Classes
DEA Class; Rx
Common Brand Names; Caduet
- Calcium Channel Blockers;
- Lipid-Lowering Agents, Statins;
- Calcium Channel Blockers, Dihydropyridine;
- HMG-CoA Reductase Inhibitors
Description
Combination calcium-channel blocker and HMG-CoA reductase inhibitor; used for HTN or angina with hyperlipidemia in patients who were previously receiving the individually titrated drug components
Indications
Indicated for the treatment of hypertension or coronary artery disease including angina (chronic stable angina or variant angina) in patients with coexisting hyperlipoproteinemia (hypercholesterolemia, type IV hypertriglyceridemia, or type III hyperlipoproteinemia) and/or patients at risk for complications of coronary artery disease (stroke prophylaxis, myocardial infarction prophylaxis).
Contraindications
Hypersensitivity to amlodipine or atorvastatin
Active liver disease, or unexplained elevated transminases
Adverse Effects
Amlodipine
Peripheral edema (2-15%)
Palpitation (1-5%)
Dizziness (1-3%)
Flushing (1-5%)
Somnolence (1-2%)
Rash (1-2%)
Fatigue (5%)
Pruritus (1-2%)
Male sexual dysfunction (1-2%)
Nausea (3%)
Dyspepsia (1-2%)
Dyspnea (1-2%)
Weakness (1-2%)
Atorvastatin
Arthralgia (4-12%)
Diarrhea (5-14%)
Nasopharingitis (4-13%)
Nausea (4-7%)
Dyspepsia (3-6%)
Increased transaminases (2-3% with 80 mg/day)
Urinary tract infection (4-8%)
Insomnia (1-5%)
Myalgia (3-8%)
Musculoskeletal pain (2-5%)
Respiratory pharyngeal pain (1-4%)
Warnings
Symptomatic hypotension is possible with use of amlodipine, particularly in patients with severe aortic stenosis; because of gradual onset of action, acute hypotension is unlikely
Use caution in congestive heart failure
Persistent progressive dermatologic reactions
Worsening angina and acute myocardial infarction can develop after starting or increasing dose of amlodipine, particularly in patients with severe obstructive coronary artery disease
Heavy alcohol use, history of liver disease, renal failure
Adverse reactions associated with atorvastatin therapy reported including anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), rhabdomyolysis, myositis, fatigue, tendon rupture, fatal and non-fatal hepatic failure, dizziness, depression, peripheral neuropathy, pancreatitis and interstitial lung disease
Pregnancy and Lactation
Atorvastatin
Owing to HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, fetal harm may occur when administered to pregnant females; discontinue therapy as soon as pregnancy is recognized; limited published data are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage
Amlodipine
- Limited available data based on postmarketing reports with use in pregnant female are not sufficient to inform a drug-associated risk for major birth defects and miscarriage
Lactation
There is no available information on effects of drug on breastfed infant or on milk production
Maximum Dosage
10 mg/day PO amlodipine and 80 mg/day PO atorvastatin.
5—10 mg/day amlodipine (based on tolerance and clinical response) and 80 mg/day PO atorvastatin.
5 mg/day PO amlodipine and 20 mg/day PO atorvastatin.
>= 10 years: 5 mg/day PO amlodipine and 20 mg/day PO atorvastatin.
< 10 years: Safety and efficacy have not been established.
How supplied
Amlodipine/atorvastatin
tablet
- 2.5/10mg
- 2.5/20mg
- 2.5/40mg
- 5/10mg
- 5/20mg
- 5/40mg
- 5/80mg
- 10/10mg
- 10/20mg
- 10/40mg
- 10/80mg