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, occurring in immunocompetent women).¹⁰⁵ ¹⁰⁶ ¹¹⁷ ¹¹⁸ ¹²⁹ ¹³¹ ¹³² ¹³⁵ ¹³⁶ ^b ^c ^d ^e

Self-medication (OTC use) for treatment of uncomplicated vulvovaginal candidiasis in otherwise healthy, nonpregnant women who have been previously diagnosed by a clinician and are having a recurrence of similar symptoms.¹⁰¹ ¹⁰⁶ ¹⁰⁸

Treatment of complicated vulvovaginal candidiasis, including infections that are recurrent (≥4 times episodes in 1 year), severe (extensive vulvar erythema, edema, excoriation, fissure formation), caused by Candida other than C. albicans, or occurring in women with underlying medical conditions (uncontrolled diabetes mellitus, HIV infection, immunosuppressive therapy, pregnancy).¹⁰⁶ ¹¹⁸ ¹³¹ ¹³² ¹³⁴ ¹³⁵ ¹³⁶ ¹⁴² ^b ^c ^d Complicated infections generally require more prolonged treatment than uncomplicated infections.¹⁰⁶ ^c ^d

Optimal regimens for treatment of vulvovaginal candidiasis caused by Candida other than C. albicans (e.g., C. glabrata, C. krusei) not identified.¹⁰⁶ ^b CDC and others state these infections may respond to an intravaginal azole antifungal given for 7–14 days or to a 14-day regimen of intravaginal boric acid (not commercially available in the US).¹⁰⁶ ^b ^d ^e

Treatment of male sexual partners of women with recurrent vulvovaginal candidiasis who have symptomatic balanitis or penile dermatitis.¹⁰⁶ Routine treatment of asymptomatic male sexual partners is not recommended but may be considered in women with recurrent infections.¹⁰⁶ ¹³³ ¹⁴²

Clotrimazole Dosage and Administration

Administration

Administer topically as oral lozenge;¹²⁵ to skin as cream, lotion, or solution;¹⁰⁰ or intravaginally as cream or tablet.¹⁰¹ ¹⁰⁶ ¹⁰⁸

Topical cream, lotion, and solution not intended for ophthalmic use.¹⁰⁰

Topical preparations containing clotrimazole in fixed combination with betamethasone dipropionate not intended for ophthalmic, oral, or intravaginal use.¹⁵⁶

Oral Topical Administration

Dissolve oral lozenges slowly in mouth over approximately 15–30 minutes.¹²⁵

Topical Administration

Apply cream, lotion, or solution sparingly in the morning and evening; rub gently into cleansed, affected area and surrounding skin.¹⁰⁰

Intravaginal Topical Administration

Administer preferably at bedtime.¹⁰⁶

Dosage

Pediatric Patients

Dermatophytoses

Topical

Apply 1% cream, lotion, or solution twice daily.¹⁰⁰

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.¹⁰⁰ Some infections (especially tinea pedis) may require up to 8 weeks of therapy for mycological cure.^a

Self-medication of Tinea Corporis, Tinea Cruris, or Tinea Pedis

Topical

Children ≥2 years of age: Apply topical cream or solution twice daily for 2 weeks (tinea cruris) or 4 weeks (tinea pedis or tinea corporis).¹⁵⁷

Pityriasis (Tinea) Versicolor

Topical

Apply 1% cream, lotion, or solution twice daily.¹⁰⁰

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.¹⁰⁰

Cutaneous Candidiasis

Topical

Apply 1% cream, lotion, or solution twice daily.¹⁰⁰

Oropharyngeal Candidiasis

Treatment

Oral Topical

Children ≥3 years of age: 10 mg (as lozenge) 5 times daily for 14 consecutive days.¹²⁵

Vulvovaginal Candidiasis

If response is inadequate following a course of therapy, reevaluate the diagnosis before instituting another course.¹⁰⁰ ¹⁰¹ ¹¹⁶

Intravaginal

Two 100-mg tablets or 1 applicatorful of 2% cream once daily for 3 consecutive days or one 100-mg tablet once daily for 7 consecutive days.¹⁰¹ ¹⁰⁶

Alternatively, 1 applicatorful of 1% cream once daily for 7–14 consecutive days.¹⁰⁶

Self-medication of Uncomplicated Vulvovaginal Candidiasis

Intravaginal

Children ≥12 years of age: One applicatorful of 1% cream once daily for 7 consecutive days; alternatively, 1 applicatorful of 2% cream once daily for 3 consecutive days.¹⁰¹ ^a

Topical

For adjunctive relief of external vulvar itching: Apply 1% topical vulvar cream 1 or 2 times daily for up to 7 days as needed.¹⁵⁸

Adults

Dermatophytoses

Topical

Apply 1% cream, lotion, or solution twice daily.¹⁰⁰ If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.¹⁰⁰ Some infections (especially tinea pedis) may require up to 8 weeks of therapy for mycological cure.^a

If combination (clotrimazole 1% and betamethasone 0.05%) cream is used, apply twice daily for 2 weeks (tinea cruris or tinea corporis) or 4 weeks (tinea pedis); if infection persists beyond this period, discontinue combination preparation and initiate clotrimazole alone.^a ¹⁵⁶

