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SANDOZ 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: Sandoz 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 Sandoz Atorvastatin, and should continue on this diet during treatment with Sandoz Atorvastatin. If appropriate, a program of weight control and physical exercise should be implemented.
• Prior to initiating therapy with Sandoz 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 Sandoz Atorvastatin should be individualized according to the baseline LDL- C, 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 Sandoz 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 Sandoz 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 Sandoz 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. 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 the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1- 844-764-7669). 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging Sandoz Atorvastatin Page 9 of 63 Protected B / Protégé B Route of Administration Dosage Form/ Strength / Composition Non-medicinal Ingredients Oral Tablets: 10 mg, 20 mg, 40 mg and 80 mg atorvastatin cellulose microcrystalline, calcium carbonate, lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, polysorbate 80, magnesium stearate, hypromellose 2910, polyethylene glycol 6000, titanium dioxide.
Sandoz Atorvastatin (atorvastatin calcium) tablets are formulated for oral administration and are available as tablet in dosage strength of 10 mg, 20 mg, 40 mg and 80 mg. 10 mg: white to off-white, round, biconvex film-coated, with debossement "A10" on one side, plain on the other side.
Available in bottles of 100 and 500 tablets and blisters (each box contains 30 tablets). 20 mg: white to off-white, round, biconvex film-coated, with debossement "A20" on one side and breaking notch on the other side. Available in bottles of 100 and 500 tablets and blisters (each box contains 30 tablets).
40 mg: white to off-white, round, biconvex film-coated, with debossement "A40" on one side and cross scored breaking notch on the other side. Available in bottles of 100 and 500 tablets and blisters (each box contains 30 tablets). 80 mg: white to off-white, round, biconvex film-coated, with debossement "A80" on one side and cross scored breaking notch on the other side.
Available in bottles of 100 and blisters (each box contains 30 tablets). 7 WARNINGS AND PRECAUTIONS General Patients should be advised to inform health professionals of the prior use of Sandoz Atorvastatin or anyother lipid-lowering agents.
, Hepatic/Biliary/Pancreatic). 2 Breast- feeding). 4 Drug-Drug Interactions). 4 Drug-Drug Interactions). 1 Dosing Considerations • Patients should be placed on a standard cholesterol-lowering diet before receiving Sandoz Atorvastatin, and should continue on this diet during treatment with Sandoz Atorvastatin.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with Sandoz 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 Sandoz Atorvastatin should be individualized according to the baseline LDL- C, 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 Sandoz 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 Sandoz 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 Sandoz 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.
Atorvastatin calcium is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). 2 Breast- feeding). 4 Drug-Drug Interactions).
4 Drug-Drug Interactions). Sandoz Atorvastatin Page 6 of 63 Protected B / Protégé B
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e. 6 mmol/L (500 mg/dL), respectively, may require triglyceride-lowering therapy Sandoz Atorvastatin Page 7 of 63 Protected B / Protégé B (fenofibrate, bezafibrate or nicotinic acid) alone or in combination with Sandoz Atorvastatin.
4 Drug-Drug Interactions). • Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10- <18 years of age) The recommended starting dose of Sandoz 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 Sandoz Atorvastatin for the primary prevention of myocardial infarction is 10 mg/day.
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 Sandoz 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).
Sandoz 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).
Sandoz Atorvastatin Sandoz Atorvastatin Page 8 of 63 Protected B / Protégé B therapy should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal).
Sandoz 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 Sandoz Atorvastatin, promptly interrupt therapy (see 7 WARNINGS AND […]
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.
Sandoz Atorvastatin Page 10 of 63 Protected B / Protégé B 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. 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 pretreatment […]
The response is maintained during chronic therapy. 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).
e. 6 mmol/L (500 mg/dL), respectively, may require triglyceride-lowering therapy Sandoz Atorvastatin Page 7 of 63 Protected B / Protégé B (fenofibrate, bezafibrate or nicotinic acid) alone or in combination with Sandoz Atorvastatin.
4 Drug-Drug Interactions). • Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10- <18 years of age) The recommended starting dose of Sandoz 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 Sandoz Atorvastatin for the primary prevention of myocardial infarction is 10 mg/day.
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 Sandoz 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).
Sandoz 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).
Sandoz Atorvastatin Sandoz Atorvastatin Page 8 of 63 Protected B / Protégé B therapy should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal).
Sandoz […]