Description

Hard gelatin capsules

COMPOSITION :

Each hard gelatin capsule contains:
Active ingredients :
Mepafuran 100 mg
Nitrofurantoin 100 mg
Inactive ingredients :
Magnesium stearate. Avicel and Maize starch.

THERAPEUTIC INDICATIONS :

For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures. Nitrofurantoin is specifically indicated for the treatment of infections due to susceptible strains of Escherichia coli, Enterococci, Staphylococci, Citrobacter, Klebsiella and Enterobacter.

POSOLOGY AND METHOD OF ADMtNtSTRATION
Dosage:

Adults
Acute Uncomplicated Urinary Tract Infections: 50 mg four times daily for seven days. Severe Chronic Recurrence: 100 mg four times day for seven cays.
Long Term Suppression: 50 mg – 100 mg once a day.
Pophylaxis: 50 mg four times daily for the duration of procedure and 3 days thereafter.
Children and Infants over three months of age
Acute Urinary Tract Infections: 3 mg/kg/day in four divided doses for seven days. Suppressive: 1 mg/kg, once a day.
For children under 25 Kg bodyweight consideration should be given to the use of nitrofurantoin suspension.
Elderty
Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. See precaution and risks to elderly patients associated
with lonq- term therapy.

CONTRAINDICATIONS :

⦁ Patients with known hypersensitivity to nitrofurantoin or other nitrofurans.
⦁ Patients suffering from renal dysfunction with a creatinine clearance of less than 60 ml/minute or elevated serum creatinine.
⦁ G6PD deficiency.
⦁ Acute porphyria.
⦁ In infants less than 3 months and at the end of pregnancy (during labour and delivery) because of the theoretical possibility of hemolytic anemia in the fetus or newborn (under 3 months) due to immature erythrocyte enzyme system.
⦁ Products containing nitrofurantoin are contraindicated in patients with previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin.