Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Foltrexyl™ Tablets are supplied as round, light yellow tablets with one side scored, the other side plain and dispensed in child-resistant bottles of 30 tablets (NDC 59088-447-54*). * 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 similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as in some cases, for insurance-reimbursement applications. 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.; PACKAGE LABEL / PRINCIPAL DISPLAY PANEL Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 List No. 44754JPA Rev. 38198 Label
- HOW SUPPLIED Foltrexyl™ Tablets are supplied as round, light yellow tablets with one side scored, the other side plain and dispensed in child-resistant bottles of 30 tablets (NDC 59088-447-54*). * 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 similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as in some cases, for insurance-reimbursement applications. 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.
- PACKAGE LABEL / PRINCIPAL DISPLAY PANEL Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 List No. 44754JPA Rev. 38198 Label
Overview
Foltrexyl™ is an orally administered prescription folate product for the dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency. Foltrexyl™ should be administered under the supervision of a licensed medical practitioner. Each tablet contains: Folate (as folic acid)……………………..1700 mcg DFE† (1000 mcg folic acid) Vitamin D3 (cholecalciferol)………....125 mcg (5000 IU) Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, stearic acid, magnesium stearate. † Dietary Folate Equivalent
Indications & Usage
INDICATIONS AND DOSAGE Foltrexyl™ is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation. Foltrexyl™ can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.
Dosage & Administration
Take one tablet daily or as directed by a healthcare practitioner.
Warnings & Precautions
Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Foltrexyl™ is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation, at 1-877-921-7873.
Storage & Handling
STORAGE KEEP OUT OF THE REACH OF CHILDREN. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from heat, light and moisture. Tamper Evident: Do not use if seal is broken or missing Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873
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