FA-8 (Oral, Injection)

Vitamins are substances that your body needs for growth and health. You only need them in small amounts, and they are usually found in the foods you eat. Folic acid (vitamin B 9) is important for healthy blood.

Not getting enough folic acid can cause anemia (weak blood). Your health care professional might treat this by prescribing folic acid for you.

Certain conditions can increase your need for folic acid, including:

• Alcoholism
• Anemia, hemolytic
• Diarrhea (continuing)
• Fever (prolonged)
• Hemodialysis
• Illness (prolonged)
• Intestinal diseases
• Liver disease
• Stress (continuing)
• Surgical removal of stomach

Additionally, infants who are smaller than normal, breast-fed infants, or those feeding on unfortified formulas (like evaporated milk or goat's milk) may need extra folic acid.

Your health care professional should determine if you need more folic acid.

Some studies suggest that women who take folic acid before they are pregnant and during early pregnancy may lower the risk of certain birth defects (neural tube defects).

Claims that folic acid and other B vitamins can prevent mental problems have not been proven. Many of these treatments involve large and costly amounts of vitamins.

Injectable folic acid is given by or under the supervision of your health care professional. Another form of folic acid can be obtained without a prescription.

For good health, it's essential to eat a balanced and varied diet. Follow any dietary plan your health care professional recommends. For your specific vitamin and/or mineral needs, ask your health care professional for a list of suitable foods. If you feel you aren't getting enough vitamins and/or minerals from your diet, you might consider taking a dietary supplement.

Folic acid is present in various foods, including vegetables, especially green vegetables; potatoes; cereals and cereal products; fruits; and organ meats (like liver or kidney). It's best to consume fresh fruits and vegetables whenever possible, as they contain the most vitamins. Some food processing can destroy certain vitamins. For instance, heat can decrease the amount of folic acid in foods.

Vitamins alone cannot replace a good diet and do not provide energy. Your body also needs other nutrients found in food, such as protein, minerals, carbohydrates, and fat. Vitamins often require the presence of other foods to be effective.

The daily amount of folic acid you need is defined in several ways.

• For U.S.—
• Recommended Dietary Allowances (RDAs) indicate the amount of vitamins and minerals needed for adequate nutrition in most healthy people. RDAs may vary based on a person's age, sex, and physical condition (e.g., pregnancy).
• Daily Values (DVs) are shown on food and dietary supplement labels to indicate the percentage of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous term United States Recommended Daily Allowances (USRDAs).

• For Canada—
• Recommended Nutrient Intakes (RNIs) help determine how much vitamins, minerals, and protein are required for adequate nutrition and to reduce the risk of chronic disease.

Normal daily recommended intakes in micrograms (mcg) for folic acid are generally defined as follows:

If you are taking this dietary supplement without a prescription, please read and follow any warnings on the label. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have been no reported problems in children when taking normal daily recommended amounts.

Geriatric

There have been no reported problems in older adults when taking normal daily recommended amounts.

Breast Feeding

Studies in women suggest that this medication is likely safe for the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if there is a possible interaction. In these instances, your doctor may need to adjust the dose, or other precautions may be necessary. When taking this dietary supplement, it is very important for your healthcare professional to know if you are using any of the medicines listed below. The following interactions have been chosen based on their potential importance and may not include all possible interactions.

Using this dietary supplement with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both of the medicines.

• Capecitabine
• Methotrexate
• Pafolacianine

Using this dietary supplement with any of the following medicines may increase the risk of certain side effects, but using both may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both of the medicines.

• Fosphenytoin
• Phenytoin
• Tea

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been selected based on their potential importance and may not include all possible interactions.

Other Medical Problems

Having other medical issues may affect the use of this dietary supplement. Be sure to tell your doctor if you have any other medical problems, especially:

• Pernicious anemia (a type of blood problem)—Taking folic acid when you have pernicious anemia may lead to serious side effects. You should confirm that you do not have pernicious anemia before starting folic acid supplementation.

Along with its necessary effects, a medicine can also cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Fever
• general weakness or discomfort
• reddened skin
• shortness of breath
• skin rash or itching
• tightness in chest
• troubled breathing
• wheezing

Other side effects that are not listed may also happen in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• FA-8
• Folacin-800
• Nature's Blend Folic Acid
• ViloFane-Dp 7.5

Available Dosage Forms:

• Capsule
• Solution
• Tablet

Therapeutic Class: Nutriceutical

Pharmacologic Class: Vitamin B (class)

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes: For the U.S. Adult and teenage males—150 to 400 micrograms (mcg) per day. Adult and teenage females—150 to 400 mcg per day. Pregnant females—400 to 800 mcg per day. Breast-feeding females—260 to 800 mcg per day. Children 7 to 10 years of age—100 to 400 mcg per day. Children 4 to 6 years of age—75 to 400 mcg per day. Children birth to 3 years of age—25 to 100 mcg per day. For Canada Adult and teenage males—150 to 220 mcg per day. Adult and teenage females—145 to 190 mcg per day. Pregnant females—445 to 475 mcg per day. Breast-feeding females—245 to 275 mcg per day. Children 7 to 10 years of age—125 to 180 mcg per day. Children 4 to 6 years of age—90 mcg per day. Children birth to 3 years of age—50 to 80 mcg per day. To treat deficiency: Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the dietary supplement in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

• Why should I take folic acid with methotrexate?