Sixime

Cefixime.

Each capsule contains Cefixime 100 mg.

Pharmacology: Pharmacodynamics: Cefixime is generally classified as a third-generation cephalosporin antibacterial. Cefixime, a semisynthetic cephalosporin, is a broad-spectrum bactericidal agent that inhibits cell wall synthesis and is stable in the presence of certain beta-lactamases. The antibacterial activity of the drug results from inhibition of mucopeptide synthesis in the bacterial cell wall. Cefixime is given orally to treat infections due to susceptible Gram-positive and Gram-negative bacteria, including gonorrhea and infections of the respiratory and urinary tracts.
Pharmacokinetics: Approximately 30-50% of a single dose of Cefixime is absorbed following oral administration. The time to peak concentration for oral administration is range 2-8 hours. Cefixime is approximately 65-70% bound to serum proteins, principally albumin. Metabolites with antimicrobial activity were not detected in the serum or urine. Cefixime is eliminated by renal and nonrenal mechanism. Approximately 7-41% of a single dose of Cefixime is excreted unchanged in urine within 24 hours. The serum elimination half-life of Cefixime in adults with normal renal function average 2.4-4 hours.

Cefixime is used orally in adults and pediatric patients for the treatment of Otitis media caused by: Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pyogenes (group A β-hemolytic streptococci).
Pharyngitis and tonsillitis caused by: Streptococcus pyogenes (group A β-hemolytic streptococci).
Respiratory tract infections: Sinusitis caused by: Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis; Acute and chronic bronchitis (acute exacerbations of chronic bronchitis) caused by: Streptococcus pneumoniae, Haemophilus influenzae; Pneumonia; Acute infective exacerbations of chronic obstructive pulmonary disease.
Urinary tract infections: Uncomplicated urinary tract infections caused by: Gram-negative bacteria including Escherichia coli or Proteus mirabilis; Gram-positive bacteria.
Complicated urinary infection: Pyelonephritis caused by Enterobacteriaceae, including Escherichia coli.
Gonorrhea and associated infections: Uncomplicated gonorrhea caused by: Neisseria gonorrhoeae; Uncomplicated cervical, urethral, or rectal gonorrhea infections.
Typhoid.

Mode of administration: Cefixime is administered orally, with or without food.
Recommended Dose: Adult Dosage: Cefixime is given orally in dose of 100 to 400 mg daily as a single dose or in two divided doses. The dose and duration of usage depend on the disease and severity of the disease or to be used as directed by the physician. The highest dose is 400 mg/day.
Otitis media: 400 mg once daily or 200 mg every 12 hours for 10-14 days.
Pharyngitis and tonsillitis: 400 mg once daily or 200 mg every 12 hours for at least 10 days.
Respiratory tract infections and Urinary tract infections: 400 mg once daily or 200 mg every 12 hours for 5-10 days.
Gonorrhea and associated infections: Uncomplicated gonorrhea: 400 mg single dose.
Uncomplicated cervical, urethral, rectal gonorrhea infection: 400 mg single dose plus azithromycin 1 g orally single dose.
Children dosage: Cefixime can be used in children 6 months to 12 years of age. The recommended children dose is 8 mg/kg daily given in 1 or 2 divided doses for the treatment of mild to moderate infections. The dose and duration of usage depend on the disease and severity of the disease or to be used as directed by the physician.
Typhoid: Children 6 months to 16 years of age have received Cefixime in a dosage of 5-10 mg/kg twice daily for 14 days.
Dosage in renal impairment: Oral doses of Cefixime should be reduced in patients with moderate to severe renal impairment according to creatinine clearance (CrCl). In the USA licensed product information recommended doses adjusted as follows: See table.

Click on icon to see table/diagram/image

Dosage in elderly patients: Modification of the usual dosage of Cefixime is not necessary in elderly patients base on age, but may be required because the age-related decreases in renal function.

