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.

Patients with known hypersensitivity to cephalosporin antibiotics.

Denvar is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self limiting in nature. Gastrointestinal disturbances: The most frequent side-effects seen with Denvar are diarrhoea and stool changes; diarrhoea has been more commonly associated with higher doses. Other gastrointestinal side-effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembraneous colitis has been reported. Central nervous system: headache and dizziness. Hypersensitivity reactions: allergies in the form of rash, pruritis, urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy. Hematological and clinical chemistry: thrombocytopenia, leukopenia and eosinophilia have been reported. These reactions were infrequent and reversible. Mild transient change in liver and renal function tests have been observed. Miscellaneous: other possible reactions include genital pruritis and vaginitis.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Denvar should be given with caution to patients who have shown hypersensitivity to other drugs. Cephalosporin should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Denvar, the drug should be discontinued and the patient treated with appropriate agents if necessary. Denvar should be administered with caution in patients with markedly impaired renal function. 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. Use in pregnancy and lactation: There are no adequate and well-controlled studies in pregnant women. Denvar should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Denvar 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 Denvar did not differ from the profile seen in patients treated at the recommended doses.

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.