Each Capsule contains: Cefixime (as Trihydrate) 400 mg.
After reconstitution each 5 mL suspension contains: Cefixime (As Trihydrate) 100 mg.
Pharmacology: Cefixime Trihydrate (Ofex) is a third generation semisynthetic cephalosporin antibacterial for oral administration. It is bactericidal against broad spectrum of Gram-positive and Gram-negative bacteria at easily achievable plasma concentrations. It is also highly stable in the presence of beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamase, may be susceptible to cefixime. Absorption is about 40% to 50% whether administered with or without food. It has longer duration of action than the other oral cephalosporins.
For the treatment of infections due to sensitive Gram-positive and Gram-negative bacteria such as: Salmonella typhi, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae, Pneumonia, Haemophilus influenzae, Streptococcus, Pyrogenes, Moraxella catarrhalis.
Adult doses of 200 to 400 mg daily as a single dose or in two divided doses.
Children over 6 months & under 50 kg may be given 8 mg/kg daily as a single dose or two divided doses or as prescribed by the physician.
It is contraindicated in hypersensitivity to cefixime or other cephalosporins.
The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis.
Dosage adjustment in only necessary in severe renal failure (creatinine clearance < 20 mL/min), in that case a dose of 200 mg once daily should not be exceeded.
There are no adequate and well-controlled studies in pregnant women. Cefixime Trihydrate (Otex) should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.
The drug is generally well tolerated. The most frequent side effects are diarrhea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritis, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon discontinuation of therapy.
Carbamazepine: Concomitant use elevates the carbamazepine level.
Warfarin and other anticoagulants: Concomitant use increases prothrombin time or without clinical bleeding.
Store at temperatures not exceeding 30°C.
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Ofex powd for oral susp 100 mg/5 mL
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