NITROFURANTOIN capsule

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Proficient Rx LP

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 distribution of other the

Přehled produktů:

Nitrofurantoin Capsules USP (macrocrystals) are available as follows: 50 mg opaque, white body and opaque, yellow cap imprinted in black ink with “WATSON ” on the cap and “5780 ” on the body. NDC 71205-365-14 bottles of 14 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Watson Pharma Private Limited  Verna, Salcette Goa 403722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Rev. A 10/2018

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

NITROFURANTOIN- NITROFURANTOIN CAPSULE
PROFICIENT RX LP
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NITROFURANTOIN
NITROFURANTOIN CAPSULES USP (MACROCRYSTALS)
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, USP (macrocrystals) is a synthetic chemical of
controlled crystal size. It is a stable,
yellow, crystalline compound. Nitrofurantoin, USP (macrocrystals) is
an antibacterial agent for specific
urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg
capsules for oral administration.
INACTIVE INGREDIENTS: Each capsule contains D&C Yellow # 10, FD&C Blue
# 1, FD&C Blue # 2,
FD&C Red # 40, gelatin, iron oxide black, lactose anhydrous, magnesium
stearate, pregelatinized corn
starch, sodium lauryl sulfate, talc and titanium dioxide. The 50 mg
and 100 mg capsules also contain
FD&C Yellow No. 6.
CLINICAL PHARMACOLOGY:
Nitrofurantoin (macrocrystals) is a larger crystal form of
nitrofurantoin. The absorption of
nitrofurantoin (macrocrystals) is slower and its excretion somewhat
less when compared to
nitrofurantoin. 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 four times a day 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 bacteria.
MECHANISM OF ACTION
The mechanism of the antimicrobial action of nitrofurantoin is unusual
among antibacterials.
Nitrofurantoin is reduced by b