NITROFURANTOIN (MACROCRYSTALS)- nitrofurantoin (macrocrystals) capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (Internationale Bezeichnung):

NITROFURANTOIN

Zusammensetzung:

NITROFURANTOIN 100 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 macrocrystals capsules are 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 distri

Produktbesonderheiten:

Nitrofurantoin Capsules, USP (Macrocrystals) are available as 50 mg and 100 mg capsules. The 50 mg capsule is a light brown opaque, hard-shell gelatin capsule filled with a yellow powder. The capsule is 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 capsule is a gray opaque, hard-shell gelatin capsule filled with a yellow powder. The capsule is 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.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

NITROFURANTOIN (MACROCRYSTALS)- NITROFURANTOIN (MACROCRYSTALS) CAPSULE
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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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, 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 capsule contains the following inactive ingredients: corn starch
and lactose monohydrate. In
addition, the 50 mg capsule contains colloidal silicon dioxide,
magnesium stearate and sodium lauryl
sulfate and the 100 mg capsule contains talc. Each empty hard shell
gelatin capsule contains gelatin,
sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 50
mg empty hard shell gelatin
capsule also contains red iron oxide and the 100 mg capsule contains
black iron oxide. The 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
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)