Nitrofurantoin (Page 3 of 3)

OVERDOSAGE

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.

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.

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

PRINCIPAL DISPLAY PANEL

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NITROFURANTOIN
nitrofurantoin suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-689
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROFURANTOIN (NITROFURANTOIN) NITROFURANTOIN 25 mg in 5 mL
Product Characteristics
Color yellow (Clear) Score
Shape Size
Flavor TUTTI FRUTTI Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-689-88 230 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201679 03/24/2011
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
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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