Occasional incidents of acute overdosage of nitrofurantoin have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended. There is no specific antidote, but a high fluid intake should be maintained to promote urinary excretion of the drug. Nitrofurantoin is dialyzable.
Nitrofurantoin capsules (monohydrate/macrocrystals) should be taken with food.
Adults and Pediatric Patients Over 12 Years
One 100 mg capsule every 12 hours for seven days.
Nitrofurantoin capsules, USP (monohydrate/macrocrystals), for oral administration, are available as:
100 mg: Black and ivory opaque capsules imprinted E 122 on the cap and body and supplied as:
NDC 68071-5076-7 BOTTLES OF 14
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.
KEEP OUT OF THE REACH OF CHILDREN.
- Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Eighth Edition. CLSI document M07-A8 [ISBN 1-56238-689-1]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2009.
- Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard -Tenth Edition. CLSI document M02-A 10 [ISBN 1-56238-688-3]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2009.
- Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Nineteenth Informational Supplement. CLSI document M100-S19 [ISBN 1-56238-716-2]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2010.
Controlled clinical trials comparing nitrofurantoin (monohydrate/macrocrystals) 100 mg p.o. q12h and nitrofurantoin (macrocrystals) 50 mg p.o. q6h in the treatment of acute uncomplicated urinary tract infections demonstrated approximately 75% microbiologic eradication of susceptible pathogens in each treatment group.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Princeton, NJ 08540
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
nitrofurantoin (monohydrate/macrocrystals) capsule
|Labeler — NuCare Pharmaceuticals,Inc. (010632300)|
|NuCare Pharmaceuticals,Inc.||010632300||repack (68071-5076)|
Revised: 02/2021 NuCare Pharmaceuticals,Inc.
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