Nitrofurantoin (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, USP (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) is available as 100 mg opaque yellowish brown and pale yellow capsules imprinted “101” on both cap and body.

NDC 68001-423-00 bottle of 100

Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature.]

Rx Only

CLINICAL STUDIES

Controlled clinical trials comparing Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) 100 mg p.o. q12h and nitrofurantoin (macrocrystals) capsule 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.

Mfg. by:

Swiss Pharmaceutical Co. Ltd.
Tainan City, 74442 Taiwan

For BluePoint Laboratories

Rev.: 10/2019

Package/Label Display Panel

Nitrorurantoin Capsules 100 mg rev 10/19
(click image for full-size original)
NITROFURANTOIN
nitrofurantoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-423
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROFURANTOIN (NITROFURANTOIN) NITROFURANTOIN 25 mg
NITROFURANTOIN MONOHYDRATE (NITROFURANTOIN) NITROFURANTOIN 75 mg
Product Characteristics
Color yellow (yellowish brown) , yellow (pale yellow) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code 101
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-423-00 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208516 11/13/2019
Labeler — BluePoint Laboratories (985523874)
Establishment
Name Address ID/FEI Operations
Swiss Pharmaceutical Company Ltd 656044344 MANUFACTURE (68001-423)

Revised: 11/2019 BluePoint Laboratories

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