Valsts: Dienvidāfrikas Republika
Valoda: angļu
Klimata pārmaiņas: South African Health Products Regulatory Authority (SAHPRA)
Pharmacare Limited û Woodmead
See ingredients
CAPSULES
EACH CAPSULE CONTAINS NITROFURANTOIN MACROCRYSTALS 100 mg
Registered
1975-11-06
_ _ Page 1 of 10 _ _ 1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE SCHEDULING STATUS S4 PROPRIETARY NAME AND DOSAGE FORM MACRODANTIN CAPSULES 50 MG (hard-gelatin capsule) MACRODANTIN CAPSULES 100 MG (hard-gelatin capsule) COMPOSITION MACRODANTIN CAPSULES 50 MG: Each hard-gelatin capsule contains 50 mg of nitrofurantoin macrocrystals. _Excipients: _ Black iron oxide (C.I. 77499), erythrosine (C.I. 45430), gelatin, lactose, maize starch, purified talc, quinolene yellow (C.I. 47005), titanium dioxide (C.I. 77891) Contains sugar: Lactose 160,57 mg MACRODANTIN CAPSULES 100 MG: Each hard-gelatin capsule contains 100 mg of nitrofurantoin macrocrystals. _Excipients: _ Black iron oxide (C.I. 77499), erythrosine (C.I. 45430), gelatin, lactose, maize starch, purified talc, quinolene yellow (C.I. 47005), titanium dioxide (C.I. 77891) Contains sugar: Lactose 192,04 mg _ _ Page 2 of 10 _ _ CATEGORY AND CLASS A 18.5 Urinary tract antiseptics _ _ PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES Nitrofurantoin is an antibacterial medicine for specific urinary tract infections. Nitrofurantoin 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 nitrofurantoin. It is not active against most strains of _Proteus_ and _Pseudomonas_ species. PHARMACOKINETIC PROPERTIES Nitrofurantoin is rapidly and completely absorbed from the gastrointestinal tract. Anti- bacterial concentrations are not achieved in plasma following ingestion of recommended doses because of rapid elimination. 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. _ _ Page 3 of 10 _ _ CONTRAINDICATIONS Anuria, oliguria and renal impairment are contraindications to therapy wit Izlasiet visu dokumentu