Duopharma Manufacturing (Bangi)


Duopharma Marketing
Concise Prescribing Info
Lower resp tract infections including bronchitis & pneumonia; skin & soft tissue infections; acute otitis media & URTI including sinusitis & pharyngitis/tonsillitis. Eradication of streptococci from oropharynx. Uncomplicated genital infections due to Chlamydia trachomatis & non-multiresistant Neisseria gonorrhoea. Chancroid due to Haemophilus ducreyi. Powd for oral susp: Alone or in combination w/ rifabutin for prophylaxis against Mycobacterium avium-intracellulare complex (MAC) infection.
Dosage/Direction for Use
Adult STD 1,000 mg as single oral dose. Other indications 1,500 mg given as 500 mg daily for 3 days or given for 5 days w/ 500 mg on day 1 then 250 mg daily on days 2-5. Childn >45 kg Adult dose, 36-45 kg 400 mg once daily on days 1-3 or 400 mg on day 1 then 200 mg once daily on days 2-5, 26-35 kg 300 mg once daily on days 1-3 or 300 mg on day 1 then 150 mg once daily on days 2-5, 15-25 kg 200 mg once daily on days 1-3 or 200 mg on day 1 then 100 mg once daily on days 2-5, <15 kg 10 mg once daily on days 1-3 or 10 mg on day 1 then 5 mg/kg once daily on days 2-5. Acute otitis media 30 mg/kg as single dose. Ped Streptococcal pharyngitis 10 or 20 mg/kg as single dose for 3 days. Max dose: 500 mg daily. Powd for oral susp Prophylaxis against MAC infections 1,200 mg once wkly.
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic.
Special Precautions
Angioedema & anaphylaxis, dermatologic reactions including SJS, TEN, DRESS. Signs of superinfection w/ non-susceptible organisms; Clostridium difficile-associated diarrhea. Congenital or documented QT prolongation; clinically relevant bradycardia, cardiac arrhythmia or insufficiency; electrolyte disturbance. Not to be co-administered w/ ergot derivatives. Concomitant use w/ substances prolonging QT interval eg, class IA & III antiarrhythmics, antipsychotics, antidepressants, fluoroquinolones. Severe renal impairment (GFR <10 mL/min). Significant hepatic disease. Pregnancy & lactation. Infantile hypertrophic pyloric stenosis. Elderly.
Adverse Reactions
Transient mild neutropenia, thrombocytopenia; hearing impairment; GI disorders; abnormal liver function; allergic reactions; local pain & inflammation at infusion site; moniliasis, vaginitis; anaphylaxis; anorexia; psychiatric, nervous system & cardiac disorders; hypotension; arthralgia; interstitial nephritis, acute renal failure.
Drug Interactions
Reduced peak serum conc w/ antacids. Raised digoxin levels. Increased phosphorylated zidovudine conc. Ergotism w/ ergot derivatives. Monitor prothrombin time w/ coumarin anticoagulants. Monitor cyclosporin levels. Increased conc by nelfinavir.
MIMS Class
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Zynomax powd for oral susp 200 mg/5 mL
20 mL x 1's
Zynomax tab 250 mg
1 × 6's
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