Beclomethasone Dipropionate eent

Class: Corticosteroids
VA Class: NT200
Molecular Formula: C₂₈H₃₇ClO₇
CAS Number: 5534-09-8
Brands: Beconase AQ

Introduction

Synthetic corticosteroid.^a

Uses for Beclomethasone Dipropionate

Seasonal and Perennial Rhinitis

Symptomatic treatment of seasonal or perennial rhinitis.¹⁰³

Generally provides symptomatic relief of watery rhinorrhea, nasal congestion, sneezing (including morning sneezing attacks), and nasal and pharyngeal itching.^a

Generally does not relieve signs and symptoms of conjunctivitis or those involving the lower respiratory tract (e.g., coughing), although improvement in ophthalmic and respiratory manifestations may occur.^a

Relieves symptoms in both allergic and nonallergic rhinitis, although intranasal route appears to provide greater relief in allergic rhinitis.^a

Continuous concomitant therapies (e.g., oral or orally inhaled corticosteroids, bronchodilators, antihistamines, decongestants) may be required for optimum symptomatic relief, especially in patients with concurrent asthmatic conditions.^a

Symptomatic relief is usually evident within several days of initiating continuous intranasal therapy; however, up to 2 weeks may be required for optimum effectiveness.^a

Nasal Polyposis

Used principally to prevent nasal polyp recurrence after surgical removal.^a

May delay need for subsequent surgery, but should not preclude polypectomy when polyp size prevents adequate penetration of drug into nasal passages.^a

May reduce polyp size and the degree of nasal obstruction, but apparently does not alter underlying disease; manifestations usually recur when the drug is discontinued.^a

Periodically monitor patients receiving prolonged intranasal corticosteroid therapy with rhinoscopic examinations, since risk for atrophic rhinitis is increased.^a

Beclomethasone Dipropionate Dosage and Administration

Administration

Intranasal Inhalation

Administer by nasal inhalation only using a metered-dose nasal spray pump.^{103 104 a}

Prime spray pump prior to initial use (6 actuations or until a fine spray appears) and after ≥7days of non-use (until a fine spray appears).¹⁰⁴

Shake spray pump well immediately prior to use.¹⁰⁴

Avoid contact with the eyes.¹⁰⁴

Blow nose to clear nasal passages prior to administration.¹⁰⁴ Adequate penetration of the drug may require a topical nasal vasoconstrictor in patients with blocked nasal passages during the first 2–3 days of therapy.¹⁰³

For each inhalation, support the base of the spray bottle with the thumb and place the middle finger and forefinger on the white collar of the bottle.¹⁰⁴ Tilt the head slightly forward, keep the bottle upright, and insert the nasal applicator into one nostril while holding the other nostril closed.¹⁰⁴

Spray the drug into one nostril by pressing down firmly on the white collar of the bottle and concurrently inhaling gently through the nose, then exhale through the mouth.¹⁰⁴

Repeat procedure for the other nostril.¹⁰⁴

To clean nasal applicator, remove dust cap and safety clip and press applicator collar gently upward to free applicator.¹⁰⁴ Wash dust cap and nasal applicator in cold water, then dry and replace applicator, safety clip, and dust cap.¹⁰⁴

To unblock nasal applicator, remove dust cap, unscrew complete pump mechanism, and soak in warm water for a few minutes.¹⁰⁴ Rinse with cold water, dry, replace on bottle, and reprime the pump.¹⁰⁴

Dosage

Available as beclomethasone dipropionate monohydrate; dosage expressed in terms of the anhydrous salt.¹⁰³

After initial priming, each actuation of the nasal aqueous suspension spray pump delivers a 100-mg dose of beclomethasone dipropionate suspension equivalent to 42 mcg of anhydrous beclomethasone dipropionate.¹⁰³ Each 25-g spray bottle delivers 180 metered doses, after which the correct amount of drug in each spray cannot be assured.^{103 104} Discard the bottle after 180 sprays have been used.^{103 104}

Adjust dosage according to individual requirements and response.^a

Therapeutic effects of intranasal corticosteroids, unlike those of decongestants, are not immediate.¹⁰³

Use of topical nasal decongestants or oral antihistamines may be necessary until the effects of intranasal beclomethasone dipropionate are fully manifested.¹⁰³

Symptomatic relief is usually evident within several days of continuous therapy; however, up to 2 weeks may be required for relief in some patients.¹⁰³

Do not continue therapy beyond 3 weeks in the absence of substantial symptomatic improvement.¹⁰³

