Description

PHARMACOLOGY:

Azitor (Azithromycin) is an azalide antibiotic, subclass of the macrolide class of antibiotics.

Azitor (Azithromycin) acts by binding to the 50S ribosomal subunit of susceptible organisms and thus interferes with microbial protein synthesis. Azitor (Azithromycin) demonstrated activity in vitro, against a

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wide range of Gram-positive and Gram-negative bacteria including: Staphylococcus aureus, streptococcus pneumoniae, Streptococcus pyogenes (Group A) and other Streptococcus species; Haemophilus influenzae and parainfluenzae, Moraxella catarrhalls; anaerobes including Bacteroides fragilis, Escherichia coli. Bordetella pertussis, Bordetella parapertussis, Borrelia burgdorferi,. Haemophilus ducreyi, Neisseria gonorrhoeae and chlamydia trachomatis Azitor (Azithromycin) also demonstrates activity in vitro against legionella pneumophila, Mycoplasma pheumoniae and hominis; Campylobacter spp. toxoplasma gondil and Treponema pallidum.

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INDICATIONS:

Azitor

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(Azithromycin) is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections.

In sexually transmitted diseases in men and women, Azitor (Azithromycin) is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

DOSAGE & ADMINISTRATION:

Azitor 500 tablet can be taken with or without food.

Adults: for lower respiratory tract infections including bronchitis and pneumonia, upper respiratory tract infections including sinusitis and pharyngitis / tonsillitis, otitis media and skin and soft tissue infections, the total dose of Azitor is 1.5 gm given as 500 mg once daily for 3 days. An alternative to this dosage schedule is that 500 mg once daily on day 1, followed by 250 gm once daily for next 4 days.

For

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sexually transmitted diseases caused by chlamydia-trachomatis, the dose of Azitor is 1.0 gm given as a single dose. Alternatively 500 mg once daily on day 1, followed by 250 mg once daily for next 2 days may also be given.

Use in the elderly: Normal adult dosage is recommended.
Children: The dose of Azitor in children over 6 months of age is 10 mg/kg body weight one daily for 3 days. Alternatively, 10 mg/kg on day 1, followed by 5 mg/kg for next 4 days is also recommended. There is no information on use of Azithromycin, on children under 6 months of age. For children with body weight 15-25 kg (3-7 years), the dose is 200 mg once daily for 3 days, for body weight 26-35 (8-11 years), the dose is 500 mg once daily for 3 days; for body weight 36-46 (12-14 years), the doses is 400 mg once daily for 3 days. For body weights over 45 kg normal adult dosages is recommended.

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CONTRAINDICATIONS & PRECAUTIONS:

Azithromycin is contra-indicated 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 used in patients with hepatic disease. Avoid concomitant administration with terfenadine or astemizole. Precaution should be taken in patients with more severe renal impairment.

 

SIDE EFFECTS:

Azitor (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 and are reversible upon discontinuation of therapy.

OVERDOSAGE:

There are no data on over dosage with Azithromycin. Typical symptoms of over dosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

DRUG INTERACTIONS:

Antacids: Peak serum levels but not the total extents of absorption are reduced by aluminium-and magnesium-containing antacids in the stomach. Azithromycin should therefore be taken at least 1 hour before or 2 hours after taking these antacids. Ergot derivatives: Because of the theoretical possibility of ergotism, concomitant administration ergot derivatives and Azithromycin should be avoided. Digoxin & Cyclosporin: Macrolides have been known to increase the plasma concentration of Digoxin & Cyclosporin and so caution should be exercised while co-administration is necessary. Anti-histamines: A potentially life threatening interaction between erythromycin and terfenadine or astemizole has been reported. Although such and interaction with Azithromycin is not established yet, it is wise to avoid concomitant use of azithromycin and terfenadine or astemizole.

USE IN PREGNANCY AND LACTATION:

Recent clinical studies have recommended that Azithromycin should be considered for the initial treatment of chlamydial cervicitis in pregnancy. In other infections, Azithromycin should be used only when clearly needed. It is not known whether Azithromycin is excreted in breast milk. Exercise caution when administering to nursing women.

PHARMACEUTICAL PRECAUTION:

Azitor (Azithromycin) tablets and reconstituted suspension should be stored at room temperature (below 300 C).

HOW SUPPLIED:

Azitor 500 mg tablet: Box containing 1x 5 Azitor film coated tablets in Alu-Alu blister pack.

Azitor dry syrup: 35 ml dry powder for suspension Box containing sealed cap bottle containing Azitor dry powder for reconstituting 35 ml Azitor suspension with a measuring cup and dropper.

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