Folic Acid, Vitamin D3
FDA Drug Information • Also known as: Dermacinrx Purefoltin, Dotremin, Folditam, Folixapure, Foltamin, Foltrexyl, Folvitra
- Brand Names
- Dermacinrx Purefoltin, Dotremin, Folditam, Folixapure, Foltamin, Foltrexyl, Folvitra
- Drug Class
- Vitamin D [EPC]
- Route
- ORAL
- Dosage Form
- TABLET
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Folixapure™ 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. Folixapure™ should be administered under the supervision of a licensed medical practitioner. Each tablet contains: Folic Acid ..........................................................................1700 mcg DFE (1000 mcg folic acid) Vitamin D 3 (cholecalciferol) ......................................125 mcg 5000 IU Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, stearic acid, magnesium stearate.
What Is Folic Acid, Vitamin D3 Used For?
INDICATIONS AND DOSAGE Folixapure™ is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation. Folixapure™ can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.
Dosage and Administration
DOSAGE AND ADMINISTRATION Take one tablet daily or as directed by a healthcare practitioner.
Side Effects (Adverse Reactions)
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.
Contraindications
CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Folixapure™ is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
How Supplied
HOW SUPPLIED Folixapure™ 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 59088-163-54*). * 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
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.