- Indications and Usage Hybutimibe tablets are indicated as an adjunct to diet for the treatment of primary hypercholesterolemia. They can be used alone or in combination with HMG-CoA reductase inhibitors (statins) to lower total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) levels.
- Dosage and Administration Recommended Dosage: The recommended dosage is 10 mg or 20 mg taken orally once daily. Administration: The tablets can be taken with or without food. Special Populations: No dosage adjustment is required for elderly patients, patients with mild-to-moderate hepatic impairment, or patients with renal impairment.
- Mechanism of Action Hybutimibe is a selective inhibitor of the cholesterol transporter protein in the small intestine. It works by inhibiting the absorption of cholesterol at the brush border of the enterocytes, thereby reducing the delivery of intestinal cholesterol to the liver.
- Safety and Warnings Hepatic Enzyme Elevation: Elevations in liver enzymes have been observed in some patients. Liver function should be monitored during treatment. Muscle Toxicity: When used in combination with statins, there is a potential risk of muscle-related adverse events (e.g., myopathy, rhabdomyolysis). Pregnancy and Lactation: Use with caution as the safety data in pregnant or breastfeeding women is limited.
- Adverse Reactions and Clinical Research Common Adverse Reactions: The most common adverse reactions include abdominal pain, diarrhea, fatigue, constipation, nausea, and elevated liver enzymes. Clinical Research: Phase 3 clinical trials have demonstrated that hybutimibe significantly lowers TC, LDL-C, and Apo B levels, both as monotherapy and when combined with statins.
- Drug Interactions Bile Acid Sequestrants: When used with bile acid sequestrants, Hybutimibe tablets should be administered at least 2 hours before or 4 hours after the sequestrant. Statins: No dosage adjustment is generally required, but monitoring for muscle pain or weakness is advised.
- Pharmaceutical Information Composition: The active ingredient is hybutimibe. Appearance: White or off-white tablets. Storage: Store at controlled room temperature and protect from moisture.
Saisimei Hybutimibe Tablets
Brand Name: 赛斯美 ®（Saisimei®）
Generic Name: Hybutimibe
Strength: 10 mg per tablet, 7 tablets per blister, 2 blisters per box
Manufacturer: Zhejiang Hisun Pharmaceutical Co., Ltd.
Marketing Authorization Holder: Zhejiang Hisun Pharmaceutical Co., Ltd.
Approval Date in China: August 13, 2021
Registration Number: 国药准字H20210030
Storage: Seal tightly, protect from light, store at temperature not exceeding 25°C. Keep away from children. Refer to the full package insert for detailed storage specifications.
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