Icosapent Ethyl 1 g/1
Icosapent Ethyl · CAPSULE · Qilu Pharmaceutical Co., Ltd.
Icosapent Ethyl is a capsule containing icosapent ethyl at 1 g/1, taken oral. Manufactured by Qilu Pharmaceutical Co., Ltd..
Key Facts
- Brand Name
- Icosapent Ethyl
- Generic Name
- Icosapent Ethyl
- NDC Code (Product)
67184-0582- Manufacturer
- Qilu Pharmaceutical Co., Ltd.
- Strength
- 1 g/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA218899
- Marketing Start
- 01/01/2025
Recall History
Zydus Pharmaceuticals (USA) Inc
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Zydus Pharmaceuticals (USA) Inc
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Zydus Pharmaceuticals (USA) Inc
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Icosapent ethyl capsules are indicated: as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid (EPA) indicated: as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. (1) Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Assess lipid levels before initiating therapy. Identify other causes of high triglyceride levels and manage as appropriate. (2.1) Patients should engage in appropriate nutritional intake and physical activity before receiving icosapent ethyl capsules, which should continue during treatment. (2.1) The daily dose of icosapent ethyl capsules are 4 grams per day taken as either four 0.5 gram capsules twice daily with food or two 1 gram capsules twice daily with food. (2.2) Advise patients to swallow capsules whole. Do not break open, crush, dissolve, or chew icosapent ethyl capsules. (2.2) 2.1 Prior to Initiation of Icosapent Ethyl Capsules Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. Patients should engage in appropriate nutritional intake and physical activity before receiving icosapent ethyl capsules, which should continue during treatment with icosapent ethyl capsules. 2.2 Dosage and Administration The daily dose of icosapent ethyl capsules are 4 grams per day taken as either: four 0.5 gram capsules twice daily with foo…
Contraindications
4 CONTRAINDICATIONS Icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components. Icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components. (4)
Drug Interactions
7 DRUG INTERACTIONS Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents: Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. Monitor patients receiving icosapent ethyl and concomitant anticoagulants and/or antiplatelet agents for bleeding. (7) 7.1 Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in those studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Monitor patients receiving icosapent ethyl and concomitant anticoagulants and/or antiplatelet agents for bleeding.
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Atrial Fibrillation or Atrial Flutter [see Warnings and Precautions (5.1)] Potential for Allergic Reactions in Patients with Fish Allergy [see Warnings and Precautions (5.2)] Bleeding [see Warnings and Precautions (5.3)] Common adverse reactions (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. (6.1) Common adverse reactions in the hypertriglyceridemia trials (incidence ≥1% more frequent than placebo): arthralgia and oropharyngeal pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact XLCare Pharmaceuticals, Inc. at 1-866-495-1995 or contact the 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Common adverse reactions (incidence ≥3% on icosapent ethyl and ≥1% more frequent than placebo) include…
Frequently Asked Questions
What is Icosapent Ethyl used for?
Icosapent Ethyl contains Icosapent Ethyl. It is a capsule taken oral. Consult your doctor for specific uses.
Is Icosapent Ethyl a controlled substance?
Icosapent Ethyl is not classified as a controlled substance by the DEA.
What is the generic name for Icosapent Ethyl?
The generic name for Icosapent Ethyl is Icosapent Ethyl. There are 7 other brand versions of Icosapent Ethyl.
What is the NDC code for Icosapent Ethyl 1 g/1?
The NDC (National Drug Code) for Icosapent Ethyl 1 g/1 is 67184-0582, listed by Qilu Pharmaceutical Co., Ltd..