Vascepa Capsules (Soft Gelatin)
Icosapent
1000mg
AMARIN PHARMACEUTICALS IRELAND LTD.
| Pack size | 120's HDPE Bottle |
|---|---|
| Dispensing mode | POM |
| Source | IRELAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 936.00 AED |
Indications
Vascepa Capsules (Soft Gelatin) is used for:
Severe Hypertriglyceridemia
Adult Dose
Severe Hypertriglyceridemia
Indicated as an adjunct to diet to reduce high triglyceride (TG) levels (ie, >500 mg/dL)
Cardiovascular risk reduction
Indicated as an adjunct to maximally tolerated statin therapy to reduce risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adults with elevated TG levels (?150 mg/dL), AND
Established cardiovascular disease, OR
Diabetes mellitus and 2 or more additional risk factors for CV disease
2g PO q12hr with food
Child Dose
Renal Dose
Administration
Swallow capsule whole; do not break open, dissolve, crush, or chew
Contra Indications
Hypersensitivity to drug or any of its components
Precautions
Associated with increased risk of atrial fibrillation or atrial flutter requiring hospitalization compared with placebo (3% vs 2%)
Contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish; unknown whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction
Use associated with increased risk of bleeding; incidence is greater if taking concomitant antithrombotic medications (eg, aspirin, clopidogrel, or warfarin)
Pregnancy-Lactation
Pregnancy
Available data from published case reports and the pharmacovigilance database on the use in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes
Animal studies
In animal reproduction studies in pregnant rats, nondose-related imbalances for some minor developmental findings were observed with oral administration of icosapent ethyl during organogenesis at exposures that were equivalent to the clinical exposure at the human dose of 4 g/day, based on body surface area comparisons
Lactation
Published studies have detected omega-3 fatty acids, including EPA, in human milk
Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk
There are no data on the effects of omega-3 fatty acid ethyl esters on the breastfed infant or on milk production
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Interactions
Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time; bleeding time reported in those studies has not exceeded normal limits and did not produce clinically significant bleeding episodes
Monitor patients receiving icosapent with anticoagulants and/or antiplatelet agents for bleeding
Adverse Effects
Side effects of Icosapent :
>10%
Bleeding event (12%)
1-10%
Musculoskeletal pain (≥3%)
Peripheral edema (≥3%)
Constipation (≥3%)
Gout (≥3%)
Atrial fibrillation or flutter (3%)
Serious bleeding event (3%)
Mechanism of Action
Ethyl ester of eicosapentaenoic acid (EPA); EPA has been shown to reduce hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion; enhances triglyceride clearance from circulating VLDL particle; may also increase beta-oxidation, inhibits acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT), decrease lipogenesis in liver, and increase plasma lipoprotein lipase activity
The mechanisms of action contributing to reduction of cardiovascular events are not completely understood but are likely multifactorial; increased EPA lipid composition from carotid plaque specimens and increased circulating EPA/arachidonic acid ratio have been observed following EPA treatment; EPA inhibits platelet aggregation under some ex vivo conditions
Note
Vascepa 1000mg Capsules (Soft Gelatin) manufactured by AMARIN PHARMACEUTICALS IRELAND LTD.. Its generic name is Icosapent. Vascepa is availble in United Arab Emirates.
Farmaco UAE drug index information on Vascepa Capsules (Soft Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.