PRODUCT DETAILS
Azithromycin USP.

After oral administration, Azithromycin is widely distributed throughout the body; bioavailability is approximately 37%. The time taken to reach peak plasma level is 2-3 hours. Plasma terminal elimination half-life closely reflects the tissue depletion half-life of 2 to 4 days. Kinetic studies have shown markedly higher Azithromycin levels in tissue than in plasma (up to 50 times the maximum observed concentration in plasma) indicating that the drug is highly tissue bound. Concentrations in target tissues such as lung, tonsil and prostate exceed the MIC 90 for likely pathogens after a single dose of 500mg.

Presentation:

Acos® 500 mg tablet : Each tablet contains Azithromycindihydrate USP equivalent to Azithromycin 500 mg.
Acos® dry powder for suspension : When reconstituted, each 5 ml suspension contains Azithromycin 200 mg as Azithromycindihydrate USP.

  Dosage and Administration

InfectionRecommended DoseDuration of Therapy
Upper Respiratory tract infections:
Pharyngitis,
Tonsillis,
Acute Bacterial Sinusitis,
Acute Otitis Media.
Lower Respiratory Infections:
Community-aquired pneumonia,
Acute bacterial exacerbations of chronic obstructive pulmonary disease(COPD),
Bronchitis
Adult:500 mg Once Daily(or 500 mg Once on Day 1 followed by 250 Once daily for next 4 Days)
Chiled:10 mg/kg once daily
3 days
Acne500 mg Once Daily for 3 days then 4 days interval12 weeks(more effective)
Skin/Skin structure infectionAdult :500 mg Once Daily,
Child :10 mg/kg once daily
3 days
Genital ulcer disease(chancroid)Adult :1 gram single dose.-
Non-gonoccocal urethritis and cervicitisAdult :1 gram single dose.-
Gonoccocal urethritis and cervicitisAdult :2 gram single dose.-
Typhoid/ParatyphoidAdult :1 gram once daily
Child :20 mg/kg once daily
5 days
DiarrhoeaAdult :1-1.5 gram once daily.
Chiled :20 mg/kg once daily
-
CholeraAdult :1 gram single dose.
Child :20 mg/kg single dose.
-
ShigellosisAdult :1-1.5 gram once daily.
Chiled :20 mg/kg once daily
1-5 days
Dental InfectionAdult :500 mg once daily.
Chiled :10 mg/kg once daily
3 days
Eye Infection(trachoma)Adult :1 gram single dose.
Chiled :20 mg/kg once daily
-

  Side Effects

Azithromycin is well tolerated with a low incidence of side-effects. The side-effects include nausea, vomiting, abdominal discomfort (pain/cramps). flatulence, diarrhoea, headache, dizziness, and skin rashes are reversible upon discontinuation of therapy. Reversible elevations in liver transaminases have been observed occasionally.

  Contraindications

Azithromycin is contraindicated is patients with a know hypersensitivity to Azithromycin or any of the macrolide antibiotics. Because of the theoretical possibility of ergotism, Azithromycin and Ergot derivatives should not be co-administered. As with erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic edema and anaphylaxis, have resulted in recurrent symptoms and required a long period of observation and treatment.

  Use in Pregnancy and Lactation

Pregnancy : US FDA pregnancy category B. In the animal studies, no evidence of harm to the fetus due to Azithromycin was found. Because animal reproduction studies are not always predictive of human response, Azithromycin should be use during pregnancy only if clearly needed.
Lactation : It is not known whether Azithromycin is excreted in human milk. Caution should be exercised when Azithromycin is administered to nursing mother.

  Drug Interaction

Peak serum levels but not the total extent of absorption were reduced by the presence of magnesium and aluminum - containing antacids. Azithromycin should be taken at least 1hr before or 2hr after these antacids. Macrolides have been know to increase the plasma concentration of digoxin& cyclosporine. Therefore, if co-administration is necessary caution should be exercised and serum levels of digoxin& cyclosporine should be checked.

Direction for reconstitution: Shake the bottle to loosen the powder. Then add 20 ml boiled and cooled water with the help of supplied measuring cup. Shake vigorously until the powder is well suspensed.

  Over Dosage

...

  Storage

Protect from light, store in dry place below 30°C.
Store the reconstituted suspension at room temperature and use within 5 days. Discard any used medicine after 5 days.
Keep out of reach out of children

  Commercial Pack

Acos® 500 mg tablet: Each box contains 6 tablets (2 x 3\'s) in Alu-Alu blister pack.
Acos® 30 ml dry powder for suspension : Bottle containing dry powder for 30 ml suspension.

  Others

Use in renal impairment: No dose adjustment is needed in patients with mild renal impairment (creatinine> 40 ml/min.) but there are no data regarding Azithromycin usage in patients with more severe renal impairment, thus caution should be exercised in using Azithromycin in these patients from.

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