Macrodantin (nitrofurantoin macrocystals capsule) is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.

Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrodantin (nitrofurantoin macrocystals capsule) and other antibacterial drugs, Macrodantin (nitrofurantoin macrocystals capsule) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Macrodantin (nitrofurantoin macrocystals capsule) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Macrodantin (nitrofurantoin macrocystals capsule) , other therapeutic agents with broader tissue distribution should be selected. In considering the use of Macrodantin (nitrofurantoin macrocystals capsule) , lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.

Macrodantin (nitrofurantoin macrocystals capsule) 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.

Macrodantin (nitrofurantoin macrocystals capsule) is available as follows:

25 mg opaque, white capsule imprinted with one black line encircling the capsule and coded "MACRODANTIN (nitrofurantoin macrocystals capsule) 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 (nitrofurantoin macrocystals capsule) 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 (nitrofurantoin macrocystals capsule) 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.

Procter & Gamble Pharmaceuticals, Inc., Cincinnati, OH 45202. REVISED January 2009.

Last reviewed on RxList: 4/15/2009
This monograph has been modified to include the generic and brand name in many instances.