Cef-3-50ml

Cef-3®(Cexime) is a broad spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic and is stable to hydrolysisby many beta-lactamases. Cef-3®kills bacteria by interfering in the synthesis of the bacterial cell wall. Cef-3®is highly active against Neisseria gonorrhoeae,Haemophilus inuenzae, Moraxella catarrhalis including beta-lactamase producers, most of the Enterobacteriaceae, beta-haemolytic Streptococcus (group A& B) and Streptococcus pneumoniae. Cef-3®is more active than other oral cephalosporins against Escherichia coli, Klebsiella spp, Proteus mirabilis and Serratia marcescens. Cef-3®is also active against Streptococcus pyogenes. 40-50% of an oral dose is absorbed from gastro-intestinal tract, whether taken with meals or not.The plasma half life is usually about 3 to 4 hours and may be prolonged when there is renal impairment. About 65% of Cef-3®in the circulation is bound to plasma protein. Cef-3®is mainly excreted unchanged in bile and urine.
COMPOSITION
Cef-3®Capsule: Each capsule contains Cexime Trihydrate USP equivalent to Cexime 200 mg.
Cef-3®DS Capsule: Each capsule contains Cexime Trihydrate USP equivalent to Cexime 400 mg.
Cef-3®Tablet: Each tablet contains Cexime Trihydrate USP equivalent to Cexime 200 mg.
Cef-3®DS Tablet: Each tablet contains Cexime Trihydrate USP equivalent to Cexime 400 mg.
Cef-3®Powder for Suspension: Each 5 ml reconstituted suspension contains Cexime Trihydrate USP equivalent to Cexime 100 mg.
Cef-3® Forte Powder for Suspension: Each 5 ml reconstituted suspension contains Cexime Trihydrate USP equivalent to Cexime 200 mg.
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 significant 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.