Company: TEVA Pharmaceuticals Ireland.
Legal category: Prescription. GMS. Sport Permitted.
Active ingredient: Ciprofloxacin 250mg, 500mg.
Description: White, film-ctd tablets with breakline. The tablet can be divided into equal halves. 250mg: Biconvex, round marked CIP 250. 500mg: Capsule shaped marked CIP500
Presentation: 250mg-10, €5.08; 250mg-20, €10.17; 500mg-10, €9.46; 500mg-20, €18.94.
Indications: Treatment of infections with Gram-negative pathogens including: Respiratory tract infections. Urinary tract infections: Acute uncomplicated cystitis, complicated infections, pyelonephritis. The genital organs: Acute, uncomplicated gonorrhoea, prostatitis. Severe bacterial enteritis. Skin and soft tissue infections. Osteomyelitis. Severe systemic infections e.g. septicaemia, peritonitis (with addition of an antibacterial agent to cover anaerobes), infections in immunosuppressed patients. Children: Acute pulmonary exacerbation of cystic fibrosis associated with P. aeruginosa infection in children and adolescents aged 5-17 years.
Pharmacology: Ciprofloxacin is a synthetic 4-quinolone derivative, with bactericidal activity. It acts via inhibition of bacterial DNA gyrase, ultimately resulting in interference with DNA function.
Dosage: Adult: 100-750mg twice daily swallowed with liquid. The dosage is determined by the severity and type of infection, the sensitivity of the causative organism(s) and the age, weight and renal function of the patient (see SPC). Should be continued for at least 3 days after body temperature returned to normal. Usual duration 3-14 days. Up to 28 days for prostatitis and 4-6 weeks or longer for osteomyelitis. Elderly: As per adults. Children: 5-17 years: Paediatric cystic fibrosis: 20mg/kg twice daily for 10-14 days; maximum, 1500mg daily. Other indications: Contraindicated.
Contraindications: Hypersensitivity to ciprofloxacin or similar quinolones. History of quinolone-related tendon disorder. Children under 5 years. Pregnancy, lactation.
Special precautions: CNS disorders, including epilepsy, myasthenia gravis, patients at risk for torsade de pointes arrhythmia. Crystalluria has been reported (patients should be well hydrated). Risk of pseudomembranous colitis, discontinue if suspected. Family history of or actual defects in glucose-6-phosphate dehydrogenase activity. Significant renal or hepatic disorders. Avoid prolonged exposure to sunlight or UV-light. Tendon inflammation and rupture may occur (discontinue). Driving/using machines. Not first-choice therapy pneumococcal pneumonia.
Drug interactions: Tizanidine (contraindicated). Cationic drugs, mineral supplements, sucralfate, antacids, antivirals with buffered didanosine, dairy products (admin 1-2 hours before of 4 hours after). Theophylline (potentially life-threatening, monitor plasma levels). Avoid opiate premedicants. Caution: CYP1A2 substrates, phenytoin, oral anticoagulants, NSAIDs, ciclosporin, glibenclamide, mexiletine, probenecid, metoclopramide, benzodiazepine, methothrexate, ropinirole.
Adverse drug reactions: Nausea, diarrhoea, rash.
Full prescribing information and references available from TEVA Pharmaceuticals Ireland. Telephone: 1800 201700.
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