Rosuvastatin is primarily used to treat hyperlipidemia and is effective in lowering blood cholesterol levels. This medication works by inhibiting HMG-CoA reductase, an enzyme involved in cholesterol synthesis in the liver, thereby reducing the production of cholesterol. As a result, it lowers the levels of LDL (low-density lipoprotein) cholesterol in the blood. Additionally, rosuvastatin can contribute to the prevention of cardiovascular diseases, helping to reduce the risk of heart disease and stroke.
Stavaster Info: Rosuvastatin, Diabetes, Rhabdomyolysis, Fenofibrate
Index
- A. Key Information
- A.1. Ingredients
- A.2. Appropriate Users
- A.3. Side Effects
- A.4. Dosage Instructions
- B. Additional Information
- B.1. Diabetes
- B.2. Rhabdomyolysis
- C. Drug Interactions
- C.1. Fenofibrate
- C.2. Fusidic Acid
- C.3. Ticagrelor
A. Key Information
Rosuvastatin is primarily used to treat hyperlipidemia and is effective in lowering blood cholesterol levels. This medication works by inhibiting HMG-CoA reductase, an enzyme involved in cholesterol synthesis in the liver, thereby reducing the production of cholesterol. As a result, it lowers the levels of LDL (low-density lipoprotein) cholesterol in the blood. Additionally, rosuvastatin can contribute to the prevention of cardiovascular diseases, helping to reduce the risk of heart disease and stroke.
This medication can be used for both adults and pediatric patients, and the safety profile for children is reported to be similar to that for adults. However, during the use of rosuvastatin, side effects such as liver dysfunction or muscle pain may occur, so it is important to consult a healthcare professional if these symptoms appear. It is not recommended for use during pregnancy, and appropriate contraceptive measures should be taken.
In conclusion, rosuvastatin plays a crucial role in the treatment of hyperlipidemia and the prevention of cardiovascular diseases.
This medication can be used for both adults and pediatric patients, and the safety profile for children is reported to be similar to that for adults. However, during the use of rosuvastatin, side effects such as liver dysfunction or muscle pain may occur, so it is important to consult a healthcare professional if these symptoms appear. It is not recommended for use during pregnancy, and appropriate contraceptive measures should be taken.
In conclusion, rosuvastatin plays a crucial role in the treatment of hyperlipidemia and the prevention of cardiovascular diseases.
| Category | Details |
|---|---|
| Product Name | Stavaster Tablets 10mg |
| Ingredients | Rosuvastatin Calcium 10mg |
| Form | Brown, round film-coated tablets |
| Company | Sandoz |
| ATC Code | C10AA07 (HMG-CoA reductase inhibitors) |
| Dosage & Administration |
Take as prescribed by a doctor |
| How to Take | Oral |
| Packaging Unit | 28 Tablets/Alu-Alu (7 Tablets/Alu-Alu x 4) |
A.1. Ingredients
• Rosuvastatin
- Role -
Rosuvastatin is primarily used to treat hyperlipidemia, with its main role being the reduction of blood cholesterol levels. It achieves this by inhibiting cholesterol synthesis in the liver, which helps decrease LDL (low-density lipoprotein) cholesterol levels and increase HDL (high-density lipoprotein) cholesterol levels.
Rosuvastatin is primarily used to treat hyperlipidemia, with its main role being the reduction of blood cholesterol levels. It achieves this by inhibiting cholesterol synthesis in the liver, which helps decrease LDL (low-density lipoprotein) cholesterol levels and increase HDL (high-density lipoprotein) cholesterol levels.
- Characteristics -
Rosuvastatin is noted for having a more potent cholesterol-lowering effect compared to other statins and is effective in the prevention of cardiovascular diseases. The drug is predominantly metabolized in the liver, has fewer drug interactions, and shows minimal pharmacokinetic differences across various ethnic groups. These characteristics make rosuvastatin a safe and effective treatment option for many patients.
