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Image 0 of Folic Acid 1 Mg 90 TabletImage 1 of Folic Acid 1 Mg 90 Tablet

Folic Acid 1 Mg 90 Tablet

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Folic Acid 1 Mg 90 Tablet. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD4485785/RXB10099320
Size : 90
Selling UoM : EA
NDC: 00603-3162-02
UPC Barcode :
Supplier: 0050000428 PAR PHARM INC
Supplier Material : 316202
Generic Code : 002366 FOLIC ACID ORAL TABLET 1 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic RX

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Product Description.:

31 62
tablet , yellow , scored , round round
Debossed

Folic Acid, N-[p-[[(2-amino-4- hydroxy-6-pteridinyl) methyl]- amino] benzoyl]-Lglutamic acid, is a B complex vitamin containing apteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of Folic Acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available Folic Acid is pre pared synthetically. Folic Acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic Acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of Folic Acid (sodium folate). Aqueous solutions of Folic Acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin solutions should be stored in a cool place protected from light.

Each tablet, for oral administration, contains 1 mg Folic Acid.

Folic Acid Tablets, USP 1 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid.

INDICATIONS AND USAGE

Folic Acid is effective in the treatment of megaloblastic anemias due to a deficiency of Folic Acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

CONTRAINDICATIONS
Folic Acid is contraindicated in patients who have shown previous intolerance to the drug.

WARNING
Administration of Folic Acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

PRECAUTIONS
General

Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive.

There is a potential danger in administering Folic Acid to patients with undiagnosed anemia, since Folic Acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system dam age before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.

Drug Interactions

There is evidence that the anti convulsant action of phenytoin is antagonized by Folic Acid. A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if Folic Acid is given.

Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., Folic Acid antagonists such as methotrexate) the administration of anticonvulsants, such as diphenylhydantoin, primidone, and barbiturates alcohol consumption and, especially, alcoholic cirrhosis and the administration of pyrimethamine and nitrofurantoin.

False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of Lactobacillus casei.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential and studies to evaluate the mutagenic potential or effect on fertility have not been con ducted.

Pregnancy

Teratogenic Effects

Pregnancy Category A

Folic Acid is usually indicated in the treatment of megaloblastic anemias of pregnancy. Folic Acid requirements are markedly increased during pregnancy, and deficiency will result in fetal damage (see INDICA TIONS AND USAGE).

Studies in pregnant women have not shown that Folic Acid increases the risk of fetal abnormalities if administered during pregnancy. If the drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, Folic Acid should be used during pregnancy only if clearly needed.

Nursing Mothers

Folic Acid is excreted in the milk of lactating mothers. During lactation, Folic Acid requirements are markedly increased however, amounts present in human milk are adequate to fulfill infant requirements, although supplementation may be needed in low- birth-weight infants, in those who are breast-fed by mothers with Folic Acid deficiency (50 μg daily), or in those with infections or prolonged diarrhea.