Composition
Cap/Tab 250 mg/500 mg: Azithromycin (as dihydrate) 250 mg/500 mg. Susp 200 mg: Per 5 ml: Azithromycin (as dihydrate) 200 mg; powder for suspension. Susp 2 gm: Azithromycin (as dihydrate) 2 gm
Indications & Dosage
Prevention of secondary case of invasive group A streptococcal infection (in patients who are allergic topenicillin): Adult & Children above 12 yrs: 500 mg once daily for 5 days. Children 6 months-11 yrs: 12 mg/kg once daily (max. per dose 500 mg) for 5 days. Respiratory-tract infections, otitis media, skin and soft-tissue infections: Adult: 500 mg once daily for 3 days, alternatively initially 500 mg once daily for 1 day, then 250 mg once daily for 4 days Child 6 months-17 years: 10 mg/kg once daily (max. per dose 500 mg) for 3 days. Uncomplicated genital chlamydial infections, Non gonococcal urethritis: Adult & Children above 12 yrs: 1 g for 1 dose. Uncomplicated gonorrhea: Adult: 1 g for 1 dose. Lyme disease (under expert supervision): Adult: 500 mg once daily for 7-10 days. Mild to moderate typhoid due to multiple-antibacterial resistant organisms: Adult: 500 mg once daily for 7 days. Community-acquired pneumonia: ORAL: Adult: 500 mg once daily for 3 days, alternatively initially 500 mg once daily for 1 day, then 250 mg once daily for 4 days. BY IV INF: For severe cases: Adult: Initially 500 mg once daily for at least 2 days, then (by mouth) 500 mg once daily for a total duration of 7-10 days. Antibacterial prophylaxis for insertion of intra-uterine device: Adult: 1 g for 1 dose. Pelvic inflammatory disease: BY IV INF: Adults: Single dose of 500 mg for 1-2 days, followed by oral daily single dose of 250 mg for 7 days.
Administration
Administer over at least 60 min. Other medications should not be infused simultaneously through the same IV line. Prepare initiation solution by adding 4.8 ml of SWFI to the 500 mg vial (resulting conc. 100 mg/ml). Use of a standard syringe is recommended due to the vacuum in the vial (which may draw additional solution through an automated syringe). The initial solution should be further diluted to a concentration of 1 mg/ml (500 ml) to 2 mg/ml (250 ml) in NS, D5W, LR.
Compatibility
Stable in NS, D5W, TR,
Stability
Store intact vials of injection at room temperature. Reconstituted solution is stable for 24 hours when stored below 30C (86F). The diluted solution is stable for 24 hours, at or below room temperature 30C (86F) and for 7 days if stored under refrigeration 5C (41T).
Contraindications
Hepatic disease.
Precautions
Renal or hepatic impairment. Electrolyte disturbances, may aggravate myasthenia gravis, predisposition to QT interval prolongation
Interactions
Ergot derivatives, antacids, cyclosporin, digoxin, warfarin.
Pregnancy
Avoid, use only if no suitable alternatives.
Lactation
Caution advised use only if no suitable alternatives,
Side Effects
Abdominal discomfort, diarrhoea, nausea, vomiting, Cholestatic jaundice, hepatotoxicity, rash, anorexia, arthralgia, disturbances in taste and vision, dizziness, dyspepsia, flatulence, headache, malaise, paraesthesia, anxiety, chest pain, constipation, gastritis, hypoaesthesia, leucopenia, oedema, photosensitivity, sleep disturbances, acute renal failure, convulsions, haemolytic anaemia, interstitial nephritis, syncope, thrombocytopenia, tongue discoloration. Rare Agitation, antibiotic-associated colitis, arrhythmias, pancreatitis, QT interval prolongation, Stevens-Johnson syndrome, toxic epidermal necrolysis. With intravenous use; Local tenderness and phlebitis