Omega 3 Fatty Acids

Omega 3 fatty acids are a lipid-regulating agent used as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL or greater) hypertriglyceridemia.

Omega 3 fatty acids are available under the following different brand names: Lovaza, Vascazen, Omtryg, and Omega-3-acid ethyl esters.

Dosage Forms and Strengths

Capsule

• Lovaza: 1g capsule contains at least 900 mg of ethyl esters of omega-3 fatty acids sourced from fish oils and includes eicosapentaenoic acid (EPA approximately 465 mg) and docosahexaenoic acid (DHA approximately 375 mg)
• Omtryg: 1.2g capsule contains at least 900 mg of ethyl esters of omega-3 fatty acids sourced from fish oils and includes eicosapentaenoic acid (EPA approximately 465 mg) and docosahexaenoic acid (DHA approximately 375 mg)
• Vascazen: 1g capsule contains at least 900 mg of ethyl esters of omega-3 fatty acids sourced from fish oils and includes eicosapentaenoic acid (EPA approximately 680 mg) and docosahexaenoic acid (DHA approximately 110 mg)

Dosage Considerations – Should be Given as Follows:

Pediatric, children under 18 years: Safety and efficacy not established

Hypertriglyceridemia (Lovaza, Omtryg)

• Adjunct to diet in patients with triglycerides 500 mg/dL or greater
• Lovaza: 4 g (4 capsules) orally once/day or 2 g (2 capsules) orally twice daily
• Omtryg: 4.8 g (4 capsules) orally once/day or 2.4 g (2 capsules) orally twice daily

Omega-3 Fatty Acid Deficiency (Vascazen)

• Prescription medical food specifically formulated to correct an omega-3 deficiency in cardiovascular patients
• Vascazen: 4 g/day orally once/day or divided twice daily

Common side effects of omega_3_fatty_acids include:

• Burping (belching)
• Infection
• Flu-like syndrome
• Indigestion
• Changes in taste
• Back pain
• Pain
• Rash
• Chest pain (angina pectoris)
• Constipation
• Upset stomach
• Vomiting
• Itching

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Omega 3 fatty acids have no known severe interactions with other drugs.

Omega 3 fatty acids have no known serious interactions with other drugs.

Omega 3 fatty acids have moderate interactions with at least 25 different drugs.

Omega 3 fatty acids have no known mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains omega 3 fatty acids. Do not take Lovaza, Vascazen, Omtryg, or Omega-3-acid ethyl esters if you are allergic to omega 3 fatty acids or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Omega 3 Fatty Acids?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Omega 3 Fatty Acids?"

Cautions

• Discontinue medications that exacerbate hypertriglyceridemia.
• Use caution in patients allergic to fish.
• May increase liver ALT witho ut increasing AST (monitor).
• May increase LDL levels (monitor).
• May prolong bleeding time (use caution).
• Recurrent atrial fibrillation (AF) or flutter observed when initial high dose of Lovaza administered (i.e., 8 g/day for 1 week, then 4 g/day thereafter).

Pregnancy and Lactation

• Use omega 3 fatty acids with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• It is not known if omega 3 fatty acids are excreted in breast milk. Use caution if breastfeeding.