Lovaza

DRUG DESCRIPTION

LOVAZA (omega-3-acid ethyl esters) , a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of LOVAZA (omega-3-acid ethyl esters) contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).

The empirical formula of EPA ethyl ester is C22H34O2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:

EPA ethyl ester Structural Formula Illustration

The empirical formula of DHA ethyl ester is C24H36O2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is:

LOVAZA (omega-3-acid ethyl esters) capsules also contain the following inactive ingredients: 4 mg ?-tocopherol (in a carrier of soybean oil), and gelatin, glycerol, and purified water (components of the capsule shell).

What are the possible side effects of omega-3 polyunsaturated fatty acids?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • chest pain; or
  • uneven heartbeats.

Less serious side effects may include:

  • back pain;
  • unusual or unpleasant taste in your mouth;
  • upset...

Read All Potential Side Effects and See Pictures of Lovaza

What are the precautions when taking omega-3-acid ethyl esters (Lovaza)?

Before taking omega-3 acid ethyl esters, tell your doctor or pharmacist if you are allergic to it; or to fish or soy products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, diabetes, liver disease, underactive thyroid (hypothyroidism).

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Lovaza


Lovaza Consumer (continued)

SIDE EFFECTS: Upset stomach, burping, and strange taste in mouth may occur. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, black/tarry stool, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking omega-3 acid ethyl esters, tell your doctor or pharmacist if you are allergic to it; or to fish or soy products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, diabetes, liver disease, underactive thyroid (hypothyroidism).

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.


Lovaza Patient Information Including Side Effects

Brand Names: Animi-3, EPA Fish Oil, Fish Oil, Icar Prenatal Essential Omega-3, Lovaza, Marine Lipid Concentrate, MaxEPA, MaxiTears Dry Eye Formula, MaxiVision Omega-3 Formula, Mi-Omega, Mi-Omega NF, Omacor, Omega-500, Proepa, Sea-Omega, Sea-Omega 30, Sea-Omega 70, TheraTears Nutrition

Generic Name: omega-3 polyunsaturated fatty acids (Pronunciation: oh MAY ga 3 POL ee un SAT yoo ray ted FAT ee AS ids)

  • What is omega-3 polyunsaturated fatty acids (Lovaza)?
  • What are the possible side effects of omega-3 polyunsaturated fatty acids?
  • What is the most important information I should know about omega-3 polyunsaturated fatty acids?
  • What should I discuss with my health care provider before taking omega-3 polyunsaturated fatty acids?
  • How should I take omega-3 polyunsaturated fatty acids?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking omega-3 polyunsaturated fatty acids?
  • What other drugs will affect omega-3 polyunsaturated fatty acids?
  • Where can I get more information?

What is omega-3 polyunsaturated fatty acids (Lovaza)?

Omega-3 polyunsaturated fatty acids are found in oil from certain types of fish, vegetables, and other plant sources. These fatty acids are not made by the body and must be consumed in the diet. Omega-3 polyunsaturated fatty acids work by lowering the body's production of triglycerides. High levels of triglycerides can lead to coronary artery disease, heart disease, and stroke.

Omega-3 polyunsaturated fatty acids are used together with diet and exercise to help lower triglyceride levels in the blood.

Omega-3 polyunsaturated fatty acids may also be used for other purposes not listed in this medication guide.

What are the possible side effects of omega-3 polyunsaturated fatty acids?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • chest pain; or
  • uneven heartbeats.

Less serious side effects may include:

  • back pain;
  • unusual or unpleasant taste in your mouth;
  • upset stomach, belching; or
  • mild skin rash.

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

What is the most important information I should know about omega-3 polyunsaturated fatty acids?

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.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs that can affect omega-3 polyunsaturated fatty acids. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using 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.

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