Atorvastatin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Heterozygous familial hypercholesterolaemia; Nonfamilial hypercholesterolaemia; Mixed dyslipidaemia Dose is individualised according to baseline LDL-C levels, the goal of therapy, and patient response. Usual initial dose: 10 or 20 mg once daily, may be adjusted according to response at 2-4 weeks interval. Usual range: 10-80 mg once daily. Max: 80 mg/day. Familial homozygous hypercholesterolaemia As an adjunct to other lipid-lowering treatments (e.g. LDL apheresis): 10-80 mg daily. Prophylaxis of cardiovascular events in high-risk patient Primary prevention: Initial: 10 mg daily, may be given at higher doses as necessary to attain LDL-cholesterol levels according to current guidelines.
Administration
Atorvastatin: May be taken with or without food. Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Active liver disease, unexplained persistent serum transaminase elevation. Pregnancy and lactation. Concomitant use with ciclosporin, systemic fusidic acid, telaprevir, glecaprevir/pibrentasvir and tipranavir/ritonavir combinations.
Special Precautions
Patients with diabetes mellitus, hypothyroidism, hereditary muscular disorders, recent stroke, transient ischaemic attack, severe acute infection, hypotension, major surgery, predisposing factors for rhabdomyolysis, severe metabolic disorder and uncontrolled seizures. Not indicated for elevated chylomicrons as the primary lipid abnormality. Patients who consume large quantities of alcoholic beverages. Renal impairment. Children. Patients taking concomitant CYP3A4 inhibitors [e.g. clarithromycin, itraconazole, fosamprenavir, ritonavir (plus darunavir, fosamprenavir, or saquinavir), elbasvir/grazoprevir, boceprevir and nelfinavir]. Monitoring Parameters Monitor lipid panel (e.g. total cholesterol, HDL, LDL, triglycerides) at baseline, 2-12 weeks after initiation, and 12-48 weeks thereafter. Monitor serum creatine kinase (CK) and LFT at baseline and periodically thereafter. Check for signs and symptoms of increased CK suggestive of myopathy (e.g. fever, muscle pain, weakness, stiffness, cramping, generalized fatigue).
Adverse Reactions
Significant: Myopathy, myalgia, diabetes mellitus, persistent serum transaminase elevations. Rarely, immune-mediated necrotising myopathy (IMNM), interstitial lung disease. Blood and lymphatic system disorders: Thrombocytopenia. Ear and labyrinth disorders: Tinnitus, hearing loss. Eye disorders: Blurred vision. Gastrointestinal disorders: Diarrhoea, constipation, nausea, dyspepsia, dysgeusia, flatulence. General disorders and administration site conditions: Malaise, asthenia, fatigue, pyrexia. Hepatobiliary disorders: Cholestasis. Investigations: Abnormal LFT, elevated serum creatine kinase, WBC urine positive. Metabolism and nutrition disorders: Hyperglycaemia. Musculoskeletal and connective tissue disorders: Muscle spasms, joint swelling, musculoskeletal and extremity pain. Nervous system disorders: Headache, dizziness, paraesthesia, amnesia. Psychiatric disorders: Insomnia, nightmares. Renal and urinary disorders: UTI. Reproductive system and breast disorders: Rarely, gynaecomastia. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, pharyngolaryngeal pain. Skin and subcutaneous tissue disorders: Alopecia, skin rash, pruritus, urticaria. Vascular disorders: Epistaxis.
Potentially Fatal: Severe rhabdomyolysis with acute renal failure, hepatitis, hepatic failure. Rarely, Stevens-Johnson syndrome, anaphylaxis, toxic epidermal necrolysis.
Drug Interactions
May increase risk of myopathy and rhabdomyolysis with moderate to potent CYP3A4 inhibitors (e.g. HIV and HCV protease inhibitors, itraconazole, ketoconazole, clarithromycin, eryhthromycin, verapamil, diltiazem), fenofibrate, gemfibrozil, ezetimibe, niacin, colchicine, fixed combination of lopinavir/ritonavir. Concomitant use with CYP3A4 inducers (e.g. rifampicin, efavirenz, phenytoin), Al or Mg antacids, and colestipol may reduce plasma concentrations of atorvastatin. May increase serum levels of digoxin and oral contraceptives (e.g. norethindrone, ethinyl estradiol).
ATC Classification
C10AA05 - atorvastatin ; 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 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 © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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