Amlodipine + atorvastatin

Full Generic Medicine Info
Dosage/Direction for Use

Prinzmetal's angina, Prophylaxis of cardiovascular events in high-risk patients, Chronic stable angina, Hypertension, Hyperlipidaemias
Adult: Available preparations: Amlodipine 2.5 mg and atorvastatin 10 mg tab Amlodipine 2.5 mg and atorvastatin 20 mg tab Amlodipine 2.5 mg and atorvastatin 40 mg tab Amlodipine 5 mg and atorvastatin 10 mg tab Amlodipine 5 mg and atorvastatin 20 mg tab Amlodipine 5 mg and atorvastatin 40 mg tab Amlodipine 5 mg and atorvastatin 80 mg tab Amlodipine 10 mg and atorvastatin 10 mg tab Amlodipine 10 mg and atorvastatin 20 mg tab Amlodipine 10 mg and atorvastatin 40 mg tab Amlodipine 10 mg and atorvastatin 80 mg tab In patients whom treatment with both drugs is considered appropriate as initial therapy, as substitute to individual titrated components, or to provide additional therapy for those currently receiving 1 of its components: 5 mg/10 mg to 10 mg/80 mg once daily; may be adjusted or titrated after 1-2 weeks (amlodipine) and 2-4 weeks (atorvastatin). Dosages must be individualised based on effectiveness and tolerance for each individual component, and current treatment guidelines.
Elderly: May initiate amlodipine component at 2.5 mg once daily.
Hepatic impairment: May initiate amlodipine component at 2.5 mg once daily.

Special Populations: Patients receiving clarithromycin, itraconazole, elbasvir/grazoprevir, or HIV protease inhibitors (e.g. saquinavir/ritonavir, darunavir/ritonavir, fosamprenavir or fosamprenavir/ritonavir): Use the lowest necessary atorvastatin doses. Max: 20 mg atorvastatin daily. Patients receiving nelfinavir or boceprevir: Max: 40 mg atorvastatin daily.
May be taken with or without food.
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).
Food Interaction
Increased plasma concentration with grapefruit or grapefruit juice. Decreased plasma concentrations with St. John's wort. Atorvastatin: May increase risk of adverse hepatic effects with alcohol.
Amlodipine, a dihydropyridine Ca-channel blocker, reduces peripheral vascular resistance and blood pressure by relaxing coronary vascular smooth muscle and coronary vasodilation through inhibition of Ca ion transmembrane influx into cardiac and vascular smooth muscles. It also increases myocardial oxygen delivery in patients with vasospastic angina. Atorvastatin selectively and competitively inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyses the conversion of HMG-CoA to mevalonate. The reduction of mevalonate production results to a compensatory increase in the expression of LDL receptors and stimulation of LDL catabolism, consequently lowering LDL-cholesterol levels.
Onset: Amlodipine: 24-48 hours (antihypertensive effect). Atorvastatin: Initial effect: 3-5 days.
Duration: Amlodipine: 24 hours (antihypertensive effect).
Absorption: Amlodipine: Well absorbed from the gastrointestinal tract. Bioavailability: Approx 64-90%. Time to peak plasma concentration: 6-12 hours. Atorvastatin: Rapidly absorbed from the gastrointestinal tract. Bioavailability: Approx 14%. Time to peak plasma concentration: 1-2 hours.
Distribution: Amlodipine: Crosses placenta and enters breast milk. Volume of distribution: 21 L/kg. Plasma protein binding: Approx 98%. Atorvastatin: Volume of distribution: Approx 381 L. Plasma protein binding: ≥98%.
Metabolism: Amlodipine: Extensively metabolised in the liver to inactive metabolites. Atorvastatin: Extensively metabolised in the liver by CYP3A4 isoenzyme to ortho- and parahydroxylated derivatives (active) and β-oxidation metabolite (inactive). Undergoes extensive first-pass metabolism in the gastrointestinal mucosa.
Excretion: Amlodipine: Via urine (60% as metabolites, 10% as unchanged drug). Terminal elimination half-life: 30-50 hours. Atorvastatin: Mainly via bile; via urine (<2% as unchanged drug). Elimination half-life: Approx 14 hours; 20-30 hours (active metabolites).
Oral: Store between 15-30°C.
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
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