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 |
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Description
11 DESCRIPTION Nitrofurantoin oral suspension, 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
16 HOW SUPPLIED/STORAGE AND HANDLING 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). Storage and Handling Avoid exposure to strong light which may darken the drug. It is stable when stored between 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F 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.
Indications & Usage
1 INDICATIONS AND USAGE Nitrofurantoin oral suspension is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli , Enterococcus species, Staphylococcus aureus , Klebsiella species and Enterobacter species. Limitations of Use Nitrofurantoin oral suspension is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions ( 5.7 )]. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin oral suspension and other antibacterial drugs, nitrofurantoin oral suspension 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. Nitrofurantoin oral suspension is a nitrofuran antibacterial indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections caused by susceptible bacteria. ( 1 ) Limitations of Use Nitrofurantoin oral suspension is not indicated for the treatment of pyelonephritis or perinephric abscesses. ( 1 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin oral suspension and other antibacterial drugs nitrofurantoin oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Adult Patients: 50 mg to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections. ( 2.1 ) Pediatric Patients: 5 mg/kg to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age). ( 2.2 ) 2.1 Recommended Dosage and Administration in Adult Patients The recommended dosage is 50 mg to 100 mg of nitrofurantoin oral suspension four times a day. For long-term suppressive therapy in adults, a reduction of dosage to 50 mg to 100 mg at bedtime may be adequate . The benefits of long-term suppressive therapy should be balanced against the increased potential for systemic toxicity and for the development of antibacterial resistance [see Warnings and Precautions ( 5.2 , 5.4 , 5.6 )]. Administer nitrofurantoin oral suspension with food to improve drug absorption [see Clinical Pharmacology ( 12.3 )] and, in some patients, tolerance. 2.2 Recommended Dosage and Administration in Pediatric Patients (1 month of age and older) The recommended dosage of nitrofurantoin oral suspension is 5 mg/kg to 7 mg/kg of body weight per 24 hours, given in four divided doses in pediatric patients aged 1 month and older. Administer nitrofurantoin oral suspension with food to improve drug absorption [ s ee Clinical Pharmacology ( 12.3 )] and, in some patients, tolerance. Table 1 lists individual dosage volumes for nitrofurantoin oral suspension 25 mg/5 mL based on body weight for pediatric patients. Table 1: Nitrofurantoin Oral Suspension Pediatric Dosing Table for Pediatric Patients 1 month of Age and Older Weight in Kilograms (kg) Pediatric Doses (mL), Frequency: Four times Daily 25 mg/5 mL oral suspension 4 kg or lower 1 Greater than 4 kg to 5 kg 1.4 Greater than 5 kg to 7 kg 1.8 Greater than 7 kg to 10 kg 2.5 Greater than 10 kg to 14 kg 3.5 Greater than 14 kg to 20 kg 5 Greater than 20 kg to 25 kg 7 Greater than 25 kg to 30 kg 8.5 Greater than 30 kg to 40 kg 10 40 kg or greater See Adult Dose To measure the correct pediatric doses, it is important to administer nitrofurantoin oral suspension with an appropriate size oral dosing syringe with graduations that align with the volume prescribed in Table 1 above. Continue therapy 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 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 and Precautions ( 5.2 , 5.4 , 5.6 )].