Pronunciation:

oh-MAY-ga-3-AS-id ETH-il ES-ters

Brand Names:

• Lovaza
• Omtryg

Dosage Forms:

• Capsule, Liquid Filled

Classifications:

Therapeutic—

Antihyperlipidemic

Chemical—

Omega-3 Fatty Acid

Uses of This Medicine:

Omega-3-acid ethyl esters are used together with a proper diet to lower very high triglyceride (fat-like substance) levels in the blood. This medicine may help prevent medical problems caused by clogged blood vessels such as heart attacks and strokes.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of omega-3-acid ethyl esters in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omega-3-acid ethyl esters in the elderly.

Breast-feeding—

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to fish or shellfish, history of—Use with caution. May increase risk of having 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 risk for hypertriglyceridemia.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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

Check with your doctor immediately 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. Also, 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 or 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.