NITROFURANTOIN (MACROCRYSTALS)- nitrofurantoin (macrocrystals) capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

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 therapeut

Product summary:

Nitrofurantoin Capsules, USP (Macrocrystals) are available containing 50 mg or 100 mg of nitrofurantoin (macrocrystals), USP. The 50 mg capsules are hard-shell gelatin capsules with a light brown opaque cap and light brown opaque body filled with a yellow powder. The capsules are axially printed with MYLAN over 1650 in black ink on both the cap and the body. They are available as follows: NDC 0378-1650-01 bottles of 100 capsules NDC 0378-1650-05 bottles of 500 capsules The 100 mg capsules are hard-shell gelatin capsules with a gray opaque cap and gray opaque body filled with a yellow powder. The capsules are axially printed with MYLAN over 1700 in black ink on both the cap and the body. They are available as follows: NDC 0378-1700-01 bottles of 100 capsules NDC 0378-1700-05 bottles of 500 capsules 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. To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The brands listed are registered trademarks of their respective owners. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 7/2018 NTFT:R6

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROFURANTOIN (MACROCRYSTALS)- NITROFURANTOIN (MACROCRYSTALS) CAPSULE
MYLAN PHARMACEUTICALS INC.
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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, 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 capsules has the following structural
formula:
1-[(5-Nitrofurfurylidene)amino]hydantoin
Each capsule contains the following inactive ingredients: corn starch
and lactose monohydrate. The 50
mg capsules also contain colloidal silicon dioxide, magnesium stearate
and sodium lauryl sulfate and the
100 mg capsules also contain talc. Each empty hard shell gelatin
capsule also contains gelatin, sodium
lauryl sulfate, titanium dioxide and yellow iron oxide. The 50 mg
empty hard shell gelatin capsules also
contain red iron oxide and the 100 mg capsules also contain black iron
oxide.
In addition, the black imprinting ink contains black iron oxide, D&C
Yellow No. 10 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red
No. 40 Aluminum
Lake, propylene glycol and shellac glaze.
CLINICAL PHARMACOLOGY
Nitrofurantoin macrocrystals is a larger crystal form of Furadantin
(nitrofurantoin). The absorption of
nitrofurantoin macrocrystals capsules is slower and 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 (0-24 hours) on
day 1 and day 7