Simvastatin 10mg 100 tablets Lipobas Tablets 10 Simvastatin lowers blood lipids

Lipovas simvastatin tablets are a statin lipid-lowering drug, mainly used to treat hypercholesterolemia and mixed hyperlipidemia, and reduce cholesterol synthesis by inhibiting HMG-CoA reductase. It is suitable for patients who have poor results with diet control and other non-drug treatments, and can reduce total cholesterol, low-density lipoprotein cholesterol (LDL-C), and increase high-density lipoprotein cholesterol (HDL-C). It is also used in patients with coronary heart disease to reduce the risk of myocardial infarction, stroke and vascular reconstruction surgery.

Basic information of medicine

1. Generic Name : Simvastatin
2. English name : LIPOVAS Tablets 5/10/20
3. Product name : リポバス tablets
4. Dosage form : Tablet (bare tablet)
5. Indications : hyperlipidemia, familial hypercholesterolemia.
6. Element :
   • Active ingredient : Each tablet contains simvastatin 5mg/10mg/20mg.
   • Additives : Lactose hydrate, crystalline silica, partially silica gel, hydrolyzed silica, chlorineロスポビドン, クエン acid hydrate, ブチルヒドロキシアニソール, ステアリン acid マグネシウム.
7. Properties :
   • リポバス ingot 5 : white round bare ingot, diameter 6.4mm, thickness 2.4mm, identified as コード726.
   • リポバス ingot 10 : white round bare ingot, diameter 8.0mm, thickness 3.0mm, identification コード735.
   • リポバス ingot 20 : White oval bare ingot, long diameter 14.0mm, short diameter 7.5mm, thickness 4.6mm, identified as コード740.

Dosage

• Usual dose : Adults take 5 mg once a day orally after dinner. The dose can be adjusted according to age and symptoms. The maximum dose should not exceed 20 mg/day.
• Time of taking : Since cholesterol synthesis is active at night, it is recommended to take it after dinner to enhance the efficacy.

Taboo

1. People who are allergic to the ingredients of this product.
2. Patients with severe liver dysfunction.
3. Pregnant women, women who may become pregnant, and breastfeeding women.
4. Patients who are taking itraconazole, miconazole, posaconazole, atazanavir, saquinavir mesylate, cobicistat and other preparations.

Precautions

1. Special Populations

• Patients with hepatic and renal dysfunction : Use with caution in patients with hepatic dysfunction. Patients with renal dysfunction should control the dose to ≤10 mg/day when used in combination with fibrates, and monitor creatine kinase (CK) and renal function.
• Elderly people : Due to low physiological functions, they need to reduce the dosage and be alert to the risk of rhabdomyolysis.
• Patients with hypothyroidism and a history of myopathy : are prone to rhabdomyolysis and require close monitoring.

2. Medication Instructions

• Diet therapy is required before taking the medicine to control risk factors such as high blood pressure and smoking.
• Monitor blood lipids, liver function and CK regularly. If the therapeutic effect is poor or symptoms such as liver damage and myalgia occur, the drug should be discontinued.
• Avoid taking with grapefruit juice as it inhibits CYP3A4 metabolism and may increase drug concentrations.

3. Drug storage

• Storage method: Store at room temperature and keep away from moisture after opening.
• Validity period: 3 years.

Adverse Reactions

1. Major side effects

• Rhabdomyolysis : Symptoms include muscle pain, fatigue, elevated CK, and may be accompanied by acute renal failure.
• Liver damage : Rarely, hepatitis and jaundice may occur, and severe cases may lead to liver failure.
• Immune myopathy : Anti-HMGCR antibodies are positive and may persist after drug discontinuation, requiring immunosuppressive therapy.

2. Other side effects

• Digestive system : abdominal pain, vomiting, diarrhea (less than 1%), rarely pancreatitis.
• Liver : AST, ALT, γ-GTP increased (more than 1%).
• Muscle : increased CK, muscle cramps (less than 1%).
• Nervous system : Headache, dizziness, cognitive impairment (frequency unknown).

Drug interactions

1. Contraindications for combined use

• CYP3A4 inhibitors : such as itraconazole, clarithromycin, cyclosporine, etc., may cause rhabdomyolysis and are prohibited from being used in combination.
• HIV protease inhibitors : such as ritonavir, increased risk of myopathy.

2. Note on combined use

• Fibrates and niacin : When used in combination, the dose of simvastatin should be controlled to ≤10 mg/day, and CK and renal function should be monitored.
• Anticoagulants (warfarin) : May enhance anticoagulant effect and coagulation function needs to be monitored.
• Amiodarone, verapamil : May increase drug concentrations and increase the risk of myopathy.

Pharmacological Action

1. Mechanism of action : It inhibits HMG-CoA reductase, reduces liver cholesterol synthesis, enhances LDL receptor activity, and lowers serum total cholesterol and LDL-C.
2. Lipid-lowering effect : reduces LDL-C and VLDL-C, increases HDL-C, and inhibits the progression of atherosclerosis.
3. Other effects : inhibit exogenous cholesterol absorption and reduce platelet aggregation.

Pharmacokinetics

1. Absorption : Rapidly absorbed after oral administration, with peak blood concentration reaching 1.4 to 3.7 hours and bioavailability of approximately 5%.
2. Metabolism : Mainly metabolized by CYP3A4 to active open-ring acid derivatives.
3. Excretion : Mainly excreted in bile, with urinary excretion rate of only 0.34% to 0.42%.

Clinical Research

• Effectiveness : Domestic trials have shown that at a dose of 5-20 mg/day, the efficacy in patients with hyperlipidemia is 85.0%, which can significantly reduce total cholesterol and LDL-C and increase HDL-C.
• Safety : Common side effects are elevated liver enzymes and muscle pain. The incidence of severe rhabdomyolysis is low and dose-related.

Packing Specifications

• Lipobus Tablets 5mg 100 tablets/box (10 tablets x 10 plates, PTP packaging)
• Lipobus Tablets 10mg 100 tablets/box (10 tablets x 10 plates, PTP packaging)
• Lipobus Tablets 20mg 100 tablets/box (10 tablets × 10 plates, PTP packaging).

Production information

Manufacturer : Orion Co., Ltd.