Brand Name
Omega-3-Acid
View Brand InformationFDA approval date: April 07, 2014
Classification: Omega-3 Fatty Acid
Form: Capsule
What is Omega-3-Acid?
Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia should be discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy. Limitations of Use: The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined. Omega-3-acid ethyl esters capsules are a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid and docosahexaenoic acid , indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Limitations of Use: The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined.
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Brand Information
OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)
1INDICATIONS AND USAGE
Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia.
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules.
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of TG-lowering drug therapy.
Limitations of Use:
The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined.
The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined.
2DOSAGE AND ADMINISTRATION
- Assess TG levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, medications) of high TG levels and manage as appropriate [see
- Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, and should continue this diet during treatment with omega-3-acid ethyl esters capsules. In clinical studies, omega-3-acid ethyl esters capsules was administered with meals.
The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day. The daily dose may be taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).
Patients should be advised to swallow omega-3-acid ethyl esters capsules whole. Do not break open, crush, dissolve, or chew omega-3-acid ethyl esters capsules.
3DOSAGE FORMS AND STRENGTHS
Omega-3-acid ethyl esters capsules USP are supplied as 1 gram oblong, clear, soft gelatin capsules filled with light yellow liquid and imprinted with "PC25" in white ink.
4CONTRAINDICATIONS
Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components.
5DESCRIPTION
Omega-3-acid ethyl esters, USP, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of 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 C
The empirical formula of DHA ethyl ester is C
Omega-3-acid ethyl esters capsules USP also contain the following inactive ingredients: gelatin, glycerin and purified water. The imprinting ink contains the following: propylene glycol, shellac glaze and titanium dioxide.
6HOW SUPPLIED/STORAGE AND HANDLING
Omega-3-acid ethyl esters capsules USP are supplied as 1 gram oblong, clear, soft gel capsules filled with slightly yellow to yellow liquid and imprinted with "PC25" in white ink. They are supplied in blistercards of 30 (NDC 0615-8550-39)
Store at 20
Protect from light.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Information for Patients:
- Omega-3-acid ethyl esters capsules should be used with caution in patients with known sensitivity or allergy to fish and/or shellfish [see
- Advise patients that use of lipid-regulating agents does not reduce the importance of adhering to diet [see
- Advise patients not to alter omega-3-acid ethyl esters capsules in any way and to ingest intact capsules only [see
- Instruct patients to take omega-3-acid ethyl esters capsules as prescribed. If a dose is missed, advise patients to take it as soon as they remember. However, if they miss one day of omega-3-acid ethyl esters capsules, they should not double the dose when they take it.
Manufactured by:
Humanwell PuraCap Pharmaceutical
Wuhan, Hubei 430206, China
Distributed by:
Epic Pharma, LLC
Laurelton, NY 11413
Rev. 09-2020-00
OE2955
8Patient Information
OMEGA-3-ACID ETHYL ESTERS CAPSULES USP
Rx Only
What are omega-3-acid ethyl esters capsules?
Omega-3-acid ethyl esters capsules are a prescription medicine used along with a low fat and low cholesterol diet to lower very high triglyceride (fat) levels in adults.
It is not known if omega-3-acid ethyl esters capsules changes your risk of having inflammation of your pancreas (pancreatitis).
It is not known if omega-3-acid ethyl esters capsules prevents you from having a heart attack or stroke.
It is not known if omega-3-acid ethyl esters capsules is safe and effective in children.
Who should not take omega-3-acid ethyl esters capsules?
Do not take omega-3-acid ethyl esters capsules if you are allergic to omega-3-acid ethyl esters or any of the ingredients in omega-3-acid ethyl esters capsules. See the end of this leaflet for a complete list of ingredients in omega-3-acid ethyl esters capsules.
Before taking omega-3-ethyl esters capsules, tell your healthcare provider about all your medical conditions, including if you:
- have diabetes.
- have a low thyroid problem (hypothyroidism).
