NITROFURANTOIN MACROCRYSTALS capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lifestar Pharma LLC

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 white opaque cap and white opaque body, hard gelatin size "5" capsules imprinted with "LS" on cap and "410" on body with black ink, containing light yellow to yellow colored powder. NDC 70756-410-11                Bottle of 100 with child-resistant closure 50 mg blue opaque cap and white opaque body, hard gelatin size "3" capsules imprinted with "LS" on cap and "411" on body with black ink containing light yellow to yellow colored powder. NDC 70756-411-11                Bottle of 100 with child-resistant closure 100 mg blue opaque cap and blue opaque body, hard gelatin size "2" capsules imprinted with "LS" on cap and "412" on body with black ink containing light yellow to yellow colored powder. NDC 70756-412-11                Bottle of 100 with child-resistant closure Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Made in India   The other brands listed are trademarks of their respective owners and are not trademarks of Lifestar Pharma LLC. Revised: November 2022, V-03

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROFURANTOIN MACROCRYSTALS - NITROFURANTOIN MACROCRYSTALS CAPSULE
LIFESTAR PHARMA LLC
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NITROFURANTOIN CAPSULES, USP (MACROCRYSTALS)
RX ONLY
SPL UNCLASSIFIED
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 bacteria.
DESCRIPTION
Nitrofurantoin capsules, USP (macrocrystals) are a synthetic chemical
of controlled
crystal size. It is a stable, lemon yellow, crystalline compound.
Nitrofurantoin capsules,
USP (macrocrystals) are 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, USP
(macrocrystals).
MOLECULAR FORMULA: C H N O MOLECULAR WEIGHT: 238.16 g/mole
1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione
INACTIVE INGREDIENTS: Each capsule contains: corn starch, gelatin,
lactose
monohydrate, talc and titanium dioxide. Additionally, each 50 mg and
100 mg capsule
shell contains FD&C Blue no. 1 and FD&C Red no. 3. The capsule is
printed with black
pharmaceutical ink which contains ferrosoferric oxide, potassium
hydroxide, and
shellac.
CLINICAL PHARMACOLOGY
Nitrofurantoin capsules (macrocrystals) is a larger crystal form of
Furadantin
(nitrofurantoin). The absorption of nitrofurantoin capsules
(macrocrystals) is slower and
8
6
4
5
®
®
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 capsules
(m