Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)
REMEDYREPACK INC.
NITROFURANTOIN
NITROFURANTOIN 100 mg
ORAL
PRESCRIPTION DRUG
Nitrofurantoin macrocrystals capsules 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 macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules 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 macrocrystals capsules 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 macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin macrocrystals capsules, 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. Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug. Because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38 to 42 weeks’ gestation), during labor and delivery, or when the onset of labor is imminent. For the same reason, the drug is contraindicated in neonates under one month of age. Nitrofurantoin macrocrystals capsules is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin macrocrystals capsules is also contraindicated in those patients with known hypersensitivity to nitrofurantoin.
100 mg opaque, yellow capsule imprinted with “MACRODANTIN 100 mg” and “52427-288”. NDC: 70518-0103-00 NDC: 70518-0103-01 NDC: 70518-0103-02 PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 20 in 1 BOTTLE PLASTIC PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 14 in 1 BOTTLE PLASTIC 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.
New Drug Application
NITROFURANTION MACROCRYSTALS- NITROFURANTION MACROCRYSTALS CAPSULE REMEDYREPACK INC. ---------- NITROFURANTOIN MACROCRYSTALS CAPSULES To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Nitrofurantoin macrocrystals capsules is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin macrocrystals capsules is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione INACTIVE INGREDIENTS: Each capsule contains edible black ink, gelatin, lactose, starch, talc, titanium dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10. CLINICAL PHARMACOLOGY Nitrofurantoin macrocrystals capsules is a larger crystal form of nitrofurantoin. The absorption of nitrofurantoin macrocrystals capsules is slower and its excretion somewhat less when compared to nitrofurantoin. Blood concentrations at therapeutic dosage are usually low. It is highly soluble in urine, to which it may impart a brown color. Following a dose regimen of 100 mg q.i.d. for 7 days, average urinary drug recoveries (0 to 24 hours) on day 1 and day 7 were 37.9% and 35.0%. Unlike many drugs, the presence of food or agents delaying gastric emptying can increase the bioavailability of nitrofurantoin macrocrystals capsules, presumably by allowing better dissolution in gastric juices. MICROBIOLOGY Nitrofurantoin is a nitrofuran antimicrobial agent with activity against certain Gram- positive and Gram-negative bacteria. MECHANISM OF ACTION The mechanism of the antimicrobial action of nitrofurantoin is unusual among antibacterials. Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermedi Prečítajte si celý dokument