Omega-3-Acid Ethyl Esters 90: Uses, Dosage, Precautions, Side Effects, and Pharmacological Aspects

What Are Omega-3-Acid Ethyl Esters 90?

Omega-3-acid ethyl esters 90, a medication authorized by the United States Food and Drug Administration (USFDA) in October 2004, is crucial in managing elevated triglyceride levels and mitigating cardiovascular risks.

This medicine has healthy fats called Omega-3, especially EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). These fats help your heart stay strong and healthy. Taking it along with good foods can help you feel better and take care of your heart.

This article highlights this medication's positive impact and importance in promoting heart health and overall well-being.

Drug Group

Omega-3-acid ethyl esters 90 belong to the drug class of lipid-regulating agents. These agents primarily focus on modifying lipid levels in the blood, often by targeting cholesterol and triglycerides.

For Patients

What Does It Mean by High Triglycerides?

Triglycerides are a type of fat in the blood. They come from the food you eat and also serve as a way for your body to store energy.

Having too many triglycerides can increase your risk of heart problems and stroke.

Normal Triglyceride Levels:

• Normal: Less than 150 mg/dL.

• Borderline High: 150 to 199 mg/dL.

• High: 200 to 499 mg/dL.

• Very High: 500 mg/dL or more.

High triglycerides can be caused by several factors, including an unhealthy diet high in sugar or fat, lack of physical activity, genetics or family history, obesity (excess body fat), diabetes (high blood sugar), and certain medications. Keeping triglyceride levels under control is important for heart health and overall well-being.

How Does the Omega-3-Acid Ethyl Esters 90 Work?

Omega-3-acid ethyl esters 90 help lower triglycerides (a type of fat in the blood) by affecting how the body handles fat. The medicine contains EPA and DHA, which are special fats from fish oil. They may work in a few ways:

• Reduce Fat Production in the Liver:

EPA and DHA are not readily converted to triglycerides, so the liver produces less fat.

• Help Burn Fat:

These Omega-3 fats may help the liver break down fats faster.

• Limit New Fat Formation:

They may also stop the liver from making new fat.

This helps lower blood triglyceride levels and supports heart health.

What Are the Clinical Uses of the Omega-3-Acid Ethyl Esters 90?

Omega-3-acid ethyl esters 90 are prescribed as a supplement to dietary measures to lower triglyceride (TG) levels in adult patients experiencing severe hypertriglyceridemia (HTG) that is more than or equal to 500 mg/dL (milligrams per deciliter).

It is used in the case of

• Hypertriglyceridemia:

Omega-3-acid ethyl esters 90 is prescribed for people with very high triglycerides. It is used along with a healthy diet to help lower triglyceride levels, which can reduce the risk of heart problems.

What Is the Dosage of the Omega-3-Acid Ethyl Esters 90?

Omega-3-acid ethyl esters 90 come as soft, clear capsules filled with light-yellow oil. Each capsule has 1 gram of medicine.

The usual dose is 4 grams a day, which means you can take 4 capsules at once or 2 capsules in the morning and 2 at night. Your doctor will tell you the best way to take them.

How Are Omega-3-Acid Ethyl Esters 90 Administered?

• Before taking this medicine, your doctor will check your triglyceride levels. They will also see if things like diabetes, thyroid problems, or other drugs are causing high triglycerides.

• You should eat a healthy, low-fat diet before and during treatment with this medicine. Take medicine with meals.

• Always swallow the capsule whole with water. Do not break, chew, or open it, or it may not work properly.

What Are the Side Effects Associated With Omega-3-Acid Ethyl Esters 90?

Omega-3-acid ethyl esters 90 have the potential to cause significant side effects, including:

• This medicine can sometimes affect the liver, which may show up in blood tests. It can also increase bad cholesterol in some people.

• In some cases, it may cause an irregular heartbeat, especially during the first few months of taking the medicine. This is more likely in people who already have heart problems.

Common side effects of Omega-3-acid ethyl esters comprise:

• Burping.

