Nitrofurantoin Macrocrystals (Page 4 of 4)

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.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 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 pink opaque capsules, imprinted with z, “Zenith 100 mg” on the cap and “2131”, underlined with a triple bar, on the body, in black ink, containing 100 mg nitrofurantoin macrocrystals.

NDC 68071-2517-6 BOTTLES OF 6

NDC 68071-2517-7 BOTTLES OF 14

NDC 68071-2517-2 BOTTLES OF 20

NDC 68071-2517-8 BOTTLES OF 28

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

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit
Ahmedabad 382213, INDIA
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 06-2020-00

PRINCIPAL DISPLAY PANEL — 100 mg

NITROFURANTOIN MACROCRYSTALS nitrofurantoin macrocrystals capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-2517(NDC:0115-1645) 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 STARCH, CORN FERROSOFERRIC OXIDE D&C YELLOW NO. 10 ALUMINUM OXIDE FD&C BLUE NO. 1 FD&C BLUE NO. 2 INDIGOTINDISULFONATE SODIUM FD&C RED NO. 40 PROPYLENE GLYCOL SHELLAC GELATIN LACTOSE MONOHYDRATE TALC TITANIUM DIOXIDE D&C RED NO. 33

Product Characteristics Color pink Score no score Shape CAPSULE Size 18mm Flavor Imprint Code Z;Zenith;100mg;2131 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68071-2517-7 14 CAPSULE in 1 BOTTLE None 2 NDC:68071-2517-8 28 CAPSULE in 1 BOTTLE None 3 NDC:68071-2517-6 6 CAPSULE in 1 BOTTLE None 4 NDC:68071-2517-2 20 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA073652 03/08/2007

Labeler — NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Operations
NuCare Pharmaceuticals,Inc.		010632300	repack (68071-2517)

Revised: 08/2021 NuCare Pharmaceuticals,Inc.