Omega-3-Acid Ethyl Ester 900 mg/1

omega-3-acid ethyl esters · CAPSULE, LIQUID FILLED · Bionpharma Inc.

No Recall History

Plain English

Omega-3-Acid Ethyl Ester is a capsule, liquid filled containing omega-3-acid ethyl esters at 900 mg/1, taken oral. Manufactured by Bionpharma Inc..

Key Facts

Brand Name: Omega-3-Acid Ethyl Ester
Generic Name: omega-3-acid ethyl esters
NDC Code (Product): 69452-175
Manufacturer: Bionpharma Inc.
Strength: 900 mg/1
Dosage Form: CAPSULE, LIQUID FILLED
Route: ORAL
Marketing Status
Application #: ANDA206455
Marketing Start: 01/15/2017

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

product odour abnormal96 reports

chest pain83 reports

off label use81 reports

diarrhoea76 reports

nausea75 reports

drug ineffective74 reports

malaise67 reports

pain67 reports

fatigue65 reports

dyspnoea61 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS 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-…

Dosage & Administration

2 DOSAGE 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 Indications and Usage ( 1 )]. 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 were 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. The daily dose of omega-3-acid ethyl esters is 4 grams per day taken as a single 4 gram dose (4 capsules) or as two 2 gram doses (2 capsules given twice daily). ( 2 ) 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 ca…

Contraindications

4 CONTRAINDICATIONS Omega-3-acid ethyl esters are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components. Omega-3-acid ethyl esters is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components.

Drug Interactions

7 DRUG INTERACTIONS Omega-3-acids may prolong bleeding time. Patients taking omega-3-acid ethyl esters and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically. ( 7.1 ) 7.1 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 omega-3-acid ethyl esters and concomitant anticoagulants. Patients receiving treatment with omega-3-acid ethyl esters and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.

Adverse Reactions

6 ADVERSE REACTIONS The most common adverse reactions (incidence > 3% and greater than placebo) were eructation, dyspepsia, and taste perversion. To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions reported in at least 3% of subjects treated with omega-3-acid ethyl esters and at a greater rate than placebo based on pooled data across 23 clinical trials are listed in Table 1. Table 1. Adverse Reactions Occurring at Incidence ≥ 3% and Greater than Placebo in Clinical Trials of Omega-3-Acid Ethyl Esters Adverse Reaction Trials included subjects with hypertriglyceridemia and severe hypertriglyceridemia. Omega-3-Acid Ethyl Esters (n = 655) Placebo (n = 370) n % n % Eructation 29 4 5 1 Dyspepsia 22 3 6 2 Taste perversion 27 4 1 < 1 Additional adverse reactions from clinical trials ar…

Frequently Asked Questions

What is Omega-3-Acid Ethyl Ester used for?

Omega-3-Acid Ethyl Ester contains omega-3-acid ethyl esters. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Omega-3-Acid Ethyl Ester a controlled substance?

Omega-3-Acid Ethyl Ester is not classified as a controlled substance by the DEA.

What is the generic name for Omega-3-Acid Ethyl Ester?

The generic name for Omega-3-Acid Ethyl Ester is omega-3-acid ethyl esters. There are 12 other brand versions of omega-3-acid ethyl esters.

What is the NDC code for Omega-3-Acid Ethyl Ester 900 mg/1?

The NDC (National Drug Code) for Omega-3-Acid Ethyl Ester 900 mg/1 is 69452-175, listed by Bionpharma Inc..

Product NDC

69452-175

Package NDC

69452-175-17

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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