NITROFURANTOIN MACROCRYSTALS capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

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 lac

Product summary:

Nitrofurantoin Capsules, USP (Macrocrystals) 100 mg are light yellow to yellow powder filled in size 2 empty hard gelatin capsules with blue opaque colored cap and blue opaque colored body imprinted with 560 in black ink and are supplied as follows: NDC 68071-4688-7 BOTTLES OF 14 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . Dispense in a tight container (USP). To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 11/18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROFURANTOIN MACROCRYSTALS- NITROFURANTOIN MACROCRYSTALS CAPSULE
NUCARE PHARMACEUTICALS,INC.
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NITROFURANTOIN CAPSULES, USP (MACROCRYSTALS)
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 is a synthetic chemical of controlled
crystal size. It is a
stable, lemon-yellow, crystalline compound. 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 is a lemon-yellow crystalline compound.
It is soluble in
dimethylformamide, very slightly soluble in water and in alcohol.
Each nitrofurantoin capsules, USP (macrocrystals) intended for oral
administration
contains 50 mg and 100 mg of nitrofurantoin macrocrystals. In
addition, each capsule
contains the following inactive ingredients: gelatin, lactose
monohydrate, magnesium
stearate, pregelatinized starch, talc and titanium dioxide.
Additionally each 50 mg and
100 mg capsule shell contains FD & C Blue # 1, FD & C Red # 3 and
sodium lauryl
sulphate. The capsule is printed with black pharmaceutical ink which
contains black iron
oxide, potassium hydroxide, propylene glycol and shellac.
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 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 gas