Pediatric Patients

Seasonal Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Initially, 1 spray (42 mcg) in each nostril twice daily (total dosage: 168 mcg/day).¹⁰³

Increase dosage to 2 sprays (84 mcg) in each nostril twice daily (total dosage: 336 mcg/day) if response is inadequate or symptoms are severe.¹⁰³

Reduce dosage to 1 spray in each nostril twice daily (total dosage: 168 mcg/day) once adequate symptom control is achieved.¹⁰³

Adolescents ≥12 years of age: 1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Perennial Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Initially, 1 spray (42 mcg) in each nostril twice daily (total dosage: 168 mcg/day).¹⁰³

Increase dosage to 2 sprays (84 mcg) in each nostril twice daily (total dosage: 336 mcg/day) if response is inadequate or symptoms are severe.¹⁰³

Reduce dosage to 1 spray in each nostril twice daily (total dosage: 168 mcg/day) once adequate symptom control is achieved.¹⁰³

Adolescents ≥12 years of age: 1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Nasal Polyposis

Intranasal Inhalation

Children 6–12 years of age: Initially, 1 spray (42 mcg) in each nostril twice daily (total dosage: 168 mcg/day).¹⁰³

Increase dosage to 2 sprays (84 mcg) in each nostril twice daily (total dosage: 336 mcg/day) if response is inadequate or symptoms are severe.¹⁰³

Reduce dosage to 1 spray in each nostril twice daily (total dosage: 168 mcg/day) once adequate symptom control is achieved.¹⁰³

Adolescents ≥12 years of age: 1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Adults

Seasonal Rhinitis

Intranasal Inhalation

1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Perennial Rhinitis

Intranasal Inhalation

1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dosage: 168–336 mcg/day).¹⁰³

Nasal Polyposis

Intranasal Inhalation

1 or 2 sprays (42–84 mcg) in each nostril twice daily (total dose: 168–336 mcg/day).¹⁰³

Prescribing Limits

No evidence that higher than recommended dosages or increased frequency of administration is beneficial.¹⁰³

Exceeding the maximum recommended daily dosage may only increase the risk of adverse systemic effects (e.g., HPA-axis suppression, Cushing’s syndrome) and should be avoided.¹⁰³

Pediatric Patients

Seasonal Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Adolescents ≥12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Perennial Rhinitis

Intranasal Inhalation

Children 6–12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Adolescents ≥12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Nasal Polyposis

Intranasal Inhalation

Children 6–12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Adolescents ≥12 years of age: Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Adults

Seasonal Rhinitis

Intranasal Inhalation

Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Perennial Rhinitis

Intranasal Inhalation

Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Nasal Polyposis

Intranasal Inhalation

Maximum 84 mcg (2 sprays) in each nostril twice daily (total dosage: 336 mcg/day).¹⁰³

Cautions for Beclomethasone Dipropionate

Contraindications

• 
  

  Known hypersensitivity to beclomethasone or any ingredient in the formulation.¹⁰³

  
  


• 
  

  Do not use in the presence of untreated localized nasal mucosa infections.¹⁰³

  
  

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Patients being switched from prolonged systemic corticosteroids to intranasal therapy should be monitored carefully since corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, and/or severe symptomatic exacerbation of asthma or other clinical conditions may occur.¹⁰³

In patients being switched to intranasal therapy, systemic corticosteroid dosage should be tapered and patients carefully monitored during dosage reduction.¹⁰³

Systemic Corticosteroid Effects

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects may cause systemic corticosteroid effects (e.g., menstrual irregularities, acneiform lesions, cataracts, cushingoid features).¹⁰³

Avoid larger than recommended dosages; potential for systemic effects increases with excessive dosage.¹⁰³

If systemic effects occur, therapy with the drug should gradually be withdrawn (tapered).¹⁰³

Immunosuppression

Although risk with intranasal use is unknown, consider the possibility that corticosteroid-induced immunosuppression could occur.^a Avoid exposure to varicella and measles in previously unexposed patients and those who have not been properly immunized.¹⁰³

If exposure to varicella or measles occurs in such individuals, administration of varicella zoster immune globulin (VZIG) or immune globulin, respectively, may be indicated.¹⁰³ If varicella develops, treatment with an antiviral agent may be considered.¹⁰³

Sensitivity Reactions

Immediate or delayed hypersensitivity reactions, including anaphylactoid/anaphylactic reactions, urticaria, angioedema, rash, wheezing, and bronchospasm, have occurred rarely.¹⁰³

