{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia, somnolence, nausea and headaches have been reported with B 6 . Mild transient diarrhea, polycythemia vera, itching. transitory exanthema, and the feeling of swelling of the entire body has been associated with B 12 ."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Homocysteine is a sulfur amino acid whose metabolism stands at the intersection of 2 pathways: remethylation, which requires folic acid and B 12 coenzymes, and transsulfuration, which requires pyridoxal-5'-phosphate, the B 6 coenzyme. Findings from the Framingham cohort indicate that prospectively elevated plasma homocysteine is associated with increased total and cardiovascular mortality, increased incidence of stroke, increased incidence of dementia and Alzheimer's disease, increased incidence of bone fracture, and higher prevalence of chronic heart failure. 1 Data suggest that nearly two-thirds of the prevalence of hyperhomocysteinemia can be attributed to low vitamin status or intake1 and that deficiencies in the three water-soluble vitamins folic acid, B 6 , and B 12 -are the primary determinants of high blood homocysteine levels. 2 Numerous clinical studies have shown that the administration of folic acid alone, or in combination with vitamin B 6 and vitamin B 12 , significantly reduces blood homocysteine levels. 3-9 Evidence suggests that sequestering pathophysiological carbonyl agents may help to ameliorate various etiological aspects of a range of chronic health conditions. 10 Primorine™ -a proprietary blend of para-aminobenzoic acid, vitamin E, and alpha-lipoic acid -is a novel carbonyl-trapping combination."],"contraindications":["CONTRAINDICATIONS Known hypersensitivity to any of the components in the product is a contraindication."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each tablet contains: ACTIVE INGREDIENTS Folic Acid ........................................ 2.5 mg B 6 .................................................... 25mg B 12 .................................................. 2mg Primorine™ .................................... 875 mg Primorine™ -a proprietary blend of para-aminobenzoic acid, vitamin E, and alpha-lipoic acid is a novel carbonyl-trapping combination. Folic acid is a synthetic folate form used for food fortification and nutritional supplements. Folate a member of the B vitamin family, is a collective term for a number of chemical forms which are structurally related and which have similar biological activity to folic acid. Folic acid is comprised of para-aminobenzoic acid linked at one end to a pteridine ring and, at the other end, to glutamic acid. The vitamers comprising the B6 family are pyridine derivatives. Specifically, they are derivatives of 3-hydroxy-5-hydroxymethyl-2-methyl pyridine. The vitamers differ by the nature of the chemical group occupying the 4 position of the parent compound. In the case of pyridoxine, the 4 position is occupied by an hydroxymethyl group. Pyridoxine is also known as 5-hydroxy-6-methyl-3, 4-pyridinedimethanol, 2-methyl-3-hydroxy-4, 5-bis(hydroxymethyl)pyridine and pyridoxol. Its molecular formula is C 8 H 11 NO 3 , and its molecular weight is 169.17 daltons. B 12 most commonly refers to one of the cobalamin forms, cyanocobalamin. Cyanocobalamin is also known as 5,6-dimethylbenzimidazolyl cyanocobamide. Its molecular formula is C 63 H 88 CoN 14 O 14 P, and its molecular weight is 1355.38 daltons. INACTIVE INGREDIENTS Microcrystalline cellulose, stearic acid, croscarmellose sodium, coating (titanium-dioxide, hypromellose,· polyethylene·glycol, sodium citrate, polysorbate 80, water), silicon dioxide, magnesium stearate, hydroxypropyl cellulose. FOLMOR TM tablets are dye-, sugar-, and lactose-free."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION The usual adult dose of FOLMOR TM is one or two tablets daily or as directed by a physician."