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MYLAN-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: MYLAN-ATORVASTATIN (atorvastatin calcium) is indicated in adults as an adjunct to lifestyle changes, including diet for: • the reduction of elevated total cholesterol (total-C), LDL-C, triglycerides (TG), apolipoprotein B (apo B), the Total-C/HDL-C ratio and for increasing HDL-C in hyperlipidemic and dyslipidemic…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Patients should be placed on a standard cholesterol-lowering diet before receiving MYLAN- ATORVASTATIN, and should continue on this diet during treatment with MYLAN-ATORVASTATIN. If appropriate, a program of weight control and physical exercise should be implemented.
• Prior to initiating therapy with MYLAN-ATORVASTATIN, secondary causes for elevations in plasma lipid levels should be excluded. A lipid profile should also be performed. • Elevated serum triglycerides are most often observed in patients with the metabolic syndrome (abdominal obesity, atherogenic dyslipidemia {elevated triglycerides, small dense LDL particles and low HDL-cholesterol}, insulin resistance with or without glucose intolerance, raised blood pressure and prothrombic and proinflammatory states).
• When drugs are prescribed attention to therapeutic lifestyle changes (reduced intake of saturated fats and cholesterol, weight reduction, increased physical activity, ingestion of soluble fibers) should always be maintained and reinforced.
• The dosage of MYLAN-ATORVASTATIN should be individualized according to the baseline LDL-C, MYLAN-ATORVASTATIN Atorvastatin (as Atorvastatin Calcium Trihydrate) Page 6 of 56 total-C/HDL-C ratio and/or TG levels to achieve the recommended desired lipid values at the lowest dose needed to achieve LDL-C desired level.
Lipid levels should be monitored periodically and, if necessary, the dose of MYLAN-ATORVASTATIN adjusted based on desired lipid levels recommended by guidelines. 2 Recommended Dose and Dosage Adjustment • Primary Hypercholesterolemia and Combined (Mixed) Dyslipidemia, Including Familial Combined Hyperlipidemia The recommended starting dose of MYLAN-ATORVASTATIN is 10 or 20 mg once daily, depending on patient’s LDL-C reduction required.
Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of MYLAN-ATORVASTATIN is 10 to 80 mg once daily. A significant therapeutic response is evident within 2 weeks, and the maximum response is usually achieved within 2-4 weeks.
The response is maintained during chronic therapy. Adjustments of dosage, if necessary, should be made at intervals of 2 to 4 weeks. The maximum dose is 80 mg/day. • Severe Dyslipidemias In patients with severe dyslipidemias, including homozygous and heterozygous familial hypercholesterolemia and dysbetalipoproteinemia (Type III), higher dosages (up to 80 mg/day) may be required (see 7 WARNINGS AND PRECAUTIONS, Pharmacokinetic Interactions, 7 WARNINGS AND PRECAUTIONS, Muscle Effects; 9 DRUG INTERACTIONS).
). For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging MYLAN-ATORVASTATIN is formulated for oral administration and are available in tablet doses of 10 mg, 20 mg, 40 mg and 80 mg.
10 mg – A white to off-white, film coated, oval, biconvex tablet debossed with 10 on one side of the tablet and blank on the other side. Available in bottles of 90’s and 500’s. 20 mg – A white to off-white, film coated, oval, biconvex tablet debossed with 20 on one side of the tablet and blank on the other side.
Available in bottles of 90’s and 500’s. 40 mg – A white to off-white, film coated, oval, biconvex tablet debossed with 40 on one side of the tablet and blank on the other side. Available in bottles of 90’s and 500’s. 80 mg – A white to off-white, film coated, oval, biconvex tablet debossed with 80 on one side of the tablet and blank on the other side.
Available in bottles of 90’s and 500’s. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablets: 10 mg, 20 mg, 40 mg and 80 mg atorvastatin Anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydroxy propyl cellulose, L-arginine, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium carbonate anhydrous, talc, titanium dioxide, and xanthan gum.
MYLAN-ATORVASTATIN Atorvastatin (as Atorvastatin Calcium Trihydrate) Page 9 of 56 7 WARNINGS AND PRECAUTIONS General Patients should be advised to inform health professionals of the prior use of MYLAN-ATORVASTATIN or any other lipid-lowering agents.
Cardiovascular Hemorrhagic Stroke in Patients with Recent Stroke or Transient Ischemic Attack (TIA) The highest dose of atorvastatin calcium (80 mg) was associated with an increased risk of hemorrhagic stroke in a post-hoc analysis of a clinical study in 4,731 patients without coronary heart disease (CHD) who had a stroke or TIA within the preceding six months compared to placebo.
