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Phosphatidylserine, DHA, and EPA

Pronunciation

(fos fa tye dil SER een DHA EPA)

Index Terms

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Vayacog: Phosphatidylserine 100 mg, DHA 19.5 mg, and EPA 6.5 mg [DSC] [contains fish oil, soybeans (glycine max)]

Vayarin: Phosphatidylserine 75 mg, DHA 8.5 mg, and EPA 21.5 mg [DSC] [contains fd&c blue #2 (indigotine), fish oil, soybeans (glycine max)]

Brand Names: U.S.

Pharmacologic Category

Pharmacology

The exact mechanism is not fully understood. Administration of phosphatidylserine may increase omega-3 fatty acid levels in the central nervous system.

Metabolism

The majority of phosphatidylserine is decarboxylated in the mucosal cells of the intestine into other phospholipids, primarily phosphatidylethanolamine.

Use: Labeled Indications

A medical food for dietary management of certain lipid imbalances associated with attention-deficit/hyperactivity disorder (ADHD) in children.

Note: A medical food is formulated to be administered enterally under the supervision of a physician and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation. Medical foods are not drugs and, therefore, are not subject to any FDA regulatory requirements that specifically apply to drugs (eg, requirement for written/oral prescription prior to dispensing, premarket review or approval, proof of safety and efficacy).

Contraindications

Known hypersensitivity (eg, anaphylactic reaction) to phosphatidylserine, docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) or any component of the formulation.

Dosing: Pediatric

Lipid imbalances associated with attention-deficit/hyperactivity disorder (ADHD): Oral: Usual dosage: Two capsules daily

Storage

Store at ≤77°F (25°C). Protect from light and moisture. Dispense and keep in original bottle.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Central nervous system: Outbursts of anger (≤2%; with high dose)

Gastrointestinal: Abdominal pain (3%)

<1%: Atopic dermatitis, headache, hyperactivity, increased serum AST, increased serum triglycerides, insomnia, nausea, tics

Warnings/Precautions

Dosage form specific issues:

• Shellfish hypersensitivity: Use with caution in patients with known hypersensitivity to shellfish; capsules contain shellfish.

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies with this combination. Use in pregnancy is not recommended by the manufacturer.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer