Vayarin

Name: Vayarin

What is the dosage for phosphatidylserine-omega-3?

The recommended dose is 2 capsules day or as directed by a physician.

Which drugs or supplements interact with phosphatidylserine-omega-3?

Vayarin may interact with some anticholinergic and cholinergic drugs.

What else should I know about phosphatidylserine-omega-3?

What preparations of phosphatidylserine-omega-3 are available?

Capsule: 167 mg

How should I keep phosphatidylserine-omega-3 stored?

Vayarin capsules should be stored at 25 C (77 F) and protected from light.

Description

Vayarin® is an orally administered prescription medical food for the clinical dietary management of complex lipid imbalances associated with ADHD. Vayarin® is a specially formulated and processed composition designed to address the distinct, medically determined lipid nutritional requirements of children with ADHD, the dietary management of which cannot be achieved by modification of the normal diet or use of dietary supplements.

Each Vayarin® capsule provides:

Lipirinen®......75 mg

Lipirinen® is a proprietary composition containing phosphatidylserine (PS) conjugated to omega-3 fatty acids enriched with Eicosapentaenoic acid (EPA).

Lipids Imbalances In ADHD

There is a growing body of scientific evidence demonstrating that low levels of certain lipids are associated with Attention Deficit Hyperactivity Disorder (ADHD). While ADHD is a complex disorder, the etiology of which is multi-factorial, ADHD has been shown to be associated with metabolic disturbances such as lipid and glucose metabolism [1, 2]. The abnormalities in lipid metabolism that may occur in ADHD are associated with increased oxidative stress, higher rates of lipid degradation and decreased synthesis of phospholipids containing omega-3 fatty acids. Reduced levels of phosphatidylserine containing omega-3 fatty acids (PS-Omega-3) have implications in membrane structure and function, where they are believed to play an important role in signal transduction pathways, secretory vesicle release, and cell growth regulation [3, 4].

Compared to healthy children of the same age, children with ADHD have lower blood levels of omega-3 LC-PUFA [5-13]. These lipids, found also in the brain, play an essential role in brain development and function. In turn, it has been reported that omega-3 fatty acid deficiency is correlated to decreased brain phosphatidylserine, which is mainly in the form of PS-Omega-3 [14, 15].

PS-Omega-3 play an important role in the functioning of neuronal membranes, such as signal transduction, secretory vesicle release, cell-tocell communication, and cell growth regulation [4]. Thus, reduced levels of PS-Omega-3 and omega-3 may represent a complex lipid imbalance playing a role in the etiology/pathogenesis of ADHD and other neuronal disorders. Vayarin® is a proprietary lipid composition of Phosphatidylserine-Omega-3 (PS-Omega-3), enriched with EPA. This form has been specially designed to deliver these essential lipids to the brain in order to support and maintain proper brain function. Moreover, the enrichment of EPA in the Vayarin® product allows for better regulation of lipids and targets the specific imbalances that appear to be associated with ADHD [16].

Figure 1: Schematic structure of phosphatidylserine conjugated to EPA.
Chemical Structure

Ingredients

Phosphatidylserine (PS), Hydroxypropyl methylcellulose, Silicon dioxide, Contains less than 1% of Mixed tocopherols (D-alpha-tocopherol, D-betatocopherol, D-gamma-tocopherol, D-delta-tocopherol), Sunflower oil, Ascorbyl palmitate, Rosemary extract (Rosemary leaf, Propylene glycol, Distilled monoglycerides) (preservative), Caramel (color), Titanium dioxide (color). Vayarin® capsules contain shellfish (Krill).

May contain soy and fish.

Vayarin® capsules do not contain sugar, lactose, yeast or gluten.

REFERENCES

3. Mozzi, R., S. Buratta, and G. Goracci, Metabolism and functions of phosphatidylserine in mammalian brain. Neurochem Res, 2003. 28(2): p. 195-214.

4. Vance, J.E. and R. Steenbergen, Metabolism and functions of phosphatidylserine. Prog Lipid Res, 2005. 44(4): p. 207-34.

14. Hamilton, L., et al., n-3 fatty acid deficiency decreases phosphatidylserine accumulation selectively in neuronal tissues. LIPIDS, 2000. 35(8): p. 863-9.

15. Murthy, M., et al., Differential effects of n-3 fatty acid deficiency on phospholipid molecular species composition in the rat hippocampus. J Lipid Res, 2002. 43(4): p. 611-7.

Side effects

Adverse Events

The adverse events of Vayarin® were evaluated in a randomized, double blind, placebo-controlled study of 15 weeks followed by an open label extension of an additional 15 weeks [38].