Overdose: Acute ingestion of large doses of cephalosporins may result in nausea, vomiting, diarrhea, and abdominal pain.
Treatment: If acute overdosage of Cefixime occurs, the stomach should be emptied by gastric lavage.
Cefixime is not removed in clinically important quantities by hemodialysis or peritoneal dialysis.

Hypersensitivity to Cefixime, any component of the formulation, or other cephalosporins.

1. This drug is contraindicated in patients with known hypersensitivity.
2. Using this drug in patients with hypersensitivity to penicillins can cause severe to fatal allergic reactions.
3. Stop using this drug and immediately consult the doctor when manifesting any signs and symptoms such as fever, skin rash, blisters, detachment of skin and epithelial lining in oral cavity, throat, nose, genital organ and conjunctivitis after taking the drug.

Use with caution in patients with a history of penicillin allergy.
Patients with a personal or familial history of some form of allergy such as bronchial asthma, rash, urticarial.
Modify dosage in patients with renal impairment is necessary.
Patients with poor oral nutrition, Patients receiving parenteral nutrition, elderly patients or patients in a debilitated status. Careful observation is essential in these patients as vitamin K deficiency symptoms may develop.
Superinfection with gram-positive bacteria has occurred in patients receiving Cefixime in prolonged use that may result in overgrowth of nonsusceptible microorganism. If superinfection occurs, appropriate therapy should be instituted.
Like most cephalosporins, Cefixime may cause false-positive results in urinary glucose determinations: however, glucose oxidase methods (e.g. Clinistix, Tes-Tape) are unaffected by the drug.
Cefixime may cause false-positive results for ketones in urine if nitroprusside tests are used; this effect has not been reported with tests using nitroferricyanide.

Pregnancy: Pregnancy category: B.
Cefixime crosses the placenta and can be detected in the amniotic fluid. No confirmation of safety for pregnant women. Cefixime should be administered to pregnant patients or women suspected of being pregnant, only if the expected therapeutic benefit is thought to outweigh any possible risk.
Lactation: It is not known if Cefixime is excreted into breast milk. Consideration is given to discontinuing nursing temporarily during treatment.

Common: Gastrointestinal: Diarrhea, loose stools, abdominal pain, anorexia, nausea, vomiting, dyspepsia, flatulence, dry mouth.
Nervous effects: Headache, dizziness, nervousness, insomnia, somnolence, malaise and fatigue.
Hematologic effects: Granulocytopenia, eosinophilia, thrombocytopenia.
Hepatic effects: Transient increase in AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin and LDH (Lactate dehydrogenase).
Others: Stridor, feeling unwell, dizziness, tinnitus, diaphoresis, candidiasis, rarely vitamin K deficiencies or vitamin B group deficiencies.
Rare but important or life-threatening: Gastrointestinal: Pseudomembranous colitis.
Nervous effects: Seizures.
Hematologic effects: Decreased prothrombin.
Renal effects: Acute renal insufficiency.
Respiratory effect: Interstitial pneumonia or PIE syndrome (Pulmonary infiltration with eosinophilia syndrome)
Sensitivity reactions: Hypersensitivity reactions include rash, urticaria, drug fever, pruritus, arthralgia, anaphylactic and anaphylactoid reactions, including shock and fatalities, have been reported; discontinuation required.

Anticoagulants: Increased prothrombin time (with or without bleeding) has been reported following concomitant use of Cefixime with an anticoagulant (e.g. warfarin).
Carbamazepine: Concomitant administration of Cefixime and carbamazepine has resulted in increased plasma carbamazepine concentrations.
Nifedipine: Concomitant administration of Cefixime and nifedipine increases oral bioavailability of Cefixime as a result of higher peak plasma concentrations and area under the plasma concentration-time curve (AUC).
Probenecid: Concomitant administration of Cefixime and probenecid has resulted in increased effects of Cefixime.

Store below 30°C.

Cephalosporins

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

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