NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE- nitrofurantoin monohydrate/macrocrystalline capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L), NITROFURANTOIN MONOHYDRATE (UNII: E1QI2CQQ1I) (NITROFURANTOIN - UNII:927AH8112L)

Disponible desde:

REMEDYREPACK INC.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Nitrofurantoin capsules (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 (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (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 infections. Consequently, many patients who are treated with nitrofurantoin capsules (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) 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 (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (monohydrate/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 (monohydrate/macrocrystals) are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin capsules (monohydrate/macrocrystals) are also contraindicated in those patients with known hypersensitivity to nitrofurantoin.

Resumen del producto:

Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are available as 100 mg opaque black and yellow capsules imprinted “(band) Macrobid (band)” on one half and “52427-285” on the other. NDC: 70518-0265-0 NDC: 70518-0265-1 NDC: 70518-0265-2 NDC: 70518-0265-3 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 14 in 1 BOTTLE PLASTIC PACKAGING: 14 in 1 BLISTER PACK PACKAGING: 10 in 1 BOTTLE PLASTIC Store at controlled room temperature 15°C to 30°C (59°F to 86°F). Rx Only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Estado de Autorización:

New Drug Application

Ficha técnica

NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE- NITROFURANTOIN
MONOHYDRATE/MACROCRYSTALLINE CAPSULE
REMEDYREPACK INC.
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NITROFURANTOIN CAPSULES, USP (MONOHYDRATE/MACROCRYSTALS)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
nitrofurantoin capsules (monohydrate/macrocrystals) and other
antibacterial drugs,
nitrofurantoin capsules (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.
Each capsule
contains 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.
Meets USP Dissolution Test 8.
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 pharmacokinetic data, the extent and rate of urinary
excretion of
nitrofurantoin from the 100 mg nitrofurant