OGB

 

Capsule

Composition:
Each capsule of CEFIXIME contains:
Cefixime trihydrate equivalent to cefixime 200 mg

Pharmacology:
Antibacterial activity
Cefixime has a bactericidal and broad spectrum activity against gram-positive and gram-negative microorganisms. As with other oral cephalosphorins, cefixime has potent activity against gram-positive microorganisms, e.g. Streptococcus sp., Streptococcus pneumoniae and gram-negative microorganisms, e.g. Branhamella catarrhalis, Escherichia coli, Proteus sp., and Haemophilus influenzae.
Its mechanism of action is by inhibition of cell wall synthesis. Cefixime has high affinity for penicillin-binding proteins (PBPs) 1 (1a, 1b and 1c) and 3, with the site of activity varying according to the strains of organisms. Cefixime is stable to β-lactamase produced by many organisms and has a good activity against β-lactamase producing organisms.

Pharmacokinetics:
Serum concentration
Following oral administration of a single dose of 50, 100 and 200 mg (potency) of cefixime in healthy, fasted adults, peak serum concentration within 4 hours after administration were 0.69, 1.13 and 1.95 μg/ml, respectively. The serum half-life is 2.3-2.5 hours. Following oral administration of a single dose of 1.5, 3.0 or 6.0 mg (potency) /kg of cefixime in pediatrics with normal renal function, peak serum concentration within 3-4 hours after administration were 1.14, 2.01 and 3.97 μg/ml, respectively. The serum half-life is 3.2-3.7 hours.

Distribution (tissue penetration)
Penetration into sputum, tonsil, maxillary sinus mucosal tissue, otorrhea, biliary fluid and gallbladder tissue is good.

Metabolism
No antibacterial-active metabolites are found in the serum and urine.

Elimination
Cefixime is primarily excreted via urine. The extent of urinary excretion (up to 12 hours) after oral administration of 50, 100 or 200 mg (potency) in healthy, fasted adults was about 20-25% from administered dose. Peak urine concentration of 42.9, 62.2 and 82.7 μg/ml, respectively, was reached within 4-6 hours after administration. The extent of urinary excretion (up to 12 hours) after oral administration of 1.5, 3.0 or 6.0 mg (potency)/kg body weight in pediatrics with normal renal function was about 13-20%.

Indications:
Treatment of infections caused by susceptible microorganisms, i.e.:

  1. Urinary infections without complication caused by Escherichia coli and Proteus mirabilis.
  2. Otitis media caused by Haemophilus influenzae (β-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which are β-lactamase positive) and Streptococcus pyogenes.
  3. Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
  4. Acute bronchitis and acute exacerbation of chronic bronchitis, caused by Streptococcus pneumoniae and Haemophilus influenzae (β-lactamase positive and negative strains).

Contraindication:
Patients with history of shock or hypersensitivity due to any ingredients of this drug.

Dosage and administration:

  • For adults and children weighing ≥30 kg, the usual daily dose is 50-100 mg (potency) of cefixime given orally twice a day.
  • Dosage should be adjusted according to age, body weight, and condition of the patients.
  • For severe infections, the dosage may be increased up to 200 mg (potency), given twice a day.
  • Patients with impaired renal function need a dosage adjustment depending on the degree of renal impairment. Recommended dosage: 75% of the standard dosage (i.e. 300 mg a day) if creatinine clearance is between 21 and 60 ml/minute or for patients on renal hemodialysis and 50% of the standard dosage (i.e. 200 mg a day) if creatinine clearance is <20 ml/minute or for patients on continuous ambulatory dialysis.

Warnings and precautions: General

  • Caution should be exercised since hypersensitivity reactions, e.g. shock may occur.
  • Cefixime should not be administered in patients who may still be treated with other antibiotics. If necessary, it should be administered with caution.
  • Patients with history of hypersensitivity to any ingredient of cefixime or any other cephalosporin antibiotics.
  • Cefixime should be administered carefully to the following patients:

- Patients with a history of hypersensitivity to penicillin.
- Patients with a personal or familial history to various forms of allergy, e.g. bronchial asthma, rash and urticaria.
- Patients with serious renal dysfunction.
- Patients with poor oral nutrition, those receiving parenteral nutrition, the elderly or patients in debilitated state. These patients must be monitored as vitamin K deficiency symptoms may develop.

  • Use in pregnancy : Safety during pregnancy has not been established. Cefixime should be administered to pregnant women only if the expected therapeutic benefits are thought to outweigh any possible risk.
  • Use in lactation : It is not known whether cefixime is excreted in human milk, therefore, nursing must be temporarily discontinued during treatment with cefixime.
  • Use in children : Safety and efficacy of cefixime administration in children <6 months has not been established (including newborns and premature).

Adverse reactions:

  • Shock : Adequate caution should be exercised since shock symptoms may sometimes occur. If any related signs or symptoms, e.g. dysphoria, oral cavity discomfort, stridor, dizziness, abnormal urge to defecate, tinnitus or diaphoresis occur, cefixime must be discontinued immediately.
  • Hypersensitivity : If signs of hypersensitivity reactions, e.g. rash, urticaria, erythema, pruritus or fever occur, the administration of cefixime should be discontinued and appropriate measures should be taken.
  • Hematology : Granulocytopenia or eosinophilia may occur rarely. Sometimes, thrombocytopenia may also occur. The use of cefixime should be discontinued if any of such disorders is found. It has been reported that hemolytic anemia has occurred in the use of other cephalosphorins.
  • Hepatic : Infrequently, an increase in SGOT, SGPT or alkaline phosphatase may occur.
  • Renal : Periodic monitoring of renal function is recommended since serious renal impairment, e.g. renal insufficiency may sometimes occur. If any of such abnormalities is found, cefixime should be discontinued and appropriate measures should be taken.
  • Digestive : In rare instances, a serious colitis, e.g. pseudomembranous colitis, manifested by blood in stools may occur. Diarrhea, loose stools, abdominal pain, dyspepsia, nausea, and vomiting.
  • Respiratory : In rare instances, interstitial pneumonia or PIE syndrome, manifested by fever, cough, dyspnea, abnormal chest X-ray or eosinophilia may occur. If any such symptoms occur, cefixime should be immediately discontinued and appropriate measures, e.g. administration of adrenocortical hormones should be taken.
  • Alteration in bacterial flora : Stomatitis or candidiasis may occur rarely.
  • Vitamin deficiencies : Vitamin K deficiencies, e.g. hypoprothrombinemia or bleeding tendencies or vitamin B group deficiencies (e.g. glossitis, stomatitis, anorexia or neuritis) may occur infrequently.
  • Others : Headache or dizziness may occur rarely. In studies where infant rats were given 1000 mg/kg body weight/day orally, a reduction in spermatogenesis was reported.
  • Influences on laboratory test values : False-positive results may occur for glucose in the urine sugar tests using Benedict's solution, Fehling's solution and Clinitest®. False-positive results have not been reported with Tes-tape®. A positive direct Coombs' test may occur.

Drug interaction:
Carbamazepine
Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. Drug monitoring may assist in detecting alterations in carbamazepine plasma concentrations.

Overdosage:
Gastric lavage may be performed if there is no specific antidote. Cefixime is not eliminated in significant quantities from the circulation by hemodialysis or peritoneal dialysis.

Presentation and registration number:
Box, 10 strips @ 10 capsules. GKL

ON MEDICAL PRESCRIPTION ONLY

STORE AT TEMPERATURE BELOW 30ºC, PROTECT FROM LIGHT

Manufactured by:
PT Dexa Medica