- have a liver problem.
- have a pancreas problem.
- have a certain heart rhythm problem called atrial fibrillation or flutter.
- are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to omega-3-acid ethyl esters capsules.
- are pregnant or plan to become pregnant. It is not known if omega-3-acid ethyl esters capsules will harm your unborn baby.
- are breastfeeding or plan to breastfeed. Omega-3-acid ethyl esters can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take omega-3-acid ethyl esters capsules.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Omega-3-acid ethyl esters capsules can interact with certain other medicines that you are taking. Using omega-3-acid ethyl esters capsules with medicines that affect blood clotting (anticoagulants or blood thinners) may cause serious side effects.
How should I take omega-3-acid ethyl esters capsules?
- Take omega-3-acid ethyl esters capsules exactly as your healthcare provider tells you to take it.
- You should not take more than 4 capsules of omega-3-acid ethyl esters capsules each day. Either take all 4 capsules at one time, or 2 capsules two times a day.
- Do not change your dose or stop omega-3-acid ethyl esters capsules without talking to your healthcare provider.
- Take omega-3-acid ethyl esters capsules with food.
- Take omega-3-acid ethyl esters capsules whole. Do not break, crush, dissolve, or chew omega-3-acid ethyl esters capsules before swallowing. If you cannot swallow omega-3-acid ethyl esters capsules whole, tell your healthcare provider. You may need a different medicine.
- If you miss a dose of omega-3-acid ethyl esters capsules, take the missed dose as soon as you remember. If you miss one day of omega-3-acid ethyl esters capsules, do not double your dose the next time you take it.
- Your healthcare provider may start you on a cholesterol-lowing diet before giving you omega-3-acid ethyl esters capsules. Stay on this diet while taking omega-3-acid ethyl esters capsules.
- Your healthcare provider should do blood tests to check your triglyceride, bad cholesterol (LDL-C) and liver function (ALT and AST) levels while you take omega-3-acid ethyl esters capsules.
What are the possible side effects of omega-3-acid ethyl esters capsules?
Omega-3-acid ethyl esters capsules may cause serious side effects, including:
- changes in certain blood tests. Omega-3-acid ethyl esters capsules may cause an increase in the results of blood tests used to check your liver function and your bad cholesterol levels.
- increased risk of a heart rhythm problem in people who have a heart rhythm problem. Omega-3-acid ethyl esters capsules may cause an increase in the frequency of a heart rhythm problem (atrial fibrillation or flutter), especially in the first few months of taking omega-3-acid ethyl esters capsules, if you already have a heart rhythm problem.
The most common side effects of omega-3-acid ethyl esters capsules include:
- burping
- upset stomach
- a change in your sense of taste.
These are not all the possible side effects of omega-3-acid ethyl esters capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store omega-3-acid ethyl esters capsules?
- Store omega-3-acid ethyl esters capsules at room temperature between 68
- Do not freeze omega-3-acid ethyl esters capsules.
- Safely throw away medicine that is out of date or no longer needed.
Keep omega-3-acid ethyl esters capsules and all medicines out of the reach of children.
General information about the safe and effective use of omega-3-acid ethyl esters capsules
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use omega-3-acid ethyl esters capsules for a condition for which it was not prescribed. Do not give omega-3-acid ethyl esters capsules to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about omega-3-acid ethyl esters capsules that is written for health professionals.
What are the ingredients in omega-3-acid ethyl esters capsules?
Active Ingredient: omega-3-acid ethyl esters, USP, mostly EPA and DHA
Inactive Ingredients: gelatin, glycerin and purified water. The imprinting ink contains the following: propylene glycol, shellac glaze and titanium dioxide.
This patient labeling has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Humanwell PuraCap Pharmaceutical
Wuhan, Hubei 430206, China
Distributed by:
Epic Pharma, LLC
Laurelton, NY 11413
Rev. 09-2020-00
OE2955
9PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
