Prescription Drug Information: Nitrofurantoin (Page 3 of 3)

Allergic:

A lupus-like syndrome associated with pulmonary reactions to nitrofurantoin has been reported. Also, angioedema; maculopapular, erythematous, or eczematous eruptions; pruritus; urticaria; anaphylaxis; arthralgia; myalgia; drug fever; chills; and vasculitis (sometimes associated with pulmonary reactions) have been reported. Hypersensitivity reactions represent the most frequent spontaneously-reported adverse events in worldwide postmarketing experience with nitrofurantoin formulations.

Gastrointestinal:

Nausea, emesis, and anorexia occur most often. Abdominal pain and diarrhea are less common gastrointestinal reactions. These dose-related reactions can be minimized by reduction of dosage. Sialadenitis and pancreatitis have been reported. There have been sporadic reports of pseudomembranous colitis with the use of nitrofurantoin. The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment (see WARNINGS).

Hematologic:

Cyanosis secondary to methemoglobinemia has been reported rarely.

Miscellaneous:

As with other antimicrobial agents, superinfections caused by resistant organisms, e.g., Pseudomonas species or Candida species, can occur.

Laboratory Adverse Events:

The following laboratory adverse events have been reported with the use of nitrofurantoin: increased AST (SGOT), increased ALT (SGPT), decreased hemoglobin, increased serum phosphorus, eosinophilia, glucose-6-phosphate dehydrogenase deficiency anemia (see WARNINGS), agranulocytosis, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia, megaloblastic anemia. In most cases, these hematologic abnormalities resolved following cessation of therapy. Aplastic anemia has been reported rarely.

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 capsules (macrocrystals) should be given with food to improve drug absorption and, in some patients, tolerance.

Adults:

50 mg 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 50-100 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:

100 mg opaque, yellow capsule imprinted in black ink with WATSON on the cap and 5781 on the body.

NDC 68071-5050-7 Bottles of 14

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

Manufactured by:
Watson Pharma Private Limited
Verna, Salcette Goa 403722 INDIA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Rev. A 10/2018

PRINCIPAL DISPLAY PANEL — 100 mg

pdp
(click image for full-size original)

NITROFURANTOIN
nitrofurantoin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-5050(NDC:0591-3686)
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
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
FERROSOFERRIC OXIDE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
STARCH, CORN
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
Product Characteristics
Color yellow (opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Watson;5781
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-5050-7 14 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091095 10/01/2015
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-5050)

Revised: 02/2021 NuCare Pharmaceuticals,Inc.

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