Cefim-3^®

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.

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Cefim 3 is indicated for the treatment of upper and lower respiratory tract infections, urinary tract infections, gonococcal urethritis, typhoid fever and acute otitis media.

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.

*Note: "Teaspoon" and "ml" calculation based on Cefim 3 powder for suspension only.

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.

Pregnancy: There are no adequate and well controlled studies in pregnant women. Therefore, cefixime should not be used in pregnancy unless considered essential by the physicians.

Lactation: There are no adequate and well controlled studies in nursing women. Therefore, cefixime should not be used in nursing mothers unless considered essential by the physicians.

Use in children and adolescents
The use of cefixime in children and adolescents has been described in dose and administration section.

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.

Cefixime is generally well tolerated. The majority of side effects observed in clinical trials were mild and self-limiting in nature. Among them diarrhea, changes in the color of stool, nausea, abdominal pain, dyspepsia, headache, dizziness, elevation of serum amylase may occur.

Cefixime is contraindicated in patients with known hypersensitivity to cephalosporin group of drugs or any components of this product.

Drug interaction with medication: In common with other cephalosporins, increases in prothrombin times 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 sulfate test tablets, but not with test based on enzymatic glucose oxidase reactions.

Drug interaction with food and others: Not applicable.

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.

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Store in a cool (below 25°C) and dry place protected from light. Keep away from the reach of children.

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.

Storage
Store below 25°C in a dry place, protected from light. Keep away from the reach of children.

Packing
Cefim 3 capsule: Carton of 14 capsules in blister pack.
Cefim 3 DS capsule: Carton of 14 capsules in blister pack.
Cefim 3 tablet: Carton of 14 tablets in blister pack.
Cefim 3 DS tablet: Carton of 14 tablets in blister pack.
Cefim 3 PD powder for pediatric drops: Bottle of 21 ml with food grade dropper and 5 ml spoon.
Cefim 3 powder for suspension: Bottles of 30 ml, 50 ml and 75 ml with food grade dropper.
Cefim 3 DS powder for suspension: Bottle of 50 ml with food grade dropper.