NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)- nitrofurantoin monohydrate/macrocrystals 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:

Amneal Pharmaceuticals LLC

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, USP (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, USP (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 the

Product summary:

Nitrofurantoin capsules, USP (monohydrate/macrocrystals), 100 mg, are supplied as a gray opaque cap and yellow opaque body imprinted axially “AN” in white ink on the cap and “478” in black ink on the body. They are available as follows: Bottles of 100:                           NDC 65162-478-10 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container. Rx Only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)- NITROFURANTOIN
MONOHYDRATE/MACROCRYSTALS CAPSULE
AMNEAL PHARMACEUTICALS LLC
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NITROFURANTOIN CAPSULES, USP (MONOHYDRATE/MACROCRYSTALS)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Nitrofurantoin capsules, USP (monohydrate/macrocrystals) and other
antibacterial
drugs, Nitrofurantoin capsules, USP (monohydrate/macrocrystals) should
be used only
to treat or prevent infections that are proven or strongly suspected
to be caused by
bacteria.
DESCRIPTION
Nitrofurantoin, USP is an antibacterial agent specific for urinary
tract infections.
Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are 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:
The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-
furanyl]methylene]amino]-2,4- imidazolidinedione monohydrate. The
chemical structure
is the following:
INACTIVE INGREDIENTS: Each capsule contains carbomer 934P,
carboxymethylcellulose,
corn starch, D&C Yellow No. 10, FD&C Red No. 40, gelatin, iron oxide
black, iron oxide
yellow, lactose, magnesium stearate, maltodextrin, povidone, sodium
lauryl sulfate,
sugar, talc and titanium dioxide. The black monogramming ink contains
butyl alcohol,
dehydrated alcohol, iron oxide black, isopropyl alcohol, potassium
hydroxide, propylene
glycol, purified water, shellac and strong ammonia solution. The white
monogramming
ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol,
povidone, propylene
glycol, shellac, sodium hydroxide and titanium dioxide.
Meets USP Dissolution Test 7.
CLINICAL PHARMACOLOGY
Each nitrofurantoin capsule (monohydrate/macrocrystals) contains two
forms of
nitrofurantoin. Twenty-five percent is macrocrystalline
nitr