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Caduet Generic Name & Formulations
Legal Class
Rx
General Description
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.
Pharmacological Class
Calcium channel blocker (CCB) + HMG-CoA reductase inhibitor.
How Supplied
Tabs—30
Manufacturer
Generic Availability
YES
Caduet Indications
Indications
Hypertension (HTN) and/or angina (vasospastic or chronic stable) with dyslipidemias in patients for whom treatment with both amlodipine and atorvastatin is appropriate. See full labeling. (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 or stroke, and reduce risk of revascularization procedures and angina; treatment of hypercholesterolemia and mixed dyslipidemia, 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).
Caduet Dosage and Administration
Adult
Individualize; see full labeling. 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, elbasvir + grazoprevir, saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir ± ritonavir, letermovir: max atorvastatin 20mg/day. Concomitant nelfinavir: max atorvastatin 40mg/day. Concomitant lopinavir + ritonavir, simeprevir, or others: use lowest atorvastatin dose necessary.
Children
<10yrs: not established. ≥10yrs: individualize; see full labeling.
Caduet Contraindications
Contraindications
Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy. Nursing mothers.
Caduet Boxed Warnings
Not Applicable
Caduet Warnings/Precautions
Warnings/Precautions
Risk for myopathy (eg, ≥65yrs of age, uncontrolled hypothyroidism, renal impairment, higher Caduet dose); discontinue if myopathy or elevated CPK levels occur. Suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Immune-mediated necrotizing myopathy; monitor. Monitor liver function prior to starting therapy and repeat as clinically indicated. Interrupt if serious liver injury and/or hyperbilirubinemia or jaundice occurs. History of liver disease. Recent stroke or TIA: increased risk of hemorrhagic stroke. Severe obstructive coronary disease. Severe aortic stenosis. Elderly. Labor & delivery. Advise females of reproductive potential to use effective contraception during therapy.
Caduet Pharmacokinetics
See Literature
Caduet Interactions
Interactions
See full labeling. Amlodipine: Concomitant with moderate or strong CYP3A4 inhibitors: monitor for hypotension, edema. Monitor BP when concomitant with CYP3A inducers. Concomitant sildenafil; monitor for hypotension. Amlodipine may potentiate cyclosporine, tacrolimus; monitor blood levels and adjust dose. Atorvastatin: Avoid with concomitant cyclosporine, gemfibrozil, tipranavir + ritonavir, glecaprevir + pibrentasvir, grapefruit juice (>1.2L/day). Potentiated by inhibitors of CYP3A4 and/or transporters (eg, OATP1B1/1B3, P-gp, BCRP). Monitor with lopinavir + ritonavir, simeprevir, ledipasvir + sofosbuvir, other fibrates, macrolide antibiotics, azole antifungals, niacin (≥1g/day), colchicine; consider the risk/benefit of concomitant use. Potentiates serum levels of digoxin, oral contraceptives (norethindrone, ethinyl estradiol); monitor digoxin. May be antagonized by CYP3A4 inducers (eg, rifampin); administer rifampin simultaneously to avoid decrease in plasma levels. Avoid with drugs that decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine).
Caduet Adverse Reactions
Adverse Reactions
Edema, dizziness, flushing, palpitations, fatigue, nausea, abdominal pain, somnolence, nasopharyngitis, arthralgia, diarrhea, pain in extremity, UTI, dyspepsia, musculoskeletal pain, muscle spasms, myalgia, insomnia; elevated liver enzymes, rhabdomyolysis with renal dysfunction, possible increase in HbA1c or fasting serum glucose.
Caduet Clinical Trials
See Literature
Caduet Note
Not Applicable
Caduet Patient Counseling
See Literature
Caduet Generic Name & Formulations
Legal Class
Rx
General Description
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.
Pharmacological Class
Calcium channel blocker (CCB) + HMG-CoA reductase inhibitor.
How Supplied
Tabs—30
Manufacturer
Generic Availability
YES
Caduet Indications
Indications
Hypertension (HTN) and/or angina (vasospastic or chronic stable) with dyslipidemias in patients for whom treatment with both amlodipine and atorvastatin is appropriate. See full labeling. (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 or stroke, and reduce risk of revascularization procedures and angina; treatment of hypercholesterolemia and mixed dyslipidemia, 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).
Caduet Dosage and Administration
Adult
Individualize; see full labeling. 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, elbasvir + grazoprevir, saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir ± ritonavir, letermovir: max atorvastatin 20mg/day. Concomitant nelfinavir: max atorvastatin 40mg/day. Concomitant lopinavir + ritonavir, simeprevir, or others: use lowest atorvastatin dose necessary.
Children
<10yrs: not established. ≥10yrs: individualize; see full labeling.
Caduet Contraindications
Contraindications
Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy. Nursing mothers.
Caduet Boxed Warnings
Not Applicable
Caduet Warnings/Precautions
Warnings/Precautions
Risk for myopathy (eg, ≥65yrs of age, uncontrolled hypothyroidism, renal impairment, higher Caduet dose); discontinue if myopathy or elevated CPK levels occur. Suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Immune-mediated necrotizing myopathy; monitor. Monitor liver function prior to starting therapy and repeat as clinically indicated. Interrupt if serious liver injury and/or hyperbilirubinemia or jaundice occurs. History of liver disease. Recent stroke or TIA: increased risk of hemorrhagic stroke. Severe obstructive coronary disease. Severe aortic stenosis. Elderly. Labor & delivery. Advise females of reproductive potential to use effective contraception during therapy.
