Usual Adult Dose for Prevention of Cardiovascular Disease

Initial dose: 10 mg or 20 mg orally once a day

• An initial dose of 40 mg may be used in patients who require a larger reduction in low density lipoprotein (e.g. more than 45%)
• Individualize dose based on goals of therapy and response

Maintenance dose: 10 mg to 80 mg orally once a day
Maximum dose: 80 mg/day

Comments:

• Following initiation and/or upon titration, lipid levels should be evaluated within 2 to 4 weeks and dosages adjusted accordingly.
• This drug is intended as an adjunct to diet when response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone have been inadequate to manage hypercholesterolemia.
• In patients with coronary heart disease (CHD) or multiple risk factors for CHD, this drug can be started simultaneously with diet.
• In patients with multiple risk factors for coronary heart disease (CHD) such as smoking, hypertension, low HDL-C,or a family history of early CHD, this drug is indicated to reduce the risk of/for: Myocardial infarction, stroke, revascularization procedures, and angina.
• In patients with type 2 diabetes and multiple risk factors for CHD such as retinopathy, albuminuria, smoking, or hypertension, this drug is indicated to reduce the risk of: Myocardial infarction and stroke.
• In patients with clinically evident CHD, this drug is indicated to reduce the risk of/for: Non-fatal myocardial infarction, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina.

Use: For the prevention of cardiovascular disease.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia

10 mg to 80 mg orally once a day

Use: To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid lowering treatment (e.g., LDL apheresis) or if such treatments are unavailable.

Usual Adult Dose for Hyperlipidemia

Initial dose: 10 mg or 20 mg orally once a day

• An initial dose of 40 mg may be used in patients who require a larger reduction in low density lipoprotein (e.g. more than 45%)
• Individualize dose based on goals of therapy and response

Maintenance dose: 10 mg to 80 mg orally once a day
Maximum dose: 80 mg/day

Comments:

• Following initiation and/or upon titration, lipid levels should be evaluated within 2 to 4 weeks and dosages adjusted accordingly.
• This drug has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Uses:

• As an adjunct to diet to reduced total cholesterol (total-C), LDL-C, apolipoprotein B (apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb).
• As an adjunct to diet for the treatment of patients with elevated TG levels (Fredrickson Type IV).
• For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

Usual Adult Dose for Hyperlipoproteinemia Type IIa (Elevated LDL)

Initial dose: 10 mg or 20 mg orally once a day

• An initial dose of 40 mg may be used in patients who require a larger reduction in low density lipoprotein (e.g. more than 45%)
• Individualize dose based on goals of therapy and response

Maintenance dose: 10 mg to 80 mg orally once a day
Maximum dose: 80 mg/day

Comments:

• Following initiation and/or upon titration, lipid levels should be evaluated within 2 to 4 weeks and dosages adjusted accordingly.
• This drug has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Uses:

• As an adjunct to diet to reduced total cholesterol (total-C), LDL-C, apolipoprotein B (apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb).
• As an adjunct to diet for the treatment of patients with elevated TG levels (Fredrickson Type IV).
• For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL)

Initial dose: 10 mg or 20 mg orally once a day

• An initial dose of 40 mg may be used in patients who require a larger reduction in low density lipoprotein (e.g. more than 45%)
• Individualize dose based on goals of therapy and response

Maintenance dose: 10 mg to 80 mg orally once a day
Maximum dose: 80 mg/day

Comments:

• Following initiation and/or upon titration, lipid levels should be evaluated within 2 to 4 weeks and dosages adjusted accordingly.
• This drug has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Uses:

• As an adjunct to diet to reduced total cholesterol (total-C), LDL-C, apolipoprotein B (apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb).
• As an adjunct to diet for the treatment of patients with elevated TG levels (Fredrickson Type IV).
• For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

Usual Adult Dose for Hyperlipoproteinemia Type III (Elevated beta-VLDL + IDL)

Initial dose: 10 mg or 20 mg orally once a day

• An initial dose of 40 mg may be used in patients who require a larger reduction in low density lipoprotein (e.g. more than 45%)
• Individualize dose based on goals of therapy and response

Maintenance dose: 10 mg to 80 mg orally once a day
Maximum dose: 80 mg/day

Comments:

• Following initiation and/or upon titration, lipid levels should be evaluated within 2 to 4 weeks and dosages adjusted accordingly.
• This drug has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Uses:

• As an adjunct to diet to reduced total cholesterol (total-C), LDL-C, apolipoprotein B (apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb).
• As an adjunct to diet for the treatment of patients with elevated TG levels (Fredrickson Type IV).
• For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

Usual Adult Dose for Hyperlipoproteinemia Type IV (Elevated VLDL)

Initial dose: 10 mg or 20 mg orally once a day

• An initial dose of 40 mg may be used in patients who require a larger reduction in low density lipoprotein (e.g. more than 45%)
• Individualize dose based on goals of therapy and response

Maintenance dose: 10 mg to 80 mg orally once a day
Maximum dose: 80 mg/day

Comments:

• Following initiation and/or upon titration, lipid levels should be evaluated within 2 to 4 weeks and dosages adjusted accordingly.
• This drug has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Uses:

