DENOVO- levomefolic acid capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

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22-09-2020

Ingredientes activos:

LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)

Disponible desde:

Magna Pharmaceuticals, Inc.

Vía de administración:

ORAL

indicaciones terapéuticas:

Adjunctive use in mood disorders Denovo is indicated for the distinct nutritional requirements for people who have suboptimal levels of L-methylfolate in cerebrospinal fluid, plasma, and/or red blood cells and have major depressive disorder (MDD), with particular emphasis as adjunctive support for individuals who are on antidepressant. Denovo is indicated regardless of MTHFR C6771 polymorphism genotype.

Estado de Autorización:

Dietary Supplement

Ficha técnica

                                DENOVO- LEVOMEFOLIC ACID CAPSULE
MAGNA PHARMACEUTICALS, INC.
----------
DENOVO
SUPPLEMENT FACTS
Serving Size: 1 capsule
Servings per Container: 30
Each capsule contains the following:
Folate [as 15,000mcg (as 15mg) DFE (dietary folate equivalents) L-5
MTHF (from L-5
methyltetrahydrofolate calcium salt)]
Other Ingredients: Microcrystalline cellulose, capsule
(gelatin,titanium dioxide, FD&C yellow #5,
FD&C yellow #6), vegetable magnesium stearate, and silica
WARNING AND PRECAUTIONS
Folic Acid, when administered in daily doses above 0.1mg may obscure
the detection of B12 deficiency
(specifically, the administration of folic acid may reverse the
hematological manifestations of B12
deficiency, including pernicious anemia, while not addressing the
neurological manifestations). 5-
MTHF may be less likely than foli acid to mask vitamin B12 deficiency.
Folate therapy alone is
inadequate for the treatment of a B12 deficiency.
A major depressive episode may be the inital presentation of bipolar
disorder. It is generally believed,
although not established in controlled trials, that treating such an
episode with an antidepressant alone
may increase the likelihood of a precipitation of mixed/manic episode
in patients at risk for bipolar
disorder. Denovo is not an antidepressant. However, 5-MTHF has been
shown to enhance antidepressant
effects of known antidepressants. Caution is recommended in patients
with a history of bipolar illness.
Patients with depressive symptoms should be adequately screened to
determine if they are at risk for
bipolar disorder since mood elevation in this population is possible.
Denovo should always be used under medical supervision.
SAFE HANDLING
Before using this product, tell your doctor or pharmacist of all of
the products you use. Keep a list of
all our medications with you and share the list with your doctor and
pharmacist. No decrease in
effectiveness of drugs has been reported witht the use of Denovo.
Allergic reactions have not been reported following the use of oral
(6S) -5-methyltetrahydrof
                                
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