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PDP-ATORVASTATIN is a brand name for Atorvastatin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .........................................................................3 CONTRAINDICATIONS .............................................................................................5 WARNINGS AND PRECAUTIONS.............................................................................5 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
Hypersensitivity to any component of this medication (for a complete listing of the components, see DOSAGE FORMS, COMPOSITION AND PACKAGING). Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal (see WARNINGS AND PRECAUTIONS).
Pregnancy and nursing women:
Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development (including synthesis of steroids and cell membranes). pdp-ATORVASTATIN (atorvastatin calcium) should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the possible harm.
(If the patient becomes pregnant while taking pdp-ATORVASTATIN, the drug should be discontinued immediately, and the patient apprised of the potential harm to the fetus. Atherosclerosis being a chronic process, discontinuation of lipid metabolism regulating drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia (see WARNINGS AND PRECAUTIONS, Special Populations, Use in Pregnancy, Use in Nursing Mothers).
Concomitant treatment with the hepatitis C antivirals glecaprevir/pibrentasvir (see WARNINGS AND PRECAUTIONS; DRUG INTERACTIONS). WARNINGS AND PRECAUTIONS General Before instituting therapy with pdp-ATORVASTATIN (atorvastatin calcium), an attempt should be made to control elevated serum lipoprotein levels with appropriate diet, exercise, and weight reduction in overweight patients, and to treat other underlying medical problems (see INDICATIONS AND CLINICAL USE).
Patients should be advised to inform subsequent physicians of the prior use of pdp-ATORVASTATIN or any other lipid-lowering agents. Pharmacokine tic Interactions The use of HMG-CoA reductase inhibitors has been associated with severe myopathy, including rhabdomyolysis, which may be more frequent when they are co-administered with drugs that inhibit the cytochrome P-450 enzyme system.
Atorvastatin is metabolized by cytochrome P-450 isoform 3A4 and as such may interact with agents that inhibit this enzyme (see WARNINGS AND PRECAUTIONS, Muscle effects; and DRUG INTERACTIONS). Muscle Effe cts Effects on skeletal muscle such as myalgia, myositis, myopathy and rarely, rhabdomyolysis have been reported in patients treated with atorvastatin calcium.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Atorvastatin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
pdp-ATORVASTATIN Product Monograph Page 6 of 53 Rare cases of rhabdomyolysis, with acute renal failure secondary to myoglobinuria, have been reported with atorvastatin calcium and with other HMG-CoA reductase inhibitors. Myopathy, defined as muscle pain or muscle weakness in conjunction with increases in creatine kinase (CK) values to greater than ten times the upper limit of normal, should be considered in any patient with diffuse myalgia, muscle tenderness or weakness, and/or marked elevation of CK.
Patients should be advised to report promptly any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Patients who develop any signs or symptoms suggestive of myopathy should have their CK levels measured.
pdp-ATORVASTATIN therapy should be discontinued if markedly elevated CK levels are measured or myopathy is diagnosed or suspected. Pre-disposing Factors for Myopathy/Rhabdomyolysis pdp-ATORVASTATIN, as with other HMG-CoA reductase inhibitors, should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis.
Such factors include: · Personal or family history of hereditary muscular disorders · Previous history of muscle toxicity with another HMG-CoA reductase inhibitor · Concomitant use of a fibrate, or niacin · Hypothyroidism · Alcohol abuse · Excessive physical exercise · Age > 65 years · Renal impairment · Hepatic impairment · Diabetes with hepatic fatty change · Surgery and trauma · Frailty · Situations where an increase in plasma levels of active ingredient may occur The risk of myopathy and rhabdomyolysis is increased with concurrent administration of drugs that increase the systemic concentration of atorvastatin via CYP 3A4, such as cyclosporin, fibric acid derivatives, erythromycin, clarithromycin, niacin (nicotinic acid), azole antifungals, nefazodone, colchicine, hepatitis C (HCV) protease inhibitors telaprevir, boceprevir elbasvir/grazoprevir, glecaprevir/pibrentasvir and simeprevir, other human immunodeficiency virus (HIV), protease inhibitor fosamprenavir and each of the following HIV protease inhibitor combinations: saquinavir/ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, darunavir/ritonavir and fosamprenavir/ritonavir.
The combined therapy with pdp-ATORVASTATIN and glecaprevir/pibrentasvir is contraindicated. The combined therapy with pdp- ATORVASTATIN and cyclosporine, gemfibrozil, telaprevir or tipranavir/ritonavir should be avoided. pdp-ATORVASTATIN dose restriction or caution is recommended for combined therapy with other CYP 3A4 inhibitors (see CONTRAINDICATIONS, Pharmacokinetic Interactions; DRUG INTERACTIONS, Drug-Drug Interactions; DETAILED PHARMACOLOGY, Human Pharmacokinetics).
pdp-ATORVASTATIN Product Monograph Page 7 of 53 The concurrent use of atorvastatin and fusidic acid should be avoided, therefore, temporary suspension of atorvastatin during fusidic acid therapy is advised (see DRUG INTERACTIONS, Drug-Drug Interactions).
Although patients with renal impairment are known to be predisposed to the development of rhabdomyolysis with administration of HMG-CoA reductase inhibitors (also known as statins), those with a history of renal impairment may also be predisposed to the development of rhabdomyolysis.
Such patients merit close monitoring for skeletal muscle effects. pdp-ATORVASTATIN therapy should be temporarily withheld or discontinued in any patient with an acute serious condition suggestive of myopathy or having a risk factor predisposing to the developme nt of renal failure se condary to rhabdomyolysis (such as sepsis, severe acute infection, […]