Folic Acid (Page 2 of 2)
OVERDOSAGE
Except during pregnancy and lactation, folic acid should not be given in therapeutic doses greater than 0.4 mg daily until pernicious anemia has been ruled out. Patients with pernicious anemia receiving more than 0.4 mg of folic acid daily who are inadequately treated with vitamin B12 may show reversion of the hematologic parameters to normal, but neurologic manifestations due to vitamin B12 deficiency will progress. Doses of folic acid exceeding the Recommended Dietary Allowance (RDA) should not be included in multivitamin preparations; if therapeutic amounts are necessary, folic acid should be given separately.
DOSAGE AND ADMINISTRATION
Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral or enteral alimentation). Doses greater than 0.1 mg should not be used unless anemia due to vitamin B12 deficiency has been ruled out or is being adequately treated with a cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine.
The usual therapeutic dosage in adults and children (regardless of age) is up to 1 mg daily. Resistant cases may require larger doses. When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent.
In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.
HOW SUPPLIED
Folic Acid Tablets, USP 1 mg are 5/16″, scored, round, yellow to orange color tablets imprinted “EP 127” and supplied in bottles of 100 (NDC 64125-127-01) and 1000 (NDC 64125-127-10).
Dispense in well-closed container with child-resistant closure. Store at controlled room temperature 20°-25°C (68°-77°F).
Manufactured by:
Excellium Pharmaceutical, Inc.
3 G Oak Road, Fairfield, NJ 07004
ISS 07/07
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
EXCELLIUM
NDC 64125-127-01
FOLIC ACID TABLETS, USP
1 mg
Rx only
100 Tablets
EXCELLIUM
NDC 64125-127-10
FOLIC ACID TABLETS, USP
1 mg
Rx only
1000 Tablets
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Labeler — Excellium Pharmaceutical Inc. (011769192) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Excellium Pharmaceutical Inc. | 011769192 | MANUFACTURE (64125-127) |
Revised: 08/2012 Excellium Pharmaceutical Inc.
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