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NDC 47781-0303-01

Nitrofurantoin Monohydrate/Macrocrystalline 25 mg/1, 75 mg/1 CAPSULE

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NDC
47781-0303-01
Generic Name
Nitrofurantoin Monohydrate/Macrocrystalline
Brand Name
Nitrofurantoin Monohydrate/ Macrocrystalline
Strength
25 mg/1, 75 mg/1
Dosage Form
CAPSULE
Route
ORAL
Package Size
—
Labeler
Alvogen Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Nitrofurantoin capsules (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus . Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (monohydrate/macrocrystals) and oth…

Important Warnings

WARNINGS Pulmonary reactions: ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, NITROFURANTOIN CAPSULES (MONOHYDRATE/MACROCRYSTALS) SHOULD BE DISCONTINUED AND APPROPRIATE MEASURES TAKEN. REPORTS HAVE CITED PULMONARY REACTIONS AS A CONTRIBUTING CAUSE OF DEATH. CHRONIC PULMONARY REACTIONS (DIFFUSE INTERSTITIAL PNEUMO…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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