{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates – including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxal 5'-phosphate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with methylcobalamin."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION Duleek™-Met NEW is an orally administered prescription vitamin/medical food. Each tablet contains the following Dietary Ingredients: Folate 3 mg Pyridoxal 5' Phosphate 35 mg Methylcobalamin 2 mg"],"description_table":["
Each tablet contains the following Dietary Ingredients:
Folate 3 mg
Pyridoxal 5' Phosphate 35 mg
Methylcobalamin 2 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION The recommended dose is one tablet twice daily (B.I.D.) or as directed. Duleek™-Met NEW must be used under medical supervision."],"drug_interactions":["INTERACTIONS Drugs which may interact with folate include: First generation anticonvulsants: High dose folic acid may result in decreased serum levels for first generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate). This may possibly reduce the effectiveness of first generation anticonvulsants and/or increase the frequency of seizures in susceptible patients. Nevertheless, caution should be used when prescribing folates among patients who are receiving treatment with first generation anticonvulsants. Second-generation anticonvulsants: Information on second-generation anticonvulsants' (including, but not limited to, lamotrigine) effect on folate levels is limited and cannot be ruled out. 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. Colchicine: Colchicine may decrease folate plasma levels. L-dopa: L-dopa may decrease folate plasma 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. Caution should be exercised when using folate with folate antagonists. Patients, typically, should not be given folate simultaneously with a folate antagonist, for the purpose of reducing or preventing clinical toxicity, as the therapeutic effect of the antagonist may be nullified. 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. 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, including, but not limited to pancreatin and pancrelipase: Reduced folate levels have occurred in some patients taking pancreatic extracts. Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. 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. Folate may enhance the toxicity of fluorouracil. Concurrent administration of chloramphenicol and folate in folate-deficient patients may result in antagonism of the haematopoietic response to folate. Caution should be exercised with the concomitant use of folate 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."],"effective_time":"20120815","general_precautions":["General: Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B 12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B 12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B 12 deficiency. Folate therapy alone is inadequate for the treatment of B 12 deficiency."],"how_supplied":["HOW SUPPLIED Duleek™-Met NEW is supplied as oval, red tablets with “S133” debossed on one side, dispensed in bottles of 90 tablets or 500 tablets. Product Code (90 Tablets): 13925-144-90 Seton Pharmaceuticals does not represent these product codes to be actual National Drug Codes (NDCs). NDC format codes are product codes adjusted according to standard industry practice to meet the formatting requirements of pharmacy and health insurance computer systems. Product Code (500 Tablets): 13925-144-50 STORAGE Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP). Protect from light and moisture. Dispense in original light-resistant container. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. R x Only Reserved for Professional Recommendation All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence."],"id":"0c69a5e1-c607-432e-8166-5979e196ccca","inactive_ingredient":["Ingredients: Folate Folates– including reduced folates, are variant forms of Vitamin B 9 , or Folic Acid. , Pyridoxal 5'-phosphate, Methylcobalamin, Citric Acid, TriPotassium Citrate, Di Calcium Phosphate, Microcrystalline Cellulose, Magnesium Stearate, Hypromellose, Polyethylene Glycol, Titanium Dioxide, FD&C Red #40 Lake, Black Iron Oxide, Talc, Vegetable Oil, and Polysorbate 80."],"indications_and_usage":["INDICATIONS AND USAGE Duleek™-Met NEW is an orally administered prescription vitamin/medical food indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of dietary supplementation."],"information_for_patients":["PATIENT INFORMATION Duleek™-Met NEW is a prescription vitamin/medical food for use only under medical supervision and direction."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL: NDC 13925- 144- 90* DuLeek TM - Met NEW Tablets R x Only 90 Tablets SETON PHARMACEUTICALS Container Label"],"precautions":["PRECAUTIONS General: Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B 12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B 12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B 12 deficiency. Folate therapy alone is inadequate for the treatment of B 12 deficiency. PATIENT INFORMATION Duleek™-Met NEW is a prescription vitamin/medical food for use only under medical supervision and direction. INTERACTIONS Drugs which may interact with folate include: First generation anticonvulsants: High dose folic acid may result in decreased serum levels for first generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate). This may possibly reduce the effectiveness of first generation anticonvulsants and/or increase the frequency of seizures in susceptible patients. Nevertheless, caution should be used when prescribing folates among patients who are receiving treatment with first generation anticonvulsants. Second-generation anticonvulsants: Information on second-generation anticonvulsants' (including, but not limited to, lamotrigine) effect on folate levels is limited and cannot be ruled out. 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. Colchicine: Colchicine may decrease folate plasma levels. L-dopa: L-dopa may decrease folate plasma 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. Caution should be exercised when using folate with folate antagonists. Patients, typically, should not be given folate simultaneously with a folate antagonist, for the purpose of reducing or preventing clinical toxicity, as the therapeutic effect of the antagonist may be nullified. 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. 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, including, but not limited to pancreatin and pancrelipase: Reduced folate levels have occurred in some patients taking pancreatic extracts. Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. 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. Folate may enhance the toxicity of fluorouracil. Concurrent administration of chloramphenicol and folate in folate-deficient patients may result in antagonism of the haematopoietic response to folate. Caution should be exercised with the concomitant use of folate 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."],"set_id":"0c69a5e1-c607-432e-8166-5979e196ccca","spl_product_data_elements":["L-Methyl-B6-B12 Levomefolate Calcium, Pyridoxal 5-Phosphate, and Methylcobalamin LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID PYRIDOXAL 5-PHOSPHATE PYRIDOXAL 5-PHOSPHATE METHYLCOBALAMIN METHYLCOBALAMIN CITRIC ACID MONOHYDRATE POTASSIUM CITRATE ANHYDROUS CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE HYPROMELLOSES POLYETHYLENE GLYCOLS TITANIUM DIOXIDE FD&C RED NO. 40 FERROSOFERRIC OXIDE TALC CORN OIL POLYSORBATE 80 S133"],"spl_unclassified_section":["Tablets R x Only","Drugs which may interact with pyridoxal 5'-phosphate: Pyridoxal 5'-phosphate should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxal 5'-phosphate. However, pyridoxal 5'-phosphate may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.","Drugs which may interact with methylcobalamin: Antibiotics may alter the intestinal microflora and may decrease the absorption of methylcobalamin. Cholestyramine, colchicines or colestipol may decrease the enterohepatic re-absorption of methylcobalamin. Metformin, para-aminosalicylic acid and potassium chloride may decrease the absorption of methylcobalamin. Nitrous oxide can produce a functional methylcobalamin deficiency.","Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 MADE IN CANADA 06/10 SETON PHARMACEUTICALS"],"storage_and_handling":["STORAGE Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP). Protect from light and moisture. Dispense in original light-resistant container. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. R x Only Reserved for Professional Recommendation All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence."],"version":"1","warnings":["WARNINGS Caution is recommended in patients with a history of bipolar illness. Do not take this product if you are at risk due to MTHFR mutation, or - specifically, are at risk due to Thermolabile MethyleneTetraHydroFolate Reductase (MTHFR), or C677T / MTHFR, mutation. Patients at risk for C1298T / MTHFR should also not take this product."]}