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions"],"drug_interactions":["Interactions Drug Interactions Because B 6 antagonizes the action of levodopa, FOLMOR TM should not be given to patients receiving the drug levodopa. However, FOLMOR TM may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may decrease the effectiveness of phenytoin, but no such decrease has been reported with the use of FOLMOR TM . Drug/Laboratory Test Interactions","Drug Interactions Because B 6 antagonizes the action of levodopa, FOLMOR TM should not be given to patients receiving the drug levodopa. However, FOLMOR TM may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may decrease the effectiveness of phenytoin, but no such decrease has been reported with the use of FOLMOR TM ."],"effective_time":"20110316","general_precautions":["General"],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Available as an oval white tablet. Debossed with 'ZVL\" on one side and \"100\" on the other. Supplied in bottles of 60 tablets. STORAGE Store at controlled room temperature between 15°-30°C (59°-86°F) (See USP). Protect from light and moisture. Dispense in original light-resistant container with child-resistant closure. NDC# 23594-100-10"],"id":"47d0ec65-3da3-4f0a-be98-d022fe6176bc","indications_and_usage":["INDICATIONS AND USAGE FOLMOR TM tablets are indicated for the distinct nutritional requirements of individuals under a physician's treatment for hyperhomocysteinemia, with particular emphasis for individuals with or at risk for atherosclerotic vascular disease in the coronary, 11 peripheral, 11 or cerebral 12 vessels, or vitamin B 12 deficiency. 13"],"information_for_patients":["Information for Patients FOLMOR TM is a medical food for use only under the direction and supervision of a licensed physician."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers"],"openfda":{},"overdosage":["OVERDOSAGE"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 7059 CL"],"pediatric_use":["Pediatric Use"],"precautions":["PRECAUTIONS Folic acid, when administered as a single agent in doses above 0.1 mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 2mgs of B 12 contained in FOLMOR™ has been shown to be sufficient to address this precaution. 14 In a study of 105 postmenopausal women (50-75 yrs), unmetabolized folic acid demonstrated the potential to reduce the cytotoxicity of natural killer cells which may impair immune response. 15 Pre-and postnatal vitamin/mineral supplements typically deliver vitamin B 6 (as pyridoxine) at a dose of between 2 to 20 milligrams daily. Pregnant women and nursing mothers should avoid doses of vitamin B 6 greater than these doses; unless higher doses are prescribed by their physicians. Those who are being treated with levodopa without concurrently taking carbidopa should avoid doses of vitamin B 6 of 5 milligrams or greater daily. The use of vitamin B 6 for the treatment of vitamin B 6 deficiency, for the prophylaxis of isoniazid-induced peripheral neuropathy, for the treatment of vitamin B 6 -dependency disorders (see Indications) or for the treatment of any other medical condition requires medical supervision. The use of vitamin B 12 to treat vitamin B 12 deficiency or to treat any medical condition requires medical supervision. Decreased levels of B 12 have been associated with reduced ability to detoxify the cyanide in exposed individuals and cyanocobalamin may increase the risk of irreversible neurological damage from optic atrophy in those affected with the disorder. Hydroxocobalamin can aid in the detoxification of cyanide. This form of B 12 is an acceptable form for B 12 supplementation in those with this disorder. A typical dose of B 12 in nutritional supplements used by pregnant women and nursing mothers is 12 micrograms daily. Pregnant women and nursing mothers should only use doses higher than this if recommended by their physicians. Administration of doses of vitamin B 12 greater than 10 micrograms daily may produce a hematological response in those with anemia secondary to folate deficiency General Information for Patients FOLMOR TM is a medical food for use only under the direction and supervision of a licensed physician. Laboratory Tests Interactions Drug Interactions Because B 6 antagonizes the action of levodopa, FOLMOR TM should not be given to patients receiving the drug levodopa. However, FOLMOR TM may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may decrease the effectiveness of phenytoin, but no such decrease has been reported with the use of FOLMOR TM . Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use"],"pregnancy":["Pregnancy Teratogenic Effects Nonteratogenic Effects"],"set_id":"47d0ec65-3da3-4f0a-be98-d022fe6176bc","spl_product_data_elements":["FOLMOR Oil and Water Soluble Vitamins with Aminobenzoic Acid FOLIC ACID FOLIC ACID CYANOCOBALAMIN CO-57 CYANOCOBALAMIN CO-57 PYRIDOXINE HYDROCHLORIDE PYRIDOXINE .ALPHA.-TOCOPHEROL SUCCINATE, D- ALPHA-TOCOPHEROL ALPHA LIPOIC ACID ALPHA LIPOIC ACID AMINOBENZOIC ACID AMINOBENZOIC ACID CELLULOSE, MICROCRYSTALLINE STEARIC ACID CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE LIGHT YELLOW CORE ZYL;100"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}