Self-medication of Tinea Corporis, Tinea Cruris, or Tinea Pedis

Topical

Apply topical cream or solution twice daily for 2 weeks (tinea cruris) or 4 weeks (tinea pedis or tinea corporis).¹⁵⁷

Pityriasis (Tinea) Versicolor

Topical

Apply 1% cream, lotion, or solution twice daily.¹⁰⁰

If clinical improvement does not occur after 4 weeks of treatment, reevaluate the diagnosis.¹⁰⁰

Cutaneous Candidiasis

Topical

Apply 1% cream, lotion, or solution twice daily.¹⁰⁰

Oropharyngeal Candidiasis

Treatment

Oral Topical

10 mg (as lozenge) 5 times daily for 14 consecutive days.¹²⁵ ^c

Prophylaxis in Immunocompromised Patients

Oral Topical

10 mg (as lozenge) 3 times daily for the duration of chemotherapy or until corticosteroid therapy is reduced to maintenance levels.¹²⁵

Vulvovaginal Candidiasis

If response is inadequate following a course of therapy, reevaluate the diagnosis before instituting another course.¹⁰⁰ ¹⁰¹ ¹¹⁶

Intravaginal

Two 100-mg tablets or 1 applicatorful of 2% cream once daily for 3 consecutive days or one 100-mg tablet once daily for 7 consecutive days.¹⁰¹ ¹⁰⁶

Alternatively, 1 applicatorful of 1% cream once daily for 7–14 consecutive days.¹⁰⁶

Self-medication of Uncomplicated Vulvovaginal Candidiasis

Intravaginal

One applicatorful of 1% cream once daily for 7 consecutive days; alternatively, 1 applicatorful of 2% cream once daily for 3 consecutive days.¹⁰¹ ^a

Topical

For adjunctive relief of external vulvar itching: Apply 1% topical vulvar cream 1 or 2 times daily for up to 7 days as needed.¹⁵⁸

Recurrent Vulvovaginal Infections Caused by Candida albicans

Intravaginal

CDC and others recommend an initial intensive regimen (7–14 days of an intravaginal azole or 3-dose regimen of oral fluconazole) to achieve mycologic remission, followed by a 6-month maintenance regimen of once-weekly oral fluconazole.¹⁰⁶ ^b ^d If the oral maintenance regimen cannot be used, use intravaginal clotrimazole (200 mg twice weekly or 500 mg once weekly) or other intravaginal treatments intermittently.¹⁰⁶

Other Complicated Vulvovaginal Infections

Intravaginal

CDC and others recommend 7–14 days of an intravaginal azole for vulvovaginal candidiasis that is severe, caused by Candida other than C. albicans, or occurring in women with underlying medical conditions.¹⁰⁶ ^d

Vulvovaginal Candidiasis in HIV-infected Women

Intravaginal

CDC and other clinicians recommend same treatment as in women without HIV infection.¹⁰⁶ ¹³⁶ ¹⁴² Some experts recommend a duration of 3–7 days.^c Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes;^c routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.¹⁰⁶ ^c

Vulvovaginal Candidiasis in Pregnant Women

Intravaginal

CDC and others recommend a 7-day regimen of an intravaginal azole antifungal (e.g., clotrimazole).¹⁰⁶ ^d

Prescribing Limits

Pediatric Patients

Oropharyngeal Candidiasis

Oral Topical

Limit therapy to short-term use if possible; limited safety and efficacy data on prolonged therapy.¹²⁵

Adults

Oropharyngeal Candidiasis

Oral Topical

Limit therapy to short-term use if possible; limited safety and efficacy data on prolonged therapy.¹²⁵

Cautions for Clotrimazole

Contraindications

Known hypersensitivity to clotrimazole or other imidazoles or any ingredient in the formulation.¹⁰⁰ ¹²⁵ ¹⁵⁶

Warnings/Precautions

Warnings

Systemic Fungal Infections

Do not use lozenges for treatment of systemic fungal infection, including candidiasis.¹²⁵ ¹⁵⁶

Diaper Dermatitis

Preparations containing clotrimazole in fixed combination with betamethasone dipropionate not recommended for treatment of diaper dermatitis.¹⁵⁶

Sensitivity Reactions

If irritation or sensitization occurs, discontinue the drug.¹⁰⁰ ¹⁵⁶

General Precautions

Hepatic Effects

Possible abnormal liver function test results (e.g., increased serum AST) in patients receiving clotrimazole lozenges.¹²⁵ Periodic liver function tests recommended during therapy with lozenges, especially in patients with preexisting hepatic impairment.¹²⁵

Self-medication of Vulvovaginal Candidiasis

Self-medication not recommended if abdominal pain, fever, or malodorous vaginal discharge occurs or if vaginal pruritus or discomfort is occurring for the first time.¹⁰¹ ¹⁵⁸

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category B (topical and intravaginal preparations).¹⁰⁰ ¹⁵⁹

