FDA Label for Folditam
View Indications, Usage & Precautions
Folditam Product Label
The following document was submitted to the FDA by the labeler of this product Puretek Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Folditam™ 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.
Folditam™ 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 D 3 (cholecalciferol)………....250 mcg (10,000 IU)
Each tablet contains the following inactive ingredients:
lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium carboxymethyl starch, stearic acid, DL-alpha- tocopheryl acetate.
† Dietary Folate Equivalent
Indications And Usage
Folditam™ is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation.
Clinical Pharmacology
The
in vivo synthesis of the major biologically active metabolites of Vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1,25-dihydroxyvitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and
phosphate levels sufficiently to permit bone mineralization. Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal tubules.
There is a time lag of 10 to 24 hours between the administration of vitamin D and the initiation of its action in the body due to the necessity of synthesis of the active metabolites in the liver and kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Folditam™ is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
Warnings And Precautions
KEEP OUT OF THE REACH OF CHILDREN.
Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breastfeeding. Consult your doctor.
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.
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.
Dosage And Administration
Take one tablet daily or as directed by a healthcare practitioner.
Folditam™ should be administered under the supervision of a licensed medical practitioner.
How Supplied
Folditam™ 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 59088-185-54*).
* 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 B 12 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
Storage
KEEP OUT OF THE REACH OF CHILDREN.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Protect from heat, light, and moisture.
Tamper Evident: Do not use if seal is broken or missing
Folditam™
Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free:
877-921-7873
* Please review the disclaimer below.