NITROFURANTOIN- nitrofurantoin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

NITROFURANTOIN

Composition:

NITROFURANTOIN 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitrofurantoin macrocrystals capsules 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 macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules 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 therapeu

Product summary:

Nitrofurantoin Capsules, USP (Macrocrystals) are available as 50 mg capsules. The 50 mg capsule is a light brown opaque, hard-shell gelatin capsule axially printed with MYLAN over 1650 in black ink on both the cap and the body. The capsule is filled with yellow powder. They are available as follows: NDC 0615-1308-39 blisterpacks of 30 capsules The 100 mg capsule is a gray opaque, hard-shell gelatin capsule axially printed with MYLAN over 1700 in black ink on both the cap and the body. The capsule is filled with yellow powder. They are available as follows: NDC 0615-7655-39 blisterpacks of 30 capsules 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROFURANTOIN- NITROFURANTOIN CAPSULE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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NITROFURANTOIN CAPSULES, USP
(MACROCRYSTALS)
50 MG AND 100 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of nitrofurantoin
macrocrystals capsules and other antibacterial drugs, nitrofurantoin
macrocrystals capsules 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 powder. Nitrofurantoin macrocrystals is
an antibacterial agent for
specific urinary tract infections. It is available in 50 mg and 100 mg
capsules for oral administration.
Nitrofurantoin macrocrystals has the following structural formula:
1-[ [(5-nitro-2-furanyl) methylene] amino]-2,4-imidazolidinedione
Each 50 mg capsule contains the following inactive ingredients: black
iron oxide, corn starch, D&C
yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2
aluminum lake, FD&C red #40
aluminum lake, gelatin, lactose monohydrate, magnesium stearate, red
iron oxide, silicon dioxide,
sodium lauryl sulfate, titanium dioxide and yellow iron oxide.
Each 100 mg capsule contains the following inactive ingredients: black
iron oxide, corn starch, D&C
yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2
aluminum lake, FD&C red #40
aluminum lake, gelatin, lactose, n-butyl alcohol, propylene glycol,
SD-45 alcohol, SDA 3A alcohol,
shellac glaze, sodium lauryl sulfate, talc, titanium dioxide and
yellow iron oxide.
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 q.i.d. for 7