Adverse events reported during the course of the double-blind phase (table 2): 12 participants from the Vayarin® group and 5 participants from the placebo group were classified by the study physicians as suffering from treatment related, or probably related, adverse events (13 and 5 adverse events, respectively). There were no significant differences between the study groups in either the incidence or number of adverse events recorded (P = 0.848 and P = 0.982, respectively).

Adverse events reported during the course of the open-label extension (table 2): 5 participants reported 7 adverse events that were classified by the study physicians as related or probably related to the study treatment.

Table 2

Study design Double-blind study (4 capsules/day) Open-label extension (2 capsules/day)
Treatment Group Adverse event* Vayarin®
(n=137)
Placebo
(n=63)
Vayarin®
(n=150)
Gastrointestinal discomfort 6 4 4
Atopic dermatitis 1 0 0
SGOT value 1 0 0
Headache 0 1 1
Insomnia 0 0 1
Tics 1 0 0
High triglycerides 0 1 1
Nausea 1 0 0
Hyperactivity 1 0 0
Tantrnm 2 0 0

Table 2. Adverse events reported during the course of the double-blind and the open label phase.

*Judged by the study physicians as related or probably related to the study treatment

Drug Abuse

Vayarin® does not have any known drug abuse or withdrawal effects.

Vayarin Interactions

Avoid eating foods that are high in fat or cholesterol. This medication will not be as effective in lowering your triglycerides if you do not follow the diet plan recommended by your doctor.

Avoid drinking alcohol. It can increase triglycerides and may make your condition worse.

Other drugs may interact with omega-3 polyunsaturated fatty acids, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Vayarin Dosage

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Swallow the omega-3 polyunsaturated capsule whole. Do not puncture or open the capsule.

This medication works best if you take it with food.

Do not crush, chew, break, or dissolve a delayed-release capsule. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

While using omega-3 polyunsaturated fatty acids, you may need frequent blood tests.

Omega-3 polyunsaturated fatty acids is only part of a treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat. Do not freeze.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I discuss with my health care provider before taking Vayarin (omega-3 polyunsaturated fatty acids)?

You should not take this medicine if you are allergic to fish, shellfish, or soybeans.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

  • diabetes;

  • liver disease;

  • a heart rhythm disorder;

  • a pancreas disorder;

  • underactive thyroid;

  • if you drink more than 2 alcoholic beverages per day.

It is not known whether omega-3 polyunsaturated fatty acids will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

It is not known whether omega-3 polyunsaturated fatty acids pass into breast milk or if this could harm a nursing baby. Ask a doctor before using this medicine if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old.

For Healthcare Professionals

Applies to omega-3 polyunsaturated fatty acids: oral capsule, oral delayed release capsule, oral kit, oral liquid, oral tablet chewable

Gastrointestinal

Common (1% to 10%): Eructation, dyspepsia, nausea, gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhea, flatulence, gastroesophageal reflux disease, vomiting)
Uncommon (0.1% to 1%): Gastrointestinal hemorrhage, gastroenteritis
Rare (less than 0.1%): Gastrointestinal pain
Very rare (less than 0.01%): Lower gastrointestinal hemorrhage[Ref]

General

The most common adverse events were eructation, dyspepsia, and taste perversion[Ref]

Other

Common (1% to 10%): Infection, pain
Uncommon (0.1% to 1%): Death[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Atopic dermatitis
Rare (less than 0.1%): Urticaria, acne, rash pruritic
Frequency not reported: Pruritus[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypotension[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperglycemia, gout, high triglycerides
Very rare (less than 0.01%): Blood lactate dehydrogenase increased[Ref]

Nervous system

Common (1% to 10%): Taste perversion
Uncommon (0.1% to 1%): Dizziness, dysgeusia, headache, hyperactivity[Ref]

Respiratory

Uncommon (0.1% to 1%): Epistaxis
Very rare (less than 0.01%): Nasal dryness
Frequency not reported: Influenza[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity
Postmarketing reports: Anaphylactic reaction[Ref]

Hematologic

Very rare (less than 0.01%): White blood count increased,
Frequency not reported: Slight prolongation of bleeding time
Postmarketing reports: Hemorrhagic diathesis[Ref]

Psychiatric

Uncommon (0.1% to 1%): Tics, tantrum, insomnia[Ref]

Hepatic

Rare (less than 0.1%): Liver disorders (including increased ALT, increased AST, and transaminases increased)[Ref]

Some side effects of Vayarin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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