macrodantin nitrofurantoin macrocrystals capsule
INDICATIONS AND USAGE Macrodantin 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 and other antibacterial drugs, Macrodantin 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 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 , other therapeutic agents with broader tissue distribution should be selected. In considering the use of Macrodantin , 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.
almatica pharma inc.
CAPSULE YELLOW Macrodantin 100 mg 52427 288
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HOW SUPPLIED Macrodantin (Nitrofurantoin capsules, USP) (macrocrystals) is available as follows: 25 mg opaque, white capsule imprinted with "MACRODANTIN 25 mg" and "52427-286". NDC 52427-286-01 bottle of 100 50 mg opaque, yellow and white capsule imprinted with "MACRODANTIN 50 mg" and "52427-287". NDC 52427-287-01 bottle of 100 100 mg opaque, yellow capsule imprinted with "MACRODANTIN 100 mg" and "52427-288". NDC 52427-288-01 bottle of 100 Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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