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Zithromax

Zithromax

azithromycin

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Azithromycin dihydrate
Indications/Uses
URTI, lower resp tract, odontostomatological & skin & soft tissue infections; acute otitis media; infections; uncomplicated genital infections due to Chlamydia trachomatis & non-multiresistant Neisseria gonorrhoeae; chancroid due to Haemophilus ducreyi. In combination w/ ethambutol for treatment of disseminated Mycobacterium avium-intracellulare complex (DMAC) infection in patients w/ advanced HIV. Alone or in combination w/ rifabutin for prophylaxis against MAC infection in advanced HIV-infected patients. IV Community-acquired pneumonia (CAP) caused by susceptible organisms including Legionella pneumophila; pelvic inflammatory disease (PID) caused by Chlamydia trachomatis, N. gonorrhoeae, Mycoplasma hominis.
Dosage/Direction for Use
Oral Adult 500 mg daily for 3 days or 500 mg given on day 1 then 250 mg daily on days 2-5. STD caused by Chlamydia trachomatis & Haemophilus ducreyi 1,000 mg as single dose. STD caused by N. gonorrhoeae Azithromycin 1,000 or 2,000 mg + ceftriaxone 250 or 500 mg. Prophylaxis against MAC infections in HIV-infected patients 1,200 mg once wkly. DMAC infections in patients w/ advanced HIV infection 600 mg once daily. Administer in combination w/ ethambutol. Oral susp Childn 10 mg/kg daily for 3 days or 10 mg/kg on day 1 then 5 mg/kg on days 2-5. Total dose: 30 mg/kg. Max recommended total dose: 1,500 mg. Acute otitis media 30 mg/kg single dose as alternative. Ped strep pharyngitis 10 or 20 mg/kg single dose for 3 days. Max daily dose: 500 mg. Inj CAP 500 mg as single daily dose IV for at least 2 days followed by oral azithromycin 500 mg single daily dose to complete 7- to 10-day course of therapy. PID 500 mg single daily dose IV for 1 or 2 days followed by oral azithromycin 250 mg single daily dose to complete 7-day course of therapy.
Administration
Tab/powd for oral susp: May be taken with or without food.
Contraindications
Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic.
Special Precautions
Discontinue therapy in case of allergic reaction; signs & symptoms of hepatitis. Allergic reactions eg, angioedema, anaphylaxis. Acute generalized exanthematous pustulosis (AGEP) SJS, TEN, & DRESS. Consider Clostridium difficile-associated diarrhoea in all patients who present w/ diarrhea following use. Observe for signs of superinfection w/ non-susceptible organisms including fungi. Exacerbations of symptoms of myasthenia gravis. Prolonged cardiac repolarization & QT interval in patients at risk of cardiac arrhythmia & Torsades de Pointes. Congenital or documented QT prolongation, receiving treatment w/ other active substances known to prolong QT interval eg, antiarrhythmics of class IA & III, antipsychotic agents, antidepressants & fluoroquinolones. Electrolyte disturbance eg, hypokalaemia & hypomagnaesemia; bradycardia, cardiac arrhythmia or insufficiency. Not to be co-administered w/ ergot derivatives. Patients w/ significant hepatic disease. Increased systemic exposure in patients w/ severe renal impairment (GFR <10 mL/min). Pregnancy & lactation. Infantile hypertrophic pyloric stenosis in neonates treated up to 42 days of life; inform parents & caregivers to contact physician if vomiting or irritability w/ feeding occurs. Elderly (more susceptible to QT interval effects). Oral susp Diabetes, fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency due to sucrose content. Inj Do not administer as IV bolus or IM. Childn.
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. Inj: local pain & inflammation at the site of infusion.
Drug Interactions
Reduced peak serum conc w/ antacids. May elevate serum conc of digoxin & colchicine. Possible ergotism w/ ergot derivatives. Increased conc of zidovudine. Possible ergotism w/ ergot derivatives. Rhabdomyolysis may occur w/ atorvastatin. Potentiated anticoagulation w/ coumarin-type oral anticoagulants. Elevated Cmax & AUC0-5 w/ cyclosporin. Decreased Cmax w/ fluconazole. Neutropenia may occur w/ rifabutin.
MIMS Class
Macrolides
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Tab/Susp: D; Inj: S
Presentation/Packing
Form
Zithromax powd for oral susp 200 mg/5 mL
Packing/Price
15 mL x 1's
Form
Zithromax powd for inj 500 mg
Packing/Price
1's
Form
Zithromax tab 250 mg
Packing/Price
6's
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