Chinese instruction manual for Nexletol, a drug used by Otsuka Pharmaceuticals in the treatment of hypercholesterolemia in Japan: Usage and side effects
Nexletol is an oral medication used to treat hypercholesterolemia, which reduces low-density lipoprotein cholesterol (LDL-C) by inhibiting ATP citrate lyase. The standard dose is 180mg per day and should be taken with meals to enhance absorption. Common side effects include muscle pain, upper respiratory tract infections, and elevated liver enzymes, which require regular monitoring of liver function.
1. Indications and mechanisms of action
(1) Indications: As an adjuvant medication for diet and maximum tolerated dose statin therapy, it is used for adult primary hypercholesterolemia or mixed dyslipidemia.
(2) Target: Selective inhibition of liver ATP citrate lyase (ACL) and reduction of cholesterol synthesis precursors.
(3) Therapeutic characteristics: It can reduce LDL-C levels by about 18% -28% and has a synergistic effect when combined with statins.
2 Usage and Dosage
(1) Standard dose: 180mg orally once daily, recommended to be taken with meals to improve bioavailability.
(2) Omission treatment: If missed, it should be taken as soon as possible on the same day, and the regular medication time should be resumed the next day. Double dosage is prohibited.
(3) Adjustment principle: No adjustment is needed for mild to moderate liver injury, and it is prohibited for severe liver injury; Renal function does not require adjustment.
3 Common Side Effects
(1) Muscle related: Muscle pain (5.1%), limb pain (3.9%), and caution should be taken against rhabdomyolysis when combined with statins.
(2) Infection risk: Upper respiratory tract infection (4.2%), nasopharyngitis (3.1%), usually mild self limiting.
(3) Laboratory abnormalities: ALT elevation (2.3%), uric acid elevation (1.8%), baseline and regular monitoring are recommended.
4. Medication for special populations
(1) Pregnancy period: Animals show embryotoxicity, and women of childbearing age need to take effective contraceptive measures.
(2) Breastfeeding period: Medications may be secreted into breast milk, and it is recommended to suspend breastfeeding during treatment.
(3) Elderly: Patients aged 65 or older do not need to adjust their dosage, but need to strengthen monitoring of adverse reactions.
5 important precautions
(1) Liver function monitoring: ALT should be tested before treatment and 12 weeks later. If there are persistent abnormalities, medication should be discontinued.
(2) Gout risk: may increase blood uric acid levels, and patients with hyperuricemia should use it with caution.
(3) Drug interactions: Combination with rosuvastatin may increase statin exposure and require adjustment of statin dosage.
Disclaimer：《Chinese instruction manual for Nexletol, a drug used by Otsuka Pharmaceuticals in the treatment of hypercholesterolemia in Japan: Usage and side effects》Edited and sorted by Seagull Pharmacy's editors. Please contact us in time if there is any infringement. In addition, the suggestions for drug usage, dosage and disease mentioned in the article are only for medical staff's reference, and can not be used as any basis for medication！