RVP

Drug Catalog - Product Detail

NITROFURANTOIN MACRO 100MG CP 100

NDC Mfr Size Str Form
57664-0233-88 SUN PHARMACEUTICALS 100 100MG CAPSULE
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Generic Name
NITROFURANTION
Substance Name
NITROFURANTOIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA201722
Description
DESCRIPTION Nitrofurantoin macrocrystals, USP is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin macrocrystals, USP is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. It is chemically designated as 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione and has the following structural formula: Each Nitrofurantoin Capsules, USP (macrocrystals) contains nitrofurantoin (macrocrystals) USP equivalent to 25 mg, 50 mg or 100 mg and the following inactive ingredients: lactose monohydrate, corn starch, talc, titanium dioxide, gelatin, sodium lauryl sulfate, shellac, propylene glycol, potassium hydroxide and black iron oxide. In addition 50 mg capsules contain FD&C Blue #1, red iron oxide and yellow iron oxide. structure
How Supplied
HOW SUPPLIED Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg are size “4” white opaque hard gelatin capsule, axially printed “231” in black ink on both cap and body containing cream to yellow colored powder available as follows: Bottles of 100 NDC 57664-231-88 Bottles of 1000 NDC 57664-231-18 Nitrofurantoin Capsules, USP (Macrocrystals), 50 mg are size “3” light brown hard gelatin capsule, axially printed “232” in black ink on both cap and body containing cream to yellow colored powder available as follows: Bottles of 100 NDC 57664-232-88 Bottles of 1000 NDC 57664-232-18 Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg are size “2” grey opaque hard gelatin capsule, axially printed “233” in black ink on both cap and body containing cream to yellow colored powder available as follows: Bottles of 100 NDC 57664-233-88 Bottles of 1000 NDC 57664-233-18 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light and moisture. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248 197 Uttarakhand, India Rev. 11/18 M. L. No. 38/UA/2007 P2081002
Indications & Usage
INDICATIONS AND USAGE: Nitrofurantoin Capsules, USP (macrocrystals) 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 Nitrofurantoin Capsules, USP (macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules, USP (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, USP (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, USP (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules, USP (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