LEVOMEFOLATE CALCIUM, PYRIDOXAL 5-PHOSPHATE, METHYLCOBALAMIN AND SCHIZOCHYTRIUM DHA OIL- levomefolate calcium, pyridoxal phosphate anhydrous, methylcobalamin and schizochytrium dha oil capsule
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DESCRIPTION: Levomefolate Calcium/Pyridoxal Phosphate/Mecobalamin/Algal Powder (3 mg-35 mg-2 mg-90.314 mg) Capsules are an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels. Levomefolate Calcium/Pyridoxal Phosphate/Mecobalamin/Algal Powder (3 mg-35 mg-2 mg-90.314 mg) Capsules should be administered under the supervision of a licensed medical practitioner.
Each opaque caramel cap and opaque white body capsule contains the following dietary ingredients:
|Serving Size: 1 capsule|
Servings per Container: 90 (NDC† 76439-325-90)
|Amount per Serving||% Daily Value|
|L-Methylfolate Calcium *||3 mg||†|
|Algal Powder ‡||90.314 mg||†|
CAUTION: FD&C Yellow #5 and #6, milk and soy.
Other Ingredients May Contain: Sodium Citrate Dihydrate, Citric Acid, Glutathione, Ascorbic Acid, Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, Gelatin, FD&C Yellow #5, FD&C Yellow #6, Titanium Dioxide, Water and other ancillary ingredients as needed to ensure product stability.
Since additives, preservatives, bioavailability enhancers, colors and/or flavors of natural origin, etc. are preferred over synthetics, it may be the case that product color, appearance and/or taste may vary slightly over time; and it may be necessary to substitute excipients during the manufacturing process as needed to preserve product appearance and continuity in order to avoid confusion in the marketplace and ensure the highest therapeutic target, safety and quality.
FOLATE MECHANISM OF ACTION: FOLATE is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoiesis. It also promotes white blood cell (WBC) and platelet production in folate-deficiency anemia. Folate is associated with methylation and transformylation biochemistry.
FOLATE REGULATION: The Federal Register Notices from 1971 to 1973 established that increased folate was proper therapy in megaloblastic anemias of tropical and nontropical sprue, nutritional origin, pregnancy, infancy and childhood4,5,6. Folate metabolism can be affected by malabsorption issues which differ widely among population groups. The March 5, 1996 Federal Register Notice (61 FR 8760) states that "The agency concluded that the scientific literature did not support the superiority of any one source of folate over others, and that the data were insufficient to provide a basis for stating that a specific amount of folate is more effective than another amount [emphasis added]9,10". The actual amount and source of folate require a licensed medical practitioner's supervision to achieve a satisfactory maintenance level, and may exceed the 0.8 mg UL. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that "dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription. Oral preparations supplying more than 0.8 mg of folate per dosage unit would be restricted to prescription dispensing and that a dietary supplement furnishing 0.8 mg could be prescribed when a maintenance level of 0.8 mg per day was indicated ... When clinical symptoms have subsided and the blood picture and/or CSF folate levels have become normal, a maintenance level should be used. 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 [emphasis added]7." However, once the level of active folate exceeds 0.8 mg - as prescribed dosages, then the product is no longer a medical food but a dietary management / prescription (Rx)-folate regardless of pregnancy/lactation status in spite of the fact that folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345)11. In the Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029) dated November 28, 2000, FDA wrote "... high intakes of folate may partially and temporarily correct pernicious anemia while the neurological damage of vitamin B12 deficiency progresses. IOM/NAS (1998) set the UL for all adults of 1 mg per day because of devastating and irreversible neurological consequences of vitamin B12 deficiency, the data suggesting that pernicious anemia may develop at a younger age in some racial or ethnic groups, and the uncertainty about the extent of the occurrence of vitamin B12 deficiency in younger age groups (IOM/NAS, 1998) [emphasis added]8." Summary: This product is a dietary management product that - due to advanced folate levels, requires administration under the care of a licensed medical practitioner, and the most appropriate way to do that is to provide the product as prescription for pedigree reporting and safety monitoring. The ingredients, indication or claims of this product are not to be construed to be drug claims.
