Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
NITROFURANTOIN MONOHYDRATE (UNII: E1QI2CQQ1I) (NITROFURANTOIN - UNII:927AH8112L), NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)
Proficient Rx LP
ORAL
PRESCRIPTION DRUG
Nitrofurantoin (monohydrate/macrocrystals) is 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) and other antibacterial drugs, nitrofurantoin (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 i
Nitrofurantoin capsules, USP (monohydrate/macrocrystals), for oral administration, are available as: 100 mg: Black and ivory opaque capsules imprinted “E 122” on the cap and body and supplied as: NDC 71205-546-10 bottles of 10 NDC 71205-546-14 bottles of 14 NDC 71205-546-20 bottles of 20 NDC 71205-546-30 bottles of 30 NDC 71205-546-60 bottles of 60 NDC 71205-546-90 bottles of 90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)- NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE PROFICIENT RX LP ---------- NITROFURANTOIN CAPSULES, USP (MONOHYDRATE/MACROCRYSTALS), 100 MG (TWICE-A-DAY DOSAGE) RX ONLY 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 bacteria. DESCRIPTION Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are hard gelatin capsule shells containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals USP and 75 mg of nitrofurantoin monohydrate USP. The chemical name of nitrofurantoin macrocrystals USP 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 USP 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, colloidal silicon dioxide, corn starch, compressible sugar, D&C yellow No. 10, edible white ink, FD&C blue No. 1, FD&C red No. 40, gelatin, lactose monohydrate, magnesium stearate, povidone, talc, and titanium dioxide. Meets USP Dissolution Test 5 CLINICAL PHARMACOLOGY Each nitrofurantoin capsule (monohydrate/macrocrystals) 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 Přečtěte si celý dokument