Category C (oral lozenges; topical preparations containing betamethasone dipropionate).¹²⁵ ¹⁵⁶

CDC and others state that a 7-day regimen of an intravaginal azole antifungal can be used, if necessary, for treatment of vulvovaginal candidiasis in pregnant women.¹⁰⁶ ^d

Lactation

Not known whether clotrimazole is distributed into milk; use with caution in nursing women.¹⁰⁰ ¹²⁹

Pediatric Use

Safety and efficacy of clotrimazole lozenges not established in children <3 years of age; use not recommended in children <3 years of age.¹²⁵ Safety and efficacy of prophylactic therapy with lozenges not established in children.¹²⁵

Topical cream or solution not recommended for self-medication in children <2 years of age.¹⁵⁷

Vaginal cream not recommended for self-medication in children <12 years of age.^a ¹⁰¹

Preparations containing clotrimazole in fixed combination with betamethasone dipropionate not recommended for use in children <17 years of age or for diaper dermatitis.¹⁵⁶

Hepatic Impairment

Periodic liver function tests recommended during therapy with lozenges, especially in patients with hepatic impairment.¹²⁵ Potential for abnormal liver function test results (e.g., increased serum AST).¹²⁵

Common Adverse Effects

Topical oral therapy: abnormal liver function test results, nausea, vomiting, unpleasant mouth sensations, pruritus.¹²⁵

Topical application to skin: blistering, erythema, edema, pruritus, burning, stinging, peeling, urticaria, general irritation of skin.¹⁰⁰

Intravaginal therapy: vaginal burning, erythema, irritation, intercurrent cystitis.¹¹¹ ^a

Clotrimazole Pharmacokinetics

Absorption

Bioavailability

Extent of absorption following dissolution of 10-mg lozenge in mouth not determined.^a Following dissolution, concentrations sufficient to inhibit most species of Candida are present in saliva for up to 3 hours.^a Long-term effective concentration in saliva apparently related to slow release of drug from oral mucosa.^a

Minimal systemic absorption following topical application to skin.^a Highest concentrations present in the stratum corneum; lower concentrations in the stratum spinosum and the papillary and reticular dermis.^a

About 3–10% of an intravaginal dose reaches systemic circulation, principally as metabolites.¹⁰³ ¹⁰⁴ Considerable interindividual variation in concentrations of drug in vaginal fluid following administration as vaginal tablets.¹⁰² ¹⁰³ ¹⁰⁴

Stability

Storage

Oral

Oropharyngeal Topical Lozenge

≤30°C; avoid freezing.¹²⁵

Topical

Cream, Lotion, and Solution

2–30°C.¹⁰⁰

Intravaginal

Cream

15–30°C; avoid temperatures >30°C.¹⁰¹

Tablets

2–30°C.¹⁵⁸

Actions and SpectrumActions

Imidazole-derivative azole antifungal.^a

Fungistatic or fungicidal against many fungi, including yeasts and dermatophytes; active against some gram-positive bacteria.¹⁰⁰ ^a

Binds phospholipids in fungal cell membrane and alters cell membrane permeability.^a Cell membrane no longer functions as a selective barrier, and potassium and other cellular constituents are lost.¹⁰⁰ ^a

Active in vitro and in clinical infections caused by most strains of T. rubrum, T. mentagrophytes, E. floccosum, and M. canis.¹⁰⁰ Less active against M. furfur (P. orbiculare), Aspergillus fumigatus, C. albicans.^a Also active in vitro against Sporothrix, Cryptococcus, Cephalosporium, and Fusarium.^a

Cross resistance can occur among the azole antifungals (e.g., clotrimazole, ketoconazole, miconazole).¹⁶⁰ Azole-resistant Candida have been reported.¹⁵⁶

Advice to Patients

Importance of completing full course of therapy.¹⁰⁰

Importance of discontinuing therapy (including self-medication) and consulting clinician if adequate response is not achieved after recommended treatment period.¹⁰⁰ ¹⁵⁷ Discontinue self-medication for vulvovaginal candidiasis and consult clinician if fever, abdominal pain, or foul-smelling discharge develops; if symptoms do not improve within 3 days; if condition persists beyond 7 days; or if symptoms recur within 2 months.^a ¹⁰¹

Importance of consulting clinician if treated area becomes irritated (redness, itching, burning, blistering, swelling, oozing).¹⁰⁰

Importance of avoiding sources of infection.¹⁰⁰

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹⁰⁰

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.^a

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Clotrimazole
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder*
Oral, Topical Use Only	Lozenges	10 mg*	Clotrimazole Lozenge (with povidone)	Paddock, Roxane
			Mycelex Troche (with povidone)	Alza
Topical	Cream	1%*	Lotrimin (with benzyl alcohol 1%)	Schering
			Lotrimin AF (with benzyl alcohol 1%)	Schering-Plough
			Lotrim AF Jock Itch Cream (with benzyl alcohol 1%)	Schering-Plough
	Lotion	1%	Lotrimin AF (with benzyl alcohol 1%)	Schering-Plough
	Solution	1%*	Fungoid Solution	Pedinol
			Lotrimin	Schering
			Lotrimin AF	Schering-Plough
Vaginal	Cream	1%*	Gyne-Lotrimin (with benzyl alcohol)	Schering-Plough
			Mycelex-7 (with benzyl alcohol; with or without disposable applicators)	Bayer
		2%	GyneLotrimin 3 (with benzyl alcohol)	Schering-Plough
	Kit	7 g Cream, topical, Clotrimazole 1% (Gyne-Lotrimin (with benzyl alcohol) 3 Tablets, vaginal, Clotrimazole 200 mg (Gyne-Lotrimin (with povidone)	Gyne-Lotrimin 3 Combination Pack	Schering-Plough
	Tablets	100 mg*
		200 mg	Gyne-Lotrimin-3 (with povidone)	Schering-Plough

