Generic Name and Formulations:
Amlodipine (as besylate), atorvastatin (as calcium); 2.5mg/10mg, 2.5mg/20mg, 2.5mg/40mg, 5mg/10mg, 5mg/20mg, 5mg/40mg, 5mg/80mg, 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg; tabs.
Company:
Pfizer Inc.
Hypertension (HTN) and/or angina (vasospastic or chronic stable) with dyslipidemias in patients for whom treatment with both amlodipine and atorvastatin is appropriate. See literature. (Amlodipine: indications include hypertension, chronic stable angina, and vasospastic angina. Atorvastatin: indications include use in patients with multiple risk factors, but no clinical evidence of, coronary heart disease, to reduce risk of MI and reduce risk of revascularization procedures and angina; treatment of hypercholesterolemia to reduce elevated total-C, LDL-C, apo B, and TG and to increase HDL-C; elevated triglycerides; dysbetalipoproteinemias; certain pediatric patients with elevated LDL-C.
Individualize; see literature. May substitute for individually titrated components, or may be added to existing therapy for patients already taking either amlodipine or atorvastatin. Or, may be used to start therapy in patients with hyperlipidemia and either HTN or angina. Concomitant clarithromycin, itraconazole, saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir, or fosamprenavir + ritonavir: max atorvastatin 20mg/day. Concomitant nelfinavir, or boceprevir: max atorvastatin 40mg/day. Concomitant lopinavir + ritonavir: use lowest atorvastatin dose necessary.
<10yrs: not recommended. ≥10yrs: individualize; see literature.
Calcium channel blocker + HMG-CoA reductase inhibitor.
Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers.
Monitor liver function prior to starting therapy and repeat as clinically indicated; reduce dose or discontinue if serum transaminase levels >3XULN persist. History of liver disease. Discontinue if myopathy or elevated CPK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Severe obstructive coronary disease. Severe aortic stenosis. Elderly. Labor & delivery.
See literature. Increased risk of myopathy with fibrates, erythromycin, nicotinic acid, cyclosporine, strong CYP3A4 inhibitors (eg, clarithromycin, HIV protease inhibitors, itraconazole), colchicine (caution). Avoid with concomitant cyclosporine, tipranivir + ritonavir, telaprevir, gemfibrozil. May be potentiated by grapefruit juice (>1.2L/day). May be antagonized by CYP3A4 inducers (eg, efavirenz, rifampin); administer rifampin simultaneously to avoid decrease in plasma levels. Caution with lopinavir + ritonavir, niacin; consider dose reduction of atorvastatin. May increase serum levels of digoxin, oral contraceptives (norethindrone, ethinyl estradiol); monitor digoxin. Caution with drugs that decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine).
Edema, dizziness, palpitation, flushing, fatigue, constipation, dyspepsia, abdominal pain, drowsiness, myopathy, elevated liver enzymes, rhabdomyolysis with renal dysfunction; possible increase in HbA1c or fasting serum glucose; rare: immune-mediated necrotizing myopathy.
Amlodipine: hepatic. Atorvastatin: hepatic (CYP3A4).
Amlodipine: renal. Atorvastatin: biliary, renal.
NO
Tabs—30
Hypertension (HTN) and/or angina (vasospastic or chronic stable) with dyslipidemias in patients for whom treatment with both amlodipine and atorvastatin is appropriate. See literature. (Amlodipine: indications include hypertension, chronic stable angina, and vasospastic angina. Atorvastatin: indications include use in patients with multiple risk factors, but no clinical evidence of, coronary heart disease, to reduce risk of MI and reduce risk of revascularization procedures and angina; treatment of hypercholesterolemia to reduce elevated total-C, LDL-C, apo B, and TG and to increase HDL-C; elevated triglycerides; dysbetalipoproteinemias; certain pediatric patients with elevated LDL-C.
Individualize; see literature. May substitute for individually titrated components, or may be added to existing therapy for patients already taking either amlodipine or atorvastatin. Or, may be used to start therapy in patients with hyperlipidemia and either HTN or angina. Concomitant clarithromycin, itraconazole, saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir, or fosamprenavir + ritonavir: max atorvastatin 20mg/day. Concomitant nelfinavir, or boceprevir: max atorvastatin 40mg/day. Concomitant lopinavir + ritonavir: use lowest atorvastatin dose necessary.
<10yrs: not recommended. ≥10yrs: individualize; see literature.
