NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS- nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

NITROFURANTOIN MONOHYDRATE (UNII: E1QI2CQQ1I) (NITROFURANTOIN - UNII:927AH8112L), NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)

Tillgänglig från:

Mylan Pharmaceuticals Inc.

INN (International namn):

NITROFURANTOIN MONOHYDRATE

Sammansättning:

NITROFURANTOIN 75 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Nitrofurantoin capsules (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus . 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 (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (monohydrate/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 therapeutic agents

Produktsammanfattning:

Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are available as 100 mg capsules. The capsules contain the equivalent of 100 mg nitrofurantoin, USP in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The 100 mg capsules are hard-shelled gelatin capsules with a light gray opaque cap and a light brown opaque body filled with one orange, round, flat faced tablet with no markings and two yellow, round, flat faced tablets with no markings. The capsules are radially printed with MYLAN over 3422 in black ink on both the cap and body. They are available as follows: NDC 0378-3422-01 bottles of 100 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.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS- NITROFURANTOIN MONOHYDRATE
AND
NITROFURANTOIN, MACROCRYSTALLINE CAPSULE
MYLAN PHARMACEUTICALS INC.
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of nitrofurantoin
capsules (monohydrate/macrocrystals) and other antibacterial drugs,
nitrofurantoin capsules
(monohydrate/macrocrystals) should be used only to treat or prevent
infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Nitrofurantoin is an antibacterial agent specific for urinary tract
infections. Nitrofurantoin capsules,
USP (monohydrate/macrocrystals) have a hard gelatin capsule shell
containing the equivalent of 100 mg
of nitrofurantoin, USP in the form of 25 mg of nitrofurantoin
macrocrystals and 75 mg of nitrofurantoin
monohydrate.
The chemical name of nitrofurantoin macrocrystals is
1-[(5-Nitrofurfurylidene)amino]hydantoin. The
chemical structure is the following:
Molecular Weight: 238.16
The chemical name of nitrofurantoin monohydrate is
1-[(5-Nitrofurfurylidene)amino]hydantoin
monohydrate. The chemical structure is the following:
Molecular Weight: 256.17
Each capsule contains the following inactive ingredients: alginic
acid, anhydrous dibasic calcium
phosphate, FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose
monohydrate, magnesium
stearate, microcrystalline cellulose, sodium alginate and sodium
lauryl sulfate. Each empty gelatin
capsule also contains black iron oxide, gelatin, red iron oxide,
titanium dioxide and yellow 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.
_Meets USP Dissolution Test 4._
CLINICAL PHARMACOLOGY
Each nitrofurantoin capsule (monohydrate/macrocrystals) contains two
forms of nitrofurantoin. Twenty-
five percent is macrocrystalline nitrofurantoin, which has slower
dissolution and absorption than
nitrofurantoin mon