Full Prescribing Info
Cefixime trihydrate.
Each capsule contains: Cefixime (as trihydrate) 200 mg.
Each mL of reconstituted suspension contains: Cefixime (as trihydrate) 20 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 3-4 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 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: Antimicrobial Action: Cefixime is a bactericidal antibiotic and is stable to hydrolysis by many beta-lactamases. It has a mode of action and spectrum of activity similar to those of the third-generation cephalosporin cefotaxime, but some Enterobacteriacae are less susceptible to cefixime. Haemophilus influenzae, Moraxella catarrhalis (Branhamella catarrhalis), and Neiserria gonorrhoeae are sensitive, including penicillinase producing strains, of the Gram-positive bacteria, streptococci, enterococci, and Listeria spp. are not.
Used in the treatment of susceptible infections, including gonorrhea, otitis media, pharyngitis, lower respiratory-tract infections such as bronchitis, and urinary-tract infections.
Dosage/Direction for Use
Cap: It is given by mouth in adult doses of 200 to 400 mg daily as a single dose or in two divided doses.
For uncomplicated gonorrhea, a single oral dose of 400 mg is given. Or as prescribed by the physician.
Oral drops: 6 months to 2 years old: 2.5 mL to 5 mL once a day, or 1.25 to 2.5 mL every 12 hours, or as prescribed by the physician.
Direction for Reconstitution: To make 30 mL reconstituted suspension; add approximately 20 mL of water. Shake well until the powder is evenly suspended. The suspension is stable for one week at temperatures not exceeding 30°C and 2 weeks under refrigeration (2° to 8°C).
Limited information is available on the acute toxicity of cefixime in humans. In healthy adults who received cefixime in single doses up to 2 g, adverse effects were similar to those seen with usual doses of the drug and included mild to moderate adverse effects.
There is no specific antidote for cefixime toxicity. In case of acute overdosage, gastric lavage may be indicated. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis.
Known hypersensitivity to other cephalosporins, to penicillins or any component of the product.
Special Precautions
Should not be given to patients who are hypersensitive to it or to other cephalosporins. About 10% of penicillin-sensitive patients may also be allergic to cephalosporins although the true incidence is uncertain; great care should be taken if cefalotin is to be given to such patients. Care is also necessary in patients with history of allergy.
Use In Pregnancy & Lactation
(Pregnancy Category B). Reproduction studies performed in mice and rats up to 400 times the human dose have not revealed evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women and the drug should be used during pregnancy only when clearly needed.
It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing breastfeeding temporarily during treatment with cefixime.
Adverse Reactions
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 Coombs' 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 a N-methylthiotetrazole side-chain, including cefamandole. Cefbuperazone, cefmenoxime, cefotetan, cefpiramide, and latamoxef. The presence of methylthiadiazolethiol side chain, as cefazolin, or a N-methylthiotriazine ring, as in ceftriaxone, might also be associated with such bleeding disorders.
Drug Interactions
Carbamazepine: Elevated carbamazepine levels have been reported when administered concomitantly with cefixime. Drug monitoring when these drugs are given together is advised.
In vitro and in vivo antagonism have been noted between cephalosporins and chloramphenicol against a variety of gram-positive and gram-negative bacteria; therefore, it is recommended that combined therapy with chloramphenicol and a cephalosporin be avoided particularly when bactericidal activity is considered important.
Nifedipine: Concomitant administration of cefixime and nifedipine increases oral bioavailability of cefixime as a result of higher Cmax and AUC.
Probenecid: Concomitant administration of probenecid reportedly increases Cmax and AUC of cefixime and decreases renal clearance and volume of distribution of the drug.
Salicylates: Concomitant administration of 650 mg oral dose of aspirin and a 400 mg oral dose of cefixime in healthy adult men may result in a 20-25% decrease in Cmax and AUC of cefixime but did not affect protein-binding, serum t½ or renal clearance. This effect may not be clinically important since serum concentrations of cefixime remained higher than MIC values reported for most susceptible organisms. However, some clinicians state that this effect may be clinically important in certain infections.
Warfarin and other Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is given concomitantly.
Interference with Laboratory Tests: Nitroprusside Test: A false positive Coombs' test has been reported during treatment with other cephalosporin antibiotics; therefore, it should be recognized that a positive Coombs' test may be due to the drug, e.g., Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition or in hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed.
Clinitest, Benedict's Solution, and Fehling's Solution: A false-positive reaction for glucose on the urine using Clinitest, Benedict's solution, or Fehling's Solution may result when done during therapy with cefixime. It is recommended that other tests based on enzymatic glucose oxidase reactions (e.g., Clinistix) be used.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Cap 200 mg x 50's. Oral drops (powd for susp) 20 mg/mL x 10 mL, 30 mL.
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