Cefodox

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Cefodox
20130617-Cefodox

Third-generation cephalosporin.

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Composition
Cefodox tablets:
Active substance: cefpodoxime;
Each tablet contains 100 mg or 200 mg of cefpodoxime (as proxetil);
Excipients: monocrystalline cellulose, croscarmellose sodium, sodium starch (type А), sodium laurilsulfate, anhydrous colloidal silicon dioxide, magnesium stearate, Opadry ОY-L white, iron oxide yellow (Е 172).
Cefodox powder for oral suspension
active substance: cefpodoxime; 5 ml of suspension contains 50 mg or 100 mg of cefpodoxime (as proxetil);
excipients: hydroxypropyl cellulose, microcrystalline cellulose, maize starch, sucrose; citric acid monohydrate, colloidal silicon dioxide, simethicone emulsion, sodium  carboxymethyl cellulose – microcrystalline cellulose, xanthan gum, sodium sucrose, lemon flavor (powder).
Pharmacotherapeutic group
Antibacterials for systemic use. Other beta-lactam antibiotics. Third-generation cephalosporins. АТС J01D D13.
Indications
Infections, caused by cefpodoxime-sensitive microorganisms:
  • Upper respiratory tract infections (including acute otitis media, sinusitis, tonsillitis, pharyngitis); Cefodox should be prescribed for the treatment of chronic or recurrent infections, in cases when the causative microorganism is known or suspected to be resistant to commonly used antibiotics;
  • Lower respiratory tract infections (including pneumonia, acute bronchitis or bronchiolitis complicated by bacterial superinfection);
  • Uncomplicated upper and lower urinary tract infections (including acute pyelonephritis and cystitis);
  • Skin and soft tissue infections (abscesses, cellulitis, infected wounds, furuncles, folliculitis, paronychia, carbuncles and ulcers);
  • uncomplicated gonococcal urethritis.
Сontraindications
Hypersensitivity to cephalosporin and penicillin antibiotics.
Pediatric age under 5 months (suspension) and under 12 years (tablets).
Hereditary galactose intolerance, lactase deficiency or glucose/galactose malabsorption (suspension).
Dosage and administration
Administer with food to increase absorption.
The course of treatment depends on disease severity and is individualized.
For children aged from 5 months to 12 years, the drug is prescribed in a dose of 10 mg/kg of body weight a day (the maximum daily dose is 400 mg) to be taken twice daily with an interval of 12 hours (the maximum single dose is 200 mg).
For adults and children aged over 12 years with a normal renal function the following doses are recommended: upper respiratory tract infections (sinusitis) - 200 mg twice daily, other infections (including tonsillitis, pharyngitis) – 100 mg twice daily; lower respiratory tract infections (including acute bronchitis, relapses or exacerbations of chronic bronchitis and bacterial pneumonia) - 100-200 mg twice daily;
uncomplicated upper urinary tract infection (acute pyelonephritis) – 200 mg twice daily;
uncomplicated lower urinary tract infection (cystitis) – 100 mg twice daily;
skin and soft tissue infections (abscesses, cellulitis, infected wounds, furuncles, folliculitis, paronychia, carbuncles and ulcers) - 200 mg twice daily;
uncomplicated gonococcal urethritis - 200 mg to be taken as a single dose.
Side effects
Infections and invasions: rare – superinfection, caused by some cefpodoxime-resistant strains of Candida, very rare – antibiotic-associated colitis.
Blood and lymphatic system disorders: rare – eosinophilia, very rare – leukopenia, thrombocytopenia, thrombosis, agranulocytosis, decreased hemoglobin, hemolytic anemia.
Immune system disorders: rare – hypersensitivity, anaphylactic reactions.
Metabolic disorders: rare – hypohydration, peripheral edema, body weight gain.
Musculoskeletal system disorders: rare – myalgia.
Nervous system disorders: rare - cephalgia, rare - vertigo, very rare – dizziness, insomnia, somnolence, neurosis, irritability, nervousness, abnormal dreams, visual deterioration, mental confusion, nightmares, paresthesia.
Respiratory disorders: rare - asthma, cough, epistaxis, rhinitis, wheezing, bronchitis, dyspnea, pleural effusion, pneumonia, sinusitis.
Gastrointestinal disorders: rare – diarrhea; common – abdominal pain, nausea; rare – thirst, tenesmus, abdominal distension, vomiting, dyspepsia, dry mouth, decreased appetite, constipation, mycotic stomatitis, anorexia, eructation, gastritis, mouth ulcers, pseudomembranous colitis.
Hepatobilliary disorders: ­rare – cholestatic liver lesions.
Skin and subcutaneous tissue disorders: rare – rash, pruritus, urticaria, hyperhidrosis, macular rash, fungal dermatitis, skin peeling, dry skin, hair loss, vesicular rash, sunburn, purpura, bullous reactions (Stevens-Johnson syndrome), toxic epidermal nercrolysis, erythema multiform.
Genitourinary system disorders: rare – hematuria, urinary infections, metrorrhagia, dysuria, urinary frequency, proteinuria, vaginal candidiasis.
Cardiovascular disorders: rare – congestive heart failure, migraine, tachycardia, vasodilatation, hematoma, arterial hypertension or hypotension.
Sense organ disorders: rare – taste disturbance, eye irritation, and tinnitus.
General disorders: rare – discomfort, fatigue, asthenia, drug fever, chest pain (the pain can shoots up the lower back), fever, generalized pain, altered microbiological tests, candidiasis, abscess, allergic reaction, facial edema, bacterial infections, parasitic infections.
Investigations: rare – elevated liver function tests, AST, ALT, AP, bilirubin, BUN and creatinine, false-positive Coomb’s test.
Marketing authorization
UA/4152/02/01, UA/4152/02/02, UA/4152/01/01, UA/4152/01/02