General Precautions

Nasopharyngeal Effects

Persistent nasopharyngeal irritation may require discontinuance of beclomethasone therapy.¹⁰³

Rarely, nasal septal perforations.¹⁰³

Rarely, localized candidal infections of the nose and/or pharynx.¹⁰³ Treat suspected infection with appropriate local therapy;¹⁰³ may require discontinuance of beclomethasone therapy.¹⁰³

Avoid use until healing occurs in patients with recurrent epistaxis, recent nasal septal ulcers, nasal surgery, or nasal trauma.¹⁰³

Ophthalmic Effects

Increased intraocular pressure (IOP), glaucoma, cataracts, and conjunctivitis have been reported rarely.¹⁰³

Hypothalamic-Pituitary-Adrenal Axis Suppression

Avoid higher than recommended dosages since suppression of hypothalamic-pituitary-adrenal (HPA) function may occur.¹⁰³

Reductions in plasma cortisol concentrations have occurred when intranasal and orally inhaled beclomethasone dipropionate were used concomitantly.^a

Cases of growth suppression also have been reported.¹⁰³ (See Pediatric Use under Cautions.)

Infection

Use cautiously, if at all, in patients with clinical tuberculosis or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; or ocular herpes simplex infections.¹⁰³

Nasal Polyposis

Treatment with beclomethasone should be considered adjunctive to surgical removal and/or use of other drugs that will permit effective penetration of the drug into the nose; polyps may recur after any treatment.¹⁰³

Nasal Mucosal Changes

During long-term intranasal therapy (several months or longer), periodically examine nasal passages for mucosal changes.¹⁰³

Specific Populations

Pregnancy

Category C.¹⁰³

Lactation

Other corticosteroids known to be distributed into milk.¹⁰³ Caution if used in nursing women.¹⁰³

Corticosteroids may cause adverse effects (e.g., growth suppression) in nursing infants if distributed into milk.^a

Pediatric Use

May be a useful therapeutic alternative to oral corticosteroids in children ≥6 years of age with seasonal or perennial allergic rhinitis, since intranasal administration is associated with a decreased risk of adverse systemic effects.^a

Intranasal corticosteroids, including beclomethasone, may reduce growth velocity in pediatric patients; use lowest effective dosage and monitor growth routinely.¹⁰³ In a placebo-controlled, 1-year study, approximately 50% of beclomethasone dipropionate-treated children were below the 10th percentile for growth velocity.¹⁰³

Safety and efficacy not established in children <6 years of age.¹⁰³

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether such patients respond differently than younger adults; select dosage with caution due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in geriatric patients.¹⁰³

Common Adverse Effects

Mild nasopharyngeal irritation, sneezing attacks, headache, nausea, lightheadedness, nasal stuffiness, nosebleeds, rhinorrhea, tearing eyes.¹⁰³

Beclomethasone Dipropionate Pharmacokinetics

Absorption

Bioavailability

Most of an intranasal dose is swallowed.^{103 105}

Systemic bioavailability (as active metabolite) is 44% (43% from swallowed portion, 1% from nasal mucosa).^{103 105}

Distribution

Extent

Moderate distribution, more extensive for active metabolite.^{103 105} Beclomethasone dipropionate and its metabolites are not stored in tissues.¹⁰³

Not known whether beclomethasone crosses the placenta or is distributed into milk; other corticosteroids are distributed into milk.^{a 103}

Plasma Protein Binding

Approximately 87%.¹⁰³

Elimination

Metabolism

Beclomethasone dipropionate is a weakly active prodrug, rapidly hydrolyzed to highly active beclomethasone-17-monopropionate (B-17-MP) by esterase enzymes found in most tissues.^{a 103 105}

Elimination Route

Excreted mainly as metabolites in feces (60%) and in urine (12%) following oral administration.¹⁰³

Half-life

Not determined following intranasal administration.^a Terminal half-life averages 0.5 hours (beclomethasone dipropionate) and 2.7 hours (active metabolite) following IV administration.¹⁰³

Stability

Storage

Nasal Suspension

15–30°C.¹⁰³

Discard the nasal pump spray after 180 sprays.^{103 104}

ActionsActions

• 
  

  Potent glucocorticoid and weak mineralocorticoid effects.^a

  
  