• Upset stomach.

• Altered sense of taste.

If the patient experiences a bothersome or persistent side effect, consult the doctor.

What Are the Things to Inform the Doctor Before Taking Omega-3-Acid Ethyl Esters 90?

Before starting Omega-3-acid ethyl esters, inform the doctor if the patient has the following:

• Diabetes.

• Experience hypothyroidism (a low thyroid problem).

• Liver problem.

• Pancreas problem.

• A heart rhythm issue known as atrial fibrillation or flutter.

• Is allergic to fish or shellfish, because it is not clear if this medicine could cause an allergic reaction.

• If you are pregnant or planning to become pregnant, as the effects on the baby are unknown.

• If the patient is breastfeeding, the medicine may pass into breast milk. Your doctor can help decide if it is safe.

Also:

• Share all medicines you take with your doctor, including prescriptions, over-the-counter drugs, vitamins, and herbal supplements.

• Be aware that Omega-3-acid ethyl esters can interact with blood-thinning medicines, which may increase the risk of bleeding.

• Keep a list of all medications to show your doctor or pharmacist when starting any new treatment.

Dietary Considerations

There are no specific dietary considerations. It is advised to follow a balanced and nutritious diet.

Missed Dose

Patients should follow the prescribed regimen for Omega-3-acid ethyl esters 90. If a dose is missed, the patient should take it as soon as they recall. However, if a day is skipped, the patients should avoid doubling the dose upon the next intake.

Overdose

If you take too much Omega-3-acid ethyl esters 90, seek immediate medical help or contact a poison control center. Taking more than the prescribed dose may cause stomach upset, nausea, or increase the risk of bleeding. Always take this medicine exactly as your doctor has prescribed to avoid side effects.

Storage and Handling

To store Omega-3-acid ethyl esters 90 properly, keep them at room temperature around 25°C (degrees Celsius) (77°F or degrees Fahrenheit). It is okay if the temperature goes slightly between 15 and 30°C (59 and 86°F). Do not freeze the capsules, and always keep them out of reach of children.

For Doctors

Chemical Taxonomy

Omega-3-acid ethyl esters are lipid-regulating agents available as liquid-filled soft gel capsules for oral use. Each 1-gram capsule of Omega-3-acid ethyl esters 90 contains at least 900 mg of ethyl esters of Omega-3 fatty acids derived from fish oil. The main components are ethyl esters of eicosapentaenoic acid (EPA) at approximately 465 mg and docosahexaenoic acid (DHA) at about 375 mg.

The empirical formula of EPA ethyl ester is C₂₂H₃₄O₂, with a molecular weight of 330.51, while the empirical formula of DHA ethyl ester is C₂₄H₃₆O₂, with a molecular weight of 356.55.

Each capsule also contains a small amount of vitamin E in soybean oil. The outside of the capsule is made of gelatin, a type of jelly, along with water and glycerol.

Dosing Considerations:

Before taking Omega-3-acid ethyl esters, follow a healthy, low-fat diet and continue it during treatment. Your doctor will check your blood fat levels and may recommend exercise, weight loss, or treatment for conditions like diabetes or thyroid problems. Some medicines that raise triglycerides may need to be adjusted.

Important Limits to Know

• It is not yet clear if this medicine can prevent pancreatitis (inflammation of the pancreas). It is also not proven that this medicine can reduce the risk of heart attacks or heart-related deaths.

Warnings and Precautions

The associated warnings and precautions are:

1. Monitoring Laboratory Tests:

• People who have liver problems should have regular blood tests while taking Omega-3-acid ethyl esters. These tests check liver enzymes (ALT, or alanine aminotransferase, and AST, or aspartate aminotransferase) to ensure the liver is functioning properly. In some people, one of these values (ALT) may increase.

• Bad cholesterol levels (LDL cholesterol) should be checked regularly, as this medicine can increase LDL levels in some patients.

• In addition, triglyceride levels should be checked periodically to assess how well the medicine is working. Regular blood tests help ensure the treatment is safe and effective.

