Nitrofurantoin (monohydrate/macrocrystals) (Page 4 of 4)

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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.

REFERENCES

1. 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.
2. 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.
3. 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.

CLINICAL STUDIES

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.

Sandoz Inc.

Princeton, NJ 08540

Rev. 05/17

MF0122REV05/17

100 mg Label

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin (monohydrate/macrocrystals) capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-5076(NDC:0185-0122) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROFURANTOIN MONOHYDRATE (NITROFURANTOIN) NITROFURANTOIN 75 mg NITROFURANTOIN (NITROFURANTOIN) NITROFURANTOIN 25 mg

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE SUCROSE

Product Characteristics Color black (ivory) , white (ivory) Score no score Shape CAPSULE Size 21mm Flavor Imprint Code E122 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68071-5076-7 14 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077066 04/06/2005

Labeler — NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Operations
NuCare Pharmaceuticals,Inc.		010632300	repack (68071-5076)

Revised: 02/2021 NuCare Pharmaceuticals,Inc.