Amlodipine + atorvastatin


Generic Medicine Info
Administration
May be taken with or without food.
Contraindications
Active liver disease or unexplained persistent elevated hepatic transaminases. Pregnancy and lactation.
Special Precautions
Patient with severe aortic stenosis or obstructive coronary artery disease, hypertrophic cardiomyopathy with outflow tract obstruction; inadequately treated hypothyroidism, recent stroke, transient ischaemic attack, history of liver disease or renal impairment. Patient who consumes large quantities of alcoholic beverages. Withhold treatment in patient with risk factors predisposing to development of renal failure secondary to rhabdomyolysis (e.g. trauma, major surgery, severe acute infection, hypotension, uncontrolled seizures; severe metabolic, endocrine, and electrolyte disorders). Renal and hepatic impairment. Elderly. Concomitant use with fusidic acid or letermovir co-administered with ciclosporin is not recommended. Monitoring Parameters Monitor blood pressure, heart rate; lipid panel (e.g. total cholesterol, HDL, LDL, triglycerides) and hepatic transaminase level at baseline and periodically as clinically indicated; creatine phosphokinase (in high risk patients or when myopathy is considered).
Adverse Reactions
Significant: Worsening angina, acute MI; increased HbA1c and fasting serum glucose levels; increased serum transaminases, hyperbilirubinaemia, jaundice, hypotension, syncope, myopathy, rhabdomyolysis, peripheral oedema. Rarely, rhabdomyolysis with acute renal failure secondary to myoglobinuria, immune-mediated necrotising myopathy. Blood and lymphatic system disorders: Leucopenia, thrombocytopenia. Cardiac disorders: Palpitation. Ear and labyrinth disorders: Tinnitus. Eye disorders: Conjunctivitis, diplopia, eye pain, blurred vision. Gastrointestinal disorders: Nausea, dyspepsia, diarrhoea, constipation, flatulence, abdominal pain, pancreatitis. General disorders and administration site conditions: Fatigue, asthenia, malaise. Immune system disorders: Anaphylaxis, myositis, oedema. Metabolism and nutrition disorders: Hyperglycaemia. Musculoskeletal and connective tissue disorders: Muscle cramps or spasms, arthralgia, pain in extremity, musculoskeletal pain, myalgia, tendon rupture. Nervous system disorders: Headache, dizziness, somnolence, peripheral neuropathy, extrapyramidal disorder. Psychiatric disorders: Insomnia, anxiety, depression. Renal and urinary disorders: Micturition disorder, nocturia, UTI. Reproductive system and breast disorders: Gynaecomastia. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, dyspnoea, pharyngolaryngeal pain, epistaxis, interstitial lung disease. Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria, bullous rashes (including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme). Vascular disorders: Flushing.
Potentially Fatal: Rarely, hepatic failure.
Drug Interactions
Amlodipine: May increase systemic exposure of immunosuppressants (e.g. ciclosporin, tacrolimus). Increased exposure with CYP3A4 inhibitors (e.g. ritonavir, azole antifungals, clarithromycin). May decrease plasma concentration with CYP3A4 inducers (e.g. rifampicin). Atorvastatin: May increase risk of myopathy or rhabdomyolysis with CYP3A4 inhibitors (e.g. HIV and HCV protease inhibitors, itraconazole, clarithromycin, erythromycin), fusidic acid, ciclosporin, fibric acid derivatives (e.g. fenofibrate), gemfibrozil, nicotinic acid, colchicine, letermovir. Concomitant use with CYP3A4 inducers (e.g. rifampicin, efavirenz, phenytoin), Al- or Mg-containing antacids, and colestipol may reduce plasma concentrations of atorvastatin. May increase serum levels of digoxin and oral contraceptives (e.g. norethindrone, ethinylestradiol).
CIMS Class
Anti-Anginal Drugs / Calcium Antagonists / Dyslipidaemic Agents
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
C08CA01 - amlodipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
Disclaimer: This information is independently developed by CIMS based on amlodipine + atorvastatin 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 © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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