INDICATION Upper and lower respiratory tract infections, Urinary tract infections, Gonococcal urethritis, Acute otitis media. DOSAGE AND ADMINISTRATION Cef-3® Capsule/Tablet: 200 mg – 400 mg, as a single dose or in 2 divided doses daily for 7-14 days, according to the severity of infection. Cef-3® Powder for Suspension: Child dose: 8 mg/kg daily as a single dose or in two divided doses for 7-14 days according to the severity of infection or for children of age 1/2-1 year: 3.75 ml or 75 mg; 1-4 years: 5 ml or 100 mg; 5-10 years: 10 ml or 200 mg; 11-12 years:15 ml or 300 mg; above 12 years: adult dose. SIDE EFFECTS Cef-3® is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature. Gastro-intestinal disturbances : Diarrhoea (if severe diarrhoea occurs, Cef-3® should be discontinued), changes in the colour of stool, nausea, abdominal pain, dyspepsia, vomiting, atulence have been reported. Central nervous system disturbances: Headache, dizziness. Others: Hypersensitivity reactions which usually subside upon discontinuation of therapy; infrequent and reversible haematological changes; elevation of serum amylase. CONTRA-INDICATION Patients with known hypersensitivity to cephalosporin group of drugs. PRECAUTION Cef-3® should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml. min-1) USE IN PREGNANCY AND LACTATION No data are available, so it is probably best to avoid using the drug during pregnancy and by the nursing mothers. USE IN ELDERLY No special precautions are necessary. Old age is not an indication for dose adjustment. USE IN CHILDREN For children younger than 12 years or weighing less than 50 kg, the usual dose is 8 mg/kg/day. DRUG INTERACTION No data are available. PHARMACEUTICAL PRECAUTION Capsule and Tablet: Store below 300 c and away from direct sunlight. Powder for Suspension: Prior to reconstitution, store below 250 c. After reconstitution, the suspension may be kept for 14 days under refrigeration or at room temperature, without signicant loss of potency. DIRECTIONS FOR RECONSTITUTION OF SUSPENSION Cef-3® Powder for Suspension: To prepare 30 ml suspension, 20 ml boiled and cooled water is required. To prepare 40 ml suspension, 25 ml boiled and cooled water is required. To prepare 50 ml suspension, 35 ml boiled and cooled water is required. INFORMATION FOR THE PATIENT 1) Shake well before using the suspension. 2) Do not discontinue the therapy suddenly, without consulting your doctor. 3) Discard unused portion of reconstituted suspension after the above mentioned time. 4) Keep away from the reach of the children.
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