• 
  

  Topical anti-inflammatory potency of beclomethasone dipropionate is about 5000 times greater than hydrocortisone; 500 times greater than beclomethasone, betamethasone, or dexamethasone; and about 5 times greater than fluocinolone or the acetonides of fluocinolone or triamcinolone, as measured by vasoconstrictor assay.^a Beclomethasone dipropionate is 6–7 times more potent as a glucocorticoid than hydrocortisone when administered orally or subcutaneously.^a

  
  


• 
  

  Local anti-inflammatory and vasoconstrictor effects following topical application to the nasal mucosa.^{a 103}

  
  


• 
  

  Reduces number of mediator cells (basophil leukocytes and mast cells) at the epithelial level, number of eosinophils, sensitivity of sensory nerves to mechanical stimuli, secretory response to cholinergic receptor stimulation, and fibroblast activity.^a

  
  


• 
  

  May inhibit capillary dilation and permeability, stabilize lysosomal membranes and prevent proteolytic enzyme release.^a

  
  


• 
  

  Adrenal suppression has not been observed when beclomethasone dipropionate inhalation aerosol (no longer commercially available in the US) was administered in clinical trials,¹⁰³ but decreases in nocturnal cortisol secretion have been reported with usual dosages of beclomethasone oral inhalation in children.¹⁰³ (See Hypothalamic-Pituitary-Adrenal Axis Suppression under Cautions.)

  
  

Advice to Patients

• 
  

  Importance of giving patient a copy of the manufacturer’s patient instructions.^{103 104}

  
  


• 
  

  Importance of instructing patient about proper techniques for assembly and priming of nasal spray pump and for administration and storage of the nasal solution.^{103 104}

  
  


• 
  

  Importance of shaking nasal spray well prior to each use.¹⁰⁴

  
  


• 
  

  Importance of discarding container after 180 actuations or once the expiration date on the label is reached.^{103 104}

  
  


• 
  

  Avoid spraying into eyes.¹⁰⁴

  
  


• 
  

  Importance of advising patient that effects are not immediate; full benefit may require ≤2 weeks of continuous use.¹⁰³

  
  


• 
  

  Importance of using at regular intervals as directed.¹⁰³

  
  


• 
  

  Importance of not continuing therapy for longer than 3 weeks in the absence of substantial symptomatic improvement.¹⁰³

  
  


• 
  

  Importance of informing clinician if symptoms fail to improve or worsen or if sneezing or nasal irritation occurs.¹⁰³

  
  


• 
  

  Importance of not increasing dosage unless directed by a clinician.¹⁰³

  
  


• 
  

  Importance of using concomitant nasal vasoconstrictor and/or oral antihistamines for 1–2 weeks if needed until the effects of beclomethasone are optimal.¹⁰³

  
  


• 
  

  Importance of avoiding exposure to chickenpox or measles if receiving immunosuppressive doses of corticosteroids; if exposed, notify a clinician.¹⁰³

  
  


• 
  

  Importance of patients with severe allergies avoiding exposure to allergens during intranasal beclomethasone dipropionate therapy to prevent the occurrence of severe allergic symptoms in the eyes and/or lower respiratory tract.^a

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹⁰³

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹⁰³

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹⁰³ (See Cautions.)

  
  

Preparations

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

Beclomethasone dipropionate inhalation aerosols containing chlorofluorocarbon (CFC) propellants are no longer marketed in the US.

Beclomethasone Dipropionate (Monohydrate)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Nasal	Suspension	equivalent to Beclomethasone Dipropionate 42 mcg/metered dose	Beconase AQ Nasal Spray (with benzalkonium chloride and phenylethyl alcohol)	GlaxoSmithKline

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.

Qvar 40MCG/ACT Aerosol (IVAX PHARMACEUTICALS INC.): 7/$91.86 or 21/$258.52

Qvar 80MCG/ACT Aerosol (IVAX PHARMACEUTICALS INC.): 7/$109.99 or 21/$309.97

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.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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

100. Schering. Vancenase (beclomethasone dipropionate) Pockethaler nasal inhaler prescribing information. In: Physicians’ desk reference. 53rd ed. Montvale, NJ: Medical Economics Company Inc; 1999(Suppl A):A292-4.

101. Schering. Vancenase (beclomethasone dipropionate) AQ 84 mcg double strength prescribing information. Kenilworth, NJ. 1996 Jun.

102. Schering. Vancenase (beclomethasone dipropionate) nasal inhaler prescribing information (dated 1997 Apr). In: Physicians' desk reference. 54th ed. Montvale, NJ: Medical Economics Company Inc; 2000:2844-5.

