(fos fa tye dil SER een DHA EPA)
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).
Known hypersensitivity (eg, anaphylactic reaction) to phosphatidylserine, docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) or any component of the formulation.
Lipid imbalances associated with attention-deficit/hyperactivity disorder (ADHD): Oral: Usual dosage: Two capsules daily
There are no dosage adjustments provided in the manufacturer 's labeling.
There are no dosage adjustments provided in the manufacturer 's labeling.
Administer without regard to food.
Store at ≤77 ‚ °F (25 ‚ °C). Protect from light and moisture. Dispense and keep in original bottle.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Vayarin: Phosphatidylserine 75 mg, DHA 8.5 mg, and EPA 21.5 mg [contains fd&c blue #2 (indigotine), fish oil, soybeans (glycine max)]
There are no known significant interactions.
1% to 10%:
Central nervous system: Outbursts of anger ( ≤2%; with high dose)
Gastrointestinal: Abdominal pain (3%)
<1% (Limited to important or life-threatening): Atopic dermatitis, increased serum AST, increased serum triglycerides, insomnia, tics
Dosage form specific issues:
- Shellfish hypersensitivity: Use with caution in patients with known hypersensitivity to shellfish; capsules contain shellfish.
Adverse events have not been observed in animal reproduction studies with this combination. Use in pregnancy is not recommended by the manufacturer.
The exact mechanism is not fully understood. Administration of phosphatidylserine may increase omega-3 fatty acid levels in the central nervous system.
The majority of phosphatidylserine is decarboxylated in the mucosal cells of the intestine into other phospholipids, primarily phosphatidylethanolamine.
- Discuss specific use of drug and side effects with caregiver as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience anger or abdominal pain (HCAHPS).
- Educate caregiver about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.