Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Smith_kb
MACRODANTIN CAPSULES 50 mg (capsule) MACRODANTIN CAPSULES 100 mg (capsule) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): MACRODANTIN CAPSULES 50 mg (capsule) MACRODANTIN CAPSULES 100 mg (capsule) COMPOSITION: Each MACRODANTIN capsule contains 50 mg or 100 mg nitrofurantoin macrocrystals, a synthetic chemical of controlled crystal size. The chemical name is 1[(5-nitrofur-furylidene)amino] hydantoin. PHARMACOLOGICAL CLASSIFICATION: A 18 5 Urinary tract antiseptics PHARMACOLOGICAL ACTION: MACRODANTIN is an antibacterial agent for specific urinary tract infections. Nitrofurantoin is rapidly and completely absorbed from the gastro-intestinal tract. Anti-bacterial concentrations are not achieved in plasma following ingestion of recommended doses because of rapid elimination. MACRODANTIN exerts bacteriostatic activity against many strains of: Escherichia coli Enterococci Anti-bacterial activity is higher in acidic urine. Many strains of Enterobacter species and Klebsiella species are resistant to MACRODANTIN. It is not active against most strains of Proteus and Pseudomonas species. INDICATIONS: MACRODANTIN is indicated for the treatment and prevention of recurrence of uncomplicated lower urinary tract infections, e.g. pyelonephritis, pyelitis and cystitis. (It is not indicated for the treatment of associated renal, cortical or perinephric abscesses). CONTRA-INDICATIONS: Anuria, oliguria and renal impairment are contra-indications to therapy with this agent. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug. Pregnant women at term, as well as infants under one month of age, because of the possibility of haemolytic anaemia due to immature enzyme systems (glutathione instability). Safe use in earlier pregnanc Les hele dokumentet