ประเทศ: สหรัฐอเมริกา
ภาษา: อังกฤษ
แหล่งที่มา: NLM (National Library of Medicine)
NITROFURANTOIN MONOHYDRATE (UNII: E1QI2CQQ1I) (NITROFURANTOIN - UNII:927AH8112L), NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)
St. Mary's Medical Park Pharmacy
NITROFURANTOIN
NITROFURANTOIN 25 mg
ORAL
PRESCRIPTION DRUG
Nitrofurantoin monohydrate/macrocrystals capsules 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 monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/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 appro
Nitrofurantoin monohydrate/macrocrystals capsules are available as 100 mg opaque black and yellow capsules imprinted “(band) Macrobid (band)” on one half and “52427-285” on the other. NDC 60760-055-14 BOTTLES OF 14 Store at controlled room temperature (59° to 86°F or 15° to 30°C). Meets USP Dissolution Test 2 Rx Only
New Drug Application
NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE- NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE CAPSULE ST. MARY'S MEDICAL PARK PHARMACY ---------- NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Nitrofurantoin is an antibacterial agent specific for urinary tract infections. The nitrofurantoin monohydrate/macrocrystals capsules brand of nitrofurantoin is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4- imidazolidinedione. The chemical structure is the following: Molecular Weight: 238.16 The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following: Molecular Weight: 256.17 INACTIVE INGREDIENTS: Each capsule contains carbomer 934P, corn starch, compressible sugar, D&C Yellow No. 10, edible gray ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, povidone, talc, and titanium dioxide. CLINICAL PHARMACOLOGY Each nitrofurantoin monohydrate/macrocrystals capsule contains two forms of nitrofurantoin. Twenty- five percent is macrocrystalline nitrofurantoin, which has slower dissolution and absorption than nitrofurantoin monohydrate. The remaining 75% is nitrofurantoin monohydrate contained in a powder blend which, upon exposure to gastric and intestinal fluids, forms a gel matrix that releases nitrofurantoin over time. Based on urinary pharmacokinetic data, the extent and rate of urinary excretion of nitrofurantoin from the 100 mg nit อ่านเอกสารฉบับเต็ม