103. GlaxoSmithKline. Beconase AQ (beclomethasone dipropionate monohydrate) nasal spray prescribing information. Research Triangle Park, NC; 2005 Apr.

104. GlaxoSmithKline. Beconase AQ (beclomethasone dipropionate monohydrate) nasal spray patient instructions for use. Research Triangle Park, NC; 2005 Apr.

105. Daley-Yates PT, Price AC, Sisson JR et al. Beclomethasone dipropionate: absolute bioavailability, pharmacokinetics and metabolism following intravenous, oral, intranasal and inhaled administration in man. Br J Clin Pharmacol. 2001; 51:400-9. [PubMed 11421996]

a. AHFS drug information 2005. McEvoy GK, ed. Beclomethasone dipropionate. Bethesda, MD: American Society of Health-System Pharmacists; 2005:2676-80.

c. Anon. FDA publishes final rule on chlorofluorocarbons in metered dose inhalers. FDA talk paper. Rockville, MD: Food and Drug Administration; 2005 Mar 31.

More Beclomethasone Dipropionate eent resources

• Beclomethasone Dipropionate eent Use in Pregnancy & Breastfeeding
• Beclomethasone Dipropionate eent Support Group
• 2 Reviews for Beclomethasone Dipropionate eent - Add your own review/rating

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Scheme

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ATC (Anatomical Therapeutic Chemical Classification)

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CAS registry number (Chemical Abstracts Service)

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Chemical Formula

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Glossary

BAN	British Approved Name
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Has a generic version of Quelicin been approved?

No. There is currently no therapeutically equivalent version of Quelicin available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Quelicin. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

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• Sweden


• Switzerland


• Turkey


• United Kingdom


• United States

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Ofloxacine Winthrop

Ofloxacine Winthrop may be available in the countries listed below.

Ingredient matches for Ofloxacine Winthrop

Ofloxacin

Ofloxacin is reported as an ingredient of Ofloxacine Winthrop in the following countries:

• France


• Tunisia

International Drug Name Search

Heparin Krka

Heparin Krka may be available in the countries listed below.

Ingredient matches for Heparin Krka

Heparin

Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Heparin Krka in the following countries:

• Slovenia

International Drug Name Search

Silfox

Silfox may be available in the countries listed below.

Ingredient matches for Silfox

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Silfox in the following countries:

• Argentina

International Drug Name Search

Nasentropfen axcount

Nasentropfen axcount may be available in the countries listed below.

Ingredient matches for Nasentropfen axcount

Xylometazoline

Xylometazoline hydrochloride (a derivative of Xylometazoline) is reported as an ingredient of Nasentropfen axcount in the following countries:

• Germany

International Drug Name Search

Papaverol-S

Papaverol-S may be available in the countries listed below.

Ingredient matches for Papaverol-S

Scopolamine

Scopolamine butylbromide (a derivative of Scopolamine) is reported as an ingredient of Papaverol-S in the following countries:

• Peru

International Drug Name Search

Throsyn

Throsyn may be available in the countries listed below.

Ingredient matches for Throsyn

Roxithromycin

Roxithromycin is reported as an ingredient of Throsyn in the following countries:

• South Africa

International Drug Name Search

Pindome

Pindome may be available in the countries listed below.

Ingredient matches for Pindome

Adapalene

Adapalene is reported as an ingredient of Pindome in the following countries:

• Taiwan

International Drug Name Search

Dextrose Electrolyte No. 75

Dosage Form: injection, USP

Dextrose Electrolyte No. 75 Description

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. Each 100 mL contains 5 g Dextrose Hydrous, USP*, 220 mg Sodium Lactate (C3H5NaO3), 205 mg Potassium Chloride, USP (KCl), 120 mg Sodium Chloride, USP (NaCl), and 100 mg Monobasic Potassium Phosphate, NF (KH2PO4). It contains no antimicrobial agents. pH 5.0 (4.0 to 6.5).

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 40 mEq sodium, 35 mEq potassium, 48 mEq chloride, 20 mEq lactate, and 15 mEq phosphate as HPO4=. The osmolarity is 402 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. The caloric content is 180 kcal/L.

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Dextrose Electrolyte No. 75 - Clinical Pharmacology

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) has value as a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) produce a metabolic alkalinizing effect. Lactate ions are metabolized in the liver to glycogen, and ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

Indications and Usage for Dextrose Electrolyte No. 75

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) is indicated as a source of water, electrolytes and calories or as an alkalinizing agent.

