Cefixime Trihydrate USP

Composition :

Bioxim Capsule: Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 200 mg. Bioxim 400 Capsule: Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 400 mg. Bioxim Powder for Suspension: After reconstitution each 5 ml suspension contains Cefixime Trihydrate USP equivalent to Cefixime 100 mg. Bioxim DS Powder for Suspension: Afte

Pharmacology :

Cefixime is a broad spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic and is stable to hydrolysis by many beta-lactamases.Cefixime kills bacteria by interfering in the synthesis of the bacterial cell wall. Cefixime is highly active against Neisseria gonorrhoeae, Haemophilus influenzae, Moraxella catarrhalis including betalactamase producers, most of the Enterobacteriaceae, betahaemolytic Streptococci (group A & B) and Streptococcus pneumoniae. Cefixime is more active than other oral cephalosporins against Escherichia coli, Klebsiella spp., Proteus mirabilis, Serratia marcescens and 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% is bound to plasma protein.Cefixime is mainly excreted unchanged in bile and urine.

Indications :

Bioxim is indicated for the treatment of urinary tract infections, upper and lower respiratory tract infections, acute otitis media, gonococcal urethritis and enteric fever.

Dosage & Administration :

Adult : 1 or 2 capsules (200-400 mg) as a single dose or in 2 divided doses daily for 7-14 days, according to the severity of the infection. Child : 8 mg/kg daily as a single dose or in two divided doses for 7-14 days 

Contraindications :

It is contraindicated in patients with known hypersensitivity to cephalosporins group of drugs

Side Effects :

Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature. Gastrointestinal disturbances include diarrhoea, nausea, abdominal pain, dyspepsia, vomiting and flatulence.CNS disturbances include headache and dizziness.

Precautions:

Cefixime should be administered with caution in patients with markedly impaired renal function\

Use in Pregnancy & Lactation :

There are no adequate and well controlled studies in pregnant women. Cefixime should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

Drug Interactions :

In common with other cephalosporins, increases in prothrombin time have been noted in a few patients. Care should therefore be taken in patients receiving anticoagulant therapy. A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets, but not with test based on enzymatic glucose oxidase reactions.

Storage :

Capsule & Dry powder for Suspension : Store in a cool and dry place, away from light. Keep out of the reach of children. The reconstituted suspension should be used within 7 days if kept in room temperature or within 14 days if refrigerated

Packing :

Bioxim Capsule: Each commercial box contains 2 x 4/3 x 4 capsules in Alu-Alu blister pack. Bioxim 400 Capsule: Each commercial box contains 1 x 4/2 x 4 capsules in Alu-Alu blister pack. Bioxim Powder for Suspension: Each bottle contains dry powder for preparation of 30/50 ml suspension. Bioxim DS Powder for Suspension: Each bottle contains dry powder for preparation of 30/37.5/50/60 ml suspensio