Caduet Pharmacokinetics
See Literature
Caduet Interactions
Interactions
See full labeling. Amlodipine: Concomitant with moderate or strong CYP3A4 inhibitors: monitor for hypotension, edema. Monitor BP when concomitant with CYP3A inducers. Concomitant sildenafil; monitor for hypotension. Amlodipine may potentiate cyclosporine, tacrolimus; monitor blood levels and adjust dose. Atorvastatin: Avoid with concomitant cyclosporine, gemfibrozil, tipranavir + ritonavir, glecaprevir + pibrentasvir, grapefruit juice (>1.2L/day). Potentiated by inhibitors of CYP3A4 and/or transporters (eg, OATP1B1/1B3, P-gp, BCRP). Monitor with lopinavir + ritonavir, simeprevir, ledipasvir + sofosbuvir, other fibrates, macrolide antibiotics, azole antifungals, niacin (≥1g/day), colchicine; consider the risk/benefit of concomitant use. Potentiates serum levels of digoxin, oral contraceptives (norethindrone, ethinyl estradiol); monitor digoxin. May be antagonized by CYP3A4 inducers (eg, rifampin); administer rifampin simultaneously to avoid decrease in plasma levels. Avoid with drugs that decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine).
Caduet Adverse Reactions
Adverse Reactions
Edema, dizziness, flushing, palpitations, fatigue, nausea, abdominal pain, somnolence, nasopharyngitis, arthralgia, diarrhea, pain in extremity, UTI, dyspepsia, musculoskeletal pain, muscle spasms, myalgia, insomnia; elevated liver enzymes, rhabdomyolysis with renal dysfunction, possible increase in HbA1c or fasting serum glucose.
Caduet Clinical Trials
See Literature
Caduet Note
Not Applicable
Caduet Patient Counseling
See Literature
Caduet Generic Name & Formulations
Legal Class
Rx
General Description
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.
Pharmacological Class
Calcium channel blocker (CCB) + HMG-CoA reductase inhibitor.
How Supplied
Tabs—30
Manufacturer
Generic Availability
YES
Caduet Indications
Indications
Hypertension (HTN) and/or angina (vasospastic or chronic stable) with dyslipidemias in patients for whom treatment with both amlodipine and atorvastatin is appropriate. See full labeling. (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 or stroke, and reduce risk of revascularization procedures and angina; treatment of hypercholesterolemia and mixed dyslipidemia, 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).
Caduet Dosage and Administration
Adult
Individualize; see full labeling. 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, elbasvir + grazoprevir, saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir ± ritonavir, letermovir: max atorvastatin 20mg/day. Concomitant nelfinavir: max atorvastatin 40mg/day. Concomitant lopinavir + ritonavir, simeprevir, or others: use lowest atorvastatin dose necessary.
Children
<10yrs: not established. ≥10yrs: individualize; see full labeling.
Caduet Contraindications
Contraindications
Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy. Nursing mothers.
Caduet Boxed Warnings
Not Applicable
Caduet Warnings/Precautions
Warnings/Precautions
Risk for myopathy (eg, ≥65yrs of age, uncontrolled hypothyroidism, renal impairment, higher Caduet dose); discontinue if myopathy or elevated CPK levels occur. Suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Immune-mediated necrotizing myopathy; monitor. Monitor liver function prior to starting therapy and repeat as clinically indicated. Interrupt if serious liver injury and/or hyperbilirubinemia or jaundice occurs. History of liver disease. Recent stroke or TIA: increased risk of hemorrhagic stroke. Severe obstructive coronary disease. Severe aortic stenosis. Elderly. Labor & delivery. Advise females of reproductive potential to use effective contraception during therapy.
Caduet Pharmacokinetics
See Literature
Caduet Interactions
Interactions
See full labeling. Amlodipine: Concomitant with moderate or strong CYP3A4 inhibitors: monitor for hypotension, edema. Monitor BP when concomitant with CYP3A inducers. Concomitant sildenafil; monitor for hypotension. Amlodipine may potentiate cyclosporine, tacrolimus; monitor blood levels and adjust dose. Atorvastatin: Avoid with concomitant cyclosporine, gemfibrozil, tipranavir + ritonavir, glecaprevir + pibrentasvir, grapefruit juice (>1.2L/day). Potentiated by inhibitors of CYP3A4 and/or transporters (eg, OATP1B1/1B3, P-gp, BCRP). Monitor with lopinavir + ritonavir, simeprevir, ledipasvir + sofosbuvir, other fibrates, macrolide antibiotics, azole antifungals, niacin (≥1g/day), colchicine; consider the risk/benefit of concomitant use. Potentiates serum levels of digoxin, oral contraceptives (norethindrone, ethinyl estradiol); monitor digoxin. May be antagonized by CYP3A4 inducers (eg, rifampin); administer rifampin simultaneously to avoid decrease in plasma levels. Avoid with drugs that decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine).
Caduet Adverse Reactions
Adverse Reactions
Edema, dizziness, flushing, palpitations, fatigue, nausea, abdominal pain, somnolence, nasopharyngitis, arthralgia, diarrhea, pain in extremity, UTI, dyspepsia, musculoskeletal pain, muscle spasms, myalgia, insomnia; elevated liver enzymes, rhabdomyolysis with renal dysfunction, possible increase in HbA1c or fasting serum glucose.
Caduet Clinical Trials
See Literature
Caduet Note
Not Applicable
Caduet Patient Counseling
See Literature
