Globexim 200 Mg Capsule

Presentation

Globexim 200 Capsule: Each capsule contains Cefixime Trihydrate USP equivalent to Cefixime 200 mg.

Globexim Powder for Suspension: When reconstituted each 5 ml suspension contains Cefixime Trihydrate BP equivalent to Cefixime 100 mg.

Description

Globexim (Cefixime) is a broad spectrum semisynthetic third generation Cephalosporin antibiotic, for oral administration. It is a bactericidal antibiotic & is stable to hydrolysis by many beta lactamases. Cefixime 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. Cefixime is mainly excreted unchanged in bile and urine.

Indications

Globexim (Cefixime) is used in the treatment of following infections caused by sensitive organisms:

• Upper respiratory tract infections: Otitis media and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics.
• Lower respiratory tract infection: Bronchitis.
• Urinary tract infections: Cystitis, cystourethritis, pyelonephritis, gonococcal urethritis.
• Gonorrhea (Uncomplicated)
• Typhoid fever

Dosage & Administration

The usual course of treatment is 7 days. This may be continued for up to 14 days if required.

Capsule:

Adult & Child over 10 years          : 200-400 mg daily 1-2 divided doses.

Gonorrhea          : 400 mg as a single dose.

Powder for Suspension:

Children above 6 months              : 8 mg/kg daily in 1-2 divided doses.

Or 6 months-1year           : 3.75 ml or 75 mg daily.

1-4 years             : 5 ml or 100 mg daily.

5-10 years           : 10 ml or 200 mg daily.

Typhoid fever     : 20 mg/kg body weight daily in 2 divided doses for 8 days.

Direction for Reconstitution of Suspension

Shake the bottle well to loosen the powder. Add 30 ml (with the help of supplied measuring cup) of boiled and cooled water to the powder in the bottle. Shake the bottle vigorously until all the powder dissolve to make a suspension. For ease of preparation add water to the bottle in two portions and shake each time.

Note: Shake the bottle vigorously before use. Keep the bottle tightly closed. The reconstituted suspension should be used within 7 days of preparation if kept at room temperature or within 14 days if kept in refrigerator.

Contraindications

Cefixime is contraindicated in patients with known hypersensitivity to cephalosporin group of drugs.

Adverse Effects

Cefixime is generally well tolerated. The majority of adverse reactions 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.

Precautions

Cefixime should be prescribed with caution in individual with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20ml/min).

Drug Interactions

Cefixime interacts with following drugs:

• Carbamazepine: Elevated carbamazepine levels have been reported.
• Warfarin and Anticoagulants: Increased prothrombin time with or without clinical bleeding has been reported when cefixime is administered concomitantly.

Pregnancy & Lactation

No data is available, so it is probably the best to avoid using the drug during pregnancy and lactation.

Storage

Store in cool and dry place protected from light. Keep out of the reach of children.

Packaging

Globexim 200 Capsule: Each box contains 8 capsules in Alu-Alu blister pack.

Globexim Powder for Suspension: Each box contains a bottle containing dry powder to reconstitute 50 ml suspension and a measuring cup.