Lovaza

There are no adequate and well-controlled studies in pregnant women. Lovaza should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.

 Lovaza is excreted in human milk and caution should be exercised when administering Lovaza to nursing women.

Capsules: 1 gm

Lovaza should be stored at 25 C (77 F) and not frozen.

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

• Anticoagulants (blood thinners), such as Coumadin or Jantoven (warfarin)
• Antiplatelet medications, such as Pletal (cilostazol), Plavix (clopidogrel), Persantine or Aggrenox (dipyridamole), Effient (prasugrel), and ticlopidine
• Aspirin or products that contain aspirin
• Beta-blockers, such as Tenormin or Tenoretic (atenolol), Trandate (labetalol), Lopressor, Toprol XL, or Dutoprol (metoprolol), Corgard or Corzide (nadolol), and Inderal, InnoPran XL, or Inderide (propranolol)
• Diuretics (water pills)
• Estrogen-containing contraceptives (birth control pills, patches, rings, and injections)
• Estrogen replacement therapy
• Nonsteroidal anti-inflammatory drugs (NSAIDs), such as Advil or Motrin (ibuprofen) and Aleve or Naprosyn (naproxen)

Lovaza and Alcohol

Drinking alcohol may affect your triglyceride levels.

Talk to your doctor before consuming alcoholic beverages while taking this medicine.

LOVAZA, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of LOVAZA 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:

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 capsules also contain the following inactive ingredients: 4 mg α-tocopherol (in a carrier of soybean oil), and gelatin, glycerol, and purified water (components of the capsule shell).

No information provided.

Tell your doctor about all of your medical conditions, including if you:

• drink more than 2 glasses of alcohol daily
• have diabetes
• have a thyroid problem called hypothyroidism
• have a liver problem
• have a pancreas problem
• have a certain heart rhythm problem called atrial fibrillation or flutter
• are allergic to fish and/or shellfish. Lovaza may not be right for you.
• are pregnant, or planning to become pregnant. It is not known if Lovaza can harm your unborn baby.
• are breastfeeding. It is not known if Lovaza passes into your milk and if it can harm your baby.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicine, vitamins, and herbal supplements.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

• It is used to lower triglycerides.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to omega-3 fatty acids or any other part of Lovaza (omega-3 fatty acid capsules).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burping.
• Change in taste.
• Upset stomach.
• Loose stools (diarrhea).
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Anticoagulants or Other Drugs Affecting Coagulation

Some trials with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these trials has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical trials have not been done to thoroughly examine the effect of Lovaza and concomitant anticoagulants. Patients receiving treatment with Lovaza and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.

More frequent side effects include: dysgeusia and eructation. See below for a comprehensive list of adverse effects.