Cefim 3 capsule: Each capsule contains Cefixime 200 mg as Cefixime Trihydrate USP.
Cefim 3 DS capsule: Each capsule contains Cefixime 400 mg as Cefixime Trihydrate USP.
Cefim 3 tablet: Each coated tablet contains Cefixime 200 mg as Cefixime Trihydrate USP.
Cefim 3 DS tablet: Each coated tablet contains Cefixime 400 mg as Cefixime Trihydrate USP.
Cefim 3 PD powder for pediatric drops: After reconstitution, each ml contains Cefixime 25 mg as Cefixime Trihydrate USP.
Cefim 3 powder for suspension: After reconstitution, each 5 ml contains Cefixime 100 mg as Cefixime Trihydrate USP.
Cefim 3 DS powder for suspension: After reconstitution, each 5 ml contains Cefixime 200 mg as Cefixime Trihydrate USP.
Cefim 3 is a preparation of Cefixime Trihydrate which is a broad spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic and is stable to hydrolysis by many ß-lactamases. Cefim 3 kills bacteria by interfering in the synthesis of the bacterial cell wall. 40%-50% of an oral dose is absorbed from gastrointestinal 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. Cefim 3 is mainly excreted unchanged in bile and urine. Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (ß-lactamase positive and negative), Moraxella catarrhalis (ß-lactamase positive and negative) and Enterobacter species. Cefixime is highly stable in the presence of ß-lactamase enzymes.
Route of administration : Cefim 3 should be taken in oral route. The usual duration of treatment of Cefim 3 is 7 days. This may be continued for up to 14 days. Child over 6 months: 8 mg/kg daily as a single dose or in two divided doses. Child 6 months-I year: 75 mg daily or 3.75 ml (3/4 teaspoonful)* daily. Child 1-4 years: 100 mg daily or 5 ml (1 teaspoonful)* daily. Child 5-10 years: 200 mg daily or 10 ml (2 teaspoonfuls)* daily. Adult and children over 10 years: 200-400 mg daily as a single dose or in two divided doses.
Directions for reconstitution of suspension Shake the bottle well before mixing the water. Cefim 3 PD powder for pediatric drops (21 ml): To prepare 21 ml pediatric drops, add 15 ml (3 teaspoonfuls) of boiled and cooled water in two portions and shake well after each addition till powder is completely mixed with water.
Cefim 3 powder for suspension (30 ml): To prepare 30 ml suspension, add 20 ml (4 teaspoonfuls) of boiled and cooled water in two portions and shake well after each addition till powder is completely mixed with water.
Cefim 3 powder for suspension (50 ml): To prepare 50 ml suspension, add 35 ml (7 teaspoonfuls) of boiled and cooled water in two portions and shake well after each addition till powder is completely mixed with water.
Cefim 3 powder for suspension (75 ml): To prepare 75 ml suspension, add 52.5 ml (10.5 teaspoonfuls) of boiled and cooled water in two portions and shake well after each addition till powder is completely mixed with water.
Cefim 3 DS powder for suspension (50 ml): To prepare 50 ml suspension, add 30 ml (6 teaspoonfuls) of boiled and cooled water in two portions and shake well after each addition till powder is completely mixed with water.
Keep the prepared suspension in a cool place and consume within 14 days of preparation. Use the supplied dropper for water measurement.
Probenecid increases cefixime peak serum concentrations and AUC; elevates carbamazepine plasma concentrations when administered concomitantly; enhances anticoagulant response of warfarin (monitor prothrombin time/INR).
Cefixime is contraindicated in patients with known hypersensitivity to cephalosporin group of drugs or any components of this product.
Common: Diarrhea, loose stools, nausea, abdominal pain, dyspepsia, headache, dizziness. Less Common: Elevated serum amylase.
Overdose
Gastric lavage may be indicated otherwise no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of cefixime did not differ from the profile seen in patients treated at the recommended doses.
Category B. No adequate and well-controlled studies in pregnant women; use during pregnancy only if considered essential. Lactation: Excretion in human milk unknown; caution advised.
Store below 25°C in a cool, dry place. Protect from light. Reconstituted suspension should be refrigerated (2°C-8°C) and used within 14 days.