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%.

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.

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.

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

No information provided.

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

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

No information provided.

No information provided.

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.

See WARNINGS and PRECAUTIONS.

No information provided

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

FOLIC ACID - ORAL

(FOH-lick)

COMMON BRAND NAME(S): FA-8

USES: Folic acid is used to treat or prevent certain anemias caused by poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, or other conditions. This medication helps to relieve symptoms such as unusual tiredness and diarrhea that can occur with these types of anemias. Women of childbearing age should maintain adequate amounts of folic acid either through diet or supplements to prevent infant spinal cord birth defects.

Folic acid is a B-complex vitamin needed to form healthy cells, especially red blood cells.

HOW TO USE: Take this product by mouth as directed by your doctor. Dosage is based on your medical condition and response to therapy.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day. Follow the diet plan recommended by your doctor or dietician. See also the Notes section.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Folic acid usually has very few side effects. If you have any unusual effects from taking this medicine, contact your doctor or pharmacist promptly.

If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking folic acid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vitamin B-12 deficiency (pernicious anemia).

Folic acid is safe to take during pregnancy when used as directed. Certain spinal cord birth defects may be prevented by maintaining adequate amounts of folic acid during pregnancy. Consult your doctor for more details.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

DRUG INTERACTIONS: If you are taking this medication under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: certain antibiotics (chloramphenicol, nitrofurantoin), methotrexate, pyrimethamine, sulfasalazine.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include mental/mood changes.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., complete blood count, folate blood level, vitamin B-12 blood level) should be performed periodically to monitor your progress. Consult your doctor for more details.

Folic acid is naturally found in leafy greens and other vegetables, organ meats (liver, kidney), and citrus fruits. You will also find it in enriched grains such as bread, pasta and cereal. Consult your doctor or dietician for a diet plan rich in folic acid.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.