Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)
NuCare Pharmaceuticals,Inc.
ORAL
PRESCRIPTION DRUG
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. 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 capsules (macrocrystals) are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin capsules (macrocrystals) are also contraindicated in those patients with known hypersensitivity to nitrofurantoin.
100 mg blue opaque cap and blue opaque body, hard gelatin size "2" capsules imprinted with "LS" on cap and "412" on body with black ink containing light yellow to yellow colored powder. NDC 68071-3460-7 Bottle of 14 with child-resistant closure NDC 68071-3460-2 Bottle of 20 with child-resistant closure. NDC 68071-3460-8 Bottle of 28 with child-resistant closure 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. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Made in India The other brands listed are trademarks of their respective owners and are not trademarks of Lifestar Pharma LLC. Revised: November 2022, V-03
Abbreviated New Drug Application
NITROFURANTOIN MACROCRYSTALS- NITROFURANTOIN MACROCRYSTALS CAPSULE NUCARE PHARMACEUTICALS,INC. ---------- NITROFURANTOIN CAPSULES, USP (MACROCRYSTALS) RX ONLY SPL UNCLASSIFIED 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 bacteria. DESCRIPTION Nitrofurantoin capsules, USP (macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, lemon yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) are 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, USP (macrocrystals). MOLECULAR FORMULA:C H N O MOLECULAR WEIGHT:238.16 g/mole 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione INACTIVE INGREDIENTS:Each capsule contains: corn starch, gelatin, lactose monohydrate, talc and titanium dioxide. Additionally, each 50 mg and 100 mg capsule shell contains FD&C Blue no. 1 and FD&C Red no. 3. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, and shellac. CLINICAL PHARMACOLOGY Nitrofurantoin capsules (macrocrystals) is a larger crystal form of Furadantin (nitrofurantoin). The absorption of nitrofurantoin capsules (macrocrystals) is slower 8 6 4 5 ® ® and its excretion somewhat less when compared to Furadantin . 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 capsule Læs hele dokumentet