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Folvite

Last reviewed on RxList: 1/18/2017
Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Drug Description

DESCRIPTION

Folic Acid, N-(p(((2-Amino-4-hydroxy-6-pteridinyl)-methyl)Amino)benzoyl) glutamic acid, is a complex organic compound present in liver, yeast and other substances, and which may be prepared synthetically.

Tablets: 1 mg folic acid

Parenteral: Each ml of folic acid-solution contains sodium folate equivalent to 5 mg of folic acid.

Inactive ingredients: Sequestrene sodium 0.2% and water for injection qs 100%. Sodium hydroxide to approx. pH 9.

Preservative: Benzyl alcohol 1.5%.

Indications & Dosage

INDICATIONS

Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or non-tropical sprue, in anemias of nutritional origin, pregnancy, infancy, or childhood.

DOSAGE AND ADMINISTRATION

Oral Administration: Folic acid is well absorbed and may be administered orally with satisfactory results except in severe instances of intestinal malabsorption.

Parenteral Administration: Intramuscular, intravenous, and subcutaneous routes may be used if the disease is exceptionally severe, or if gastrointestinal absorption may be, or is known to be, impaired.

Usual Therapeutic Dosage: Adults and children regardless of age, up to 1.0 mg daily. Resistant cases may require larger doses.

Maintenance Level: When clinical symptoms have subsided and the blood picture has become normal, a maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under four years of age, 0.4 mg for adults and children four or more years of age, and 0.8 mg for pregnant and lactating women, per day, but never less than 0.1 mg per 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

Side Effects & Drug Interactions

SIDE EFFECTS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DRUG INTERACTIONS

No information provided.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Warnings & Precautions

WARNINGS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

PRECAUTIONS

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

Overdosage & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

No information provided.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

In man, an exogenous source of folate is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid, whether given by mouth or parenterally, stimulates specifically the production of red blood cells, white blood cells, and platelets in persons suffering from certain megaloblastic anemias.

Medication Guide

PATIENT INFORMATION

See WARNINGS and PRECAUTIONS.

No information provided

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