NITROFURANTOIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

NITROFURANTOIN

Composition:

NITROFURANTOIN 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Nitrofurantoin Capsules, USP (macrocrystals) are available as follows: 25 mg opaque, white body and opaque, white cap imprinted in black ink with “WATSON ” on the cap and “5779 ” on the body NDC 0591-3684-01 bottles of 100 50 mg opaque, white body and opaque, yellow cap imprinted in black ink with “WATSON ” on the cap and “5780 ” on the body. NDC 0591-3685-01 bottles of 100 100 mg opaque, yellow capsule imprinted in black ink with “WATSON ” on the cap and “5781 ” on the body. NDC 0591-3686-01 bottles of 100 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. Manufactured by: Watson Pharma Private Limited  Verna, Salcette Goa 403722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. B 4/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROFURANTOIN- NITROFURANTOIN CAPSULE
ACTAVIS PHARMA, INC.
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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. Each capsule contains 25
mg, 50 mg, or
100 mg of nitrofurantoin macrocrystals.
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 nitrofuran