COMPOSITION
Each Capsule contains 250mg Azithromycin in the form of Azithromycin dihydrate.

PHARMACOLOGY:
Azithromycin is an azalide derived from the macrolide class of antibiotics with anti-infective action against large number of pathogens, gram negative and gram positive including: Staphylococcus aureus, Streptococcus pneumonia, Streptococcus pyogenes (Group A) and other streptococcal species, Hemophilus influenzae and Parainfluenzae and anaerobes including: Bacteroides fragilis, Escherischia coli, Bordetella pertussis, Bordetella parapertussis, Neisseria gonorrheae and Chlamydia trachomatis.

PHARMACOKINETICS :
Following oral administration 40% of a dose is bioavailable. Absorption is reduced by food . Peak plasma concentrations are achieved in 2 to 3 hours after a dose, but azithromycin is extensively distributed to the tissues and tissue concentrations subsequently remain much higher than those in the blood indicating that the drug is highly tissue bound. High concentrations are taken up into white cells.

INDICATIONS:
Azitromed is indicated for the treatment of infections caused by susceptible organisms in:
- lower respiratory tract infections including bronchitis and pneumonia.
- Skin and soft tissue infections.
- Otitis media.
- Upper respiratory infections including sinusitis and pharyngitis and tonsillitis.
- Sexually transmitted diseases in men and women.
- Uncomplicated genital infections due to chlamydia.
- AIDS patients with cerebral toxoplasmosis.

SIDE EFFECTS:
Azitromed is well tolerated with a low incidence of side - effects. Most of them were mild to moderate in severity. The majority of side-effects were gastrointestinal in origin with nausea, abdominal discomfort (pain/spasms)vomiting, flatulence, diarrhea some times being observed.

DOSAGE AND ADMINISTRATION:
Azitromed should be administered as a single daily dose at least 1 hour before or 2 hours after meal. Adults daily dose starts with 500 mg (2 capsules) at first day followed by 250 mg (1 capsule) daily for the following 4 days. For sexually transmitted diseases caused by Chlamydia the dose is 1g. given as a single dose. AIDS patients with cerebral toxoplasmosis 500mg of Azithromycin daily with the dose of pyrimethanine produce complete resolution of brain lesions within 2 weeks. For other indications, 500mg daily for 3 days.

CONTRA-INDICATIONS:
Azitromed is contraindicated in patients with a known hypersensitivity to Azithromycin or any of the macrolide antibiotics.

PRECAUTIONS & WARNINGS:
- As with Erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic oedema and anaphylaxis, have been reported.
- As with all antibiotics, observation for signs of superinfection with non susceptible organisms, including fungi is recommended.
- Azithromycin should be used with caution when it is administered to patients with severe renal/hepatic impairment.
- As the liver is the principal route of excretion of Azithromycin, it should not be used in patients with hepatic diseases.
- Animal reproduction studies have demonstrated that Azithromycin crosses the placenta,but have revealed no evidence of harm to the foetus.
- There are no adequate and well controlled studies in pregnant women, Azitromed should be used during pregnancy only if adequate alternatives are not available.
- No data on secretion of Azithromycin in breast milk are available, so that it should only be used in nursing women where alternatives are not available.

DRUG INTERACTIONS:
Antacids : In patients receiving antacids, Azithromycin should be taken at least 1 hour before or 2 hours after the antacid.
Ergot Derivatives : Azithromycin and ergot derivatives should not be co-administered.
Warfarin : Azithromycin and Warfarin may be co-administered, but monitoring of the prothrombin time should be continued as routinely performed
Cyclosporin : Some of the related macrolide antibiotics interfere with the metabolism of cyclosporin . In the absence of pharmacokinetic studies or clinical data investigating a potential interaction between the two drugs caution should be taken before co-administration .

OVERDOSAGE:
There are no data on overdosage with Azitromed. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhea. Gastric lavage and general supportive measures are indicated.

PACKING:
Pack of 6 capsules.