Rosuvastatin is noted for having a more potent cholesterol-lowering effect compared to other statins and is effective in the prevention of cardiovascular diseases. The drug is predominantly metabolized in the liver, has fewer drug interactions, and shows minimal pharmacokinetic differences across various ethnic groups. These characteristics make rosuvastatin a safe and effective treatment option for many patients.
A.2. Appropriate Users
Rosuvastatin is used to treat hyperlipidemia and belongs to the HMG-CoA reductase inhibitors class. It is mainly used for the prevention and treatment of cardiovascular diseases. Women who may become pregnant should use appropriate contraception, and it should not be used during pregnancy.
A.3. Side Effects
Common side effects include headache, dizziness, elevated liver enzyme levels, and muscle pain. Rarely, cognitive impairments (such as memory loss and confusion) may occur, which are reversible upon discontinuation of the medication. Serious side effects like liver failure can also occur.
A.4. Dosage Instructions
Rosuvastatin is taken orally, and the dosage varies according to the doctor’s prescription. In case of overdose, there is no specific treatment, and supportive care is needed. Liver function and CK levels should be monitored, and hemodialysis is not considered effective.
• Primary Hypercholesterolemia
- Initial dose: 15 mg once daily.
- Maintenance dose can be adjusted to 10 mg once daily as needed, with a maximum dose of 20 mg. The dosage should be individualized based on treatment goals.
- Maintenance dose can be adjusted to 10 mg once daily as needed, with a maximum dose of 20 mg. The dosage should be individualized based on treatment goals.
• Heterozygous Familial Hypercholesterolemia in Pediatric Patients
- Age: 10 to 17 years.
- Usual dose range: 15 mg to 20 mg once daily.
- Clinical data for doses above 20 mg are not available, and dose adjustments should be made at intervals of at least four weeks.
- Usual dose range: 15 mg to 20 mg once daily.
- Clinical data for doses above 20 mg are not available, and dose adjustments should be made at intervals of at least four weeks.
• Elderly Patients
- No special dose adjustment is necessary for elderly patients. The usual adult dose applies.
• Patients with Renal Impairment
- Mild to moderate renal impairment: No dose adjustment is necessary.
- Severe renal impairment: Rosuvastatin should not be administered. Caution is needed when administering 20 mg to patients with moderate renal impairment.
- Severe renal impairment: Rosuvastatin should not be administered. Caution is needed when administering 20 mg to patients with moderate renal impairment.
• Patients with Hepatic Impairment
No specific dosage adjustment guidelines are provided for patients with hepatic impairment. Caution is advised, and dose adjustments may be necessary based on the patient's condition.
B. Additional Information
B.1. Diabetes
• Incidence of Adverse Reactions
The frequency of adverse reactions falls between 1/100 and 1/10. These reactions were generally mild and temporary. Less than 4% of patients discontinued the study due to adverse reactions.
• General Precautions
- Risk of Diabete -
Statins like rosuvastatin can increase the risk of developing diabetes. This risk is more pronounced in high-risk patients, who should be monitored for the onset of diabetes.
- Blood Glucose Monitoring -
Blood glucose levels should be regularly monitored during treatment. If blood glucose levels rise, appropriate action should be taken.
- Patient Education -
Educate patients about the symptoms of diabetes (e.g., excessive thirst, frequent urination, fatigue) and instruct them to promptly inform healthcare providers if such symptoms occur.
Statins like rosuvastatin can increase the risk of developing diabetes. This risk is more pronounced in high-risk patients, who should be monitored for the onset of diabetes.
- Blood Glucose Monitoring -
Blood glucose levels should be regularly monitored during treatment. If blood glucose levels rise, appropriate action should be taken.
- Patient Education -
Educate patients about the symptoms of diabetes (e.g., excessive thirst, frequent urination, fatigue) and instruct them to promptly inform healthcare providers if such symptoms occur.
