Simvastatin Tablets 20mg (14tabs/blister, 2blisters/box)

• Dossier: Ctd
• Transport Package: Free
• Specification: 20mg
• Trademark: Sinolead
• Origin: China
• Model NO.: tablets

Product Description

 

 

Basic Info.

 

Generic Name	Simvastatin Tablets 20mg
Strength	20mg
Packing	14tabs/blister,2blisters/box
Origin	China

Component:
Simvastatin.

Character:

This product is a pink oval film coating.

Indications:

Hyperlipidemia In patients with primary hypercholesterolemia including heterozygous familial hypercholesterolemia, hyperlipidemia, or mixed hyperlipidemia, when dietary control and other non-pharmacological treatments are not ideal, in combination with dietary control, this product can be used to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, and triglycerides. It can also raise HDL cholesterol, thereby reducing the ratio of LDL cholesterol to HDL cholesterol and total cholesterol to HDL cholesterol. In patients with homozygous familial hypercholesterolemia, combined with dietary control and non-dietary therapy, this product can be used to reduce elevated total cholesterol, low-density lipoprotein cholesterol and apolipoprotein B.

Coronary heart disease For patients with coronary heart disease combined with hypercholesterolemia, this product is suitable for: Decrease the risk of death from coronary heart disease and non-fatal myocardial infarction Decrease the risk of stroke and transient cerebral ischemia Decrease the risk of cardiac revascularization surgery (coronary artery bypass grafting and percutaneous transluminal coronary angioplasty) Delay the progression of coronary atherosclerosis including reduced formation of new lesions and total blockages

Pediatric patients with heterozygous familial hypercholesterolemia In adolescent boys and girls aged 10-17 years (at least 1 year after menarche) with heterozygous familial hypercholesterolemia, in combination with dietary control, this product can be used to lower total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides.
 

Usage and dosage:

Patients should receive a standard cholesterol-lowering diet prior to treatment with this product and continue to do so during treatment.

The recommended starting dose is 5-40mg daily, taken once in the evening. For patients who are at high risk for CHD events due to a history of coronary heart disease, diabetes, peripheral vascular disease, stroke, or other cerebrovascular disease, the recommended starting dose is 10 or 20mg per day. For patients with only moderate LDL cholesterol reduction, the starting dose is 10mg. The dosage used should be individually adjusted based on the basal LDL cholesterol level, recommended treatment goals, and patient response. The dose should be adjusted at intervals of 4 weeks or more.

Matters needing attention:

Myopathy/rhabdomyolysis

Simvastatin occasionally causes myopathy, which is characterized by muscle pain, tenderness, or weakness, and is accompanied by an increase in creatine kinase (CK) that exceeds the upper limit of normal by 10 times. Myopathy sometimes results in rhabdomyolysis, with or without acute renal failure secondary to myoglobinuria, and fatal events are rare. High plasma levels of HMG-CoA reductase inhibitors increase the risk of myopathy. Predictable causes of myopathy include old age (≥65 years), femininity, uncontrolled hypothyroidism, and renal insufficiency.

The risk of myopathy/rhabdomyolysis is dose-dependent. In a clinical trial database, 41,413 patients were treated with simvastatin. These studies included 24,747 people (about 60%) with a median follow-up period of at least 4 years, and the incidence of myopathy at 20,40 and 80mg/ day was about 0.03%, 0.08% and 0.61%, respectively. In these trials, patients are carefully monitored and certain interacting drugs are excluded.

In a clinical trial of 12,064 patients with a history of myocardial infarction followed for an average of 6.7 years, the incidence of myopathy was approximately 1.0% in patients receiving simvastatin 80mg/ day and 0.02% in patients receiving 20mg/ day. The incidence of rhabdomyolysis was approximately 0.4% in patients treated with simvastatin 80mg/ day and 0% in patients treated with simvastatin 20mg/ day. About half of all myopathy cases occur within the first year of treatment. In each subsequent year of treatment, the incidence of myopathy was about 0.1%.