NITROFURANTOIN (nitrofurantoin- monohydrate/macrocrystals capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

NuCare Pharmaceuticals,Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.

Ringkasan produk:

Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are available as 100 mg grey opaque cap and brown opaque body, hard gelatin, size "1" capsules imprinted with logo on cap and "404" on body with white ink, containing light yellow to yellow color powder and one oval uncoated tablet plain on both sides. NDC 68071-3569-4 BOTTLES OF 14 NDC 68071-3569-2 BOTTLES OF 20 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

NITROFURANTOIN- NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
NITROFURANTOIN CAPSULES, USP (MONOHYDRATE/MACROCRYSTALS)
RX ONLY
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
capsule, USP (monohydrate/macrocrystals) is hard gelatin capsule. Each
capsule
contains 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
2,4-Imidazolidinedione, 1-
[[(5-nitro-2-furanyl)methylene]-amino]. The chemical structure is the
following:
Molecular Weight: 238.16
Molecular formula: C
H
N
O
The chemical name of nitrofurantoin monohydrate, USP is
2,4-Imidazolidinedione, 1-[[(5-
nitro-2-furanyl)methylene]-amino]-monohydrate. The chemical structure
is the following:
8
6
4
5
Molecular Weight: 256.18
Molecular formula: C
H
N
O
· H
O
INACTIVE INGREDIENTS:Each capsule contains carbomer homopolymer type
B, corn
starch, D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No. 40, FD&C Red
No. 3, gelatin,
lactose monohydrate, magnesium stearate, potassium hydroxide, povidone
K 30,
povidone K 90, shellac, sucrose, talc, and titanium dioxide.
FDA approved dissolution test specifications differ from USP
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 ma