NITROFURANTOIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitrofurantoin capsules, USP (macrocrystals) is 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, USP (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (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 distributio

Product summary:

Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg are white opaque cap / white opaque body, size 4, hard gelatin capsules imprinted with “A219” on cap in black ink, filled with light yellow to yellow, free flowing powder. NDC 46708-389-31                Bottle of 100 capsules NDC 46708-389-91                Bottle of 1000 capsules Nitrofurantoin Capsules, USP (Macrocrystals), 50 mg are yellow opaque cap / white opaque body, size 3, hard gelatin capsules imprinted with “A220” on cap in black ink, filled with light yellow to yellow, free flowing powder. NDC 46708-390-31                Bottle of 100 capsules NDC 46708-390-91                Bottle of 1000 capsules Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg are yellow opaque cap / yellow  opaque body, size 2, hard gelatin capsules imprinted with “A221” on cap in black ink, filled with light yellow to yellow, free flowing powder. NDC 46708-391-31                Bottle of 100 capsules NDC 46708-391-91                Bottle of 1000 capsules Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°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: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India. Revised: 02/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROFURANTOIN - NITROFURANTOIN CAPSULE
ALEMBIC PHARMACEUTICALS LIMITED
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NITROFURANTOIN CAPSULES, USP (MACROCRYSTALS)
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
nitrofurantoin capsules, USP (macrocrystals)and other antibacterial
drugs,
nitrofurantoin capsules, USP (macrocrystals)should be used only to
treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Nitrofurantoin macrocrystals, USP is a synthetic chemical of
controlled crystal size. It is
a stable, brown yellow, macrocrystalline compound. Nitrofurantoin
macrocrystals, USP
is an antibacterial agent for specific urinary tract infections. It is
available in 25 mg, 50
mg, and 100 mg capsules for oral administration.
1-[[(5-NITRO-2-FURANYL)METHYLENE]AMINO]-2,4-IMIDAZOLIDINEDIONE
Inactive Ingredients: Lactose monohydrate, maize starch, corn starch
and talc. The hard
gelatin capsules contain gelatin, titanium dioxide, D&C Red No. 33 (50
mg and 100 mg
capsules only) and D&C Yellow No. 10 (50 mg and 100 mg capsules only).
The capsules
are printed with edible black ink containing shellac, propylene
glycol, potassium
hydroxide and ferrosoferric oxide.
FDA approved dissolution specification differs from the USP
dissolution specification.
CLINICAL PHARMACOLOGY
Nitrofurantoin macrocrystals are 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 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%.
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