NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)- nitrofurantoin monohydrate/macrocrystals capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Bryant Ranch Prepack

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules, USP (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, USP (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules, USP (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.

Produktbesonderheiten:

Nitrofurantoin capsules, USP (monohydrate/macrocrystals), 100 mg, are supplied as a gray opaque cap and yellow opaque body imprinted axially “AN” in white ink on the cap and “478” in black ink on the body. They are available as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container. Rx Only Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)- NITROFURANTOIN
MONOHYDRATE/MACROCRYSTALS CAPSULE
BRYANT RANCH PREPACK
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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, USP is an antibacterial agent specific for urinary
tract infections.
Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are a hard
gelatin capsule
shell containing the equivalent of 100 mg of nitrofurantoin, USP 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:
The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-
furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The
chemical structure
is the following:
INACTIVE INGREDIENTS: Each capsule contains carbomer 934P,
carboxymethylcellulose,
corn starch, D&C Yellow No. 10, FD&C Red No. 40, gelatin, iron oxide
black, iron oxide
yellow, lactose, magnesium stearate, maltodextrin, povidone, sodium
lauryl sulfate,
sugar, talc and titanium dioxide. The black monogramming ink contains
butyl alcohol,
dehydrated alcohol, iron oxide black, isopropyl alcohol, potassium
hydroxide, propylene
glycol, purified water, shellac and strong ammonia solution. The white
monogramming
ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol,
povidone, propylene
glycol, shellac, sodium hydroxide and titanium dioxide.
Meets USP Dissolution Test 7.
CLINICAL PHARMACOLOGY
Each nitrofurantoin capsule (monohydrate/macrocrystals) contains two
forms of
nitrofurantoin. Twenty-five percent is macrocrystalline
nitrofuran