Usual Adult Dose for Hyperlipidemia

Initial dose: Amlodipine 5 mg-Atorvastatin 10 to 20 mg orally once a day
Maximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a day

Comments:

• Individualized dose based on effectiveness and tolerance; select doses of amlodipine and atorvastatin independently.
• Small adult, fragile, or elderly patients may be started on amlodipine 2.5 mg orally once a day; most coronary artery disease patients will require amlodipine 10 mg orally once a day for adequate effect.
• Patients who require greater than 45% low-density lipoprotein (LDL) reduction may be started on atorvastatin 40 mg orally once a day.
• Amlodipine may be titrated after 1 to 2 weeks; atorvastatin after 2 to 4 weeks.
• Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson types I and V).

Use: This combination drug is for patients for whom treatment with both amlodipine and atorvastatin is appropriate.

• Amlodipine is for the treatment of hypertension, coronary artery disease (i.e., chronic stable angina, vasospastic angina, angiographically documented coronary artery disease
• Atorvastatin is for prevention of cardiovascular disease in adults and hyperlipidemia.

Usual Adult Dose for Hypertension

Initial dose: Amlodipine 5 mg-Atorvastatin 10 to 20 mg orally once a day
Maximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a day

Comments:

• Individualized dose based on effectiveness and tolerance; select doses of amlodipine and atorvastatin independently.
• Small adult, fragile, or elderly patients may be started on amlodipine 2.5 mg orally once a day; most coronary artery disease patients will require amlodipine 10 mg orally once a day for adequate effect.
• Patients who require greater than 45% low-density lipoprotein (LDL) reduction may be started on atorvastatin 40 mg orally once a day.
• Amlodipine may be titrated after 1 to 2 weeks; atorvastatin after 2 to 4 weeks.
• Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson types I and V).

Use: This combination drug is for patients for whom treatment with both amlodipine and atorvastatin is appropriate.

• Amlodipine is for the treatment of hypertension, coronary artery disease (i.e., chronic stable angina, vasospastic angina, angiographically documented coronary artery disease
• Atorvastatin is for prevention of cardiovascular disease in adults and hyperlipidemia.

Usual Adult Dose for Angina Pectoris

Initial dose: Amlodipine 5 mg-Atorvastatin 10 to 20 mg orally once a day
Maximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a day

Comments:

• Individualized dose based on effectiveness and tolerance; select doses of amlodipine and atorvastatin independently.
• Small adult, fragile, or elderly patients may be started on amlodipine 2.5 mg orally once a day; most coronary artery disease patients will require amlodipine 10 mg orally once a day for adequate effect.
• Patients who require greater than 45% low-density lipoprotein (LDL) reduction may be started on atorvastatin 40 mg orally once a day.
• Amlodipine may be titrated after 1 to 2 weeks; atorvastatin after 2 to 4 weeks.
• Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson types I and V).

Use: This combination drug is for patients for whom treatment with both amlodipine and atorvastatin is appropriate.

• Amlodipine is for the treatment of hypertension, coronary artery disease (i.e., chronic stable angina, vasospastic angina, angiographically documented coronary artery disease
• Atorvastatin is for prevention of cardiovascular disease in adults and hyperlipidemia.

Usual Adult Dose for Coronary Artery Disease

Initial dose: Amlodipine 5 mg-Atorvastatin 10 to 20 mg orally once a day
Maximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a day

Comments:

• Individualized dose based on effectiveness and tolerance; select doses of amlodipine and atorvastatin independently.
• Small adult, fragile, or elderly patients may be started on amlodipine 2.5 mg orally once a day; most coronary artery disease patients will require amlodipine 10 mg orally once a day for adequate effect.
• Patients who require greater than 45% low-density lipoprotein (LDL) reduction may be started on atorvastatin 40 mg orally once a day.
• Amlodipine may be titrated after 1 to 2 weeks; atorvastatin after 2 to 4 weeks.
• Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson types I and V).

Use: This combination drug is for patients for whom treatment with both amlodipine and atorvastatin is appropriate.

• Amlodipine is for the treatment of hypertension, coronary artery disease (i.e., chronic stable angina, vasospastic angina, angiographically documented coronary artery disease
• Atorvastatin is for prevention of cardiovascular disease in adults and hyperlipidemia.

Usual Adult Dose for Prevention of Cardiovascular Disease

Initial dose: Amlodipine 5 mg-Atorvastatin 10 to 20 mg orally once a day
Maximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a day

Comments:

• Individualized dose based on effectiveness and tolerance; select doses of amlodipine and atorvastatin independently.
• Small adult, fragile, or elderly patients may be started on amlodipine 2.5 mg orally once a day; most coronary artery disease patients will require amlodipine 10 mg orally once a day for adequate effect.
• Patients who require greater than 45% low-density lipoprotein (LDL) reduction may be started on atorvastatin 40 mg orally once a day.
• Amlodipine may be titrated after 1 to 2 weeks; atorvastatin after 2 to 4 weeks.
• Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson types I and V).

Use: This combination drug is for patients for whom treatment with both amlodipine and atorvastatin is appropriate.

• Amlodipine is for the treatment of hypertension, coronary artery disease (i.e., chronic stable angina, vasospastic angina, angiographically documented coronary artery disease
• Atorvastatin is for prevention of cardiovascular disease in adults and hyperlipidemia.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Contraindicated

Dose Adjustments

Concomitant use of the following drugs with atorvastatin has been associated with increased risk of myopathy/rhabdomyolysis and therefore dose adjustments are recommended:

• Avoid atorvastatin in patients taking cyclosporine, tipranavir plus ritonavir, glecaprevir plus pibrentasvir, letermovir when co-administered with cyclosporine
• Atorvastatin dose should not exceed 20 mg/day when coadministered with clarithromycin, itraconazole, saquinavir plus

ritonavir (use lowest dose necessary), darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovir

• Atorvastatin dose should not exceed 40 mg/day when coadministered with nelfinavir

Use caution and the lowest dose necessary when coadministered with: Lopinavir plus ritonavir, simeprevir, fibric acid
derivatives, erythromycin, azole antifungals, lipid-modifying doses of niacin, and colchicine

Precautions

CONTRAINDICATIONS:

• Active liver disease
• Pregnancy
• Lactation

Safety and efficacy for this combination product have not been established in patients younger than 18 years; pediatric dosing information is available for the individual components of this drug.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:

• Take orally once a day at any time of day (about the same time each day) with or without food
• Swallow whole; do not break before taking

MISSED DOSE:

• If you miss a dose take as soon as remembered, unless it has been more than 12 hours since last dose; if so, skip the missed dose and resume regular dosing; do not take 2 doses at the same time

Monitoring:
Atorvastatin:

• Monitor liver enzymes before and during treatment.
• Check lipid levels 2 to 4 weeks after initiation and/or titration and adjust dose accordingly.
• Monitor for skeletal muscle effects, especially in patients with a history of renal impairment.

Patient advice:

• Patients should be advised to read the FDA-approved patient labeling (Patient Information).
• Advise patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever; risk of myopathy is increased when taking certain types of medication or consuming greater than 1 L of grapefruit juice.
• Advise patients to promptly report any symptoms that may indicate liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
• Advise women of reproductive age of the potential risks to a fetus; women should be advised to use effective contraception during treatment and notify their healthcare provider if they suspect they are pregnant.
• Advise women not to breastfeed while taking this drug.