, Musculoskeletal 10/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics.................................................................................................................
2 Geriatrics ................................................................................................................. 5 2 CONTRAINDICATIONS .................................................................................................
5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ............................................................................................ 2 Recommended Dose and Dosage Adjustment .......................................................
4 Administration ........................................................................................................ 5 Missed Dose ............................................................................................................
7 5 OVERDOSAGE............................................................................................................. 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS ..................................................................................
10/2023 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 10/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics.................................................................................................................
2 Geriatrics ................................................................................................................. 5 2 CONTRAINDICATIONS .................................................................................................
5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ............................................................................................ 2 Recommended Dose and Dosage Adjustment .......................................................
4 Administration ........................................................................................................ 5 Missed Dose ............................................................................................................
7 5 OVERDOSAGE............................................................................................................. 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS ..................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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e. 6 mmol/L (500 mg/dL), respectively, may require triglyceride-lowering therapy (fenofibrate, bezafibrate or nicotinic acid) alone or in combination with MYLAN-ATORVASTATIN. 4 Drug-Drug Interactions). • Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-<18 years of age) The recommended starting dose of MYLAN-ATORVASTATIN is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg/day have not been studied in this patient population).
1 Pediatrics and 14 CLINICAL TRIALS). Adjustments should be made at intervals of 4 weeks or more. Health Canada has not authorized an indication for pediatric use in a population under 10 years of age. • Prevention of Cardiovascular Disease The recommended starting dose of MYLAN-ATORVASTATIN for the primary prevention of myocardial infarction is 10 mg/day.
MYLAN-ATORVASTATIN Atorvastatin (as Atorvastatin Calcium Trihydrate) Page 7 of 56 For secondary prevention of myocardial infarction, optimal dosing may range from 10 mg to 80 mg atorvastatin once daily, to be given at the discretion of the prescriber, taking into account the expected benefit and safety considerations relevant to the patient to be treated.
5 mL/sec)] should be given lowest dose (10 mg/day) of MYLAN-ATORVASTATIN (see 7 WARNINGS AND PRECAUTIONS, Renal). 1 Pregnant Women). If increases in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) show evidence of progression, particularly if they rise to greater than 3 times the upper limit of normal and are persistent, the dosage should be reduced or the drug discontinued (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
MYLAN-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 development of renal failure secondary to rhabdomyolysis (such as sepsis, severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures).
MYLAN-ATORVASTATIN therapy should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal). MYLAN-ATORVASTATIN should be discontinued if hypersensitivity is suspected (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance).
5 Post-Market Adverse Reactions). If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with MYLAN-ATORVASTATIN, promptly […]
Patients with hemorrhagic stroke on entry appeared to be at increased risk for recurrent hemorrhagic stroke. The potential risk of hemorrhagic stroke should be carefully considered before initiating treatment with atorvastatin in patients with recent (1-6 months) stroke or TIA.
Effect on Ubiquinone (CoQ10) Levels Significant decreases in circulating ubiquinone levels in patients treated with atorvastatin and other statins have been observed. The clinical significance of a potential long-term statin-induced deficiency of ubiquinone has not been established.
It has been reported that a decrease in myocardial ubiquinone levels could lead to impaired cardiac function in patients with borderline congestive heart failure. CoQ10 Levels should be measured when clinically indicated. Endocrine and Metabolism Endocrine Function HMG-CoA reductase inhibitors interfere with cholesterol synthesis and as such might theoretically blunt adrenal and/or gonadal steroid production.
Clinical studies with atorvastatin and other HMG-CoA reductase inhibitors have suggested that these agents do not reduce plasma cortisol concentration or impair adrenal reserve and do not reduce basal plasma testosterone concentration.
However, the effects of HMG-CoA reductase inhibitors on male fertility have not been studied in adequate numbers of patients. The effects, if any, on the pituitary-gonadal axis in premenopausal women are unknown. Patients treated with atorvastatin who develop clinical evidence of endocrine dysfunction should be evaluated appropriately.
g. ketoconazole, spironolactone or cimetidine) that may decrease the levels of endogenous steroid hormones. Increases in fasting glucose and HbA1c levels have been reported with inhibitors of HMG-CoA reductase as a class. For some patients, at high risk of diabetes mellitus, hyperglycemia was sufficient to shift them to the diabetes status.
