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MAR-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: ], atorvastatin raised HDL-C 7% to 14%. These changes were independent of the dose administered. Atorvastatin also decreased total-C/HDL-C, LDL-C/HDL-C, and non-HDL-C/HDL-C ratios from baseline in a dose dependent manner (Table 4). Atorvastatin (10, 20, 40 and 80 mg QD) increased HDL-C levels from baseline for both…
Verbatim from this product's HC label. Tap a section to expand.
). 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. When the dosage of atorvastatin was reduced, or when drug treatment was interrupted or discontinued, serum transaminase levels returned to pretreatment 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 without clinical sequelae. Liver function tests should be performed before the initiation of treatment, and repeated as clinically indicated.
There have been rare post marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including atorvastatin. If an alternate etiology is not found, do not restart MAR- ATORVASTATIN. MAR-ATORVASTATIN, as well as other HMG-CoA reductase inhibitors, should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
Active liver disease or unexplained transaminase elevations are contraindications to the use of MAR-ATORVASTATIN; if such a condition should develop during therapy, the drug should be discontinued. MAR-ATORVASTATIN (atorvastatin calcium) Page 10 of 59 Protected B / Protégé B Musculoskeletal Pharmacokinetic 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.
2 Drug Interactions Overview). Muscle Effects Effects on skeletal muscle such as myalgia, myositis, myopathy and rarely, rhabdomyolysis have been reported in patients treated with atorvastatin. Rare cases of rhabdomyolysis, with acute renal failure secondary to myoglobinuria, have been reported with atorvastatin 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.
). 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). MAR-ATORVASTATIN (atorvastatin calcium) Page 8 of 59 Protected B / Protégé B 6 Dosage Forms, Strengths, Composition and Packaging Table – Dosage Forms, Strengths, and Composition Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablets: 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin calcium) Calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, talc and titanium dioxide.
MAR-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 colored, oval shaped, biconvex, film coated tablets debossed with “I10” on one side and plain on other side.
Available in blisters of 30’s and bottles of 100’s and 500’s. 20 mg: white to off white colored, oval shaped, biconvex, film coated tablets debossed with “I20” on one side and plain on other side. Available in blisters of 30’s and bottles of 100’s and 500’s.
40 mg: white to off white colored, oval shaped, biconvex, film coated tablets debossed with “I40” on one side and plain on other side. Available in blisters of 30’s and bottles of 100’s and 500’s. 80 mg: white to off white colored, oval shaped, biconvex, film coated tablets debossed with “I80” on one side and plain on other side.
Available in blisters of 30’s and bottles of 100’s. 7 Warnings and Precautions General Patients should be advised to inform health professionals of the prior use of MAR-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 (80mg) 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.
, 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 MAR-ATORVASTATIN, and should continue on this diet during treatment with MAR-ATORVASTATIN.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with MAR-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 MAR-ATORVASTATIN should be individualized according 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 MAR-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 MAR-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 MAR-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.
1 Pregnant Women) Fertility -There is no available data on effect of atorvastatin on human fertility. Non-clinical studies did not show an effect on animal fertility (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
1 Pregnant Women MAR-ATORVASTATIN is contraindicated during pregnancy (see 2 CONTRAINDICATIONS).
The extent of exposure in pregnancy during clinical trials:
No experience. MAR-ATORVASTATIN should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking MAR-ATORVASTATIN, the drug should be discontinued and the patient apprised of the potential risk to the fetus.
There is evidence from animal experimental studies that HMG-CoA reductase inhibitors may affect the development of embryos or fetuses. In rats, rabbits and dogs atorvastatin had no effect on fertility and was not teratogenic, however, at maternally toxic doses fetal toxicity wasobserved in rats and rabbits.
The development of the rat offspring was delayed and post-natal survival reduced during exposure of the dams to high doses of atorvastatin. In rats, there is evidence of placental transfer (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
2 Breastfeeding It is unknown if atorvastatin is excreted in human milk. Precaution should be exercised because many drugs can be excreted in human milk. Because of the potential for adverse reactions in nursing infants, women taking MAR-ATORVASTATIN should not breast-feed (see 2 CONTRAINDICATIONS).