• As an adjunct to diet to reduced total cholesterol (total-C), LDL-C, apolipoprotein B (apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb).
• As an adjunct to diet for the treatment of patients with elevated TG levels (Fredrickson Type IV).
• For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

Usual Adult Dose for Hypertriglyceridemia

Initial dose: 10 mg or 20 mg orally once a day

• An initial dose of 40 mg may be used in patients who require a larger reduction in low density lipoprotein (e.g. more than 45%)
• Individualize dose based on goals of therapy and response

Maintenance dose: 10 mg to 80 mg orally once a day
Maximum dose: 80 mg/day

Comments:

• Following initiation and/or upon titration, lipid levels should be evaluated within 2 to 4 weeks and dosages adjusted accordingly.
• This drug has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Uses:

• As an adjunct to diet to reduced total cholesterol (total-C), LDL-C, apolipoprotein B (apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb).
• As an adjunct to diet for the treatment of patients with elevated TG levels (Fredrickson Type IV).
• For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

Usual Adult Dose for Heterozygous Familial Hypercholesterolemia

Initial dose: 10 mg or 20 mg orally once a day

• An initial dose of 40 mg may be used in patients who require a larger reduction in low density lipoprotein (e.g. more than 45%)
• Individualize dose based on goals of therapy and response

Maintenance dose: 10 mg to 80 mg orally once a day
Maximum dose: 80 mg/day

Comments:

• Following initiation and/or upon titration, lipid levels should be evaluated within 2 to 4 weeks and dosages adjusted accordingly.
• This drug has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Uses:

• As an adjunct to diet to reduced total cholesterol (total-C), LDL-C, apolipoprotein B (apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb).
• As an adjunct to diet for the treatment of patients with elevated TG levels (Fredrickson Type IV).
• For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia

10 years or older:
Initial dose: 10 mg orally once a day

• Individualize dose based on goals of therapy and response

Maintenance dose: 10 mg to 20 mg orally once a day
Maximum dose: 20 mg/day

Comments:

• This drug is indicated in pediatric patients who, despite diet therapy, have an LDL-C of 190 mg/dL or greater, or have an LDL-C of 160 mg/dL or greater with a positive family history of premature cardiovascular disease (CVD) OR 2 or more other CVD risk factors.
• Doses greater than 20 mg/day have not been studied in this patient population.
• Dose adjustments should be made at intervals of 4 weeks or more.

Use: As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in pediatric patients 10 years or older with heterozygous familial hypercholesterolemia.

Usual Pediatric Dose for Homozygous Familial Hypercholesterolemia

10 years or older: 10 mg to 80 mg orally once a day

Comments:

• Clinical efficacy with dosages up to 80 mg/day for 1 year was evaluated in an uncontrolled study of patients with homozygous familial hypercholesterolemia (HoFH); this study included 8 pediatric patients.

Use: To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid lowering treatment (e.g., LDL apheresis) or if such treatments are unavailable.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Active liver disease (including unexplained persistent elevations in hepatic transaminase levels): Contraindicated

Dose Adjustments

Elderly: Use caution as patients 65 years or older are at risk for myopathy

Concomitant lipid lowering therapy:

• This drug may be used with bile acid resins; the combination of HMG-CoA reductase inhibitors (statins) and fibrates should be used with caution

AVOID concomitant atorvastatin use with cyclosporine, tipranavir plus ritonavir, glecaprevir plus pibrentasvir

Use the LOWEST atorvastatin dose necessary with lopinavir plus ritonavir

LIMIT atorvastatin dose to 20 mg/day with concomitant use of clarithromycin, itraconazole, elbasvir plus grazoprevir, or with HIV combinations of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir; appropriate clinical assessment is recommended to ensure the lowest effective dose is employed

LIMIT atorvastatin dose to 40 mg/day with concomitant use of nelfinavir; appropriate clinical assessment is recommended to ensure the lowest effective dose is employed

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active substance or any of the product ingredients
• Active liver disease or unexplained persistent elevations in serum transaminases levels
• Pregnancy
• Lactation

Safety and efficacy have not been established in patients younger than 10 years with HeFH (heterozygous familial hypercholesterolemia) or pre-pubertal adolescents.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis is not expected to significantly enhance atorvastatin clearance since this drug is extensively bound to plasma proteins
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• Take orally once a day at any time, with or without food

General:

• Prior to initiating treatment, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism) should be identified and treated.
• This drug has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Monitoring:

• Hepatic: Check transaminase levels prior to initiating therapy; repeat, if signs/symptoms of liver injury occur, and as clinically indicated throughout therapy
• Musculoskeletal: Monitor for skeletal muscle effects
• Metabolic: Obtain lipid levels within 2 to 4 weeks of initiating therapy and adjusting dose; periodically test during therapy to determine goal attainment

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
• Advise patients to report immediately any unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever, or if muscle signs/symptoms persist after discontinuing therapy.
• Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; this drug is not recommended for use during pregnancy or lactation.
• Counsel patients on the importance of contraceptive methods while taking this drug.
• Patients should be aware that there are a number of potential drug interactions with this drug and they should speak with a healthcare professional before starting any new medications including over the counter medications.

Frequently asked questions

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