Drug Catalog - Product Detail
NITROFURANTOIN ORAL SUSPENSION SUSP 25MG/5ML 230ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65162-0689-88 | AMNEAL PHARMACEUTICALS | 230 | 25MG/5ML | SUSPENSION |
PACKAGE FILES
Generic Name
NITROFURANTOIN
Substance Name
NITROFURANTOIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA201679
Description
DESCRIPTION Nitrofurantoin oral suspension USP, 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. Inactive Ingredients Nitrofurantoin oral suspension, USP contains anhydrous citric acid, artificial fruit flavor, carboxymethylcellulose sodium, glycerin, magnesium aluminum silicate, methylparaben, propylparaben, purified water, saccharin insoluble, sodium citrate, and sorbitol solution 52ae3bb2-figure-01
How Supplied
HOW SUPPLIED Nitrofurantoin oral suspension, USP (a clear, yellow colored, tutti frutti flavored suspension) containing 25 mg nitrofurantoin, USP in each teaspoonful (5 mL) is available as follows: 230 mL in an 8 oz amber bottle. NDC 65162-689-88 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 between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, amber glass bottles. Use within 30 days. Keep out of reach of children. Rx only Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2021-04
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 oral suspension 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 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, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin oral suspension, 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 oral suspension 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 Weight in Kilograms (kg) Pediatric Doses (milliliters) and 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 .