In rats, milk concentrations of atorvastatin are similar to those in plasma. 3 Pediatrics Since the safety and tolerability profile of atorvastatin in pediatric patients (10-<18 years) is generally similar to the known safety profile of atorvastatin in adult patients, similar warning apply to this patient population.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Pre-disposing Factors for Myopathy/Rhabdomyolysis:
MAR-ATORVASTATIN, as with other HMG-CoA reductase inhibitors, should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis. 4 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. 5 Post-Market Adverse Reactions).
IMNM is clinically characterized by:
MAR-ATORVASTATIN (atorvastatin calcium) Page 11 of 59 Protected B / Protégé B • persistent proximal muscle weakness and elevated serum creatine kinase, which persistdespite discontinuation of statin treatment • positive anti-HMG CoA reductase antibody • muscle biopsy showing necrotizing myopathy without significant inflammation • improvement with immunosuppressive agents.
5 Post-Market Adverse Reactions) including causing recurrence when the same or a different statin was administered. MAR-ATORVASTATIN should be used with caution in patients with these conditions and should be discontinued if the symptoms are induced or aggravated Ophthalmologic Effect on the Lens Current long-term data from clinical trials do not indicate an adverse effect of atorvastatin on the human lens.
However, since several cases of rhabdomyolysis have been reported in patients with a history of renal insufficiency of unknown severity, as a precautionary measure and pending further experience in renal disease, the lowest dose (10 mg/day) of MAR- ATORVASTATIN should be used in these patients.
2 Recommended Dose and Dosage Adjustment). Sensitivity/Resistance An […]
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 andother 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. MAR-ATORVASTATIN (atorvastatin calcium) Page 9 of 59 Protected B / Protégé B 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 coronaryheart 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.
When the dosage of atorvastatin was reduced, or when drug treatment was interrupted or discontinued, serum transaminase levels returned to pretreatment levels. The increases were generally not associated with jaundice or other clinical signs or symptoms.
Most […]
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).
e. 6 mmol/L (500 mg/dL), respectively, may require triglyceride-lowering therapy (fenofibrate, bezafibrate or nicotinic acid) alone or in combination with MAR-ATORVASTATIN. 4 Drug-Drug Interactions). • Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10- <18 years of age) The recommended starting dose of MAR-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 MAR-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 MAR-ATORVASTATIN. 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 7WARNINGS AND PRECAUTIONS, MAR-ATORVASTATIN (atorvastatin calcium) Page 7 of 59 Protected B / Protégé B Hepatic/Biliary/Pancreatic).
MAR-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).
MAR- ATORVASTATIN therapy should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal). MAR-ATORVASTATIN should be discontinued if hypersensitivity is […]
: headache, gastrointestinal,musculoskeletal and connective tissue disorders). Doses greater than 20 mg have not been studied in this patient population. Safety and effectiveness of atorvastatin in pediatric patients has not been determined in the prevention of myocardial infarction.
Atorvastatin had no effect on growth or sexual maturation in boys and in girls. 2 Recommended Dose and Dose Adjustment, Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-<18 years of age)]. 1 Pregnant Women). Atorvastatin has not been studied in controlled clinical trials involving pre-pubertal patients or patients younger than 10 years of age.
3 Pharmacokinetics, Special Populations and Conditions: Pediatrics). Doses of atorvastatin up to 80 mg/day for 1 year have been evaluated in 8 pediatric patients with homozygous familial hypercholesterolemia (see 14 CLINICAL TRIALS - Heterozygous Familial Hypercholesterolemia in pediatric patients).
4 Geriatrics Treatment experience in adults 70 years or older (N=221) with doses of atorvastatin up to 80 mg/day has demonstrated that the safety and effectiveness of atorvastatin in this population was similar to that of patients <70 years of age.
Pharmacokinetic evaluation of atorvastatin in subjects over the age of 65 years indicates an increased AUC. 3 Pharmacokinetics, Special Populations and Conditions: Geriatrics). Elderly patients may be more susceptible to myopathy (see 7 WARNINGS AND PRECAUTIONS,Pre-disposing Factors for Myopathy/Rhabdomyolysis).
5 Post-Market Adverse Reactions). 2 Clinical Trial Adverse Reactions). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adversedrug reactions in real-world use. Adverse reactions with atorvastatin have usually been mild and transient. 0% of the patients on placebo.
Adverse experiences occurring at an incidence 1% in patients participating in placebo- controlled clinical studies of atorvastatin and reported to be possibly, probably or definitely drugrelated are shown in Table 1 below: […]