Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L), NITROFURANTOIN MONOHYDRATE (UNII: E1QI2CQQ1I) (NITROFURANTOIN - UNII:927AH8112L)
Trigen Laboratories, LLC
ORAL
PRESCRIPTION DRUG
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) 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 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 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
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) is available as 100 mg opaque yellowish brown and pale yellow capsules imprinted “101” on both cap and body. NDC 13811-719-10 bottle of 100 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature.] Rx Only
Abbreviated New Drug Application
NITROFURANTOIN- NITROFURANTOIN CAPSULE TRIGEN LABORATORIES, LLC ---------- NITROFURANTOIN CAPSULES, USP (MONOHYDRATE/MACROCRYSTALS) 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) 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 974P, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, Opacode black ink S-1-17843 (consist of shellac, ferrosoferric oxide, butyl alcohol, propylene glycol, isopropyl alcohol and ammonia), povidone, pregelatinized starch, sodium lauryl sulfate, sucrose, talc, titanium dioxide. FDA approved dissolution test specifications differ from USP. CLINICAL PHARMACOLOGY: Each Nitrofurantoin Capsules, USP (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 intestin Aqra d-dokument sħiħ