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Vayarin Caps 60 By Vaya Pharma

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Vayarin Caps 60 By Vaya Pharma

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Vayarin Caps 60 By Vaya Pharma. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD4403150/RXB10097198
Size : 60
Selling UoM : EA
NDC: 75959-0233-60
UPC Barcode : 375959233602
Supplier: 0050002655 VAYA PHARMA INC.
Supplier Material : 023360
Generic Code : 067342 PHOSPSERIN/OMEGA-3/DHA/EPA ORAL CAPSULE
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

Capsule , tan , oblong oblong

Vayarin? is an orally administered prescription medical food for
the clinical dietary management of certain lipid imbalances
associated with ADHD in children.
Each capsule contains Lipirinen? 167 mg, providing:
Phosphatidylserine (PS) ................................................. 75 mg
Eicosapentaenoic acid (EPA) ...................................... 21.5 mg
Docosahexaenoic acid (DHA) ........................................ 8.5 mg
CHEMICAL STRUCTURE*
* Schematic structure of one of the most abundant molecules
present in Vayarin?.
INGREDIENTS
Phosphatidylserine, Hypromellose, Silicon Dioxide, Rosemary
Extract (preservative), Mixed Tocopherols (E306-E309), Ascorbyl
Palmitate (E304), Titanium Dioxide (color), FD&C Blue #1 (color).
Vayarin? capsules contain shellfish (krill).
May contain soy and fish.
Vayarin? capsules do not contain sugar, lactose, yeast or gluten.
PHARMACOLOGY
Vayarin? is a prescription medical food used under medical
supervision.
? Mechanism of action
Omega 3 long-chain polyunsaturated fatty acids (LC-PUFA) have
an important role in brain and central nervous system
development and functioning [1-4]. Decreased omega 3 fatty
acids levels, mainly DHA and EPA, are associated with the
occurrence of psychiatric, neurodegenerative, and other
neurodevelopmental disorders such as dyspraxia, dyslexia,
autism [3], peroxisomal disorders [5], Alzheimer?s disease [6],
and ADHD [3]. Administration of phosphatidylserine (PS) enriched
with omega 3 fatty acids was found to significantly increase DHA
level in rats brain [7].
While the exact mechanism by which Vayarin? exerts its effects
is not fully understood, PS present in the mammalian nervous
system, which is characterized by its substantial levels of
omega-3 fatty acids, has been implicated in numerous
membrane related functions, such as maintaining the integrity of
cell membranes, cell excitability, cell-to-cell recognition and
communication [8]. PS has been found to regulate key proteins in
neuronal membranes, including sodium/calcium ATPase [9] and
protein kinase C [10] which undertake crucial functions in
diverse signal transduction pathways. Similarly, PS interacts with
Raf-1 protein kinase to promote a cascade of reactions that are
believed to be involved in cell survival [11]. Additionally, PS has
been found to influence neurotransmitter activity, such as the
release of acetylcholine, dopamine and noradrenaline [12, 13]
and to increase brain glucose levels.
? Absorption and Metabolism
Following dietary ingestion of phospholipids, pancreatic digestive
enzymes cleave specific fatty acids leading to the formation of
lysophospholipids that are absorbed by the mucosal cells of the
intestine and could be recycled into phospholipid [14]. The fatty
acids released can be further used for triglyceride synthesis.
Because of the high activity of decarboxylases in the mucosal
cells, the majority of the PS is converted into other phospholipids,
primarily to phosphatidylethanolamine [15]. The recycled PS,
phosphatidylethanolamine and other phospholipids enter the
lymph and circulation, and are redistributed.
? Drug interactions
PS can potentially interact with some anticholinergic and
cholinergic medications. It is recommended to consult with a
physician about Vayarin? interactions that may apply to specific
medical conditions.
? Toxicity
Vayarin?, similar to phosphatidylserine extracted from bovine
cortex (BC-PS), contains saturated and monounsaturated fatty
acids as well as Omega-3 LC-PUFA. The safety profile of BC-PS
was determined in several non clinical studies. Repeat-dose
safety studies in rats and dogs show that oral administration of
BC-PS at doses up to 1000 mg/kg/day for up to 6 months was
without any significant adverse effects of toxicological concern
[16]. The results of teratogenicity studies in rats at doses up to
200 mg/kg/day and in rabbits at doses up to 450 mg/kg/day
showed that oral administration of PS did not affect embryonic
and fetal development [16]. In a micronucleus test, BC-PS was
administered to mice at total dosages of 30, 150 and 300 mg/kg
in two equal doses separated by 24-hours. The results of the
study did not reveal any evidence of mutagenic potential or bone
marrow toxicity [16].
CLINICAL EXPERIENCE [17]
Double-blind study
Method: A 15-week, double-blind, placebo-controlled clinical
trial was conducted with 200 ADHD children randomized to
receive either Vayarin? or placebo (4 capsules/day). The effect of
Vayarin? was assessed by rating scales and questionnaires,
including the Conners? parent (CRS-P) and teacher (CRS-T) rating
scales and the child health questionnaire (CHQ).
Results: 162 participants completed the study, of whom 147
were included in the efficacy analysis. Significant reduction in
ADHD scores was detected in the CRS-P assessmen