Contraindications

Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Warnings

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.

The intravenous administration of 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.

In patients with diminished renal function, administration of 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) may result in sodium or potassium retention.

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) is not for use in the treatment of lactic acidosis.

Precautions

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be used with caution. Excess administration may result in metabolic alkalosis.

Caution must be exercised in the administration of 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) to patients receiving corticosteroids or corticotropin.

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be used with caution in patients with overt or subclinical diabetes mellitus.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP). It is also not known whether 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness of 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) in pediatric patients have not been established by adequate and well controlled trials, however, the use of dextrose and electrolytes solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible hemorrhage.

Geriatric Use

Clinical studies of 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) 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 the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Carcinogenesis and Mutagenesis and Impairment of Fertility

Studies with 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) is administered to a nursing mother.

Do not administer unless solution is clear and seal is intact.

Adverse Reactions

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Dextrose Electrolyte No. 75 Dosage and Administration

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Additives may be incompatible. Complete information is not available.

Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

How is Dextrose Electrolyte No. 75 Supplied

5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) in VIAFLEX plastic containers is available as shown below:

Code	Size (mL)	NDC
2B2112	250	NDC 0338-0141-02
2B2113	500	NDC 0338-0141-03
2B2114	1000	NDC 0338-0141-04

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINERS

Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn in from the primary container before administration of the fluid from the secondary container is completed.

To Open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.

Preparation for Administration

1. Suspend container from eyelet support.

2. Remove plastic protector from outlet port at bottom of container.

3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning: Additives may be incompatible.

To add medication before solution administration

1. Prepare medication site.

2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.

3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To add medication during solution administration

1. Close clamp on the set.

2. Prepare medication site.

3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.

4. Remove container from IV pole and/or turn to an upright position.

5. Evacuate both ports by squeezing them while container is in the upright position.

6. Mix solution and medication thoroughly.

7. Return container to in use position and continue administration.

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

BAXTER, VIAFLEX and PL 146 are trademarks of Baxter International Inc.

07-19-47-766

Rev. June 2005.

DEXTROSE AND ELECTROLYTE NO. 75  sodium lactate, sodium chloride, potassium chloride, potassium phosphate and dextrose  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0338-0141 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Dextrose Hydrous (dextrose) Active 5 GRAM  In 100 MILLILITER Sodium Lactate (sodium lactate) Active 220 MILLIGRAM  In 100 MILLILITER Potassium Chloride (potassium chloride) Active 205 MILLIGRAM  In 100 MILLILITER Sodium Chloride (sodium chloride) Active 120 MILLIGRAM  In 100 MILLILITER Potassium Phosphate, monobasic (potassium phosphate, monobasic) Active 100 MILLIGRAM  In 100 MILLILITER Water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0338-0141-02 250 mL (MILLILITER) In 1 BAG None 2 0338-0141-03 500 mL (MILLILITER) In 1 BAG None 3 0338-0141-04 1000 mL (MILLILITER) In 1 BAG None

Revised: 08/2006Baxter Healthcare Corporation

Sandostatina

Sandostatina may be available in the countries listed below.

Ingredient matches for Sandostatina

Octreotide

Octreotide is reported as an ingredient of Sandostatina in the following countries:

• Italy


• Portugal

International Drug Name Search

Arteolol

Arteolol may be available in the countries listed below.

Ingredient matches for Arteolol

Carteolol

Carteolol hydrochloride (a derivative of Carteolol) is reported as an ingredient of Arteolol in the following countries:

• Spain

International Drug Name Search

Wick Formel 44 Husten-Löser

Wick Formel 44 Husten-Löser may be available in the countries listed below.

Ingredient matches for Wick Formel 44 Husten-Löser

Guaifenesin

Guaifenesin is reported as an ingredient of Wick Formel 44 Husten-Löser in the following countries:

• Austria

International Drug Name Search

Cethexonium

Scheme

DCF

ATC (Anatomical Therapeutic Chemical Classification)

D08AJ

CAS registry number (Chemical Abstracts Service)

0006810-42-0

Chemical Formula

C24-H50-N-O

Molecular Weight

368

Therapeutic Categories

Antiseptic

Disinfectant

Chemical Names

Cyclohexanaminium, N-hexadecyl-2-hydroxy-N,N-dimethyl-

N-Hexadecyl-2-hydroxy-N,N-dimethylcyclohexanaminium

Foreign Names

• Cethexonium (German)
• Céthexonium (French)
• Cetexonio (Spanish)

Generic Name

• Céthexonium (OS: DCF)

Brand Names

• Bactyl
  Cooperation Pharmaceutique Française, Tunisia; Europhta, Tunisia



• Biocidan
  Menarini, France



• Monosept
  Horus, France

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
OS	Official Synonym

Click for further information on drug naming conventions and International Nonproprietary Names.

