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Drug Catalog - Product Detail

NITROFURANTOIN MACRO 100MG CAP 100CT

NDC Mfr Size Str Form
00591-3686-01 ACTAVIS PHARMA 100 100MG CAPSULE
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Description
DESCRIPTION: Nitrofurantoin, USP (macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin, USP (macrocrystals) is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin macrocrystals. Inactive Ingredients: Each capsule contains D&C Yellow # 10, FD&C Blue # 1, FD&C Blue # 2, FD&C Red # 40, gelatin, iron oxide black, lactose anhydrous, magnesium stearate, pregelatinized corn starch, sodium lauryl sulfate, talc and titanium dioxide. The 50 mg and 100 mg capsules also contain FD&C Yellow No. 6. structure
How Supplied
HOW SUPPLIED: Nitrofurantoin Capsules, USP (macrocrystals) are available as follows: 25 mg opaque, white body and opaque, white cap imprinted in black ink with “ WATSON ” on the cap and “ 5779 ” on the body NDC 0591-3684-01 bottles of 100 50 mg opaque, white body and opaque, yellow cap imprinted in black ink with “ WATSON ” on the cap and “ 5780 ” on the body. NDC 0591-3685-01 bottles of 100 100 mg opaque, yellow capsule imprinted in black ink with “ WATSON ” on the cap and “ 5781 ” on the body. NDC 0591-3686-01 bottles of 100 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. B 4/2022
Indications & Usage
INDICATIONS AND USAGE: Nitrofurantoin capsules (macrocrystals) are 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 nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) 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 nitrofurantoin capsules (macrocrystals) 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 nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION: Nitrofurantoin capsules (macrocrystals) should be given with food to improve drug absorption and, in some patients, tolerance. Adults: 50 mg to 100 mg four times a day -- the lower dosage level is recommended for uncomplicated urinary tract infections. Pediatric Patients: 5 to 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.