NITROFURANTOIN MACROCRYSTALS capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

NITROFURANTOIN

Composition:

NITROFURANTOIN 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitrofurantoin Capsules USP (Macrocrystals) 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 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 (Macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules USP (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 approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Capsules USP (Macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Capsules USP (Macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules USP (Macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized. Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug. Because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38 to 42 weeks’ gestation), during labor and delivery, or when the onset of labor is imminent. For the same reason, the drug is contraindicated in neonates under one month of age. Nitrofurantoin capsules (macrocrystals) are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin capsules (macrocrystals) are also contraindicated in those patients with known hypersensitivity to nitrofurantoin.

Product summary:

Nitrofurantoin Capsules USP (Macrocrystals) are available as pink opaque/white opaque capsules, imprinted with z, “Zenith 50 mg” on the cap and “2130”, underlined with a double bar, on the body, in black ink, containing 50 mg nitrofurantoin macrocrystals, packaged in bottles of 100 (NDC 0115-1643-01) and 1000 capsules (NDC 0115-1643-03). Nitrofurantoin Capsules USP (Macrocrystals) are available as pink opaque capsules, imprinted with z, “Zenith 100 mg” on the cap and “2131”, underlined with a triple bar, on the body, in black ink, containing 100 mg nitrofurantoin macrocrystals, packaged in bottles of 100 (NDC 0115-1645-01) and 1000 capsules (NDC 0115-1645-03). 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, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROFURANTOIN MACROCRYSTALS- NITROFURANTOIN MACROCRYSTALS CAPSULE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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NITROFURANTOIN CAPSULES, USP (MACROCRYSTALS)
50 MG AND 100 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
nitrofurantoin macrocrystals and other antibacterial drugs,
nitrofurantoin macrocrystals
should be used only to treat or prevent infections that are proven or
strongly suspected
to be caused by bacteria.
DESCRIPTION
Nitrofurantoin Capsules, USP (Macrocrystals) are a synthetic chemical
of controlled
crystal size. It is a stable, yellow, crystalline compound.
Nitrofurantoin Capsules, USP
(Macrocrystals) are an antibacterial agent for specific urinary tract
infections.
Nitrofurantoin, USP (macrocrystals) is chemically designated as
2,4-Imidazolidinedione,
1-[[(5-nitro-2-furanyl)methylene]amino]- and has the following
structural formula:
C H N O (anhydrous) M.W. 238.16
Each capsule, for oral administration, contains 50 mg or 100 mg of
nitrofurantoin, USP
(macrocrystals). In addition, each capsule contains the following
inactive ingredients:
corn starch, edible black ink (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, shellac glaze), gelatin, lactose
monohydrate, talc,
titanium dioxide and colorant D&C Red No. 33.
CLINICAL PHARMACOLOGY
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Nitrofurantoin macrocrystals are 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) on day 1 and day 7 were 37.9% and 35%.
Unlike many drugs, the presence of food or agents delaying gastric
emptying can
increase the bioavailability of nitrofurantoin macrocrysta