Winolip(Bempedoic Acid)
Therapeutic Group: Lipid Regulating Agent
Presentation
Winolip : Each film coated tablet contains Bempedoic Acid INN 180 mg
Description
Winolip Film Coated Tablet is a preparation of Bempedoic Acid. Bempedoic Acid is an adenosine triphosphate-citrate lyase(ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibition of cholesterol synthesis in the liver. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Bempedoic acid and its active metabolite, ESP15228 , require coenzyme A(CoA) activation by very long-chain acyl-CoA synthetase 1 (ACSVL1) to ETC-1002-CoA and ESP15228-CoA, respectively. ACSVL1 is expressed primarily in the liver. Inhibition of ACL by ETC-1002-CoA results in decreased cholesterol synthesis in the liver and lowes LDL-C in blood via upregulation of low-density lipoprotein receptors
Indications
Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
Dosage & Administration
Administer 180 mg orally once daily with or without food
Side Effects
• Upper respiratory tract infection
• Muscle Spasms
• Hyperuricemia
• Back pain
• Abdominal pain or discomfort
• Bronchitis
• Pain in extremity
• Anemia
• Elevated liver enzymes
Precautions
Elevations in serum uric acid have occurred. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. Tendon rupture has occurred. Discontinue Bempedoic acid at the first sign of tendon rupture. Avoid Bempedoic Acid in patients who
have a history of tendon disorders or tendon rupture.
Use in Pregnancy & Lactation
Discontinue Bempedoic Acid when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. There are no available data on Bempedoic Acid Acid use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There is no information
regarding the presence of Bempedoic Acid in human or animal milk, the effects of the drug on the breastfeed infant,or the effects of the drug on milk production. Breastfeeding is not recommended during treatment with Bempedoic Acid.
Drug Interaction
Simvastatin: Avoid concomitant use of Bempedoic Acid with simvastatin greater than 20mg.
Pravastatin: Avoid concomitant use of Bempedoic acid with pravastatin greater than 40mg.
Storage
Do not store above 30 0C temperature. Keep away from light and out of the reach of children
Commercial Pack
Winolip Film Coated Tablet: Each box contains 3 ALU-ALU blister strips of 10 tablets
