Omega-3-acid ethyl esters

Take this medication exactly as directed on the label, or as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended.

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

This medication is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

There may be other drugs that can interact with omega-3 polyunsaturated fatty acids. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

• Cholesterol
• Diabetes (Type 1 and Type 2)

Do not take omega-3-acid ethyl esters if you are allergic to any of its ingredients. 

Omega-3-acid ethyl esters may cause serious side effects, including:

• increases in the results of blood tests used to check your liver function (ALT and AST) and your bad cholesterol levels (LDL-C) cholesterol.
• increases in the frequency of a heart rhythm problem (atrial fibrillation or flutter) may especially happen in the first few months of taking omega-3-acid ethyl esters if you already have that problem.

Antilipemic agent; combination consisting predominantly of ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).1 2 8 16

General

• Patients should be placed on a standard cholesterol-lowering diet before initiation of omega-3-acid ethyl esters therapy and should remain on this diet during treatment with the drug.1 2 16

Administration

Oral Administration

Lovazais administered with meals in clinical studies.1 2 8 Manufacturer recommends administering Omtryg capsules with meals.16

Swallow capsules whole; do not break, crush, dissolve, or chew.1 16

Dosage

Each 1- or 1.2-g capsule contains ≥900 mg of the ethyl esters of omega-3 fatty acids (approximately 465 mg from ethyl esters of EPA and 375 mg from ethyl esters of DHA).1 2 16

Adults

Lovaza: 4 g daily as a single dose or in 2 equally divided doses.1 2 8 Discontinue if adequate response not achieved after 2 months of therapy.1

Omtryg: 4.8 g daily as a single dose or in 2 equally divided doses.16

AHA suggests incorporating omega-3 fatty acids in diet,3 although benefit in reducing CHD risk or total mortality not established.5

For primary prevention†, AHA suggests consumption of a variety of fish (preferably fatty fish such as herring, mackerel, salmon, sardines, or tuna) at least twice weekly and inclusion of oils and foods rich in α-linolenic acid (e.g., canola/flaxseed/soybean oils, flaxseeds, English walnuts) in diet.3

For secondary prevention†, AHA suggests consumption of approximately 1 g of a combination of EPA and DHA daily, preferably through dietary means (i.e., consumption of fatty fish); if intake cannot be achieved with diet alone, may consider supplements, but only in consultation with a clinician.3

Third Report of the National Cholesterol Education Program (NCEP) (Adult Treatment Panel [ATP] III) did not recommend specific amount of omega-3 fatty acids for daily intake but does support AHA's recommendation to include fish in diet.4 Higher dietary intakes (1–2 g daily) identified by ATP III as an option for secondary prevention, but more definitive clinical trials required before such high dosages can be strongly recommended for either primary or secondary prevention.4

Special Populations

No special population recommendations at this time.13

Drugs Affecting Coagulation

Monitor (e.g., PT/INR) periodically during concomitant therapy.1 13 16 (See Prolongation of Bleeding Time under Cautions.)

Drugs Metabolized by Hepatic Microsomal Enzymes

Free forms of EPA and DHA cause modest inhibition of CYP isoenzymes 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A in vitro.2 13 However, because free forms of EPA and DHA are undetectable in systemic circulation (<1 mcM), clinically important interactions with drugs metabolized by the CYP enzyme system not expected to occur in humans.1 2 16

Specific Drugs

• EPA and DHA, collectively known as marine-derived omega-3 fatty acids (n-3 fatty acids), are long-chain, polyunsaturated fatty acids (PUFAs) obtained primarily from marine sources such as fatty fish (e.g., herring, mackerel, salmon, sardines, tuna).3 10 12

• Mechanism of action not completely understood; may inhibit diacylglycerol O-acyltransferase, increase mitochondrial and peroxisomal β-oxidation in the liver, decrease lipogenesis in the liver, and increase plasma lipoprotein lipase activity.1 2 16

• May reduce synthesis of triglycerides and VLDL-cholesterol8 in the liver; also may inhibit esterification of other fatty acids.1 2 16

Use omega-3-acid ethyl esters only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered. Also, do not stop or change your dose without checking first with your doctor.

omega-3-acid ethyl esters comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Remember that omega-3-acid ethyl esters will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your triglyceride (fats) levels down.

Before prescribing medicine for your condition your doctor will probably try to control your condition prescribing a personal diet for you. Carefully follow the special diet your doctor gave you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed. Also, omega-3-acid ethyl esters is less effective if you are greatly overweight. It may be very important for you to go on a weight-reducing diet. However, check with your doctor before going on any diet.

omega-3-acid ethyl esters may be taken with meals.

Swallow the capsule whole. Do not break, crush, chew, dissolve, or open the capsule. If you are using a disposable foam plastic cup (Styrofoam cup), do not puncture the capsule and do not let its contents contact the foam plastic cup.

Take omega-3-acid ethyl esters at the same time each day.

Dosing

The dose of omega-3-acid ethyl esters will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of omega-3-acid ethyl esters. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For high triglycerides or fats in the blood:
    • Adults—4 capsules per day, either taken as a single dose once per day, or 2 capsules two times a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of omega-3-acid ethyl esters, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Pregnancy

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. It is unknown whether Omega-3-Acid Ethyl Esters can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Omega-3-Acid Ethyl Esters should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.

Animal Data: Omega-3-Acid Ethyl Esters have been shown to have an embryocidal effect in pregnant rats when given in doses resulting in exposures 7 times the recommended human dose of 4 grams/day based on a body surface area comparison.

In female rats given oral gavage doses of 100, 600, and 2,000 mg/kg/day beginning 2 weeks prior to mating and continuing through gestation and lactation, no adverse effects were observed in the high dose group (5 times human systemic exposure following an oral dose of 4 grams/day based on body surface area comparison).

In pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg/kg/day from gestation day 6 through 15, no adverse effects were observed (14 times human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison).

In pregnant rats given oral gavage doses of 100, 600, and 2,000 mg/kg/day from gestation day 14 through lactation day 21, no adverse effects were seen at 2,000 mg/kg/day (5 times the human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison). However, decreased live births (20% reduction) and decreased survival to postnatal day 4 (40% reduction) were observed in a dose-ranging study using higher doses of 3,000 mg/kg/day (7 times the human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison).

In pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg/kg/day from gestation day 7 through 19, no findings were observed in the fetuses in groups given 375 mg/kg/day (2 times human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison). However, at higher doses, evidence of maternal toxicity was observed (4 times human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison).

Nursing Mothers

Studies with Omega-3-Acid Ethyl Esters have demonstrated excretion in human milk. The effect of this excretion on the infant of a nursing mother is unknown; caution should be exercised when Omega-3-Acid Ethyl Esters is administered to a nursing mother. An animal study in lactating rats given oral gavage 14C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk than in plasma.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

A limited number of subjects older than 65 years were enrolled in the clinical trials of Omega-3-Acid Ethyl Esters. Safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years.

Omega-3-Acid Ethyl Esters does not have any known drug abuse or withdrawal effects.

Omega-3 Label (120 count)