PRODUCT DETAILS
Azithromycin USP

Azithromycin is an azalide, a sub-class macrolide antibiotics. Azithromycin demonstrates activity in vitro, against a wide range of Gram-positive and Gram-negative bacteria including : Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes (Group A) and other Streptococcal species; Haemophilusinfluenzae, parainfluenzae; Moraxellacatarrhalis; anaerobes pertussis; Bordetellaparapertussis; Neisseriagonorrhoeae and Chlamydia trachomatis. Azithromycin also demonstrates in vitro activity against Mycoplasmapneumoniae; Campylobacter spp., and Treponemapallidum.

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:

Xolide® 250 mg capsule : Each capsule contains Azithromycindihydrate USP equivalent to Azithromycin 250 mg.
Xolide® 500 mg capsule : Each capsule contains Azithromycindihydrate USP equivalent to Azithromycin 500 mg.
Xolide® Dry powder for suspension : Each 5 ml reconstituted suspension contains Azithromycin 200 mg as Azithromycindihydrate USP.

  Dosage and Administration

InfectionRecommended DoseDuration of Therapy
Upper Respiratory tract infections:Pharyngitis,Tonsillitis,Acute bacterial sinusitis,Acute otitis media.Lower Respiratory tract infections:Community-acquired pneumonia,Acute bacterial exacerbations of chronic Obstructive, pulmonary disease (COPD),BronchitisAdult : 500 mg once daily or 500 mg once on day 1, followed by 250 mg once daily for next 4 days. Child : 10 mg/kg once daily5 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 daily3 days
Genital ulcer disease (chancroid)Adult : 1 gram single dose-
Non-gonoccocalurethritis and cervicitisAdult : 1 gram single dose-
Gonococcalurethritis and cervicitisAdult : 2 gram single dose-
Typhoid/ ParatyphoidAdult : 1 gram once daily.Child : 20 mg/kg once daily 5 days
DiarrhoeaAdult : 1-1.5 mg once daily.Child : 20 mg/kg once daily -
CholeraAdult : 1 gram single dose.Child : 20 mg/kg single dose-
ShigellosisAdult : 1-1.5 gram once daily.Child : 20 mg/kg once daily1 - 5 days
Dental infectionAdult : 500 mg once daily.Child : 10 mg/kg once daily3 days
Eye infection (trachoma)Adult : 1 gram single dose.Child : 20 mg/kg single dose-

  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 in patients with a known 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.

  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 known 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.
Suspension : First shake the bottle to loosen the powder. Then add 20 ml boiled and cooled water with the help of our provided measuring cup into the bottle and shake well to make 30 ml suspension.

  Storage

Protect from light, store in cool & dry
Discard any unused portion of reconstituted Xolide® suspension after 10 days.

  Commercial Pack

Xolide® 250 mg capsule: Each Box contains 6 capsule (1 x 6\\\\\\\'s) in Alu-Alu Blister Pack.
Xolide® 500 mg capsule: Each Box contains 3 capsule (1 x 3\\\\\\\'s) in Alu-Alu Blister Pack.
Xolide® 30 ml 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.

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