Indications
Treatment of the following infections caused by susceptible strains of the designated microorganisms: Middle Ear: Otitis media caused by S. pneumoniae, H. influenzae (beta-lactamase positive and negative strains), B. catarrhalis (beta-lactamase positive and negative strains) and S. pyogenes. Paranasal Sinuses: Sinusitis caused by S. pneumoniae, H. influenzae (beta-lactamase positive and negative strains), and B. catarrhalis (beta-lactamase positive and negative strains). Urinary Tract: Acute uncomplicated cystitis and urethritis caused by E. coli, P. mirabilis, and Klebsiella species. Upper Respiratory Tract: Pharyngitis and tonsillitis caused by S. pyogenes. Lower Respiratory Tract: Acute bronchitis caused by S. pneumoniae, B. catarrhalis (beta-lactamase positive and negative strains) and H. influenzae (beta-lactamase positive and negative strains). Uncomplicated Gonorrhea: Uncomplicated gonorrhea (cervical/urethral and rectal) caused by N. gonorrhoeae, including penicillinase (beta-lactamase-positive) and nonpenicillinase (beta-lactamase-negative) producing strains.
Dosage & Administration
Adult: 1 or 2 capsules (200-400 mg) as once or in 2 divided doses daily for 7-14 days, according to the severity of the infection. Children above 6 months: 8 mg per kg body weight as a single dose or in two divided doses for 7-14 days according to the severity of the infection or as following: 6 months-1 year: 75 mg/day 1-4 years: 100 mg/day 5-10 years: 200 mg/day 11-12 years: 300 mg/day Above 12 years: Adult dose may be administered. Efficacy and safety in infants aged less than six months have not been established.
Side Effects
Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials was mild and self-limiting in nature. Gastro-intestinal disturbances: such as Diarrhoea (if severe diarrhoea occurs, Cefixime should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence have been reported. Central nervous system disturbances: Headache, dizziness, etc. Others: Hypersensitivity reactions which usually subsided upon discontinuation of therapy; infrequent and reversible haematological changes; elevation of serum amylase, etc.
Precautions
Cefixime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min). Use in pregnancy and lactation: No data is available, so it is probably the best to avoid using the drug during pregnancy and by the nursing mothers.
Contraindications
Cefixime is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
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