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Rozenta

Rozenta

azithromycin

Manufacturer:

S Kant Healthcare
/
Theon Pharmaceuticals

Distributor:

Trumed
Concise Prescribing Info
Contents
Azithromycin dihydrate
Indications/Uses
Lower resp tract infections including bronchitis & pneumonia, skin & soft tissue infections, acute otitis media; URTI including sinusitis & pharyngitis/tonsillitis. Eradication of strep from the oropharynx; STD in men & women; uncomplicated genital infections due to Chlamydia trachomatis; chancroid due to Hemophilus ducreyi & uncomplicated genital infections due to non-multiresistant Neisseria gonorrhoeae excluding concurrent infection w/ Treponema pallidum. Prophylaxis against Mycobacterium avium-intracellulare complex (MAC) infection in patients w/ advanced HIV alone or in combination w/ rifabutin. Disseminated MAC infection in patients w/ advanced HIV in combination w/ ethambutol.
Dosage/Direction for Use
FC tab Adult STD caused by Chlamydia trachomatis & Hemophilus 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 infected w/ HIV 1,200 mg once/wk. DMAC infection in patient w/ advanced HIV infection 600 mg once daily. CAP 500 mg IV as single daily dose for at least 2 days followed by oral 500 mg as single daily dose to complete a 7-10-day course of therapy. PID 500 mg IV as single dose for 1 or 2 days followed by oral 250 mg as single daily dose to complete a 7-day course of therapy. All other indications in which the oral formulation is administered 500 mg daily for 3 days (total dosage: 1,500 mg). Alternatively, 500 mg on day 1, then 250 mg daily on days 2-5. Powd for oral susp Childn Max daily dose: 1,500 mg. Streptococcal pharyngitis 10 mg/kg daily for 3 days or 10 mg/kg on day 1 then 5 mg/kg on days 2-5. Acute otitis media 30 mg/kg as single dose. Streptococcal pharyngitis 10 mg/kg or 20 mg/kg for 3 days. Max daily dose: 500 mg. Childn weighing >45 kg 3-day/5-day regimen: Adult dose. Max daily dose: 500 mg; 36-45 kg 3-day regimen: 10 mL once daily on days 1-3. 5-day regimen: 10 mL on day 1, then 5 mL once daily on days 2-5; 26-35 kg 3-day regimen: 7.5 mL once daily on days 1-3. 5-day regimen: 7.5 mL on day 1, then 3.75 mL once daily on days 2-5; 15-25 kg 3-day regimen: 5 mL once daily on days 1-3. 5-day regimen: 5 mL on day 1 then 2.5 mL once daily on days 2-5; <15 kg 3-day regimen: 10 mg once daily on days 1-3. 5-day regimen 10 mg/kg on day 1, then 5 mg/kg once daily on days 2-5.
Administration
May be taken with or without food: Tab: Swallow whole.
Contraindications
Hypersensitivity to azithromycin, erythromycin or any macrolide or ketolide antibiotic.
Special Precautions
Angioedema & anaphylaxis (rarely fatal), dermatologic reactions including acute generalized exanthematous pustulosis, SJS, TEN (rarely fatal), DRESS. Theoretical possibility of ergotism w/ ergot derivatives. Observe for signs of superinfection including fungi. Consider C. difficile-associated diarrhea in patients presenting diarrhea following antibiotic use. Risk of developing cardiac arrhythmia & torsades de pointes. Exacerbations of symptoms of myasthenia gravis. Significant hepatic disease. Discontinue immediately if signs & symptoms of hepatitis occur. Severe renal impairment (GFR <10 mL/min). Pregnancy & lactation. Infantile hypertrophic pyloric stenosis following use in neonates (treatment up to 42 days of life). Drug associated effects on the QT interval in elderly patients. Powd for oral susp: Contains 3.87 g of sucrose; fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency.
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 site of infusion.
Drug Interactions
Increase serum levels of P-gp substrates eg, digoxin & colchicine. Possibility of interaction w/ ergot. Elevated Cmax & AUC0-5 w/ cyclosporin.
MIMS Class
Macrolides
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Rozenta FC tab 500 mg
Packing/Price
30's
Form
Rozenta powd for oral susp 200 mg/5 mL
Packing/Price
15 mL x 1's
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