NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS- nitrofurantoin monohydrate and nitrofurantoin macrocrystalline capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

NITROFURANTOIN MONOHYDRATE

Composition:

NITROFURANTOIN 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitrofurantoin capsules, USP (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 age

Product summary:

Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are available as 100 mg capsules. The 100 mg capsules have a light gray opaque cap and a light brown opaque body. The hard-shell gelatin capsule is filled with one orange round, flat faced tablet with no markings and two yellow round, flat faced tablets with no markings. The capsule is radially printed with MYLAN over 3422 in black ink on both the cap and body. They are available as follows: NDC 51079-348-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS- NITROFURANTOIN MONOHYDRATE
AND
NITROFURANTOIN MACROCRYSTALLINE CAPSULE
MYLAN INSTITUTIONAL 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-nitro-2-furanyl]methylene]amino]-2,4-
imidazolidinedione. The chemical structure is the following:
Molecular Weight: 238.16
The chemical name of nitrofurantoin monohydrate is
1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-
imidazolidinedione 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 contains the following: black iron oxide, gelatin, red iron
oxide, titanium dioxide and yellow
iron oxide. The imprinting ink contains the following: 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
d