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Clotrimazole Combinations
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Cream	1% with Betamethasone Dipropionate 0.05% (of betamethasone)*	Clotrimazole with Betamethasone Dipropionate Cream (with benzyl alcohol and prophylene glycol)	Altana, Taro
	Lotion	1% with Betamethasone Dipropionate 0.05% (of betamethasone)*	Lotrisone (with benzyl alcohol and prophylene glycol)	Schering

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Clotrimazole 1% Cream (PERRIGO): 28/$34.99 or 84/$79.97

Clotrimazole 1% Cream (TARO): 15/$17.99 or 45/$32.97

Clotrimazole 1% Cream (TARO): 30/$35.99 or 90/$89.97

Clotrimazole 1% Cream (TARO): 45/$39.99 or 135/$105.97

Clotrimazole 1% Solution (TEVA PHARMACEUTICALS USA): 30/$24.99 or 90/$53.97

Clotrimazole 1% Solution (TEVA PHARMACEUTICALS USA): 10/$17.99 or 30/$33.97

Clotrimazole 10MG Troches (ROXANE): 70/$89.99 or 210/$269.96

Clotrimazole-Betamethasone 1-0.05% Cream (ACTAVIS MID ATLANTIC): 15/$14.99 or 60/$39.97

Clotrimazole-Betamethasone 1-0.05% Cream (FOUGERA): 45/$35.99 or 135/$89.97

Clotrimazole-Betamethasone 1-0.05% Lotion (FOUGERA): 30/$39.99 or 90/$119.95

Lotrisone 1-0.05% Lotion (SCHERING): 30/$86.72 or 90/$238.47

Mycelex 10MG Troches (MCNEIL): 70/$122.99 or 210/$356.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Schering Corporation. Lotrimin (clotrimazole) cream 1%, lotion 1%, topical solution 1% prescribing information (dated 1999 Jan). In: Physicians’ desk reference. 56th edition. Montvale, NJ; Medical Economics Company Inc; 2002:3128-9.

101. Schering-Plough. Gyne-lotrimin 3 (clotrimazole) vaginal cream (2%) 3-day treatment prescribing information. In: Physicians’ desk reference for nonprescription drugs and dietary supplements. 23rd ed. Montvale, NJ; Medical Economics Company Inc; 2002:765.

102. Mendling W, Plempel M. Vaginal secretion levels after 6 days, 3 days and 1 day of treatment with 100, 200 and 500 mg vaginal tablets of clotrimazole and their therapeutic efficacy. Chemotherapy. 1982; 28(Suppl 1):43-7. [IDIS 168384] [PubMed 7160240]

103. Ritter W, Patzschke K, Krause U et al. Pharmacokinetic fundamentals of vaginal treatment with clotrimazole. Chemotherapy. 1982; 28(Suppl 1):37-42. [IDIS 168383] [PubMed 7160239]

104. Ritter W. Pharmacokinetic fundamentals of vaginal treatment with clotrimazole. Am J Obstet Gynecol. 1985; 152:945-7. [IDIS 203426] [PubMed 4025444]

105. Anon. Drugs for vulvovaginal candidiasis. Med Lett Drugs Ther. 2001; 43:3-4. [PubMed 11151090]

106. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. 2006; 55(No. RR-11):1-96.

107. Loendersloot EW, Goormans E, Wiesenhaan PE et al. Efficacy and tolerability of single-dose versus six-day treatment of candidal vulvovaginitis with vaginal tablets of clotrimazole. Am J Obstet Gynecol. 1985; 152:953-5. [IDIS 203427] [PubMed 3895960]

108. Fleury F, Hughes D, Floyd R. Therapeutic results obtained in vaginal mycoses after single-dose treatment with 500 mg clotrimazole vaginal tablets. Am J Obstet Gynecol. 1985; 152:968-70. [IDIS 203431] [PubMed 3895963]

109. Lebherz T, Guess E, Wolfson N. Efficacy of single- versus multiple-dose clotrimazole therapy in the management of vulvovaginal candidiasis. Am J Obstet Gynecol. 1985; 152:965-8. [IDIS 203430] [PubMed 3895962]

110. Goormans E, Bergstein NAM, Loendersloot EW et al. One-dose therapy of Candida vaginitis. I: results of an open multicentre trial. Chemotherapy. 1982; 28(Suppl 1):106-9. [IDIS 168392] [PubMed 6761083]

