L-METHYL-B6-B12- levomefolate calcium, pyridoxal phosphate anhydrous, and methylcobalamin tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC), PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6), METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)

Available from:

VIRTUS PHARMACEUTICALS LLC

INN (International Name):

LEVOMEFOLATE CALCIUM

Composition:

LEVOMEFOLATE CALCIUM 3 mg

Administration route:

ORAL

Therapeutic indications:

Hyperhomocysteinemia of any etiology. Medical foods are intended for the patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone1 . L-Methyl-B6-B12 is a specially formulated medical food for the dietary support of patients with hyperhomocysteinemia. It also is helpful in managing patients with high total homocysteine concentrations associated with malabsorption of vitamin B12 or suboptimal intake of B vitamins. L-Methyl-B6-B12 Tablets should always be used under medical supervision. L-METHYL-B6∙B12 is contraindicated in patients with known hypersensitivity to any of the components contained in this product. Discontinue use if patient exhibits signs of hypersensitivity such as tachycardia, urticaria, or shortness of breath.

Product summary:

L-Methyl-B6-B12 is available as a round coated purple colored tablet, debossed with "V362" on one side and blank on the other. Commercial product is supplied in bottles of five hundred (500) tablets. Commercial Product (500 tablets) 76439-362-50 Store at controlled room temperature 15°C to 30°C (59°F to 86°F) Protect from light and moisture. Dispense in tight, light-resistant container.

Authorization status:

MEDICAL FOOD

Summary of Product characteristics

L-METHYL-B6-B12- LEVOMEFOLATE CALCIUM, PYRIDOXAL PHOSPHATE ANHYDROUS,
AND
METHYLCOBALAMIN TABLET, COATED
VIRTUS PHARMACEUTICALS LLC
----------
L-METHYL-B6-B12 TABLETS
DESCRIPTION
L-Methyl-B6-B12 is a medical food for the clinical dietary management
of the metabolic
imbalances associated with hyperhomocysteinemia that cannot be managed
by diet
modification alone. Dispense by prescription. Use under medical
supervision.
Each round coated purple colored tablet contains:
Pyridoxal 5'-phosphate
35 mg
L-methylfolate Calcium
3 mg
Methylcobalamin
2 mg
DIETARY INGREDIENTS
Dibasic Calcium Phosphate Dihydrate, Microcrystalline Cellulose 90,
PYRIDOXAL-5'-
PHOSPHATE, Microcrystalline Cellulose HD 90, Opadry II Purple 40L10045
(Polydextrose,
Titanium Dioxide, Hypromellose 3cP, Hypromellose 6cP, Glycerol
Triacetate,
Hypromellose 50cP, FD&C Blue #2, FD&C Red #40 and Polyglycol 8000),
Microcrystalline Cellulose 50, Opadry II Clear Y-19-7483 (Hypromellose
6cP, Maltodextrin,
Hypromellose 3cP, Polyglycol 400 and Hypromellose 50cP),
L-METHYLFOLATE CALCIUM,
Magnesium Stearate, METHYLCOBALAMIN, and Carnauba Wax.
CONTAINS FD&C BLUE #2 AND FD&C RED #40.
INDICATIONS
Hyperhomocysteinemia of any etiology.
INTENDED USE
Medical foods are intended for the patient who has a limited or
impaired capacity to
ingest, digest, absorb, or metabolize ordinary foodstuffs or certain
nutrients, or who
has other special medically determined nutrient requirements, the
dietary management
of which cannot be achieved by the modification of the normal diet
alone .
L-Methyl-B6-B12 is a specially formulated medical food for the dietary
support of
patients with hyperhomocysteinemia. It also is helpful in managing
patients with high
total homocysteine concentrations associated with malabsorption of
vitamin B
or
suboptimal intake of B vitamins.
L-Methyl-B6-B12 Tablets should always be used under medical
supervision.
1
12
BACKGROUND
Folic acid itself does not occur in nature; it is synthetic and lacks
coenzyme activity. To
be beneficial in human metabolism, orally ad