L-Methylfolate Calcium 15 mg

L-Methylfolate Calcium 15 mg by Virtus Pharmaceuticals lists one ingredient: 15 mg of L-methylfolate calcium per serving of 1 tablet. Its current label entered the NIH Dietary Supplement Label Database on August 23, 2013.

What is in L-Methylfolate Calcium 15 mg?

Each row as the label prints it, per serving of 1 tablet. The capsule beside an amount places it among every product in the NIH database that lists the same ingredient: the bar is the middle half of their amounts, the line in it the median, the whiskers the 10th and 90th percentiles; the green tick is the FDA Daily Value and the red dashed tick the adult upper limit (IOM).

Is that a lot?

The rows in the top or bottom tenth of the products that list the same ingredient, and any above the adult upper limit at the most servings a day the directions give:

• Its 15,000 mcg of L-methylfolate calcium (filed by NIH under folate) is higher than over 99% of the 7,022 folate products that print an amount; 50 list more.

The NIH database records one serving a day from the label's directions; its % Daily Values are for adults and children 4 or more years of age. The directions as printed are further down this page.

The Tolerable Upper Intake Level is the most of a nutrient per day, from food, water and supplements together, that is likely to pose no risk for almost all adults (Institute of Medicine, 2011). It does not apply under medical supervision. This page compares labels; it is not medical advice.

Which products have the closest formulas?

6 products list the very same ingredients; the nearest amounts come first.

• FolaQOLOncoQOL · off the market same ingredients
• 5-MTHF 15 mgThorne Research · off the market same ingredients
• 5-MTHF 15 mgFresh Nutrition same ingredients
• DenovoMagna Pharmaceuticals same ingredients
• L-Methylfolate 15mgWoodstock Vitamins same ingredients
• Folic Acid 20 mgBio-Tech Pharmacal same ingredients

What does the label say about taking it?

Quoted from the label as DSLD transcribed it: the maker's words, including any claim about what the product does, which the FDA has not evaluated and PlainVitamins does not endorse.

Directions

DOSAGE AND ADMINISTRATION: The usual adult dose is 15 mg daily with or without food or as directed by a licensed medical practitioner.

INDICATIONS AND USAGE: L-Methylfolate Calcium 15 mg is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. L-Methylfolate Calcium 15 mg should be administered under the supervision of a licensed medical practitioner.

Warnings

If you are pregnant or nursing a baby, ask a health professional.

KEEP THIS OUT OF REACH OF CHILDREN.

Call your medical practitioner about side effects.

This product contains FD&C Yellow #6 Lake.

L-Methyfolate Calcium 15 mg should be administered under the supervision of a licensed medical practitioner.

DRUG INTERACTIONS: Drugs which may interact with folate include: - Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. - Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin and other anticonvulsants. - Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine. - Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. - Colestipol: Reduces folic acid absorption and reduces serum folate levels. - Cycloserine: Reduces folic acid absorption and reduces serum folate levels. - Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim. - Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. - Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin. - L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels. - Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac. - Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. - Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone. - Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts, such as pancreatin and pancrelipase. - Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. - Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine.

- Smoking and Alcohol: Reduced serum folate levels have been noted.

- Sulfasalazine: Inhibits the absorption and metabolism of folic acid. - Metformin treatment in patients with type 2 diabetes decreases serum folate. - Warfarin can produce significant impairment in folate status after a 6-month therapy. - Folinic acid may enhance the toxicity of fluorouracil. - Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate. - Caution should be exercised with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.

These products are dietary supplements that – due to increased folate levels (8/2/73 38 FR 20750), require an Rx on the label because of increased risk associated with masking of B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements.

It is not known whether or not l-methylfolate can obscure pernicious anemia above 0.1 mg doses, so caution is advised also with this form of folate.

PREGNANCY and NURSING MOTHERS: L-Methylfolate Calcium 15 mg is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains a B vitamin in reduced form. Talk with your medical practitioner before using if pregnant or lactating.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate.

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. WARNINGS: Caution is recommended in patients with a history of bipolar illness. PRECAUTIONS: General: Folate, when administered as a single agent in doses about 0.1 mg daily, may obscure the detection of vitamin B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Folate therapy alone is inadequate for treatment of a vitamin B12 deficiency. A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed, (although not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of a precipitation of a mixed/manic episode in patients at risk for bipolar disorder. L-Methylfolate Calcium 15 mg is not an antidepressant; however, folate has been shown to enhance antidepressant effects of known antidepressants. Caution is recommended in patients with a history of bipolar illness. Patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder since mood elevation in this population is possible.

PATIENT INFORMATION: L-Methylfolate Calcium 15 mg is a prescription dietary supplement to be used only under licensed medical supervision.

Storage

STORAGE: Store at controlled room temperature 15(0)-30(0)C (59(0)-86(0)F). [See USP]. Protect from light and moisture.

What else is on the label?

Other ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid, film coat.

How many labels does L-Methylfolate Calcium 15 mg have?

One label is on file, entered on August 23, 2013.

1. Label 22186 (current) Entered August 23, 2013 · on the market · 90 tablets · UPC 3 76439 20590 4

Who makes it?

The label names Virtus Pharmaceuticals, LLC (distributor), Tampa, FL. All Virtus Pharmaceuticals products.

Where next?

• L-Methylfolate Calcium
• Methylfolate (5-MTHF)
• Virtus Pharmaceuticals
• Compare with FolaQOL
• Check an amount of folate