Nitrofurantoin Macrocrystals 25 mg Nitrofurantoin Monohydrate 75 mg
INDICATIONS AND USAGE: Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus . 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 (monohydrate/macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules, USP (monohydrate/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 (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (see CLINICAL STUDIES ). 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 (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules, USP (monohydrate/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.
trigen laboratories, llc
CAPSULE YELLOW 101 101
101 101 CAPSULE YELLOW
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Nitrofurantoin Macrocrystals 25 mg Nitrofurantoin Monohydrate 75 mg
trigen laboratories, llc
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HOW SUPPLIED:
NITROFURANTOIN capsules, USP (monohydrate/macrocrystals) is available as 100 mg opaque yellowish brown and pale yellow capsules imprinted “101” on both cap and body. NDC 13811-719-10 bottle of 100 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature.] Rx Only
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