B.2. Rhabdomyolysis
• Incidence of Adverse Reactions
- The incidence of rhabdomyolysis falls between 1/10,000 and 1/1,000.
• Contraindications
Rosuvastatin 40 mg is contraindicated in patients who are at higher risk for myopathy or rhabdomyolysis. These risk factors include:
- Moderate renal impairment (creatinine clearance < 60 mL/min)
- Hypothyroidism
- Personal or family history of genetic muscle disorders
- History of muscle toxicity with other HMG-CoA reductase inhibitors or fibrates
- Alcohol abuse
- Situations that may increase plasma concentration
- Asian patients
- Concomitant use of fibrate medications
- Hypothyroidism
- Personal or family history of genetic muscle disorders
- History of muscle toxicity with other HMG-CoA reductase inhibitors or fibrates
- Alcohol abuse
- Situations that may increase plasma concentration
- Asian patients
- Concomitant use of fibrate medications
• Precautions
- Like other HMG-CoA reductase inhibitors, this drug can affect skeletal muscle, with reported cases of muscle pain, myopathy, and rarely, rhabdomyolysis in patients. Immune-mediated necrotizing myopathy has also been reported in patients taking or discontinuing statins, including this drug. Immune-mediated myopathy is characterized by proximal muscle weakness and elevated blood CK (creatine kinase) levels, with symptoms persisting even after discontinuation of the medication.
- As with other HMG-CoA reductase inhibitors, in patients with risk factors for myopathy or rhabdomyolysis, the benefits and risks of treatment should be carefully considered, and clinical monitoring is recommended. Treatment should not be started if baseline CK levels are significantly elevated (more than five times the upper limit of normal).
- In cases of acute severe conditions that may worsen underlying muscle disease or lead to renal impairment (e.g., sepsis, hypotension, trauma, severe metabolic/endocrine/electrolyte disorders, uncontrolled seizures), discontinuation of this medication is advised.
- As with other HMG-CoA reductase inhibitors, in patients with risk factors for myopathy or rhabdomyolysis, the benefits and risks of treatment should be carefully considered, and clinical monitoring is recommended. Treatment should not be started if baseline CK levels are significantly elevated (more than five times the upper limit of normal).
- In cases of acute severe conditions that may worsen underlying muscle disease or lead to renal impairment (e.g., sepsis, hypotension, trauma, severe metabolic/endocrine/electrolyte disorders, uncontrolled seizures), discontinuation of this medication is advised.
C. Drug Interactions
C.1. Fenofibrate
• Pharmacokinetic Interactions
The pharmacokinetic interactions between fenofibrate and rosuvastatin are not well-documented. However, pharmacodynamic interactions may occur.
• Risks with Fibrate Drugs
Fenofibrate, ciprofibrate, and other fibrates can cause myopathy when used alone. The risk of myopathy is increased when fibrates are used in combination with HMG-CoA reductase inhibitors like rosuvastatin.
• Dosage Adjustment
When used in combination with fibrates, rosuvastatin should not be administered at a dose of 40 mg. The recommended starting dose is 5 mg.
C.2. Fusidic Acid
• Interaction with Rosuvastatin
There is no specific research on the interaction between rosuvastatin and fusidic acid. However, post-marketing experience with other statins has shown that combining statins with fusidic acid can lead to muscle-related adverse effects, including rhabdomyolysis.
• Recommendation
Combining rosuvastatin with fusidic acid is not recommended. If the combination is necessary, it is advisable to temporarily discontinue rosuvastatin if possible. If the combination cannot be avoided, close monitoring is essential.
C.3. Ticagrelor
Ticagrelor can affect the renal excretion of rosuvastatin, potentially increasing the risk of rosuvastatin accumulation. In some cases, the combination of ticagrelor and rosuvastatin has led to reduced kidney function, elevated CPK (creatine phosphokinase) levels, and rhabdomyolysis.