The benefit of treatment continues to outweigh the small increased risk. Periodic monitoring of these patients is recommended. MYLAN-ATORVASTATIN Atorvastatin (as Atorvastatin Calcium Trihydrate) Page 10 of 56 Effect on Lipoprotein (a) In some patients, the beneficial effect of lowered total cholesterol and LDL-C levels may be partly blunted by a concomitant increase in Lp(a) lipoprotein concentrations.
Present knowledge suggests the importance of high Lp(a) levels as an emerging risk factor for coronary heart disease. It is thus desirable to maintain and reinforce lifestyle changes in high risk patients placed on atorvastatin therapy.
Patients with Severe Hypercholesterolemia Higher drug dosages (80 mg/day) required for some patients with severe hypercholesterolemia (including familial hypercholesterolemia) are associated with increased plasma levels of atorvastatin.
4 Drug-Drug Interactions; 4 DOSAGE AND ADMINISTRATION). Hepatic/Biliary/Pancreatic Hepatic Effects In clinical trials, persistent increases in serum transaminases greater than three times the upper limit of normal occurred in <1% of patients who received atorvastatin calcium.
When the dosage of atorvastatin calcium was reduced, or when drug treatment was interrupted or discontinued, serum transaminase levels returned to pre-treatment levels. The increases were generally not associated with jaundice or other clinical signs or symptoms.
Most patients continued treatment with a reduced dose of atorvastatin calcium without clinical sequelae. Liver function tests should be performed before the initiation of […]
1 Special Populations ............................................................................................... 1 Pregnant Women .............................................................................................. 2 Breast-feeding ...................................................................................................
3 Pediatrics........................................................................................................... 4 Geriatrics ...........................................................................................................
14 8 ADVERSE REACTIONS................................................................................................ 1 Adverse Reaction Overview .................................................................................. 2 Clinical Trial Adverse Reactions ............................................................................
1 Clinical Trial Adverse Reactions – Pediatrics..................................................... 3 Less Common Clinical Trial Adverse Reactions ..................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data..............................................................................................................
5 Post-Market Adverse Reactions............................................................................ 17 9 DRUG INTERACTIONS ............................................................................................... 1 Serious Drug Interactions .....................................................................................
2 Drug Interactions Overview .................................................................................. 3 Drug-Behavioural Interactions .............................................................................. 4 Drug-Drug Interactions .........................................................................................
5 Drug-Food Interactions ......................................................................................... 6 Drug-Herb Interactions ......................................................................................... 7 Drug-Laboratory Test Interactions........................................................................
26 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ............................................................................................ 2 Pharmacodynamics ...............................................................................................
3 Pharmacokinetics .................................................................................................. 28 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 29 12 SPECIAL HANDLING INSTRUCTIONS...........................................................................
30 PART II: SCIENTIFIC INFORMATION ...................................................................................... 31 13 PHARMACEUTICAL INFORMATION ........................................................................... 31 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by Indication ................................................................................... 2 Comparative Bioavailability Studies ..................................................................... 44 15 MICROBIOLOGY .......................................................................................................
44 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 44 17 […]
1 Special Populations ............................................................................................... 1 Pregnant Women .............................................................................................. 2 Breast-feeding ...................................................................................................
3 Pediatrics........................................................................................................... 4 Geriatrics ...........................................................................................................
14 8 ADVERSE REACTIONS................................................................................................ 1 Adverse Reaction Overview .................................................................................. 2 Clinical Trial Adverse Reactions ............................................................................
1 Clinical Trial Adverse Reactions – Pediatrics..................................................... 3 Less Common Clinical Trial Adverse Reactions ..................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data..............................................................................................................
5 Post-Market Adverse Reactions............................................................................ 17 9 DRUG INTERACTIONS ............................................................................................... 1 Serious Drug Interactions .....................................................................................
2 Drug Interactions Overview .................................................................................. 3 Drug-Behavioural Interactions .............................................................................. 4 Drug-Drug Interactions .........................................................................................
5 Drug-Food Interactions ......................................................................................... 6 Drug-Herb Interactions ......................................................................................... 7 Drug-Laboratory Test Interactions........................................................................
26 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ............................................................................................ 2 Pharmacodynamics ...............................................................................................
3 Pharmacokinetics .................................................................................................. 28 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 29 12 SPECIAL HANDLING INSTRUCTIONS...........................................................................
30 PART II: SCIENTIFIC INFORMATION ...................................................................................... 31 13 PHARMACEUTICAL INFORMATION ........................................................................... 31 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by Indication ................................................................................... 2 Comparative Bioavailability Studies ..................................................................... 44 15 MICROBIOLOGY .......................................................................................................
44 16 NON-CLINICAL TOXICOLOGY […]