Omega-3-carboxylic acids

Name: Omega-3-carboxylic acids

Pregnancy & Lactation

Pregnancy: There are no studies in pregnant women and the limited available data are not sufficient to inform a drug-associated risk for major birth defects or miscarriages

Lactation: Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from therapy or from the underlying maternal condition

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Omega-3-Carboxylic Acids Drug Class

Omega-3-Carboxylic Acids is part of the drug class:

  • Other lipid modifying agents

Side Effects of Omega-3-Carboxylic Acids

Serious side effects have been reported with omega-3-carboxylic acids. See the “Omega-3-carboxylic acids Precautions” section.

Common side effects of omega-3-carboxylic acids include:

  • diarrhea
  • nausea
  • abdominal pain
  • burping

This is not a complete list of omega-3-carboxylic acids side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Omega-3-Carboxylic Acids Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • anticoagulants such as warfarin (Coumadin, Jantoven)
  • antiplatelet agents such as aspirin, clopidogrel (Plavix), and dipyridamole (Aggrenox)

This is not a complete list of omega-3-carboxylic acids drug interactions. Ask your doctor or pharmacist for more information.

Inform MD

Before taking omega-3-carboxylic acids, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to omega-3-carboxylic acids or to any of its ingredients
  • have thyroid problems
  • have liver disease
  • have pancreatic disease
  • are allergic to fish or shellfish
  • are pregnant or breastfeeding

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

Other Requirements

  • Store omega-3-carboxylic acids at room temperature. Do not freeze omega-3-carboxylic acids capsules.
  • Keep this and all medications out of the reach of children.

Proper Use of omega-3-carboxylic acids

Take omega-3-carboxylic acids exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

omega-3-carboxylic acids should come with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the capsule whole. Do not crush, break, chew, or open it. If you cannot swallow the capsule whole, tell your doctor.

Take omega-3-carboxylic acids with or without food.

Dosing

The dose of omega-3-carboxylic acids 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-carboxylic acids. 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 severe hypertriglyceridemia:
      • Adults—2 grams (2 capsules) or 4 grams (4 capsules) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of omega-3-carboxylic acids, 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.

omega-3-carboxylic acids Side Effects

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
  • Cough
  • difficulty swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, or skin rash
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • 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:

More common
  • Change in taste
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • fever
  • full or bloated feeling
  • headache
  • loss of taste
  • muscle aches
  • muscle pain or stiffness
  • nausea
  • pain in the joints
  • pressure in the stomach
  • sore throat
  • stuffy or runny nose
  • swelling of the abdominal or stomach area
  • unusual tiredness or weakness
  • vomiting
Less common
  • Abdominal or stomach pain or discomfort
  • belching
  • bloated or full feeling
  • excess air or gas in the stomach

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.

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