NITROFURANTOIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Trigen Laboratories, LLC

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

Product summary:

Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) is available as 100 mg opaque yellowish brown and pale yellow capsules imprinted “101” on both cap and body. NDC 13811-719-10 bottle of 100 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature.] Rx Only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROFURANTOIN- NITROFURANTOIN CAPSULE
TRIGEN LABORATORIES, 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 is an antibacterial agent specific for urinary tract
infections.
Nitrofurantoin Capsules , USP (monohydrate/macrocrystals) is a hard
gelatin capsule
shell containing the equivalent of 100 mg of nitrofurantoin 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
INACTIVE INGREDIENTS: Each capsule contains carbomer 974P, colloidal
silicon dioxide,
D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No. 6,
gelatin,
lactose, magnesium stearate, Opacode
black ink S-1-17843 (consist of shellac,
ferrosoferric oxide, butyl alcohol, propylene glycol, isopropyl
alcohol and ammonia),
povidone, pregelatinized starch, sodium lauryl sulfate, sucrose, talc,
titanium dioxide.
FDA approved dissolution test specifications differ from USP.
CLINICAL PHARMACOLOGY:
Each Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) contains
two forms of
nitrofurantoin. Twenty-five percent is macrocrystalline
nitrofurantoin, which has slower
dissolution and absorption than nitrofurantoin monohydrate. The
remaining 75% is
nitrofurantoin monohydrate contained in a powder blend which, upon
exposure to
gastric and intestin