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:
- 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.
- 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
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MACRODANTIN nitrofurantoin, macrocrystalline capsule | ||||||||||||||||||||||
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MACRODANTIN nitrofurantoin, macrocrystalline capsule | ||||||||||||||||||||||
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Labeler — Procter & Gamble Pharmaceuticals |
Revised: 03/2009 Procter & Gamble Pharmaceuticals
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