111. Krause U. Results of single-dose treatment of vaginal mycoses with 500 mg Canesten vaginal tablets. Chemotherapy. 1982; 28:99-105. [IDIS 168391] [PubMed 7160245]

113. Miles Pharmaceuticals. One day treatment of vulvovaginal candidiasis with 500 mg clotrimazole vaginal tablet compared with 3 day regimen two 100 mg vaginal tablets daily. Summary report of studies at six centers. Miles Medical Research Report D82-101. West Haven, CT; 1983 Dec 21. (unpublished data)

115. Cuttner J, Troy KM, Funaro L et al. Clotrimazole treatment for prevention of oral candidiasis in patients with acute leukemia undergoing chemotherapy: results of a double-blind study. Am J Med. 1986; 81:771-4. [IDIS 224406] [PubMed 3535491]

116. Anon. Drugs for treatment of fungal infections. Med Lett Drugs Ther. 1992; 34:14-6. [PubMed 1310518]

117. Anon. Drugs for sexually transmitted infections. Med Lett Drugs Ther. 1999; 41:85-90. [PubMed 10906932]

118. Doering PL, Santiago TM. Drugs for treatment of vulvovaginal candidiasis: comparative efficacy of agents and regimens. DICP. 1990; 24:1078-83. [IDIS 274670] [PubMed 2275233]

119. Sobel JD. Pathogenesis and treatment of recurrent vulvovaginal candidiasis. Clin Infect Dis. 1992 14(Suppl 1):S148-53.

120. Anon. Drugs for AIDS and associated infections. Med Lett Drugs Ther. 1995; 37:87-94. [PubMed 7565297]

121. American Thoracic Society. Fungal infection in HIV-infected persons. Am J Respir Crit Care Med. 1995; 152:816-22. [IDIS 352046] [PubMed 7633749]

122. US Public Health Service (USPHS) and Infectious Diseases Society of America (IDSA) Prevention of Opportunistic Infections Working Group. 2001 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons with human immunodeficiency virus. From HIV/AIDS Treatment Information Services (ATIS) website ().

123. Powderly WG, Mayer KH, Perfect JR. Diagnosis and treatment of oropharyngeal candidiasis in patients infected with HIV: a critical reassessment. AIDS Res Hum Retroviruses. 1999; 15:1405-12. [PubMed 10555102]

124. Reef SE, Levine WC, McNeil MM et al. Treatment options for vulvovaginal candidiasis, 1993. Clin Infect Dis. 1995; 20(Suppl 1):S80-90. [IDIS 345863] [PubMed 7795112]

125. Alza. Mycelex (clotrimazole) troche for topical oral administration prescribing information (dated 1998 Jun). In: Physician’s desk reference. 54th ed. Montvale, NJ: Medical Economics Company Inc; 2000:514-5.

126. Committee on Infectious Diseases, American Academy of Pediatrics. 2000 Red book: report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000:569-76.

127. Reef SE, Mayer KH. Opportunistic candidal infections in patient infected with human immunodeficiency virus: prevention and priorities. Clin Infect Dis. 1995; 21(Suppl 1):S99-102. [IDIS 352670] [PubMed 8547520]

128. Smith GH. Treatment of infections in the patient with acquired immunodeficiency syndrome. Arch Intern Med. 1994; 154:949-73. [IDIS 329350] [PubMed 8179453]

129. Hay RJ. Yeast infections. Dermatol Clin. 1996; 14:113-24. [PubMed 8821164]

130. Marren P, Powell S. Contact sensitivity to tioconazole and other imidazoles. Contact Dermatitis. 1992; 27:129-30. [PubMed 1395626]

131. Sobel JD. Vaginitis. N Engl J Med. 1997; 337:1896-903. [IDIS 401347] [PubMed 9407158]

132. Sobel JD, Faro S, Force RW et al. Vulvovaginal candidiasis: epidemiologic, diagnostic, and therapeutic considerations. Am J Obstet Gynecol. 1998; 178:203-11. [IDIS 402301] [PubMed 9500475]

133. Bisschop MPJM, Merkus JMWM, Scheygrond H et al. Co-treatment of the male partner in vaginal candidosis: a double-blind randomized control study. Br J Obstet Gynecol. 1986; 93:79-81.

134. Bohannon NJV. Treatment of vulvovaginal candidiasis in patients with diabetes. Diabetes Care. 1998; 21:451-6. [IDIS 402373] [PubMed 9540031]

135. Tobin MJ. Vulvovaginal candidiasis: topical vs. oral therapy. Am Fam Physician. 1995; 51:1715-24. [IDIS 348350] [PubMed 7754931]

136. Sobel JD. Controversial aspects in the management of vulvovaginal candidiasis. J Am Acad Dermatol. 1994; 31:S10-3. [IDIS 335764] [PubMed 8077494]

137. Spinillo A, Capuzzo E, Gulminetti R et al. Prevalence of and risk factors for fungal vaginitis caused by non-albicans species. Am J Obstet Gynecol. 1997; 176:138-41. [PubMed 9024104]