Cefotetan Sodium

Cefotetan Sodium may be available in the countries listed below.

Ingredient matches for Cefotetan Sodium

Cefotetan

Cefotetan Sodium (JAN) is known as Cefotetan in the US.

International Drug Name Search

Glossary

JAN	Japanese Accepted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Diazen

Diazen may be available in the countries listed below.

Ingredient matches for Diazen

Metformin

Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Diazen in the following countries:

• Philippines

International Drug Name Search

Disopyramide PCH

Disopyramide PCH may be available in the countries listed below.

Ingredient matches for Disopyramide PCH

Disopyramide

Disopyramide phosphate (a derivative of Disopyramide) is reported as an ingredient of Disopyramide PCH in the following countries:

• Netherlands

International Drug Name Search

Pergolide A

Pergolide A may be available in the countries listed below.

Ingredient matches for Pergolide A

Pergolide

Pergolide mesilate (a derivative of Pergolide) is reported as an ingredient of Pergolide A in the following countries:

• Netherlands

International Drug Name Search

Flunarizina Farmoz

Flunarizina Farmoz may be available in the countries listed below.

Ingredient matches for Flunarizina Farmoz

Flunarizine

Flunarizine dihydrochloride (a derivative of Flunarizine) is reported as an ingredient of Flunarizina Farmoz in the following countries:

• Portugal

International Drug Name Search

Brodifac

Brodifac may be available in the countries listed below.

Ingredient matches for Brodifac

Ketorolac

Ketorolac tromethamine (a derivative of Ketorolac) is reported as an ingredient of Brodifac in the following countries:

• Chile

International Drug Name Search

Reprexain

Generic Name: hydrocodone and ibuprofen (Oral route)

hye-droe-KOE-done bye-TAR-trate, eye-bue-PROE-fen

Commonly used brand name(s)

In the U.S.

• Ibudone


• Reprexain


• Vicoprofen

Available Dosage Forms:

• Tablet

Therapeutic Class: Opioid/NSAID Combination

Pharmacologic Class: NSAID

Chemical Class: Hydrocodone

Uses For Reprexain

Hydrocodone and ibuprofen combination is used to relieve acute pain. This medicine should only be used for short periods of time, usually for a total of less than 10 days. This combination is not used for osteoarthritis or rheumatoid arthritis.

Hydrocodone is a narcotic analgesic that acts on the central nervous system to relieve pain. If hydrocodone is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal side effects when you stop taking the medicine. Since hydrocodone and ibuprofen combination is only used for short-term (10 days or less) relief of pain, physical dependence will probably not occur.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used in this combination to relieve inflammation, swelling, and pain.

This medicine is available only with your doctor's prescription.

Before Using Reprexain

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

Appropriate studies have not been performed on the relationship of age to the effects of hydrocodone and ibuprofen combination in children and teenagers below 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone and ibuprofen combination in the elderly. However, elderly patients are more likely to develop age-related kidney or stomach problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Ketorolac


• Naltrexone


• Pentoxifylline

Using this medicine 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.

