NITROFURANTOIN suspension

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Nostrum Laboratories, Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Nitrofurantoin Oral Suspension, USP is 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Oral Suspension, USP 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 Oral Suspension, USP, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Oral Suspension, USP, lower eradication rates

Rezumat produs:

Nitrofurantoin Oral Suspension, USP is a lemon yellow liquid with a fruity scent available in: NDC 70408-239-32              240 mL amber PET bottle with a child resistant cap NDC 70408-239-34              480 mL amber PET bottle with a child resistant cap Avoid exposure to strong light which may darken the drug. This package is child-resistant. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP for Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in a tight, light- resistant container made of either glass or amber PET. Use within 90 days. Keep this and all medication out of the reach of children. Manufactured by: Nostrum Laboratories, Inc. Bryan, OH 43506 7466T01 Iss: 06/21

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

NITROFURANTOIN- NITROFURANTOIN SUSPENSION
NOSTRUM LABORATORIES, INC.
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NITROFURANTOIN ORAL SUSPENSION, USP
FOR ORAL USE ONLY
RX ONLY
DESCRIPTION:
Nitrofurantoin, a synthetic chemical, is a stable, yellow, crystalline
compound.
Nitrofurantoin Oral Suspension, USP is an antibacterial agent for
specific urinary tract
infections.
Nitrofurantoin Oral Suspension, USP is available in 25 mg/5 mL liquid
suspension for oral
administration.
1-[[(5-nitro-2-furanyl)methylene]amino]-2, 4-imidazolidinedione
INACTIVE INGREDIENTS:
Nitrofurantoin Oral Suspension, USP contains carboxymethylcellulose
sodium, citric acid,
glycerin, magnesium aluminum silicate, methylparaben, N&A fruit gum
flavor #960
(MN72), propylparaben, purified water, sodium citrate, sorbitol, and
sucralose.
CLINICAL PHARMACOLOGY
Orally administered Nitrofurantoin Oral Suspension, USP is readily
absorbed and rapidly
excreted in urine. 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 42.7% and 43.6%.
Unlike many drugs, the presence of food or agents delaying gastric
emptying can
increase the bioavailability of Nitrofurantoin Oral Suspension, USP,
presumably by
allowing better dissolution in gastric juices.
MICROBIOLOGY:
Mode of Action
Nitrofurantoin is reduced by a wide range of enzymes including
bacterial flavoproteins to
reactive intermediates which are damaging to macromolecules such as
DNA and
proteins.
Cross- Resistance
Although cross-resistance with other antimicrobials may occur, cross
resistance with
sulfonamides has not been observed.
Interaction with Other Antimicrobials
Antagonism has been demonstrated_ in vitro_ between nitrofurantoin and
quinolone
antimicrobial agents. Nitrofurantoin, in the form of Nitrofurantoin
Oral Suspension, USP,
has been shown to be active against most strains of the following
bacteria both_ in vitro_
and in clinical