ALLERGY STATEMENT: This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Individuals with allergic tendencies to these substances should use discretion.
INTERACTIONS: Talk to your healthcare practitioner and/or pharmacist before taking or using any prescription or over-the-counter medicines or herbal/health supplements alongside this product.
CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. This product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated.
WARNINGS: Caution is recommended in patients with a history of bipolar illness. Mood elevation is possible in this population.
Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group.
Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study.13
Patients undergoing cancer treatment should consult their licensed medical practitioner for advice.
PRECAUTIONS: Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress.
ADVERSE REACTIONS: Allergic reactions have been reported following the use of oral and parenteral folate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin. Nausea, vomiting, diarrhea, transient skin rash, flushing, epigastric pain, and constipation have been associated with acetylcysteine.
Call your medical practitioner about side effects.
DRUG INTERACTIONS: Drugs which may interact with folate include:
PHARMACOLOGY: FOLATE - Folates are best known for reducing the incidence of fetal neural tube defects (NTDs). NTDs are congenital malformations produced by failure of the neural tube to form and close properly during embryonic development.3 During the first four weeks of pregnancy - when many women do not even realize that they have conceived, adequate maternal folate intake is essential to reduce the risk of NTDs. As the postnatal period approaches there is increased demand again for folate regardless of lactation status. Folate is involved in transformylation and methylation metabolism as well as - indirectly, succinylation metabolism (through the "methyl trap" hypothesis). Folate plays a central role in the formation of nucleic acid precursors, such as thymidylic acid and purine nucleotides, which are essential for nucleic acid synthesis and cell division. IOM/NAS (1998) noted that the evidence for a protective effect from folate supplements is much stronger than that for food folate10. Other dietary ingredients are added to folate as cofactors, coenzymes and co-metabolites; in studies by Czeizel and Dudas (1992) and Berry et al. (1999), factors other than folate intakes may affect the magnitude of risk reduction or participate in a co-protective effect with folate10.
PREGNANCY and NURSING MOTHERS: Levomefolate Calcium/Pyridoxal Phosphate/Mecobalamin/Algal Powder (3 mg-35 mg-2 mg-90.314 mg) is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains B vitamins in active form. Talk with your medical practitioner before using if pregnant or lactating.
DOSAGE AND ADMINISTRATION: One capsule twice daily or as directed by a licensed medical practitioner.
HOW SUPPLIED: Levomefolate Calcium/Pyridoxal Phosphate/Mecobalamin/Algal Powder (3 mg-35 mg-2 mg-90.314 mg) capsules are opaque caramel cap and opaque white body capsules with the imprint "ME3X", and are supplied in bottles of 90 capsules.
NDC† 76439-325-90 (90 ct. bottle / 90 capsules)
†This product is a prescription-folate with or without other dietary ingredients that - due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia).
Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) - or similar product code, as required by pedigree reporting requirements and supply-chain control as well as - in some cases, for insurance-reimbursement applications.
This product may - under certain circumstances, be dispensed through a certified mail-order program so long as there is record of prescription AND confirmation that the patient is under licensed medical supervision. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable.
STORAGE: Store at Controlled Room Temperature 15°-30° C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.
Call your medical practitioner about side effects. You may report side effects by calling 813-283-1344.
KEEP THIS OUT OF THE REACH OF CHILDREN.
Prescription Dietary Supplement
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Virtus Pharmaceuticals, LLC
Tampa, FL 33619
MADE IN USA
|LEVOMEFOLATE CALCIUM, PYRIDOXAL 5-PHOSPHATE, METHYLCOBALAMIN AND SCHIZOCHYTRIUM DHA OIL
levomefolate calcium and algal powder capsule
|Labeler - Virtus Pharmaceuticals (969483143)|