Arrow Simvastatin Tablets
Clinical Summary
Quick overview from the medicine insert
Indication
Management of hyperlipidemia to reduce the risk of cardiovascular events.
Dosage (summary)
Initial dose is 10 mg to 40 mg once daily in the evening, adjusted based on response and tolerability.
Onset of Action / Duration
Lipid-lowering effects may be observed within 2 to 4 weeks, with maximum effect typically seen after 4 to 6 weeks.
Special Populations
- Elderly patients
- Patients with renal impairment
- Patients with hepatic impairment
Pregnancy & Breastfeeding
Simvastatin is contraindicated during pregnancy and lactation due to potential harm to the fetus and nursing infant.
Key Drug Interactions
- Increased risk of myopathy when used with other lipid-lowering agents, especially gemfibrozil.
- Caution with drugs that inhibit CYP3A4 (e.g., ketoconazole, erythromycin) as they may increase simvastatin levels.
- Avoid concomitant use with strong CYP3A4 inhibitors.
Contraindications
- Active liver disease
- Pregnancy
- Lactation
- Hypersensitivity to simvastatin or any component of the formulation
Common side effects
- Myopathy
- Rhabdomyolysis
- Elevated liver enzymes
- Gastrointestinal disturbances (e.g., nausea, constipation)
- Headache
Counselling Points
- Take the medication in the evening for optimal effectiveness.
- Adhere to prescribed diet and lifestyle changes.
- Report any unexplained muscle pain, tenderness, or weakness.
- Regular monitoring of liver function tests may be required.
Serious warnings
- Use with caution in patients with a history of liver disease.
- Monitor for signs of muscle pain or weakness, especially when starting therapy or increasing the dose.
- Avoid excessive alcohol consumption while on therapy.
Important Disclaimer
The Arrow Simvastatin Tablets professional information leaflet below is the property of Astral Pharma and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
Healthcare Professionals Only
This content is for registered healthcare professionals
Sign in or create a free account to read the full package insert.
Free for HPCSA-registered professionals. Powered by Medinsert.
