DOTREMIN- folic acid, vitamin d3 tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

PureTek Corporation

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Dotremin™ is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation. This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Dotremin ™ is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Ringkasan produk:

Dotremin™ 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 59088-524-54*). * 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

Status kebenaran:

unapproved drug other

Ciri produk

DOTREMIN- 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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DOTREMIN
(FOLIC ACID, VITAMIN D3 TABLET)
RX ONLY
11-24-2021 - EDIT MARKETING DATE FROM 11-29-2021 TO 03-01-2022.
DESCRIPTION
DOTREMIN™ 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.
DOTREMIN™ 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
(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
DOTREMIN™ 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
†
3
†
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