Macrodantin 100Mg Capsule

Description

MACRODANTIN 100MG CAPSULE

Description :

Each capsule contains 50 mg or 100 mg nitrofurantoin in macrocrystal form.

Excipients/Inactive Ingredients: Lactose, maize starch and talc.

Indications / Uses :

Nitrofurantoin macrocrystals (MACRODANTIN) is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, Enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.

Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.

Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin macrocrystals (MACRODANTIN) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin macrocrystals (MACRODANTIN), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin macrocrystals (MACRODANTIN), low eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.

Administration :

Should be taken with food: Take w/ or immediately after meals.

Contraindications :

Known hypersensitivity to nitrofurantoin or to other nitrofurans; in patients with oliguria, anuria or significant impairment of renal function (creatinine clearance under 60 mL/min or clinically significant elevated serum creatinine); because of the possibility of hemolytic anemia produced by the drug to the fetus or neonate, due to immature erythrocyte enzyme systems, it is also contraindicated in pregnancy at term (38-42 weeks) and during labor and delivery; glucose-6-phosphate dehydrogenase deficiency, simultaneous administration of MAO inhibitors; perinephric abscesses or pyelonephritis; previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin.

Special Precautions :

During treatment, acute, subacute, or chronic pulmonary hypersensitivity reactions may occur. If these reactions occur, Nitrofurantoin macrocrystals (MACRODANTIN) should be discontinued and appropriate measures taken. Chronic reactions (interstitial pneumonitis and fibrosis) occur as an exception and generally in patients receiving therapy for six months or longer. Close monitoring of the pulmonary function of patients receiving long-term therapy with Nitrofurantoin macrocrystals (MACRODANTIN) is required, and benefits of therapy should be weighed against potential risks.

Nitrofurantoin may cause hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency. Hemolysis ceases when the drug is withdrawn.

Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, have occurred. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for possible changes in biochemical tests that would indicate liver injury.

Peripheral neuropathy cases, occasionally severe or irreversible, have been reported.

Fatalities have been reported. Optic neuritis has been reported rarely.

In case of pulmonary, hematologic, hepatic or neurologic toxicity, treatment with Nitrofurantoin macrocrystals (MACRODANTIN) should be discontinued immediately and appropriate measures be taken.

The occurrence of pseudomembranous colitis has been reported with use of nearly all antibacterial agents, including nitrofurantoin; once the diagnosis is made, administration of nitrofurantoin should be discontinued and appropriate treatment be given.

Remarks: It imparts a coffee, reddish or orange color to urine.

Use in Pregnancy & Lactation: The safe use of nitrofurantoin during pregnancy has not been established. Therefore this drug should not be taken during pregnancy unless need has been clearly established. Nitrofurantoin has been detected in human breast milk in trace amounts, therefore the use of Nitrofurantoin macrocrystals (MACRODANTIN) is contraindicated during nursing of preterm infants or during the first month of G-6-PD-deficient infants due to the risk of hemolytic anemia.