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Product Details

Supraxim®
Cefixime
Description
Supraxim (Cefixime) is a broad spectrum cephalosporin antibiotic of 3rd generation for oral administration. It is a bacteriocidal antibiotic and is stable to hydrolysis by many β lactamases. Supraxim kills bacteria by interfering in the synthesis of the bacterial cell wall. 40-50% of an oral dose is absorbed from GIT, 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. Supraxim is mainly excreted unchanged in bile and urine.
Presentation
Supraxim® Capsule: Each capsule contains Cefixime Trihydrate USP equivalent to 200 mg Cefixime anhydrous.
Supraxim® Powder for suspension: Each 5 ml dry suspension contains Cefixime Trihydrate USP equivalent to 100 mg Cefixime anhydrous

Indications
Supraxim is indicated for the treatment of the following acute infections when caused by susceptible micro-organisms:
• UPPER RESPIRATORY TRACT INFECTIONS (URTI): e.g. otitis media; and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk.
• LOWER RESPIRATORY TRACT INFECTION: e.g. bronchitis.
• URINARY TRACT INFECTIONS: e.g. cystitis, cystourethritis, uncomplicated pyelonephritis.
• TYPHOID FEVER
• GONOCOCCAL URETHRITIS

Dosage & administration
Absorption of Cefixime is not significantly modified by the presence of food. The usual course of treatment is 7 days. This may be continued for up to 14 days if required.
ADULTS AND CHILDREN OVER 10 YEARS: The recommended adult dosage is 200-400 mg daily according to the severity of infection, given either as a single dose or in two divided doses.
THE ELDERLY: Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe renal impairment (See “Dosage in Renal Impairment”).
CHILDREN (USE PAEDIATRIC ORAL SUSPENSION): The recommended dosage for children is 8 mg/kg/day administered as a single dose or in two divided doses. As a general guide for prescribing in children the following daily doses in terms of volume of Paediatric Oral Suspension are suggested:
Children 6 months -1 year: 3.75 ml daily
Children 1-4 years: 5 ml daily
Children 5-10 years: 10 ml daily
Children weighing more than 50 kg or older than 10 years should be treated with the recommended adult dose (200-400 mg daily depending on the severity of infection). The safety and efficacy of Cefixime has not been established in children less than 6 months.
DOSAGE IN RENAL IMPAIRMENT: Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearances of 20 mUmin or greater. In patients whose creatinine clearance is less than 20 ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded. The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or haemodialysis should follow the same recommendation as that for patients with creatinine clearances of less than 20 ml/min.

Contraindications, side-effects and warnings

Contraindications:
Patients with known hypersensitivity to cephalosporin antibiotics.

Side-effects:
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 colour stool changes, nausea, abdominal pain, dyspepsia, headache, dizziness, elevation of serum amylase may occur.

Use in pregnancy and lactation:
Reproduction studies have been performed in mice and rats at doses up to 400 times of the human dose and have revealed no evidence of impaired fertility or harm to the foetus due to Cefixime. In the rabbit, at doses up to 4 times the human dose, there was no evidence of a teratogenic effect; there was a high incidence of abortion and maternal death which is an expected consequence of the known sensitivity of rabbits to antibiotic-induced changes inthe population of the microflora of the intestine.

There are no adequate and well-controlled studies in pregnant women. Cefixime should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

Interaction with other medicinal products and other forms of interaction:
A false positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solutuions or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions.
A false positive direct Coombs test has been reported during treatment with cephalosporin antibiotics, therefore it should be recognised that a positive Coombs test may be due to the drug.
In common with other cephalosporins, increases in prothrombin times have been noted in a few patients. Care should therefore be taken in patients receiving anticoagulation therapy.

Special warnings and precautions for use:
Cefixime should be given with caution to patients who have shown hypersensitivity to other drugs. Cephalosporins should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins.
Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Cefixime, the drug should be discontinued and the patient treated with appropriate agents if necessary.
Cefixime should be administered with caution in patients with markedly impaired renal function (See “Dosage in Renal impairment”).
Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated diarrhoea. Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins, lincosamides and cephalosporins); it is therefore important to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment.
Management of pseudomembranous colitis should include sigmoidoscopy, appropriate bacteriologic studies, fluids, electrolytes and protein supplementation. If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral
vancomycin is the drug of choice for antibiotic-associated pseudomembranous colitis
produced by C. difficile. Other causes of colitis should be excluded.

Packaging quantity
Supraxim® Capsule: 2×3’s capsule in Alu-Alu Blister.
Supraxim® Powder for suspension: Amber glass bottle containing powder to prepare 30 ml suspension.
Supraxim® Powder for suspension: Amber glass bottle containing powder to prepare 50 ml suspension.