Simvastatin


Generic Medicine Info
Administration
May be taken with or without food. Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Active liver disease or unexplained persistent elevations of serum transaminases, myopathy secondary to other lipid-lowering agents. Concurrent use with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, erythromycin, telithromycin, nefazodone, HIV protease inhibitors, cobicistat containing products, fusidic acid), ciclosporin, danazol and gemfibrozil. Pregnancy and lactation.
Special Precautions
Patients with diabetes mellitus, predisposing factors for myopathy/rhabdomyolysis (e.g. uncontrolled hypothyroidism, personal or family history of muscular disorders, history of muscular toxicity with a statin or fibrate, alcohol abuse). Renal and hepatic impairment. Children and elderly. Patients with SLCO1B1 gene polymorphism. Coadministration of niacin (≥1 g) in patients of Chinese descent. A dose of 80 mg should be restricted to patients who have been taking simvastatin 80 mg for 12 months or more. Temporarily discontinue simvastatin prior to elective major surgery. Patient Counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Monitor lipid profile, LFT and creatine kinase. Monitor for signs and symptoms of myopathy and rhabdomyolysis.
Adverse Reactions
Significant: Increased serum transaminase. Blood and lymphatic system disorders: Anaemia. Gastrointestinal disorders: Constipation, abdominal pain, flatulence, dyspepsia, diarrhea, nausea, acid regurgitation, vomiting, pancreatitis. Hepatobiliary disorders: Hepatitis, jaundice. Immune system disorders: Hypersensitivity reactions. Metabolism and nutrition disorders: Hyperglycaemia. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia. muscle cramps. Nervous system disorders: Headache, paraesthesia, dizziness, peripheral neuropathy. Psychiatric disorders: Insomnia, depression. Respiratory, thoracic and mediastinal disorders: Upper respiratory infection, bronchitis, interstitial lung disease. Reproductive system and breast disorders: Erectile dysfunction. Skin and subcutaneous tissue disorders: Rash, pruritus, alopecia.
Potentially Fatal: Myopathy, rhabdomyolysis with or without acute renal failure, hepatic failure.
Drug Interactions
May increase risk of myopathy and rhabdomyolysis with concurrent use with amiodarone, amlodipine, verapamil, diltiazem, lomitapide, daptomycin, and colchicine. May increase serum concentrations of elbasvir and grazoprevir. May increase prothrombin time with coumarin anticoagulants.
CIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Disclaimer: This information is independently developed by CIMS based on simvastatin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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