138. Chaim W. Fungal vaginitis caused by nonalbicans species. Am J Obstet Gynecol. 1997; 177:485. [IDIS 393344] [PubMed 9290485]

139. Spinillo A, Capuzzo E. Fungal vaginitis caused by nonalbicans species. Am J Obstet Gynecol. 1997; 177:485-6. [IDIS 393344] [PubMed 9290485]

140. Redondo-Lopez V, Lynch M, Schmitt C et al. Torulopsis glabrata vaginitis: clinical aspects and susceptibility to antifungal agents. Obstet Gynecol. 1990; 76:651-5. [IDIS 273142] [PubMed 2216197]

141. Stubb S, Heikkila H, Reitamo S et al. Contact allergy to tioconazole. Contact Dermatitis. 1992; 26:155-8. [PubMed 1387056]

142. Reviewers’ comments (personal observations) on Tioconazole 84:04.08.

143. Gupta AK, Einarson TR, Summerbell RC et al. An overview of topical antifungal therapy in dermatomycoses: a North American perspective. Drugs. 1998; 55:645-74. [PubMed 9585862]

144. Piérard GE, Arrese JE, Piérard-Franchimont C. Treatment and prophylaxis of tinea infections. Drugs. 1996; 52:209-24. [PubMed 8841739]

145. Sunenshine PJ, Schwartz RA, Janniger CK. Tinea versicolor: an update. Cutis. 1998; 61:65-72. [PubMed 9515210]

146. Assaf RR, Weil ML. The superficial mycoses. Dermatol Clin. 1996; 14:57-67. [PubMed 8821158]

147. Lesher JL. Recent developments in antifungal therapy. Dermatol Clin. 1996; 14:163-9. [PubMed 8821170]

148. Hay RJ. Dermatophytosis and other superficial mycoses. In: Mandel GL, Douglas RG Jr, Bennett JE, eds. Principles and practices of infectious disease. 4th ed. New York: Churchill Livingston; 1995:2375-86.

149. Drake LA, Dincehart SM, Farmer ER et al. Guidelines of care for superficial mycotic infections of the skin: tinea corporis, tinea cruris, tinea faciei, tinea manuum, and tinea pedis. J Am Acad Dermatol. 1996; 34:282-6. [IDIS 363962] [PubMed 8642094]

150. Drake LA, Dinehart SM, Farmer ER et al. Guidelines of care for superficial mycotic infections of the skin: pityriasis (tinea) versicolor. J Am Acad Dermatol. 1996; 34:287-9. [IDIS 363963] [PubMed 8642095]

151. Reviewers’ comments (personal observations) on Sulconazole 84:04.08.

152. Bigardi AS, Pigatto PD, Altomare G. Allergic contact dermatitis due to sulconazole. Contact Dermatitis. 1992; 26:281-2. [PubMed 1395584]

153. Machet L, Vaillant L, Muller C et al. Contact dermatitis and cross-sensitivity from sulconazole nitrate. Contact Dermatitis. 1992; 26:352-3. [PubMed 1395603]

154. Jones SK, Kennedy CTC. Contact dermatitis from tioconazole. Contact Dermatitis. 1990; 22:122-3. [PubMed 2138969]

155. Baes H. Contact sensitivity to miconazole with ortho-chloro cross-sensitivity to other imidazoles. Contact Dermatitis. 1991; 24:89-93. [PubMed 1828223]

156. Schering Corporation. Lotrisone (clotrimazole and betamethasone dipropionate) cream, lotion prescribing information (dated 2004 Apr.) In: Physicians’ desk reference. From the PDR electronic library website (http://pdrel.thomsonhc.com) . Accessed 2006 Dec 4.

157. Schering-Plough. Lotrimin AF Antifungal (clotrimazole) cream 1%, solution 1%, lotion 1%, jock itch cream 1% prescribing information. In: Physicians’ desk reference for nonprescription drugs and dietary supplements. 23rd ed. Montvale, NJ; Medical Economics Company Inc; 2002:765.

158. Schering-Plough. Gyne-Lotrimin 3-Day Combination Pack clotrimazole vaginal inserts and external vulvar cream antifungal. In: Physicians’ desk reference for nonprescription drugs and dietary supplements. 23rd ed. Montvale, NJ; Medical Economics Company Inc; 2002:734-5.

159. Bayer Corporation. Mycelex-G (clotrimazole) vaginal tablets. In: Physicians’ desk reference for nonprescription drugs and dietary supplements. 22nd ed. Montvale, NJ; Medical Economics Company Inc; 2001:863.

