NITROFURANTOIN- MONOHYDRATE/MACROCRYSTALS capsule

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Sandoz Inc

INN (Међународно име):

NITROFURANTOIN MONOHYDRATE

Састав:

NITROFURANTOIN 75 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 infections. Consequently, many patients who are treated with nitrofurantoin (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 (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin (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 (monohydrate/macrocrystals) is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin (monohydrate/macrocrystals) is also contraindicated in those patients with known hypersensitivity to nitrofurantoin.

Резиме производа:

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 0185-0122-01 bottles of 100 NDC 0185-0122-10 bottles of 1,000 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.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)- NITROFURANTOIN
(MONOHYDRATE/MACROCRYSTALS) CAPSULE
EON LABS, INC.
----------
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 p