Nitrofurantoin (Page 4 of 4)

OVERDOSAGE

Occasional incidents of acute overdosage of nitrofurantoin macrocrystals 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 macrocrystals capsules 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).

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 Capsules, USP (Macrocrystals) are available as 50 mg and 100 mg capsules.

The 50 mg capsule is a light brown opaque, hard-shell gelatin capsule axially printed with MYLAN over 1650 in black ink on both the cap and the body. The capsule is filled with yellow powder. They are available as follows:

NDC 0378-1650-01
bottles of 100 capsules

NDC 0378-1650-05
bottles of 500 capsules

The 100 mg capsule is a gray opaque, hard-shell gelatin capsule axially printed with MYLAN over 1700 in black ink on both the cap and the body. The capsule is filled with yellow powder. They are available as follows:

NDC 0378-1700-01
bottles of 100 capsules

NDC 0378-1700-05
bottles of 500 capsules

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

REFERENCES

  1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically–Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December 1993.
  2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests–Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December 1993.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

REVISED AUGUST 2004 NTFT:R2

43063173 labels
(click image for full-size original)

PDRx Label43063173 labels
NITROFURANTOIN nitrofurantoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-173(NDC:0378-1700)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROFURANTOIN (NITROFURANTOIN) NITROFURANTOIN 100 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
LACTOSE
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color GRAY (Gray opaque) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code MYLAN;1700
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-173-02 2 CAPSULE (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074967 05/06/2011
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack

Revised: 11/2006 PD-Rx Pharmaceuticals, Inc.

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