ACH-ATORVASTATIN CALCIUM 40 MG

What is ACH-ATORVASTATIN CALCIUM?

ACH-ATORVASTATIN CALCIUM 40 MG contains ATORVASTATIN (ATORVASTATIN CALCIUM) : 40 MG. It is listed in the Health Canada Drug Product Database under DIN 02457776, held by ACCORD HEALTHCARE INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 18-Oct-2019. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is ACH-ATORVASTATIN CALCIUM used for?

ACH-ATORVASTATIN CALCIUM (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 conditions, including: • Primary hypercholesterolemia (Type IIa); • Combined (mixed) hyperlipidemia (Type IIb), including familial combined hyperlipidemia, regardless of whether cholesterol or triglycerides are the lipid abnormality of concern; • Dysbetalipoproteinemia (Type III); • Hypertriglyceridemia (Type IV); • Familial hypercholesterolemia (homozygous and heterozygous). For homozygous familial hypercholesterolemia, ACH-ATORVASTATIN CALCIUM should be used as an adjunct to treatments such as LDL apheresis, or as monotherapy if such treatments are not available. • the prevention of Cardiovascular Disease, to reduce the risk of myocardial infarction in the following conditions: • hypertensive patients without clinically evident coronary heart disease, but with at least three additional risk factors for coronary heart disease such as age ≥55 years, male sex, smoking, type 2 diabetes, left ventricular hypertrophy, other specified abnormalities on ECG, microalbuminuria or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥6, or premature family history of coronary heart disease. • patients with type 2 diabetes mellitus and hypertension without clinically evident coronary heart disease, but with other risk factors such as age ≥55 years, retinopathy, albuminuria or smoking. It also reduced the risk of stroke in this population. • patients with clinically evident coronary heart disease.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Patients should be placed on a standard cholesterol-lowering diet before receiving ACH-ATORVASTATIN CALCIUM, and should continue on this diet during treatment. A program of weight control and physical exercise should be implemented. Prior to initiating therapy, secondary causes for elevations in plasma lipid levels should be excluded. A lipid profile should also be performed. The dosage should be individualized according to baseline LDL-C, total-C/HDL-C ratio and/or TG levels to achieve recommended desired lipid values at the lowest dose needed. Lipid levels should be monitored periodically and adjusted as needed. The maximum dose is 80 mg/day. Primary Hypercholesterolemia and Combined (Mixed) Dyslipidemia, Including Familial Combined Hyperlipidemia: Recommended starting dose is 10 or 20 mg once daily. Patients requiring a large reduction in LDL-C (more than 45%) may start at 40 mg once daily. Dosage range is 10 to 80 mg once daily. Adjustments should be made at intervals of 2 to 4 weeks. Maximum dose is 80 mg/day. Severe Dyslipidemias (including homozygous and heterozygous familial hypercholesterolemia and dysbetalipoproteinemia Type III): Higher dosages (up to 80 mg/day) may be required. Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10- <18 years of age): Recommended starting dose is 10 mg/day; maximum recommended dose is 20 mg/day. Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more. Prevention of Cardiovascular Disease: Recommended starting dose for primary prevention of myocardial infarction is 10 mg/day. For secondary prevention, optimal dosing may range from 10 mg to 80 mg once daily. Dosage in Patients with Renal Insufficiency: Patients with a history of renal insufficiency or severe renal insufficiency (creatinine clearance <30 mL/min) should be given the lowest dose (10 mg/day). Drug discontinuation: If pregnancy occurs, discontinue immediately. If ALT or AST show evidence of progression (rise to >3 times ULN and persistent), reduce dosage or discontinue. Temporarily withhold or discontinue in acute serious conditions suggestive of myopathy or risk factors for rhabdomyolysis. Discontinue if hypersensitivity is suspected or interstitial lung disease is suspected. Promptly interrupt therapy if serious liver injury occurs. Administration: Doses can be given at any time of the day, preferably in the evening, with or without food. Missed Dose: If a dose is missed, take it immediately unless close to the next dose. Do not double the dose.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at controlled room temperature 15 to 30°C. Keep out of reach and sight of children.

How is it supplied?

