Drug Catalog - Product Detail
NITROFURANTOIN ORAL SUSPENSION SUSP 25MG/5ML 236ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00472-1992-08 | ACTAVIS MID ATLANTIC | 230 | 25MG/5ML | NA |
PACKAGE FILES
Generic Name
NITROFURANTOIN
Substance Name
NITROFURANTOIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA205180
Description
DESCRIPTION Nitrofurantoin, USP, a synthetic chemical, is a stable, yellow, crystalline compound. Nitrofurantoin, USP is an antibacterial agent for specific urinary tract infections. Nitrofurantoin, USP is available in 25 mg/5 mL liquid suspension for oral administration. Inactive Ingredients Nitrofurantoin Oral Suspension USP contains carboxymethylcellulose sodium, anhydrous citric acid, glycerin, magnesium aluminum silicate, methylparaben, natural and artificial flavor (peach), propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol solution. 1
How Supplied
HOW SUPPLIED Nitrofurantoin Oral Suspension USP, 25 mg/5 mL is a yellow, peach flavored liquid. It is supplied in an 8 fl. oz. amber glass bottle (NDC 0472-1992-08). Avoid exposure to strong light which may darken the drug. It is stable when stored between 20° to 25°C (68° to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature]. Protect from freezing. SHAKE VIGOROUSLY. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days. Keep out of reach of children. Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA I602-1460 GW 7066 Rev. A 10/2018
Indications & Usage
INDICATIONS AND USAGE Nitrofurantoin oral suspension 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 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, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin, 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Nitrofurantoin should be given with food to improve drug absorption and, in some patients, tolerance. Adults 50 to 100 mg four times a day -- the lower dosage level is recommended for uncomplicated urinary tract infections. Pediatric Patients 5 to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age). The following table is based on an average weight in each range receiving 5 to 6 mg/kg of body weight per 24 hours, given in four divided doses. It can be used to calculate an average dose of nitrofurantoin oral suspension (25 mg/5 mL) for pediatric patients. Table 3: Pediatric Dosing Table Pediatric Doses (milliliters) and Weight in Kilograms (kg) Frequency 7 kg to 11 kg 2.5 mL Four times Daily 12 kg to 21 kg 5 mL Four times Daily 22 kg to 30 kg 7.5 mL Four times Daily 31 kg to 41 kg 10 mL Four times Daily 42 kg or greater See Adult Dose Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation. For long-term suppressive therapy in adults, a reduction of dosage to 50 to 100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG TERM THERAPY.