Macrobid (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:

Macrobid capsules should be taken with food.

Adults and Pediatric Patients Over 12 Years: One 100 mg capsule every 12 hours for seven days.

HOW SUPPLIED:

Macrobid is available as 100 mg opaque black and yellow capsules imprinted “Macrobid” on one half and “Norwich Eaton” on the other.

NDC 0149-0710-01 bottle of 100

Store at controlled room temperature (59° to 86°F or 15° to 30°C).

Meets USP Dissolution Test 2

Rx Only

REFERENCES:

  1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – 5th Edition. Approved Standard NCCLS Document M7-A5. NCCLS: Wayne, PA; 2003.
  2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard – 8th Edition. Approved Standard NCCLS Document M2-A7. NCCLS: Wayne, PA; 2003.

CLINICAL STUDIES:

Controlled clinical trials comparing Macrobid 100 mg p.o. q12h and Macrodantin 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: Norwich Pharmaceuticals, Inc.
North Norwich, NY 13814
Dist. by: Procter & Gamble Pharmaceuticals, Inc.,
TM Owner, Cincinnati, OH 45202

REVISED January 2009

MACROBID
nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0149-0710
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitrofurantoin monohydrate (nitrofurantoin) nitrofurantoin 75 mg
nitrofurantoin, macrocrystalline (nitrofurantoin) nitrofurantoin 25 mg
Inactive Ingredients
Ingredient Name Strength
carbomer 934P
corn starch
compressible sugar
D&C Yellow No. 10
edible gray ink
FD&C Blue No. 1
FD&C Red No. 40
gelatin
lactose
magnesium stearate
povidone
talc
titanium dioxide
Product Characteristics
Color black (BLACK) , yellow (YELLOW) Score no score
Shape CAPSULE (Capsule) Size 20mm
Flavor Imprint Code Macrobid;Norwich;Eaton
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0149-0710-01 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
Labeler — Procter and Gamble Pharmaceuticals, Inc.

Revised: 03/2009 Procter and Gamble Pharmaceuticals, Inc.

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