Composition: Bempedoic acid 180 mg + ezetimibe 10 mg
Form: Film-coated tablets
Indications: As an adjunct to diet, alone or in combination with other LDL-C lowering therapies, for reduction of LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia. The bempedoic acid component also helps reduce the risk of myocardial infarction and coronary revascularization in adults who cannot take recommended statin therapy.
Contraindications: Hypersensitivity to the active substances or any excipient.
Dosage: One tablet orally once daily. Swallow whole, with or without food. If a dose is missed, take it as soon as possible but do not double the next dose. Lipid profile assessment is recommended 8 to 12 weeks after treatment initiation.
Side effects: Upper respiratory tract infections, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremities, anemia, elevated liver enzymes.
Interactions: Avoid concomitant use with simvastatin at doses above 20 mg and pravastatin at doses above 40 mg.
Warnings: Serum uric acid should be monitored according to clinical indications during therapy. Treatment should be discontinued at the first signs of tendon rupture. The bempedoic acid and ezetimibe combination is not recommended in patients with moderate or severe hepatic impairment.
Age restrictions: For adult patients only.
Pregnancy: Discontinue treatment if pregnancy is confirmed unless the expected benefit outweighs the potential risk to the fetus. Breastfeeding is not recommended during therapy.
Country of origin: Bangladesh
Manufacturer: Incepta Pharmaceuticals Ltd.
Storage conditions: Store below 30°C, protected from light, out of reach of children.