Calcium channel blocker + HMG-CoA reductase inhibitor.
Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers.
Monitor liver function prior to starting therapy and repeat as clinically indicated; reduce dose or discontinue if serum transaminase levels >3XULN persist. History of liver disease. Discontinue if myopathy or elevated CPK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Severe obstructive coronary disease. Severe aortic stenosis. Elderly. Labor & delivery.
See literature. Increased risk of myopathy with fibrates, erythromycin, nicotinic acid, cyclosporine, strong CYP3A4 inhibitors (eg, clarithromycin, HIV protease inhibitors, itraconazole), colchicine (caution). Avoid with concomitant cyclosporine, tipranivir + ritonavir, telaprevir, gemfibrozil. May be potentiated by grapefruit juice (>1.2L/day). May be antagonized by CYP3A4 inducers (eg, efavirenz, rifampin); administer rifampin simultaneously to avoid decrease in plasma levels. Caution with lopinavir + ritonavir, niacin; consider dose reduction of atorvastatin. May increase serum levels of digoxin, oral contraceptives (norethindrone, ethinyl estradiol); monitor digoxin. Caution with drugs that decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine).
Edema, dizziness, palpitation, flushing, fatigue, constipation, dyspepsia, abdominal pain, drowsiness, myopathy, elevated liver enzymes, rhabdomyolysis with renal dysfunction; possible increase in HbA1c or fasting serum glucose; rare: immune-mediated necrotizing myopathy.
Amlodipine: hepatic. Atorvastatin: hepatic (CYP3A4).
Amlodipine: renal. Atorvastatin: biliary, renal.
NO
Tabs—30
Hypertension (HTN) and/or angina (vasospastic or chronic stable) with dyslipidemias in patients for whom treatment with both amlodipine and atorvastatin is appropriate. See literature. (Amlodipine: indications include hypertension, chronic stable angina, and vasospastic angina. Atorvastatin: indications include use in patients with multiple risk factors, but no clinical evidence of, coronary heart disease, to reduce risk of MI and reduce risk of revascularization procedures and angina; treatment of hypercholesterolemia to reduce elevated total-C, LDL-C, apo B, and TG and to increase HDL-C; elevated triglycerides; dysbetalipoproteinemias; certain pediatric patients with elevated LDL-C.
Individualize; see literature. May substitute for individually titrated components, or may be added to existing therapy for patients already taking either amlodipine or atorvastatin. Or, may be used to start therapy in patients with hyperlipidemia and either HTN or angina. Concomitant clarithromycin, itraconazole, saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir, or fosamprenavir + ritonavir: max atorvastatin 20mg/day. Concomitant nelfinavir, or boceprevir: max atorvastatin 40mg/day. Concomitant lopinavir + ritonavir: use lowest atorvastatin dose necessary.
<10yrs: not recommended. ≥10yrs: individualize; see literature.
Calcium channel blocker + HMG-CoA reductase inhibitor.
Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers.
Monitor liver function prior to starting therapy and repeat as clinically indicated; reduce dose or discontinue if serum transaminase levels >3XULN persist. History of liver disease. Discontinue if myopathy or elevated CPK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Severe obstructive coronary disease. Severe aortic stenosis. Elderly. Labor & delivery.
See literature. Increased risk of myopathy with fibrates, erythromycin, nicotinic acid, cyclosporine, strong CYP3A4 inhibitors (eg, clarithromycin, HIV protease inhibitors, itraconazole), colchicine (caution). Avoid with concomitant cyclosporine, tipranivir + ritonavir, telaprevir, gemfibrozil. May be potentiated by grapefruit juice (>1.2L/day). May be antagonized by CYP3A4 inducers (eg, efavirenz, rifampin); administer rifampin simultaneously to avoid decrease in plasma levels. Caution with lopinavir + ritonavir, niacin; consider dose reduction of atorvastatin. May increase serum levels of digoxin, oral contraceptives (norethindrone, ethinyl estradiol); monitor digoxin. Caution with drugs that decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine).
Edema, dizziness, palpitation, flushing, fatigue, constipation, dyspepsia, abdominal pain, drowsiness, myopathy, elevated liver enzymes, rhabdomyolysis with renal dysfunction; possible increase in HbA1c or fasting serum glucose; rare: immune-mediated necrotizing myopathy.
Amlodipine: hepatic. Atorvastatin: hepatic (CYP3A4).
Amlodipine: renal. Atorvastatin: biliary, renal.
NO
Tabs—30