NITROFURANTOIN- MACROCRYSTALS capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)

Tilgængelig fra:

Aurobindo Pharma Limited

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

INDICATIONS AND USAGE: Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. 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 (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (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 d

Produkt oversigt:

HOW SUPPLIED: Nitrofurantoin Capsules, USP (macrocrystals) are available as follows: 50 mg light brown opaque cap/light brown opaque body, hard gelatin capsule filled with yellow powder. The capsule printed with ‘NT 50’ with black ink on cap.                                Bottles of 100                                  NDC 59651-753-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 05/2023

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NITROFURANTOIN (MACROCRYSTALS) - NITROFURANTOIN
(MACROCRYSTALS) CAPSULE
AUROBINDO PHARMA LIMITED
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NITROFURANTOIN CAPSULES, USP
(MACROCRYSTALS)
50 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
nitrofurantoin (macrocrystals) and other antibacterial drugs,
nitrofurantoin
(macrocrystals) should be used only to treat or prevent infections
that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION: Nitrofurantoin (macrocrystals) is a synthetic chemical of
controlled
crystal size. It is lemon-yellow crystals. Nitrofurantoin
(macrocrystals) is an antibacterial
agent for specific urinary tract infections. It is available in 50 mg
capsules for oral
administration. Each capsule contains 50 mg of nitrofurantoin USP
(macrocrystals).
1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione
INACTIVE INGREDIENTS: Each capsule contains colloidal silicon dioxide,
corn starch,
gelatin, lactose monohydrate, magnesium stearate, red iron oxide,
sodium lauryl sulfate,
titanium dioxide and yellow iron oxide. The capsules are imprinted
with black ink
containing black iron oxide, potassium hydroxide, propylene glycol and
shellac.
CLINICAL PHARMACOLOGY: Nitrofurantoin (macrocrystals) is a larger
crystal form of
Furadantin (nitrofurantoin). The absorption of nitrofurantoin
(macrocrystals) is slower
and its excretion somewhat less when compared to Furadantin. Blood
concentrations at
therapeutic dosage are usually low. It is highly soluble in urine, to
which it may impart a
brown color.
Following a dose regimen of 100 mg q.i.d. for 7 days, average urinary
drug recoveries (0
to 24 hours) on day 1 and day 7 were 37.9% and 35.0%.
®
Unlike many drugs, the presence of food or agents delaying gastric
emptying can
increase the bioavailability of nitrofurantoin (macrocrystals),
presumably by allowing
better dissolution in gastric juices.
MICROBIOLOGY
Nitrofurantoin is a nitrofuran antimicrobial agent with activity
against certain Gram-
positive and Gram-negative ba