FOLTREXYL- folic acid, vitamin d3 tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41)

Available from:

PureTek Corporation

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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.

Product summary:

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.

Authorization status:

unapproved drug other

Summary of Product characteristics

FOLTREXYL- FOLIC ACID, VITAMIN D3 TABLET
PURETEK CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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FOLTREXYL
[FOLATE (AS FOLIC ACID) 1700 MCG DFE (1000 MCG FOLIC ACID), VITAMIND3
(CHOLECALCIFEROL) 125 MCG
(5000IU)]
RX ONLY
DESCRIPTION
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 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._
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