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Vascepa Generic Name & Formulations
Legal Class
Rx
General Description
Icosapent ethyl 0.5g, 1g; soft gelatin caps.
Pharmacological Class
Lipid-regulating agent.
How Supplied
Caps 0.5g—240; 1g—120
Manufacturer
Generic Availability
NO
Vascepa Indications
Indications
Adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adults with elevated triglyceride (TG) levels (≥150mg/dL) and established cardiovascular disease (CVD), or diabetes plus ≥2 additional CVD risk factors. Adjunct to diet to reduce TG levels in adults with severe hypertriglyceridemia (≥500mg/dL).
Limitations of Use
The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Vascepa Dosage and Administration
Adult
Swallow whole. 4 caps (0.5g) or 2 caps (1g) twice daily with food; max 4g/day.
Children
Not established.
Vascepa Contraindications
Not Applicable
Vascepa Boxed Warnings
Not Applicable
Vascepa Warnings/Precautions
Warnings/Precautions
Obtain baseline lipids before initiating therapy. Identify other causes of high triglycerides and manage appropriately (eg, diabetes, hypothyroidism, or alcohol intake). Increased risk of atrial fibrillation or atrial flutter requiring hospitalization. Bleeding events. Hepatic impairment; monitor ALT/AST levels periodically during therapy. Fish and/or shellfish allergy. Pregnancy. Nursing mothers.
Vascepa Pharmacokinetics
See Literature
Vascepa Interactions
Interactions
Increased risk of bleeding with concomitant antithrombotics (eg, aspirin, clopidogrel, warfarin); monitor.
Vascepa Adverse Reactions
Adverse Reactions
Musculoskeletal pain, peripheral edema, constipation, gout, atrial fibrillation, arthralgia, oropharyngeal pain.
Vascepa Clinical Trials
See Literature
Vascepa Note
Not Applicable
Vascepa Patient Counseling
See Literature
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