Cefitax-100/200 (Cefixime Tablets USP)
Cefixime is an oral third generation cephalosporin which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms.
Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumonia, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenza (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. It is highly stable in the presence of beta-lactamase enzymes.
Cefixime is an orally active cephalosporin antibiotic which has marked in vitro bactericidal activity against a wide variety of Gram-positive and 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, and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk.
Lower respiratory tract infections: e.g. bronchitis.
Urinary tract infections: e.g. cystitis, cystourethritis, uncomplicated pyelonephritis.
Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumonia, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenza, Branhamella catarrhalis and Enterobacter species. Cefixime is highly stable in the presence of beta-lactamase enzymes.
Posology and method of administration
Adults and children over 10 years: the recommended adult dosage is 200-400mg daily according to the severity of infection, given either as a single doe or in two divided doses.
The elderly: elderly patients may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe renal impairments
Children: weighing more than 50kg or older than 10 years should be treated with the recommended adult dose (200-400mg daily depending on the severity of infection). The safety and efficacy of cefixime has not been established in children less than 6 months.
Patients with known hypersensitivity to cephalosporin antibiotics or any of the other components of the product.
Warnings and precautions
Severe cutaneous adverse reactions: severe cutaneous adverse reactions such as toxic epidermal necrolysis, Stevens Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in some patients on cefixime. When severe cutaneous adverse reactions occur, cefixime should be discontinued and appropriate therapy and/or measures should be taken.
Cefixime should be given with caution to patients who have shown hypersensitivity to other drugs.
Hypersensitivity to penicillin: as with other cephalosporin, cefixime should be given with caution to patients with a history of hypersensitivity to penicillin, as there is some evidence of partial cross-allergenicity between the penicillin and cephalosporin.
Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Cefixime, the drug should be discontinued and the patient treated with appropriate agents if necessary.
Haemolytic anaemia: Drug-induced haemolytic anaemia, including severe cases with a fatal outcome, has been described for cephalosporin (as a class). The recurrence of haemolytic anaemia after re-administration of cephalosporin in a patient with a history of cephalosporin (including cefixime)-associated haemolytic anaemia has been reported.
Renal failure acute: as with other cephalosporin, cefixime may cause acute renal failure including tubulointerstitial nephritis as an underlying pathological condition. When acute renal failure occurs, cefixime should be discontinued and appropriate therapy and/or measures should be taken.
Renal impairment: cefixime should be administered with caution in patients with markedly impaired renal function.
Paediatric use: Safety of cefixime in premature or newborn infant has not been established.
Anticoagulants: In common with other cephalosporin, increases in prothrombin times have been noted in a few patients. Care should therefore be taken in patients receiving anticoagulation therapy.
Cefixime should be administered with caution to patients receiving coumarin-type anticoagulants, e.g. warfarin potassium. Since cefixime may enhance effects of the anticoagulants, prolonged prothrombin time with or without bleeding may occur.
Other forms of interactions
A false positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solutions or with copper sulphate test tablets, but not with tests 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.
Pregnancy and lactation
Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the foetus due to cefixime. In the rabbit, at doses up to 4 times the human dose, there was no evidence 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 antibiotics induced changes in the population of the microflora of the intestine. There are no adequate and well controlled studies in pregnant women. Cefixime should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.
Symptoms of overdose include neuromuscular hypersensitivity and convulsions.
Many beta-lactam containing antibiotics have the potential to cause neuromuscular hyperirritability or convulsive seizures. Hemodialysis may be helpful to aid in the removal of drug from blood; otherwise, treatment is supportive or symptom-directed.