| L-Methylfolate Calcium (as or 6(S)-5-MTHF-Ca)L-Methylfolate Calcium (Form: or 6(S)-5-MTHF-Ca) Note: contains less than 1% d-methylfolate | 7.5 mg | † |
Other ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, FD&C Blue #2, Titanium Dioxide, Modified Cellulose, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Silicon Dioxide, Polyethylene Glycol, Food Glaze
% Daily Values for: Adults and children 4 or more years of age.
Where this label comes from
An original label of the NIH's Dietary Supplement Label Database, entered there on 24 December 2013, shown here as it was entered. The NIH's record
General information
- Product name
- L-Methylfolate Calcium 7.5 mg
- Brand
- Virtus Pharmaceuticals
- Barcode (UPC)
- 3 76439 20690 1
- Net contents
- 90 Tablet(s)
- Market status
- On market
- DSLD ID
- 25626
Classification
- Supplement form
- Tablet or Pill
- Product type
- Vitamin
- Claim types on the label
- Nutrient, All Other
- Intended for
- Adult (18 - 50 Years)
Label statements
Precautions: All Other: Call your medical practitioner about side effects.
Storage: STORAGE: Store at controlled room temperature 15(0)-30(0)C (59(0)-86(0)F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.
Precautions: All Other: L-Methylfolate Calcium 7.5 mg should be administered under the supervision of a licensed medical practitioner.
FDA Statement of Identity: Prescription Dietary Supplement
Directions: DOSAGE AND ADMINISTRATION: The usual adult dose is 7.5 to 15 mg daily with or without food or as directed by a licensed medical practitioner.
Precautions: Pregnant or Nursing or Prescription Medications: If you are pregnant or nursing a baby, ask a health professional.
Precautions: Children: KEEP THIS OUT OF REACH OF CHILDREN.
Precautions: Allergies: CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Precautions: Pregnant or Nursing or Prescription Medications: 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.
Directions: INDICATIONS AND USAGE: L-Methylfolate Calcium 7.5 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 7.5 mg should be administered under the supervision of a licensed medical practitioner.
Precautions: Pregnant or Nursing or Prescription Medications: - 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. PREGNANCY and NURSING MOTHERS: L-Methylfolate Calcium 7.5 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.
Precautions: All Other: Call your medical practitioner about side effects.
Precautions: All Other: 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 7.5 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.
Precautions: All Other: PATIENT INFORMATION: L-Methylfolate Calcium 7.5 mg is a prescription dietary supplement to be used only under licensed medical supervision.
Precautions: All Other: - Smoking and Alcohol: Reduced serum folate levels have been noted.
Precautions: Allergies: 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.
Directions: DOSAGE AND ADMINISTRATION: The usual adult dose is 7.5 to 15 mg daily with or without food or as directed by a licensed medical practitioner.
Precautions: All Other: 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.
Storage: STORAGE: Store at controlled room temperature 15(0)-30(0)C (59(0)-86(0)F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.
Precautions: Children: KEEP THIS OUT OF REACH OF CHILDREN.
Brand information
Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL
More labels from Virtus Pharmaceuticals
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