Tablets: 10 mg, 20 mg, 40 mg and 80 mg atorvastatin per tablet. 10 mg: White, to off-white, oval shaped, biconvex, film-coated tablets, debossed with "FFI" on one side and plain on other side. Available in bottles of 90, 100, 500 tablets and blister of 30 tablets (3 strips X 10). 20 mg: White, to off-white, oval shaped, biconvex, film-coated tablets, debossed with "FF2" on one side and plain on other side. Available in bottles of 90, 100, 500 tablets and blister of 30 tablets (3 strips X 10). 40 mg: White, to off-white, oval shaped, biconvex, film-coated tablets, debossed with "FF3" on one side and plain on other side. Available in bottles of 90, 100, 500 tablets and blister of 30 tablets (3 strips X 10). 80 mg: White, to off-white, oval shaped, biconvex, film-coated tablets, debossed with "FF4" on one side and plain on other side. Available in bottles of 90, 100, 500 tablets and blister of 30 tablets (3 strips X 10).

Contraindications

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. • Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal. • Pregnancy and breastfeeding women. • Concomitant treatment with hepatitis C antivirals. • Concomitant treatment with the immunosuppressant cyclosporine.

Warnings and precautions

General: Patients should inform health professionals of prior use of ACH-ATORVASTATIN CALCIUM or other lipid-lowering agents. Cardiovascular: Hemorrhagic Stroke in Patients with Recent Stroke or Transient Ischemic Attack (TIA): The highest dose (80mg) was associated with an increased risk of hemorrhagic stroke in a post-hoc analysis. The potential risk should be carefully considered before initiating treatment in patients with recent stroke or TIA. Effect on Ubiquinone (CoQ10) Levels: Significant decreases in circulating ubiquinone levels have been observed. Clinical significance of long-term statin-induced deficiency has not been established. CoQ10 levels should be measured when clinically indicated. Endocrine and Metabolism: HMG-CoA reductase inhibitors might theoretically blunt adrenal and/or gonadal steroid production. Clinical studies suggest these agents do not reduce plasma cortisol or impair adrenal reserve. Effects on male fertility and pituitary-gonadal axis in premenopausal women are unknown. Patients with clinical evidence of endocrine dysfunction should be evaluated. Caution should be exercised if an HMG-CoA reductase inhibitor is administered with other drugs that may decrease steroid hormone levels. Increases in fasting glucose and HbA1c levels have been reported. Periodic monitoring is recommended for patients at high risk of diabetes mellitus. Effect on Lipoprotein (a): Beneficial effect of lowered total cholesterol and LDL-C may be blunted by concomitant increase in Lp(a) lipoprotein concentrations. Lifestyle changes should be maintained and reinforced. Patients with Severe Hypercholesterolemia: Higher dosages (80 mg/day) are associated with increased plasma levels of atorvastatin. Caution should be exercised in severely renally impaired, elderly patients, or those concomitantly administered digoxin or CYP 3A4 inhibitors. Hepatic/Biliary/Pancreatic: Persistent increases in serum transaminases occurred in <1% of patients. Liver function tests should be performed before and during treatment. Rare post-marketing reports of fatal and non-fatal hepatic failure. Do not restart ACH-ATORVASTATIN CALCIUM if an alternate etiology is not found. Use 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. Musculoskeletal: Severe myopathy, including rhabdomyolysis, may be more frequent with co-administration of drugs that inhibit CYP 3A4. Effects on skeletal muscle such as myalgia, myositis, myopathy, and rhabdomyolysis have been reported. Myopathy is defined as muscle pain or weakness with CK values >10 times ULN. Patients should report unexplained muscle pain, tenderness, or weakness. CK levels should be measured in such patients. Pre-disposing factors for myopathy/rhabdomyolysis include personal/family history of muscular disorders, previous muscle toxicity with other HMG-CoA reductase inhibitors, concomitant use of fibrate or niacin, hypothyroidism, alcohol abuse, excessive physical exercise, age >65 years, renal/hepatic impairment, diabetes with hepatic fatty change, surgery/trauma, frailty, and situations increasing plasma levels of active ingredient. The risk of myopathy and rhabdomyolysis is increased with concurrent administration of drugs that increase systemic concentration of atorvastatin via inhibition of CYP 3A4 or transporter proteins. Patients with renal impairment merit close monitoring for skeletal muscle effects. Rare reports of immune-mediated necrotizing myopathy (IMNM) have occurred. Sensitivity/Resistance: An apparent hypersensitivity syndrome has been reported with other HMG-CoA reductase inhibitors.

What can be used instead?

Other Canadian products sharing ATC code C10AA05 ATORVASTATIN. 87 of 216 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies ATORVASTATIN worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. ATORVASTATIN appears in 2136 registered pack listings across 12 markets, published on 10 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.