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Levomefolate Calcium Algal Capsules

Generic Name: levomefolate calcium and schizochytrium dha oil
Dosage Form: capsule

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Levomefolate Calcium Algal Powder Capsules

Levomefolate Calcium/ Algal Powder Capsules

(15 mg-90.314 mg)

DIETARY MANAGEMENT / PRESCRIPTION (Rx) FOLATE

58657-208-90 (90 Capsules)

Certified Gluten Free

Rx

DESCRIPTION:

Levomefolate Calcium/ Algal Powder Capsules (15 mg-90.314 mg) are an orally administered prescription folate-containing product specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels. This product should be administered under the supervision of a licensed medical practitioner.

Each capsule contains: 15 mg of L-Methylfolate Calcium*, 90.314 mg of Algal Powder (Schizochytrium).

*CAS#151533-22-1

INGREDIENTS: Each opaque orange cap and opaque white body capsule contains the following ingredients:

L-Methylfolate Calcium*                 15 mg

Algal Powder (Schizochytrium)       90.314 mg

* CAS#151533-22-1

Other Ingredients May Contain: Microcrystalline Cellulose, Gelatin, Glutathione, Ascorbic Acid, Vegetable Magnesium Stearate, Silica, Titanium Dioxide (color), Modified Starch, Sugar, Maltodextrin, Tocopherol, Corn Oil, Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia Solution, FD&C Yellow #6, Red #40, and Water.

CAUTION: Contains soy. This product also contains bovine gelatin, FD&C Yellow #6, and Red #40.

INDICATIONS AND USAGE:

Levomefolate Calcium/ Algal Powder Capsules (15 mg-90.314 mg) are indicated for the distinct nutritional requirements of patients in need of advanced folate supplementation, specifically suboptimal L-methylfolate or maintenance-level needs, as determined by a licensed medical practitioner.

DOSAGE AND ADMINISTRATION:

The usual adult dose is one capsule daily with or without food or as directed by a licensed medical practitioner.

FOLATE is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. About 70% of food folate and cellular folate is comprised of L-methylfolate. It is the primary form of folate in circulation, and is also the form transported across membranes – particularly across the blood brain barrier – into peripheral tissues. In the cell, L-methylfolate is used in the remethylation of homocysteine to form methionine and tetrahydrofolate (THF). L-methylfolate is converted into functional, metabolically active coenzyme forms for use in the body, and supplies the active folate substrate, THF for use in transformylation and methylation biochemistry.1

Folates are best known for reducing the incidence of fetal neural tube defects (NTDs).2,3,4 NTDs are congenital malformations produced by failure of the neural tube to form and close properly during embryonic development.4,5 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. Folate 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 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 folate.4 Other 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 intake may affect the magnitude of risk reduction or participate in a co-protective effect with folate.4,5

Folate supplementation increases BH4 synthesis through a pterin “salvage pathway”, which converts sepiapterin/dihydrobiopterin (BH2) to BH4 through the enzymatic activity of dihydrofolate reductase (DHFR). Additionally, L-methylfolate may enhance or even “stand in” for BH4. BH4 can also be regenerated from quinonoid dihydrobiopterin by dihydropteridine reductase (DHPR) and synthesized de novo by conversion from guanosine triphosphate (GTP). BH4 functions as a cofactor for the enzymes responsible for the production of monoamine neurotransmitters (serotonin, epinephrine, dopamine). BH4 is the cofactor for conversion of phenylalanine to tyrosine. Tyrosine is then converted into DOPA, and eventually to norepinephrine and epinephrine. The conversion of tryptophan to serotonin also requires BH4.

FOLATE REGULATION: The Federal Register Notices from 1971 to 1973 establish that increased folate is proper supplement in megaloblastic anemias of tropical and nontropical sprue, nutritional origin, pregnancy, infancy and childhood.6,7 Folate metabolism may be affected by malabsorption issues that differ widely among population groups. The March 5, 1996 Federal Register Notice (61 FR 8760) states “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].1 The actual amount and source of folate require the supervision of a licensed medical practitioner 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.7” 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 supervision of a licensed practitioner 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].9” 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 / prescription folate that, due to advanced folate levels, requires administration under the care of a licensed medical practitioner. The "Rx" on the label is to ensure prescription dispensing and that the product is administered under the supervision of a licensed medical practitioner due to the increased risk associated with masking of B12 deficiency (pernicious anemia). The "Rx" status and a National Drug Code (NDC), or similar Product Code, facilitate pedigree reporting requirements and supply-chain control as well as, in some cases, insurance-reimbursement applications.

These statements have not been evaluate by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease.

CONTRAINDICATIONS:

This product is contraindicated in patients with a known hypersensitivity to any of the articles 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 family 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.

