Composition
Cefimax 200 capsule : Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 200 mg.
Cefimax powder for suspension: After reconstitution, each 5 ml suspension contains Cefixime Trihydrate USP equivalent to Cefixime 100 mg.
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. It is highly active against Neisseria gonorrhoeae, Haemophilus influenzae, Moraxella catarrhalis including beta-lactamase producers, most of the Enterobacteriaceae, beta-haemolytic Streptococcus (group A & B) and Streptococcus pneumoniae. Cefixime is more active than other oral cephalosporins against Escherichia coli, Klebsiella spp, Proteus mirabilis and Serratia marcescens. Cefixime 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 Cefixime in the circulation is bound to plasma protein. Cefixime is mainly excreted unchanged in bile and urine.
Indication
Cefixime is indicated in the following infectious diseases-
• Upper and lower respiratory tract infections
• Acute Otitis Media
• Typhoid fever
• Urinary Tract Infections
• Uncomplicated gonorrhea (cervical/urethral and rectal).
Dosage & administration
Cefimax capsule: 200 mg - 400 mg, as a single dose or in 2 divided doses daily for 7-14 days, according to the severity of infection.
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. or as directed by the physician.
Contra-indication
Patients with known hypersensitivity to cephalosporin group of drugs.
Warning & precaution
Cefixime 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)
Side effects
Cefixime 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, Cefixime should be discontinued), changes in the colour of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence 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.
Use in pregnancy & lactation
Cefixime should be used during pregnancy only if clearly needed. Caution should be exercised when administered to a nursing woman.
Use in children & adolescents
For children younger than 12 years or weighing less than 50 kg, the usual dose is 8 mg/kg/day.
Drug interaction
Cefixime should be administered with caution to patients receiving coumarin type anticoagulants such as warfarin potassium. It may enhance the effects of anticoagulants, prolonged prothrombin time with or without bleeding may occur.
Overdose
Symptoms of overdose include blood in the urine, diarrhea, nausea, upper abdominal pain, and vomiting.
Storage
Keep out of the reach of children. Keep below 30°C, protect from light.
Packing
Cefimax 200 capsule: Each box contains 2x6's capsules in blister pack.
Cefimax Powder for suspension: Each bottle containing dry powder for the preparation of 50 ml suspension with a measuring cup and a dropper.
