NITROFURANTOIN MACROCRYSTALS 50 MG Oral Capsule
INDICATIONS AND USAGE: Nitrofurantoin capsules (macrocrystals) are 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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) 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 capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower 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.
Actavis Pharma, Inc.
CAPSULE WHITE Watson 5780
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HOW SUPPLIED: Nitrofurantoin capsules, USP (macrocrystals) are available as follows: 25 mg opaque, white body and opaque, white cap imprinted in black ink with “ WATSON ” on the cap and “ 5779 ” on the body NDC 0591-3684-01 bottles of 100 50 mg opaque, white body and opaque, yellow cap imprinted in black ink with “ WATSON ” on the cap and “ 5780 ” on the body. NDC 0591-3685-01 bottles of 100 100 mg opaque, yellow capsule imprinted in black ink with “ WATSON ” on the cap and “ 5781 ” on the body. NDC 0591-3686-01 bottles of 100 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. B 4/2022
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