160. Holt RJ, Azmi A. Miconazole-resistant Candida. Lancet. 1978; 1:50-1. [PubMed 74535]

a. AHFS Drug Information 2003. McEvoy GK, ed. Clotrimazole. American Society of Health-System Pharmacists; 2003: 3344-7.

b. Pappas GP, Rex JR, Sobel JD et al. Guidelines for treatment of candidiasis. Clin Infect Ids. 2004; 38:161-89.

c. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-15):1-112.

d. ACOG Committee on Practice Bulletins. ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists, number 72, May 2006: vaginitis. Obste Gynecol. 2006; 107:1195-296.

e. Anon. Antifungal drugs. Treat Guidel Med Lett. 2005; 3:7-14. [PubMed 15671963]

More Clotrimazole resources

Clotrimazole Use in Pregnancy & Breastfeeding
Clotrimazole Support Group
2 Reviews for Clotrimazole - Add your own review/rating

Clotrimazole Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Clotrimazole Prescribing Information (FDA)

Clotrimazole Professional Patient Advice (Wolters Kluwer)

clotrimazole Concise Consumer Information (Cerner Multum)

clotrimazole Mucous membrane, oral Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Clotrimazole with other medications

Cutaneous Candidiasis
Tinea Corporis
Tinea Cruris
Tinea Pedis
Tinea Versicolor
Vaginal Yeast Infection

Tuesday, 5 June 2012

Heparin sodium 1000 IU / ml ampoule, solution for infusion (Leo Laboratories Ltd)

1. Name Of The Medicinal Product

Heparin sodium 1000 IU/ml ampoule, solution for infusion

2. Qualitative And Quantitative Composition

Heparin sodium 1,000 IU/ml

3. Pharmaceutical Form

Solution for infusion.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of thrombo-embolic disorders such as: deep vein thrombosis, acute arterial embolism or thrombosis, thrombophlebitis, pulmonary embolism, fat embolism.

4.2 Posology And Method Of Administration

This product may be used when heparin is being administered intravenously as an alternative to diluting heparin taken from multidose vials.

500 IU/kg bodyweight daily or 5,000 - 10,000 IU every 4 hours as a continuous infusion in sodium chloride injection or dextrose injection. The dose should be individually adjusted according to coagulation tests.

Dosage adjustment: It is recommended that dosages be adjusted to maintain a thrombin clotting time, whole blood clotting time or activated partial thromboplastin time 1.5 to 2 times that of control on blood withdrawn 4-6 hours after commencement of infusion and at similar intervals until the patient is stabilised.

Dosage in the elderly: Lower dosages may be required, however, standard dosages should be given initially and then subsequent dosages and/or dosage intervals should be individually adjusted according to changes in thrombin clotting time, whole blood clotting time and/or activated partial thromboplastin time.

Pregnancy: See Section 4.6, Pregnancy and Lactation. If treatment is considered appropriate, standard dosages should be given initially. Intermittent intravenous injections are not advised. Subsequent dosages and/or dosage intervals should be individually adjusted according to changes in thrombin clotting time, whole blood clotting time and/or activated partial thromboplastin time.

4.3 Contraindications

Known hypersensitivity to constituents.

Current or history of heparin-induced thrombocytopenia.

Generalised or local haemorrhagic tendency, including uncontrolled severe hypertension, severe liver insufficiency, active peptic ulcer, acute or subacute septic endocarditis, intracranial haemorrhage or injuries and operations on the central nervous system, eyes and ears, and in women with abortus imminens.

An epidural anaesthesia during birth in pregnant women treated with heparin is contraindicated (see Section 4.6).

In patients receiving heparin for treatment rather than prophylaxis, locoregional anaesthesia in elective surgical procedures is contra-indicated because the use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis.

4.4 Special Warnings And Precautions For Use

Heparin should be used with caution in patients with hypersensitivity to low molecular weight heparin.

Care should be taken when heparin is administered to patients with increased risk of bleeding complications, hypertension, renal or hepatic insufficiency.

Heparin can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, a raised plasma potassium or taking potassium sparing drugs. The risk of hyperkalaemia appears to increase with duration of therapy but is usually reversible. Plasma potassium should be measured in patients at risk before starting heparin therapy and monitored regularly thereafter particularly if treatment is prolonged beyond about 7 days.

Drugs affecting platelet function or the coagulation system should in general not be given concomitantly with heparin (see Section 4.5).

In patients undergoing peridural or spinal anaesthesia or spinal puncture, the prophylactic use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis. The risk is increased by the use of a peridural or spinal catheter for anaesthesia, by the concomitant use of drugs affecting haemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors or anticoagulants, and by traumatic or repeated puncture.

In decision making on the interval between the last administration of heparin at prophylactic doses and the placement or removal of a peridural or spinal catheter, the product characteristics and the patient profile should be taken into account. Subsequent dose should not take place before at least four hours have elapsed. Re-administration should be delayed until the surgical procedure is completed.

Should a physician decide to administer anti-coagulation in the context of peridural or spinal anaesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurologic impairment, such as back pain, sensory and motor deficits and bowel or bladder dysfunction. Patients should be instructed to inform immediately a nurse or a clinician if they experience any of these.

Heparin should not be administered by intramuscular injection due to the risk of haematoma.

Due to increased bleeding risk, care should be taken when giving concomitant intramuscular injections, lumbar puncture and similar procedures.

As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving heparin treatment for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.

Heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The anticoagulant effect of heparin may be enhanced by concomitant medication with other drugs affecting platelet function or the coagulation system, e.g. platelet aggregation inhibitors, thrombolytic agents, salicylates, non-steroidal anti-inflammatory drugs, vitamin K antagonists, dextrans, activated protein C. Where such combination cannot be avoided, careful clinical and biological monitoring is required.