2. Fish Allergy:

Omega-3 fatty acids (EPA and DHA) come from fish. It is not fully known whether people who are allergic to fish or shellfish will also be allergic to this medicine.

Patients with a known allergy to fish or shellfish should inform their physician before starting this medication, as it may increase the risk of adverse reactions.

3. Recurrent Atrial Fibrillation (AF) or Flutter:

• A study in people with irregular heartbeat (atrial fibrillation or flutter) found that taking Omega-3-acid ethyl esters slightly increased the risk of the heartbeat problem returning, especially in the first two to three months.

• The exact reason is unclear, so this medicine is not recommended to treat atrial fibrillation or flutter. People with heart rhythm problems should use it only under a doctor’s supervision.

What Are the Pharmacological Actions of Omega-3-Acid Ethyl Esters 90?

1. What It Does (Pharmacodynamics):

Omega-3-acid ethyl esters help lower triglycerides (a type of fat in the blood). They mainly work by affecting how fats are made and processed in the liver.

2. How It Works (Mechanism of Action):

The exact way this medicine works is not fully known. However, it is believed to:

• Reduce the amount of fat the liver makes.

• Help the body burn fat more efficiently.

• Increase the breakdown of fats in the blood.

The main ingredients, EPA and DHA, are special types of fats from fish oil that make it harder for the liver to produce triglycerides.

3. How the Body Handles It (Pharmacokinetics):

This medicine has not been adequately studied in children, so its effects in children are not fully known. It has also not been adequately studied in people with kidney or liver problems, so its absorption, metabolism and elimination in these conditions is unclear.

Because of this, people with liver or kidney disease should use this medicine only under a doctor’s supervision.

Non-Clinical Toxicity

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

Studies in rats show that long-term use of Omega-3-acid ethyl esters did not cause cancer or harm to genes or DNA.

Other studies also showed it did not affect fertility, even at very high doses. This suggests the medicine is unlikely to affect fertility in humans when taken at normal doses.

What Are the Contraindications of Omega-3-Acid Ethyl Esters 90?

Omega-3-acid ethyl esters 90 should not be used in patients with a confirmed hypersensitivity, such as an anaphylactic reaction, to Omega-3-acid ethyl esters or any of its components.

What Are the Drug Interactions of Omega-3-Acid Ethyl Esters 90?

• Some studies have shown that Omega-3-acid ethyl esters 90 can slightly increase bleeding time, which means blood may take a little longer to clot. However, this increase usually stays within normal limits and does not cause serious bleeding problems.

• There have not been enough extensive studies to fully understand how this medicine works when taken together with blood thinners.

• If you are taking Omega-3-acid ethyl esters 90 along with blood-thinning medicines (such as anticoagulants or antiplatelet drugs), your doctor may advise regular check-ups and blood tests to make sure everything remains safe.

Clinical Studies

Two studies were done in adults with very high triglyceride levels. People took Omega-3-acid ethyl esters 90 for 6 to 16 weeks.

The results showed that this medicine:

• Lowered triglycerides.

• Lowered other harmful fats in the blood.

• Increased good cholesterol (HDL).

However, in some people, this medicine may also increase bad cholesterol (LDL). Because of this, doctors should regularly check cholesterol levels during treatment. It is still not clearly known whether this medicine can prevent pancreatitis (inflammation of the pancreas) or reduce the risk of heart attacks or heart-related deaths.

Use in Specific Populations

• Pregnancy:

There is insufficient research to determine whether this medicine is safe during pregnancy. It should be used only if clearly needed and prescribed by a doctor.

• Breastfeeding:

Omega-3-acid ethyl esters 90 medicine can pass into breast milk. Its effect on babies is not fully known, so it should be used with caution in breastfeeding mothers.

• Children:

The safety and effectiveness of this medicine in children have not been established.

• Older Adults:

Studies show that this medicine works similarly in older and younger adults, with no major differences in safety.