Omtryg (Oral)

Omega-3-acid ethyl esters are used along with a proper diet to lower very high triglyceride levels in the blood. This medicine may help prevent medical issues caused by blocked blood vessels, like heart attacks and strokes.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check how you are doing at regular visits to ensure that this medicine is working correctly and to determine if you should keep taking it. You may need blood tests to monitor for any unwanted effects.

Do not take any other medicines unless your doctor has talked about them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your health care professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on the effects of omega-3-acid ethyl esters in children. Safety and effectiveness have not been established.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the use of omega-3-acid ethyl esters.

Breast Feeding

Studies suggest that this medication may change milk production or composition. If you are not prescribed a different medication, you should watch the infant for side effects and ensure they are getting enough milk.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction might happen. In these cases, your doctor might adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may influence the use of this medicine. Make sure to tell your doctor if you have any other medical conditions, especially:

• Allergy to fish or shellfish, history of—Use with caution. May increase the risk of an allergic reaction.

• Atrial fibrillation or flutter (heart rhythm problem), or history of—Use with caution. May cause this condition to occur again.

• Diabetes or
• Hypothyroidism (underactive thyroid)—May increase the risk for hypertriglyceridemia.

• Liver problems—Your doctor may want to monitor you more closely for unwanted effects.

Along with its needed effects, a medicine may cause some unwanted effects. While not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects occur:

Incidence not known

• Bleeding gums
• cough
• coughing up blood
• difficulty with breathing or swallowing
• dizziness
• fast or irregular heartbeat
• headache
• hives, itching, or skin rash
• increased menstrual flow or vaginal bleeding
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red or black, tarry stools
• red or dark brown urine
• sweating
• tightness in the chest
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Acid or sour stomach
• bad, unusual, or unpleasant (after) taste
• belching
• bloated or full feeling
• change in taste
• excess air or gas in the stomach
• heartburn
• indigestion
• stomach discomfort, upset, or pain

Incidence not known

• Diarrhea
• difficulty having a bowel movement (stool)
• loss of appetite
• nausea or vomiting
• passing of gas
• stomach fullness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Lovaza
• Omtryg

Available Dosage Forms:

• Capsule, Liquid Filled

Therapeutic Class: Antihyperlipidemic

Chemical Class: Omega-3 Fatty Acid

Use this medicine 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.

This medicine 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 this medicine 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, this medicine 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.

This medicine 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 this medicine at the same time each day.

Dosing

The dose of this medicine 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 this medicine. 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 this medicine, 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.

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