Combined use with ACE inhibitors or angiotensin II antagonists may increase the risk of hyperkalaemia.

Use of glyceryl trinitrate infusion may reduce the anticoagulant effect of heparin.

4.6 Pregnancy And Lactation

Because of the known haemorrhagic effect, heparin should be used with caution in pregnant women and only if the benefits outweigh the risks according to the physician's judgement. Precaution is particularly required because of uteroplacental haemorrhage, especially at the time of delivery. If epidural anaesthesia is envisaged, heparin treatment should be suspended, whenever possible.

The use of heparin in women with abortus imminens is contraindicated (see Section 4.3).

Heparin does not cross the placental barrier and is not excreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Heparin has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

Very common	>1/10
Common	>1/100 and <1/10
Uncommon	>1/1,000 and <1/100
Rare	>1/10,000 and <1/1,000
Very rare	<1/10,000

The most frequently reported undesirable effects are bleeding events, reversible increase in liver enzymes, reversible thrombocytopenia and various skin reactions. Isolated reports of generalised allergic reactions, skin necrosis and priapism have been reported.

•Blood and lymphatic system disorders

Heparin can cause thrombocytopenia either through a direct effect or through an immune effect producing a platelet-aggregating antibody (see Section 4.4). Reversible after drug withdrawal.

Common:	Thrombocytopenia type I
Rare:	Thrombocytopenia type II, probably of an immunoallergic nature (see section 4.4)

In some cases thrombocytopenia type II has been accompanied by venous or arterial thrombi.

•Immune system disorders

Rare:	Allergic reactions of all types and severities, with various manifestations
Very rare:	Anaphylactoid reactions and anaphylactic shock

•Metabolism and nutrition disorders

Rare:

Hypoaldosteronism.

Heparin products can cause hypoaldosteronism which may result in an increase in plasma potassium. Rarely, clinically significant hyperkalaemia may occur particularly in patients with chronic renal failure and diabetes mellitus (see Section 4.4).

•Vascular disorders

Common:

Haemorrhage.

Haemorrhages may affect any organ, particularly in connection with high doses.

In some cases haemorrhage has resulted in death or permanent disability.

Very rare cases of epidural and spinal haematoma have been reported in patients receiving heparin for prophylaxis undergoing spinal or epidural anaesthesia or spinal puncture (see Section 4.4).

•Hepatobiliary disorders

Common:

Raised transaminases, gamma-GT, LDH and lipase levels. They are reversible after drug withdrawal.

•Skin and subcutaneous tissue disorder

Uncommon:

Rash (various types of rash such as erythematous and maculopapular), urticaria, pruritus.

Rare:

Skin necrosis. If this occurs treatment must be withdrawn immediately.

One case of erythema multiforme was also reported.

•Musculoskeletal and connective tissue disorders

Uncommon:

Osteoporosis has been reported in connection with long-term heparin treatment.

•Reproductive system and breast disorders

Very rare:

Priapism

•General disorders and administration site conditions

Common:

Injection site reactions; local irritation may occur when injected subcutaneously

4.9 Overdose

Bleeding is the main sign of overdose with heparin. As heparin is eliminated quickly, a discontinuation of treatment is sufficient in case of minor haemorrhages. In case of severe haemorrhages heparin may be neutralised with protamine sulphate injected slowly intravenously. One mg of protamine sulphate neutralises approximately 100 IU of heparin. Nevertheless, the required protamine sulphate dose varies according to the time of heparin administration and the dose administered.

It is important to avoid overdosage of protamine sulphate because protamine itself has anticoagulant properties. A single dose of protamine sulphate should never exceed 50 mg. Intravenous injection of protamine may cause a sudden fall in blood pressure, bradycardia, dyspnoea and transitory flushing, but these may be avoided or diminished by slow and careful administration.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Heparin is a naturally occurring anticoagulant which prevents the coagulation of blood in-vivo and in-vitro. It potentiates the inhibition of several activated coagulation factors, including thrombin and factor X.

5.2 Pharmacokinetic Properties

The anticoagulant effect of heparin after intravenous infusion becomes apparent immediately.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium chloride

Sodium citrate

Water for Injections

6.2 Incompatibilities

Heparin has been reported to be incompatible in aqueous solution with certain substances, e.g. some antibiotics, hydrocortisone, phenothiazines, narcotic analgesics and some antihistamines.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store below 25ºC.

6.5 Nature And Contents Of Container

Ph. Eur. Type I glass ampoules

10 x 5ml ampoules

10 x 10ml ampoules

10 x 20ml ampoules

6.6 Special Precautions For Disposal And Other Handling

Contains no preservative, any portion of the contents not used at once should be discarded.

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks HP27 9RR

8. Marketing Authorisation Number(S)

PL 0043/0149

9. Date Of First Authorisation/Renewal Of The Authorisation

16 May 1996

10. Date Of Revision Of The Text

April 2007

LEGAL CATEGORY

POM