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Tgocef (Cefixime)

Pharmacology:

Tgocef (Cefixime) is a broad spectrum semisynthetic third generation Cephalosporin antibiotic for oral administration. It is a bacteriocidal antibiotic and is stable to hydrolysis by many beta lactamases.

Tgocef (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. Tgocef is mainly excreted unchanged in bile and urine.

COMPOSITION:

Tgocef 200 Capsule : Each Capsule contains Cefixime Trihydrate BP equivalent to Cefixime 200 mg.

Tgocef 400 Capsule : Each Capsule contains Cefixime Trihydrate BP equivalent to Cefixime 400 mg.

Tgocef Powder for: When reconstituted each 5 ml Suspension Suspension contains Cefixime Trihydrate BP equivalent to Cefixime 100 mg. Tgocef DS powder for :When reconstituted each 5 ml Suspension suspension contains Cefixime Trihydrate BP equivalent to Cefixime 200 mg.

INDICATION:

  • Upper Respiratory Tract Infections e.g. Sinusitis, Tonsillitis, Pharyngitis, Laryangitis.
  • Lower Respiratory Tract Infections e.g. Pneumonia, Acute bronchitis and Acute Exacerbations of Chronic Bronchitis, Bronchiectasis.
  • Acute Otitis Media.
  • Typhoid & Paratyphoid fever.
  • Urinary Tract Infections e.g. Cystitis, Cystourethritis, Uncomplicated Pyelonephritis, Glomerulonephritis.
  • Gonococcal Infections.

DOSAGE AND ADMINISTRATION:

Adult & child over 10 years : 200 - 400 mg daily in 1-2 divided doses for 7-14 days according to severity of infection

Child over 6 months            : 8 mg/kg in 1-2 divided doses

Or 6 months-1 year             : 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 and Paratyphoid

Adult         : 200 mg 12 hourly

Child         : 10 mg/kg 12 hourly

Gonorrhea : 400-800 mg as a single dose

CONTRAINDICATION:

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

SIDE EFFECT:

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

PRECAUTION:

Tgocef (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).

USE IN PREGNANCY AND LACTATION:

Pregnancy: Pregnancy category B.

This drug should be used during pregnancy only if clearly needed.

Lactation: It is not known whether Cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

DRUG INTERACTION:

Carbamazepine: Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly.

Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when Cefixime is administered concomitantly.

STORAGE:

Capsule: Store at room temperature and away from direct sunlight.

Powder for Suspension: Prior to reconstitution, store at room temperature. After reconstitution, the suspension may be kept for 14 days under refrigeration or at room temperature without significant loss of potency.

DIRECTION FOR RECONSTITUTION OF SUSPENSION:

Shake the bottle to loosen the powder. Add 35 ml (7 measuring spoonfuls) of boiled cool water to the dry powder in the bottle. For ease of preparation, add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension. After reconstitution it may be used for 14 days.

NFORMATION FOR THE PATIENT:

  • Shake well before using the suspension.
  • Do not discontinue the therapy suddenly, without consulting your physician.
  • Discard unused portion of reconstituted suspension after the abovementioned time.
  • Keep away from the reach of the children.

PACKAGING:

Tgocef 200 Capsule : Each box contains 3 x 4 capsules in alu-alu pack.

Tgocef 400 Capsule : Each box contains 1 x 4 capsules in alu-alu pack.

Tgocef Powder for Suspension: Box containing two bottles. Large bottle contains Cefixime powder and small bottle contains diluent for suspension. After reconstitution as per direction bottle containing 30 & 50 ml suspension.

Tgocef DS Powder for Suspension: Each bottle contains dry powder for

preparation of 50 ml suspension.

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