Roltesim 20 mg is a prescription medicine containing simvastatin that is primarily used to lower elevated total cholesterol and low-density lipoprotein (LDL) cholesterol levels in the blood, especially when dietary and other non-pharmacological measures are insufficient[1][2].
This medication is indicated for adults in the following cases:
- Primary hypercholesterolaemia: To decrease high cholesterol and LDL-cholesterol levels where diet alone is inadequate.[2]
- Heterozygous familial hypercholesterolaemia: For patients with a genetic predisposition to high cholesterol.[2]
- Mixed hyperlipidaemia: When both cholesterol and triglyceride levels are elevated and not controlled by non-drug methods.[2]
- Coronary heart disease: To reduce the risk of non-fatal myocardial infarction, lower total mortality (by reducing coronary deaths), slow the progression of coronary atherosclerosis, and decrease the risk of undergoing revascularisation procedures such as angioplasty or bypass surgery.[2]
The usual recommended starting dose for coronary heart disease is 20 mg as a single dose in the evening.[2][4] The tablet can be taken with or without food and should be swallowed whole.[4]
Dosage adjustments may be made based on cholesterol response at intervals of at least four weeks, with a maximum daily dose of 80 mg.[2]
Special considerations:
- Patients with severe renal insufficiency should be closely monitored, and doses above 10 mg daily should be administered with caution.[2]
- Roltesim is contraindicated in pregnancy, lactation, acute or chronic liver disease, unexplained elevated liver enzymes, and in patients with porphyria or hypersensitivity to simvastatin or its ingredients.[2]
- Not for use in paediatric patients; efficacy and safety have not been established in this group.[2][4]
- Use with certain medicines (e.g., ciclosporin, fibrates, niacin) may require dose adjustment; strong CYP3A4 inhibitors and some other drugs are contraindicated due to risk of severe muscle side effects.[2]
Mechanism of action: Simvastatin (the active ingredient) works by blocking an enzyme needed by the body to make cholesterol, thereby reducing cholesterol production.[1]
Leave a Reply