Occasional incidents of acute overdosage of nitrofurantoin oral suspension have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended. There is no specific antidote, but a high fluid intake should be maintained to promote urinary excretion of the drug. It is dialyzable.
Nitrofurantoin oral suspension should be given with food to improve drug absorption and, in some patients, tolerance.
50 to 100 mg four times a day — the lower dosage level is recommended for uncomplicated urinary tract infections.
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.
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.
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.
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
| NITROFURANTOIN |
|Labeler — Amneal Pharmaceuticals LLC (123797875)|
|Amneal Pharmaceuticals, LLC||963900878||analysis (65162-689), label (65162-689), manufacture (65162-689), pack (65162-689)|
Revised: 09/2021 Amneal Pharmaceuticals LLC
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