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.
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.
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).
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 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.
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit
Ahmedabad 382213, INDIA
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
PRINCIPAL DISPLAY PANEL — 100 mg
| NITROFURANTOIN MACROCRYSTALS |
nitrofurantoin macrocrystals capsule
|Labeler — NuCare Pharmaceuticals,Inc. (010632300)|
|NuCare Pharmaceuticals,Inc.||010632300||repack (68071-2517)|
Revised: 08/2021 NuCare Pharmaceuticals,Inc.
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