• Abciximab


• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Aprobarbital


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Bromazepam


• Brotizolam


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Certoparin


• Chloral Hydrate


• Chlordiazepoxide


• Chlorzoxazone


• Cilostazol


• Citalopram


• Clobazam


• Clonazepam


• Clopidogrel


• Clorazepate


• Clovoxamine


• Codeine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Dantrolene


• Desirudin


• Dezocine


• Diazepam


• Dipyridamole


• Enoxaparin


• Escitalopram


• Estazolam


• Ethchlorvynol


• Femoxetine


• Fentanyl


• Flesinoxan


• Flunitrazepam


• Fluoxetine


• Flurazepam


• Fluvoxamine


• Fondaparinux


• Fospropofol


• Ginkgo


• Halazepam


• Heparin


• Hydrocodone


• Hydromorphone


• Ketazolam


• Lepirudin


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Methotrexate


• Midazolam


• Morphine


• Morphine Sulfate Liposome


• Nadroparin


• Nalbuphine


• Nefazodone


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Parnaparin


• Paroxetine


• Pemetrexed


• Pentazocine


• Pentobarbital


• Phenobarbital


• Prazepam


• Propoxyphene


• Protein C


• Quazepam


• Remifentanil


• Reviparin


• Rivaroxaban


• Secobarbital


• Sertraline


• Sibutramine


• Sodium Oxybate


• Sufentanil


• Tacrolimus


• Tapentadol


• Temazepam


• Thiopental


• Ticlopidine


• Tinzaparin


• Tirofiban


• Triazolam


• Vilazodone


• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amikacin


• Amiloride


• Arotinolol


• Aspirin


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desipramine


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Escitalopram


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Phenytoin


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Tacrine


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Voriconazole


• Xipamide


• Zofenopril

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland problem) or


• Enlarged prostate (BPH, prostatic hypertrophy) or


• Hypothyroidism (underactive thyroid) or


• Kidney disease, severe or


• Liver disease, severe or


• Problems with urination or


• Systemic lupus erythematosus (SLE) or


• Weakened physical condition—Use with caution. May increase risk for more serious side effects.

• Anemia or


• Bleeding problems or


• Breathing problems (e.g., respiratory depression) or


• Edema (fluid retention) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• Hypertension (high blood pressure) or


• Kidney disease or


• Liver disease or


• Lung disease or


• Stomach ulcers or bleeding, history of or


• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or


• Aspirin sensitivity, history of—Should not be used in patients with these conditions.

• Drug abuse or dependence, or history of—Dependence may be more likely to develop.

• Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

Proper Use of hydrocodone and ibuprofen

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

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 oral dosage form (tablets):
  
  • For pain:
    
    • Adults and teenagers above 16 years of age—One tablet every 4 to 6 hours as needed. However, the dose is usually not more than 5 tablets per day.
    
    
    • Children and teenagers younger than 16 years of age—Use and 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

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Reprexain

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Some signs of serious heart problems are chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Stop taking this medicine and check with your doctor right away if you notice any of these warning signs.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely to occur if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner). Call your doctor right away if you have severe stomach pain; black, tarry stools; or are vomiting blood or material that looks like coffee grounds.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you have more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; a severe skin rash or acne; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Hydrocodone and ibuprofen combination will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, sleeping medicine; or other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. 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.

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 not alert. If these reactions are especially bothersome, check with your doctor.

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.

Hydrocodone and ibuprofen combination may cause dry mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if you take this medicine for a long time and 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.

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called meningitis.

If you have heart disease or congestive heart failure (CHF), tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Reprexain 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.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

• Bloody stools


• burning feeling in the chest or stomach


• congestion in the chest


• changes in facial skin color


• cough


• diarrhea


• difficulty with swallowing


• fast or irregular breathing


• fever


• frequent urge to urinate


• heartburn


• inability to urinate


• irregular heartbeat


• lightheadedness or dizziness


• loss of bladder control


• puffiness or swelling of the eyelids or around the eyes


• ringing or buzzing in the ears


• shortness of breath, troubled breathing, tightness in the chest or wheezing


• skin rash, hives, or itching


• stomach pain


• tenderness in the stomach

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

Symptoms of overdose

• Blurred vision


• cold or clammy skin


• confusion


• difficulty hearing or ringing or buzzing in the ears


• dizziness


• general feeling of illness


• headache


• mood or mental changes


• nausea or vomiting


• severe drowsiness


• severe stomach pain


• skin rash


• slow heartbeat


• slow or troubled breathing


• stiff neck or back


• swelling of the face, fingers, feet, or lower legs

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

• Anxiety


• constipation


• dry mouth


• gas


• increased sweating


• nervousness


• pounding heartbeat


• sleepiness


• trouble in sleeping


• unusual tiredness or weakness

Less common or rare

• Decreased appetite


• decrease in sexual ability


• depression


• headache


• heartburn


• increased thirst


• irritability


• mood or mental changes


• mouth ulcers


• pain or burning in the throat


• runny nose


• sensation of burning, warmth, heat, numbness, tightness, or tingling


• slurred speech


• stomach upset


• thinking abnormalities


• trembling or shaking of the hands or feet


• unexplained weight loss


• unusual feeling of well-being


• visual disturbances

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: Reprexain 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.

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More Reprexain resources

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

• Reprexain MedFacts Consumer Leaflet (Wolters Kluwer)


• Reprexain Prescribing Information (FDA)


• Ibudone Prescribing Information (FDA)


• Vicoprofen Prescribing Information (FDA)


• Vicoprofen Consumer Overview

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