Advertisement
Advertisement
Zithromax

Zithromax

azithromycin

Manufacturer:

Pfizer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Azithromycin dihydrate
Indications/Uses
Infections caused by susceptible organisms in lower resp (including bronchitis & pneumonia) & upper resp (including sinusitis & pharyngitis/tonsillitis) tract, skin & soft tissue infections, acute otitis media. Uncomplicated genital infections due to Chlamydia trachomatis, chancroid due to Haemophilus ducreyi & uncomplicated genital infections due to non-multiresistant Neisseria gonorrhoeae; concurrent infection w/ Treponema pallidum should be excluded. Alone or in combination w/ rifabutin for prophylaxis against Mycobacterium avium-intracellulare complex (MAC) infection. In combination w/ ethambutol for disseminated MAC (DMAC) infection in patients w/ advanced HIV infection. Powd for IV infusion: Community-acquired pneumonia (CAP) caused by susceptible organisms, including Legionella pneumophila, in patients who require initial IV therapy. Pelvic inflammatory diseases (PID) caused by susceptible organisms (Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma hominis) in patients who require initial IV therapy.
Dosage/Direction for Use
Oral Adult STD caused by Chlamydia trachomatis & Haemophilus ducreyi 1,000 mg as single dose. Susceptible Neisseria gonorrhoeae 1,000 mg or 2,000 mg in combination w/ ceftriaxone 250 mg or 500 mg. Prophylaxis against MAC infection in patient w/ HIV 1,200 mg once wkly. DMAC infection in patient w/ advanced HIV 600 mg once daily. All other indications in which oral formulation is administered Give total dose of 1,500 mg as 500 mg daily for 3 days or alternatively over 5 days w/ 500 mg on day 1, then 250 mg on days 2-5. Childn Total dose: 30 mg/kg given as single dose of 10 mg/kg daily for 3 days or over 5 days w/ single daily dose of 10 mg/kg on day 1, then 5 mg/kg on days 2-5. Max total dose for any treatment: 1,500 mg. Acute otitis media Alternatively, 30 mg/kg as single dose. Strep pharyngitis 10 mg/kg as single dose or 20 mg/kg for 3 days. Max: Not to exceed 500 mg daily. Susp should be administered as follows: 3-day regimen: Childn >45 kg Adult dose, 36-45 kg 400 mg once daily on days 1-3, 26-35 kg 300 mg once daily on days 1-3, 15-25 kg 200 mg once daily on days 1-3, <15 kg 10 mg/kg once daily on days 1-3. 5-day regimen: Childn >45 kg Adult dose, 36-45 kg 400 mg on day 1, then 200 mg once daily on days 2-5, 26-35 kg 300 mg on day 1, then 150 mg once daily on days 2-5, 15-25 kg 200 mg on day 1, then 100 mg once daily on days 2-5, <15 kg 10 mg/kg on day 1, then 5 mg/kg once daily on days 2-5. IV Adult CAP 500 mg as single daily dose by IV infusion for at least 2 days, followed by oral azithromycin 500 mg as single daily dose to complete 7-10 day therapy course. PID 500 mg as single daily dose by IV infusion for 1 or 2 days, followed by oral azithromycin 250 mg as single daily dose to complete 7-day therapy course.
Administration
FC 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 use in case of allergic reaction; signs & symptoms of hepatitis. Risk of QT prolongation in at-risk groups including patients w/ congenital or documented QT prolongation; currently receiving treatment w/ other active substances known to prolong QT interval (eg, class IA & III antiarrhythmics, antipsychotic agents, antidepressants, & fluoroquinolones); electrolyte disturbance, particularly in cases of hypokalemia & hypomagnesemia; clinically relevant bradycardia, cardiac arrhythmia or insufficiency. Exacerbations of symptoms of myasthenia gravis. Observe for signs of superinfection w/ non-susceptible organisms, including fungi. Consider Clostridium difficile-associated diarrhea in all patients who present w/ diarrhea following use. Not to be co-administered w/ ergot derivatives. Caution in patients w/ significant hepatic disease. Increased systemic exposure in patients w/ severe renal impairment (GFR <10 mL/min). Infantile hypertrophic pyloric stenosis. Pregnancy & lactation. Safety & efficacy have not been established for treatment of MAC in childn. Elderly. Powd for oral susp: Not indicated for persons w/ fructose intolerance (hereditary fructose intolerance), glucose-galactose malabsorption or saccharase-isomaltase deficiency. Powd for IV infusion: Not to be administered as IV bolus or IM inj. Safety & efficacy have not been established for treatment of infections in 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; local pain & inflammation at the site of infusion.
Drug Interactions
Reduced peak serum conc w/ antacids. Increased serum levels of P-gp substrates eg, digoxin & colchicine. Possible ergotism w/ ergot derivatives. Increased conc of phosphorylated zidovudine. Post-marketing cases of rhabdomyolysis w/ statins; potentiated anticoagulation w/ coumarin-type oral anticoagulants. Elevated Cmax & AUC0-5 of cyclosporin. Neutropenia w/ rifabutin. Increased conc w/ nelfinavir.
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
Form
Zithromax FC tab 500 mg
Packing/Price
3's
Form
Zithromax powd for IV infusion 500 mg
Packing/Price
1's
Form
Zithromax powd for oral susp 200 mg/5 mL
Packing/Price
15 mL x 1's;22.5 mL x 1's
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement