Macrodantin (Page 4 of 4)

DOSAGE AND ADMINISTRATION:

Macrodantin 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:

Macrodantin is available as follows:

25 mg opaque, white capsule imprinted with one black line encircling the capsule and coded “MACRODANTIN 25 mg” and “0149-0007.”*

NDC 0149-0007-05 bottle of 100

50 mg opaque, yellow and white capsule imprinted with two black lines encircling the capsule and coded “MACRODANTIN 50 mg” and “0149-0008.”*

NDC 0149-0008-05 bottle of 100
NDC 0149-0008-67 bottle of 1000

100 mg opaque, yellow capsule imprinted with three black lines encircling the capsule and coded “MACRODANTIN 100 mg” and “0149-0009.”*

NDC 0149-0009-05 bottle of 100
NDC 0149-0009-67 bottle of 1000

*Capsule design, registered trademark of Procter & Gamble Pharmaceuticals.

Rx Only

REFERENCES:

  1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically — Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December 1993.
  2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests — Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December 1993.

Procter & Gamble Pharmaceuticals, Inc.,
Cincinnati, OH 45202

REVISED January 2009

MACRODANTIN
nitrofurantoin, macrocrystalline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0149-0007
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitrofurantoin, macrocrystalline (nitrofurantoin) nitrofurantoin 25 mg
Inactive Ingredients
Ingredient Name Strength
edible black ink
gelatin
lactose
starch
talc
titanium dioxide
FD&C Yellow No. 6
D&C Yellow No. 10
Product Characteristics
Color white (opaque;white) Score no score
Shape OVAL (oval) Size 14mm
Flavor Imprint Code Macrodantin;25;mg;0149-0007
Contains
Coating false Symbol true
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0149-0007-05 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
MACRODANTIN
nitrofurantoin, macrocrystalline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0149-0008
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitrofurantoin, macrocrystalline (nitrofurantoin) nitrofurantoin 50 mg
Inactive Ingredients
Ingredient Name Strength
edible black ink
gelatin
lactose
starch
talc
titanium dioxide
FD&C Yellow No. 6
D&C Yellow No. 10
Product Characteristics
Color yellow (opaque; yellow) , white (opaque; white) Score no score
Shape OVAL (oval) Size 16mm
Flavor Imprint Code Macrodantin;50;mg;0149-0008
Contains
Coating false Symbol true
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0149-0008-05 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
2 NDC:0149-0008-67 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE None
MACRODANTIN
nitrofurantoin, macrocrystalline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0149-0009
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nitrofurantoin, macrocrystalline (nitrofurantoin) nitrofurantoin 100 mg
Inactive Ingredients
Ingredient Name Strength
edible black ink
gelatin
lactose
starch
talc
titanium dioxide
FD&C Yellow No. 6
D&C Yellow No. 10
Product Characteristics
Color yellow (opaque; yellow) Score no score
Shape OVAL (oval) Size 18mm
Flavor Imprint Code Macrodantin;100;mg;0149-0009
Contains
Coating false Symbol true
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0149-0009-05 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
2 NDC:0149-0009-67 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE None
Labeler — Procter & Gamble Pharmaceuticals

Revised: 03/2009 Procter & Gamble Pharmaceuticals

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