Azithromycin Capsule 250 mg Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Local Product Insert

Concise Prescribing Info

Contents

Azithromycin dihydrate

Indications/Uses

Mild to moderate upper & lower resp tract infections [pharyngitis & tonsillitis, acute sinusitis, acute exacerbations of chronic bronchitis & mild to moderate community-acquired pneumonia (CAP)], uncomplicated skin & skin structure infections caused by susceptible organisms, urethritis or cervicitis caused by Chlamydia trachomatis or Neisseria gonorrheae, chancroid caused by Haemophilus ducreyi, disseminated infections caused by Mycobacterium avium complex (MAC) in patients w/ HIV infection.

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Dosage/Direction for Use

Pharyngitis or tonsillitis 500 mg single dose on 1st day, followed by 250 mg once daily on days 2-5. Acute sinusitis 500 mg once daily for 3 days. Acute exacerbations of chronic bronchitis 500 mg once daily for 3 days. Alternative dose: 500 mg single dose for 1st day, followed by 250 mg once daily on days 2-5. Mild to moderate CAP & uncomplicated skin & skin structure infections 500 mg single dose on 1st day, followed by 250 mg once daily on days 2-5. Uncomplicated chlamydial infection & chancroid 1 g as single dose. Gonorrhea caused by Neisseria gonorrhoeae 2 g as single dose. Disseminated infection caused by MAC in patient w/ HIV infection 500-600 mg once daily in combination w/ ethambutol 15 mg/kg once daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity to azithromycin or any macrolide or ketolide antibiotic. History of cholestatic jaundice/hepatic dysfunction associated w/ prior azithromycin use.

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Special Precautions

Discontinue immediately if symptoms of hepatitis occur (malaise, nausea, vomiting, abdominal colic, fever); if C. difficile-associated diarrhea (CDAD) is suspected or confirmed; if allergic reaction occurs. Arrhythmias, ventricular tachycardia, hypotension, QT prolongation & Torsades de Pointes. Serious allergic reactions, including angioedema, anaphylaxis, & dermatologic reactions, including SJS & TEN. Risk of fungal or bacterial superinfection, including CDAD w/ prolonged use. Patients at risk of prolonged cardiac repolarization; w/ myasthenia gravis. Consider avoiding use in patient w/ prolonged QT interval, uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, or concurrent use of class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, dofetilide, sotalol) antiarrhythmic agents. Patients w/ GFR <10 mL/min. Renal & hepatic impairment. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhea, nausea. Pruritus, rash; abdominal pain, anorexia, cramping, vomiting; vaginitis. Erythema multiforme, SJS, TEN.

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Drug Interactions

Concomitant use w/ BCG, highest risk QTc-prolonging agents, ivabradine, mifepristone, pimozide, quinine, terfenadine. Increased levels/effects of amiodarone, cardiac glycosides, cyclosporine, highest & moderate risk QTc-prolonging agents, ivermectin, pimozide, quinine, rivaroxaban, tacrolimus, terfenadine, vit K antagonists. Increased level/effects w/ ivabradine, mifepristone, nelfinavir, QTc-prolonging agent. Decreased levels/effects of BCG, Na picosulfate, typhoid vaccine.

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Storage

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Description

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Action

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MIMS Class

Macrolides

ATC Classification

J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.

Thai FDA Category

Presentation/Packing

Form

Azithromycin Capsule 250 mg cap 250 mg

Packing/Price

1 × 6's;10 × 6's

Azithromycin Capsule 250 mg

azithromycin

Manufacturer:

Pond Chemical

Distributor:

Pond's Chemical