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. Daily ingestion of more than 3 grams per day of omega-3 fatty acids (DHA, ALA, and EPA) may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diathesis, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

ADVERSE REACTIONS:

Allergic reactions have been reported following the use of oral and parenteral folate.9

Call your licensed medical practitioner about side effects.

DRUG INTERACTIONS:

Talk to your licensed medical practitioner, healthcare practitioner, personal physician, and/or pharmacist before taking or using any prescription, over-the-counter medicines, or herbal/health supplements alongside this product. 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.
  • 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.
  • 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 serum 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.
  • 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.

DOSAGE AND ADMINISTRATION:

The usual adult dose is one capsule daily, or as directed by a licensed medical practitioner.

HOW SUPPLIED:

Levomefolate Calcium/ Algal Powder Capsules (15 mg-90.314 mg) are opaque orange cap and opaque white body capsules with the imprint "M208", and are supplied in bottles of 90 capsules and are dispensed under the supervision of a licensed medical practitioner.

Bottle of 90†       58657-208-90 (90 ct. bottle / 90 capsules)

†This product is a prescription folate with or without other dietary ingredients, due to increased folate levels (AUG 2 1973 FR 20750). The "Rx" on the label is to ensure prescription dispensing and that the product is administered under the supervision of a licensed medical practitioner due to the increased risk associated with masking of B12 deficiency (pernicious anemia).

Based on the risk of obscuring pernicious anemia, this product requires supervision of a licensed medical practitioner, an Rx status, and a National Drug Code (NDC) or similar Product Code, for pedigree reporting requirements and supply-chain control as well as, in some cases, for insurance-reimbursement applications.

FOR THE PHARMACIST

This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable. There are no claims of bioequivalence or therapeutic equivalence.

This product may, under certain circumstances, be dispensed through a certified mail-order program as long as there is record of prescription AND confirmation that the patient is under the supervision of a licensed medical practitioner.

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 877-250-3427.

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

KEEP THIS OUT OF THE REACH OF CHILDREN.

Rx

DIETARY MANAGEMENT / PRESCRIPTION (Rx) FOLATE

REFERENCES:

  1. Federal Register Notice of March 5, 1996 (61 FR 8759-60).
  2. Hendler SS, Rorvik D, eds. PDR for Nutritional Supplements. Montvale, NJ: Thomson Healthcare; 2001. 10.
  3. Hendler SS, Rorvik D. PDR for Nutritional Supplements. 2nd ed. Montvale, NJ. Physicians’ Desk Reference Inc; 2008. 11.
  4. Bendich A, Deckelbaum R. Preventive Nutrition: The Comprehensive Guide for Health Professionals. 2009. Dietary Supplement Facts Regulations at http: / / www.fda.gov / Food / GuidanceRegulation / GuidanceDocumentsRegulatoryInformation / DietarySupplements / ucm2006823.htm.
  5. Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects. October 10, 2000.
  6. Federal Register Notice of April 9, 1971 (36 FR 6843).
  7. Federal Register Notice of August 2, 1973 (38 FR 20750).
  8. Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease. November 28, 2000.
  9. Natural Standard Research Collaboration (NIH). Folate (folic acid) Monograph 2009.

Manufactured for:
Method Pharmaceuticals, LLC
Arlington, TX 76006
www.methodpharm.com
MADE IN USA

Method Pharmaceuticals, LLC
Rev. 03/15


PRINCIPAL DISPLAY PANEL

58657-208-90
Levomefolate Calcium /
Algal Powder Capsules

(1
5 mg/90.314 mg)
DIETARY MANAGEMENT /

PRESCRIPTION (Rx )
FOLATE
Certified Gluten Free
Rx
90 Capsules
            MADE IN THE USA

LEVOMEFOLATE CALCIUM AND ALGAL 
levomefolate calcium and schizochytrium dha oil capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58657-208
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLATE CALCIUM 15 mg
SCHIZOCHYTRIUM DHA OIL (SCHIZOCHYTRIUM DHA OIL) SCHIZOCHYTRIUM DHA OIL 90.314 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
GELATIN  
GLUTATHIONE  
ASCORBIC ACID  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
TITANIUM DIOXIDE  
SUCROSE  
MALTODEXTRIN  
TOCOPHEROL  
CORN OIL  
SHELLAC  
ALCOHOL  
ISOPROPYL ALCOHOL  
BUTYL ALCOHOL  
PROPYLENE GLYCOL  
AMMONIA  
FD&C YELLOW NO. 6  
FD&C RED NO. 40  
WATER  
Product Characteristics
Color ORANGE (opaque orange cap and opaque white body) , WHITE (opaque orange cap and opaque white body) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code M208
Contains         
Packaging
# Item Code Package Description
1 NDC:58657-208-90 90 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 04/01/2015
Labeler - Method Pharmaceuticals, LLC (060216698)
Revised: 04/2015
 
Method Pharmaceuticals, LLC



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