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Copyright © All Samadhan - Operated by M/S. Genius Experts | All Rights Reserved
DBID
Registration ID: 176322642
Trade License: TRAD/DNCC/040904/2023
Copyright © All Samadhan - Operated by M/S. Genius Experts | All Rights Reserved
DBID
Registration ID: 176322642
Trade License: TRAD/DNCC/040904/2023
Navana Pharmaceuticals Ltd. · Tablet
/ Piece
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Bempedoic acid is 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.
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 lowers LDL-C in blood via upregulation of low-density lipoprotein receptors.
Administer 180 mg orally once daily with or without food.
Simvastatin: Avoid concomitant use of Bempedoic Acid with simvastatin greater than 20 mg.Pravastatin: Avoid concomitant use of Bempedoic Acid with pravastatin greater than 40 mg.
Upper respiratory tract infection
Muscle spasms
Hyperuricemia
Back pain
Abdominal pain or discomfort
Bronchitis
Pain in extremity
Anemia
Elevated liver enzymes
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 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 breastfed infant, or the effects of the drug on milk production. Breastfeeding is not recommended during treatment with Bempedoic Acid.
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.
Store below 30ºC temperature. Keep away from light and wet place. Keep out of reach of children.