Zithromax

Zithromax

azithromycin

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Azithromycin dihydrate
Indications/Uses
Lower resp tract infections including bronchitis & pneumonia; odontostomatological infections, skin & soft tissue infections, acute otitis media & URTI including sinusitis & pharyngitis/tonsillitis. Uncomplicated genital infections due to Chlamydia trachomatis & non-multiresistant Neisseria gonorrhoeae & concurrent infection w/ Treponema pallidum. Chancroid due to Haemophilus ducreyi. Monotherapy or in combination w/ rifabutin for prophylaxis against Mycobacterium avium-intracellulare complex (MAC) infection prevalent in patients w/ advanced HIV.
Dosage/Direction for Use
Adult & elderly STD due to Chlamydia trachomatis, Haemophilus ducreyi or susceptible Neisseria gonorrhoeae 1,000 mg as a single dose. Prophylaxis against MAC infections in patient w/ HIV 1,200 mg once/wk. All other indications Total dosage of 1,500 mg to be given as 500 mg daily for 3 days or 500 mg on day 1 then 250 mg daily on days 2-5. Childn weighing >45 kg Max: 1,500 mg. Total dose: 30 mg/kg should be given as a single daily dose of 10 mg/kg daily for 3 days or given over 5 days w/ a single daily dose of 10 mg/kg on day 1 then 5 mg/kg on days 2-5.
Administration
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity to azithromycin, erythromycin, any macrolides or ketolides.
Special Precautions
Possible serious allergic reactions including angioedema & anaphylaxis, dermatologic reactions including acute generalized exanthematous pustulosis, SJS, TEN & DRESS; discontinue if an allergic reaction occurs. Patients w/ significant hepatic disease; immediately discontinue if signs & symptoms of hepatitis (eg, abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis & failure) occur. Infantile hypertrophic pyloric stenosis. Inform parents & caregivers to contact physician if vomiting or irritability w/ feeding occurs. Possible ergotism when co-administered w/ ergot derivatives. Observe signs of superinfection w/ non-susceptible organisms including fungi. Consider Clostridium difficile-associated diarrhea in patients who present diarrhea following therapy. Diabetic patients due to sucrose content. Not indicated for persons w/ hereditary fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency. Prolonged cardiac repolarization & QT interval. Consider QT prolongation risk in patients w/ congenital or documented QT prolongation; currently receiving treatment w/ other QT interval-prolonging drugs (eg, class IA & III antiarrhythmics, antipsychotics, antidepressants & fluoroquinolones); electrolyte disturbance particularly in cases of hypokalemia & hypomagnesemia; clinically relevant bradycardia, cardiac arrhythmia or insufficiency. Exacerbations of myasthenia gravis symptoms. Renal impairment (GFR <10 mL/min). Pregnancy & lactation. Childn (for prevention of MAC). Elderly (more susceptible to drug-associated effects on QT interval).
Adverse Reactions
Transient episodes of mild neutropenia; hearing impairment (including hearing loss, deafness &/or tinnitus); nausea, vomiting, diarrhea, loose stools, abdominal discomfort (pain/cramps), flatulence; abnormal liver function; allergic reactions (including rash & angioedema).
Drug Interactions
Reduced peak serum conc w/ antacids. Increased serum levels of digoxin. Possible INT w/ ergot derivatives. Increased conc of phosphorylated zidovudine. Consider frequent monitoring of prothrombin time when used concomitantly w/ coumarin-type oral anticoagulants. Elevated Cmax & AUC0-5 of cyclosporin. Decreased Cmax w/ fluconazole. Neutropenia may occur in concomitant w/ rifabutin.
MIMS Class
Macrolides
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Zithromax FC tab 250 mg
Packing/Price
6's
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