Nitrofurantion Macrocrystals (Page 4 of 4)

OVERDOSAGE

Occasional incidents of acute overdosage of Nitrofurantoin Macrocrystals 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. It is dialyzable.

DOSAGE AND ADMINISTRATION: Nitrofurantoin Macrocrystals should be given with food to improve drug absorption and, in some patients, tolerance.

Adults: 50-100 mg four times a day — the lower dosage level is recommended for uncomplicated urinary tract infections.

Pediatric Patients: 5-7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.

For long-term suppressive therapy in adults, a reduction of dosage to 50-100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.

HOW SUPPLIED

Nitrofurantoin Macrocrystals is available as follows:

25 mg opaque, white capsule imprinted with “MACRODANTIN 25 mg” and “52427-286”.

50 mg opaque, yellow and white capsule imprinted with “MACRODANTIN 50 mg” and“52427-287”.

100 mg opaque, yellow capsule imprinted with “MACRODANTIN 100 mg” and “52427-288”.

55700-295-14

55700-295-20

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

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.

Made in USA

Distributed by: Alvogen, Inc.
Pine Brook, NJ 07058 USA

To request medical information or to report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Rev: 09/2013 PI306-04

NITROFURANTION MACROCRYSTALS nitrofurantion macrocrystals capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-295(NDC:47781-308) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROFURANTOIN (NITROFURANTOIN) NITROFURANTOIN 100 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 GELATIN LACTOSE TALC TITANIUM DIOXIDE

Product Characteristics Color YELLOW (opaque) Score no score Shape CAPSULE (capsule) Size 14mm Flavor Imprint Code MACRODANTIN;100;mg;52427;288 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55700-295-14 14 CAPSULE in 1 BOTTLE, PLASTIC None 2 NDC:55700-295-20 20 CAPSULE in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA016620 09/27/2010

Labeler — Lake Erie Medical DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Operations
Lake Erie Medical DBA Quality Care Products LLC		831276758	repack (55700-295)

Revised: 01/2022 Lake Erie Medical DBA Quality Care Products LLC