CEFIMEX DS Suspension

INDICATIONS:

Cefimex is an orally active cephalosporine antibiotic, which has marked in vitro bactericidal activity against a wide variety of Gram positive & Gram negative organisms. It 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, sinusitis, pharyngitis & tonsillitis Lower respiratory tract infections (LRTI) e.g. bronchitis, urinary tract infections (UTI): e.g. cystitis, cystourethritis, uncomplicated pyelonephritis & uncomplicated gonorrhoea (cervical/urethral, rectal and pharyngeal).

DOSAGE & ADMINISTRATION:

Children (use paediatric oral suspension): the recommended dosage for children is 8mg/kg/day administered as a single dose. As a general guide for prescribing in children, the following daily doses in terms of volume of Paediatric oral suspension are suggested.

For Cefimex Suspension:

Children 1-4 years 5ml daily

Children 5-9 years 10ml daily

Children 10-12 years 15ml daily

For Cefimex DS suspension:

Children 1-4 years 2.5ml daily

Children 5-9 years 5ml daily

Children 10-12 years 7.5ml daily

Adults & Children Above 12 years 10ml daily

The dosage in children aged 6 months to one year should be calculated on mg/kg basis. Children weighing more than 30kg or older than 12 years should be treated with the recommended adult dose. The safety & efficacy of Cefixime. Trihydrate has not been established in children aged less than 6 months or as directed by the physician.

Absorption of Cefimex is not significantly modified by the presence of food. The usual course of treatment is 5-14days. Adults & children over 12 years. The recommended adult dosage is 400mg daily administered as a single dose.

Patients with known hypersensitivity to Cephalosporin antibiotics.

Cefimex is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature.

No significant drug interactions have been reported to data. A false positive reaction for glucose in the urine may occur with Benedicts or solutions or with copper sulphate test tablets, but not with test based on enzymatic glucose oxidase reactions. A false positive direct Coombs test has been reported during treatment with cephalosporin antibiotics, therefore it should be recognized that a positive Coombs test may be due to the drug.

Reproduction studies have been performed in mice and rats at does up to 400 times the human dose and reveated no evidence of impaired fertility or harm to the fetus due to Cefixime Trihydrate in the rabbit, at doses upto 4 times the human dose. There are no evidences 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 in the population of the microflora of the intestine. There are no adequate and well-controlled studies in pregnant women. Cefimex should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

Cefimex should be given with caution to patients who have shown hypersensitivity to other drugs Cephalosporins would be given with caution to penicillin-sensitives, as there is more some evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Patients have severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Cefimex the drug should be discontinued and the patient treated with appropriate agents, if necessary.

Cefimex should be administered with caution in patients with markedly impaired renal function (see dosage in renal impairment). Treatment with broad spectrum antibiotics alter 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 associates with the use of broad-spectrum antibiotics including macrolides, semi-synthetic penicillins lincosamides and cephalosporins. It is therefore important to consider its diagnosis on patients who develop diarrhoea is association with the use of antibiotics Symptoms of pseudomembranous colitis may occur.