NITROFURANTOIN MACROCRYSTALS 100 MG Oral Capsule

INDICATIONS AND USAGE: Nitrofurantoin macrocrystals capsules 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 macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules 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 macrocrystals capsules 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 capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin macrocrystals capsules, 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.

Zydus Pharmaceuticals (USA) Inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] pain` `[3] fatigue` `[4] nausea` `[5] arthralgia` `[6] headache` `[7] off label use` `[8] diarrhoea` `[9] dizziness` `[10] dyspnoea`

4 years ago

CAPSULE BLUE 560

HOW SUPPLIED: Nitrofurantoin capsules, USP (Macrocrystals) 50 mg are light yellow to yellow powder filled in size "3" empty hard gelatin capsules with blue opaque colored cap and white opaque colored body imprinted with '559' in black ink and are supplied as follows: NDC 68382-559-01 in bottles of 100 capsules NDC 68382-559-10 in bottles of 1000 capsules NDC 68382-559-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Nitrofurantoin capsules, USP (Macrocrystals) 100 mg are light yellow to yellow powder filled in size "2" empty hard gelatin capsules with blue opaque colored cap and blue opaque colored body imprinted with '560' in black ink and are supplied as follows: NDC 68382-560-01 in bottles of 100 capsules NDC 68382-560-10 in bottles of 1000 capsules NDC 68382-560-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage 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: Zydus Lifesciences Ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 10/22

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