Ceftrimed

Each 5 mL of reconstituted suspension contains Cefixime (as trihydrate) 100 mg.

Pharmacology: Pharmacokinetics: Only 40% to 50% of an oral dose of cefixime is absorbed from the gastrointestinal tract, whether taken before or after meals, although the rate of absorption may be decreased in the presence of food. Cefixime is better absorbed from oral suspension than from tablets. Absorption is fairly slow; peak plasma concentrations of 2 to 3 μg per mL and 3.7 to 4.6 μg per mL have been reported between 2 and 6 hours after single doses of 200 and 400 mg, respectively. The plasma half-life is usually about 3 to 4 hours and may be prolonged when there is renal impairment. About 65% of cefixime in the circulation is bound to plasma proteins. Information on the distribution of cefixime in body tissues and fluids is limited. It crosses the placenta. Relatively high concentrations may be achieved in bile and urine. About 20% of an oral dose (or 50% of an absorbed dose) is excreted unchanged in the urine within 24 hours. Up to 60% may be eliminated by nonrenal mechanisms; there is no evidence of metabolism but some is probably excreted into the faeces from bile. It is not substantially removed by dialysis.
Microbiology: Cefixime is bactericidal and is stable to hydrolysis by many beta-lactamases. It has a mode of action and spectrum of activity similar to those third-generation cephalosporin cefotaxime, but some Enterobacteriaceae are less susceptible to cefixime. Haemophilus influenzae, Moraxella catarrhalis (Branhamella catarrhalis), and Neisseria gonorrhoeae are sensitive, including penicillinase-producing strains. Of the Gram-positive bacteria, streptococci are sensitive to cefixime but most strains of staphylococci, enterococci, and Listeria spp. are not. Enterobacter spp., Pseudomonas aeruginosa, and Bacteroides spp. are resistant to cefixime.

In the treatment of susceptible infections, including gonorrhea, otitis media, pharyngitis, lower respiratory-tract infections such as bronchitis, and urinary-tract infections.

See table.

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History of allergy to any ingredient in this product or other cephalosporins.
History of hypersensitivity to penicillins.

Should not be given to patients who are hypersensitive to it or to other cephalosporins. Immunological studies have suggested that up to 20% of penicillin-sensitive patients may also be allergic to cephalosporins although clinical studies indicate a lower frequency and the true incidence is uncertain; great care should be taken if cefalotin is to be given of such patients. Care is also necessary in patients with a history of allergy.

The most common are hypersensitivity reactions, including skin rashes, urticaria, eosinophilia, fever, reactions resembling serum sickness, and anaphylaxis.
There may be a positive response to the Coomb's test although haemolytic anaemia rarely occurs. Neutropenia and thrombocytopenia have occasionally been reported. Agranulocytosis has been associated rarely with some cephalosporins. Bleeding complications related to hypoprothrombinaemia and/or platelet dysfunction have occurred especially with cephalosporins and cephamycins having an N-methylthiotetrazole side-chain, including cefamandole, cefbuperazone, cefmenoxime, cefmetazole, cefonicid, cefoperazone, ceforanide, cefotetan, cefpiramide, and latamoxef. The presence of a methylthiadiazolethiol side-chain, as in cefalozin, or an N-methylthiotriazine ring, as in ceftriaxone, might also associated with such bleeding disorders.

Care should be exercised in patients receiving anticoagulants and cefixime due to the possibility that cefixime may increase prothrombin times.

Direction for Reconstitution: 100 mg/5 mL Granules for Suspension: To make 30 mL reconstituted suspension, add approximately 20 mL of water. Shake well until the powder are evenly suspended. The suspension is stable for one week at temperatures not exceeding 30°C and two weeks under refrigeration (2-8°C).
100 mg/5 mL Granules for Suspension: To make 60 mL reconstituted suspension, add approximately 40 mL of water. Shake well until the powder are evenly suspended. The suspension is stable for one week at temperatures not exceeding 30°C and two weeks under refrigeration (2-8°C).

Store at temperatures not exceeding 30°C.

Cephalosporins

J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

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