Cefim-3®

Prescribing Details

Description

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 β-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 (β·lactamase positive and negative), Moraxella catarrhalis (β·lactamase positive and negative) and Enterobacter species. Cefixime is highly stable in the presence of β-lactamase enzymes.

Uses

No Data

Indications

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.

Dosage and administration

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 2 divided doses.

Child 6 months-1 year: 75 mg daily or 3.75 ml(% 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 2 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® 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.

Use in pregnancy & lactation

Pregnancy: Cefixime is pregnancy category B drug. Reproduction studies was performed in mice and rats at doses up to 400 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to cefixime. 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 explained in dose and administration section.

Precautions

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.

Side effects

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.

Contraindications

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

Drug interactions

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.

Drug interaction with food and others: 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.

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.

Preparation

No Data

Pharmaceutical precautions

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

Presentation

Cefim-3® capsule: Each capsule contains Cefixime 200 mg as Trihydrate USP.

Cefim-3® DS capsule: Each capsule contains Cefixime 400 mg as Trihydrate USP.

Cefim-3® tablet: Each coated tablet contains Cefixime 200 mg as Trihydrate USP.

Cefim-3® DS tablet: Each coated tablet contains Cefixime 400 mg as Trihydrate USP.

Cefim-3® pediatric drops: After reconstitution, each ml contains Cefixime 25 mg as Trihydrate USP.

Cefim-3® powder for suspension: After reconstitution, each 5 ml contains Cefixime 100 mg as Tri hydrate USP. Cefim-3″ DS powder for suspension: After reconstitution, each 5 ml contains Cefixime 200 mg as Tri hydrate USP.

Package quantitie

Cefim-3® capsule: Carton of 12 capsules in blister pack.

Cefim-3® DS capsule: Carton of 6 capsules in blister pack.

Cefim-3® tablet: Carton of 14 tablets in blister pack.

Cefim-3® DS tablet: Carton of 7 tablets in blister pack.

Cefim-3® 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 drdroper