HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CADUET safely and effectively. See full prescribing information for CADUET.
CADUET® (amlodipine besylate and atorvastatin calcium) tablets, for oral use
Initial U.S. Approval: 2004
RECENT MAJOR CHANGES
|Dosage and Administration (2)||12/2019|
|Warnings and Precautions, Myopathy and Rhabdomyolysis (5.1)||12/2019|
|Warnings and Precautions, Immune-Mediated Necrotizing Myopathy (5.2)||9/2020|
INDICATIONS AND USAGE
CADUET is a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a HMG CoA-reductase inhibitor, indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.
Amlodipine is indicated for the treatment of hypertension, to lower blood pressure (1.1). Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Amlodipine is indicated for the treatment of Coronary Artery Disease (1.2).
Atorvastatin is indicated as an adjunct therapy to diet for prevention of cardiovascular disease (1.3) and hyperlipidemia (1.4).
DOSAGE AND ADMINISTRATION
|Usual starting dose|
DOSAGE FORMS AND STRENGTHS
Tablets contain amlodipine besylate equivalent to amlodipine 2.5, 5, or 10 mg and atorvastatin calcium equivalent to atorvastatin 10, 20, 40, or 80 mg (3).
- Active liver disease (4)
- Pregnancy (4)
- Lactation (4)
WARNINGS AND PRECAUTIONS
- Myopathy and Rhabdomyolysis: Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness. CADUET therapy should be discontinued if myopathy is diagnosed or suspected (2, 5.1, 8.5).
- Immune-Mediated Necrotizing Myopathy (IMNM): Monitor for myalgia and treat (5.2).
- Hepatic Transaminitis: Monitor liver enzymes before and during treatment (5.3).
- Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely (5.5).
- Angina or myocardial infarction may occur with initiation or dose increase (5.4).
Most common adverse reaction (3% greater than placebo) to amlodipine is edema (6.1).
Most common adverse reactions leading to atorvastatin discontinuation were myalgia and diarrhea (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
|Increased Risk of Myopathy/Rhabdomyolysis (2, 5.1, 7, 12.3)|
|Cyclosporine, tipranavir plus ritonavir, glecaprevir plus pibrentasvir, letermovir when co-administered with cyclosporine||Avoid atorvastatin|
|Clarithromycin, itraconazole, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovir||Do not exceed 20 mg atorvastatin daily|
|Nelfinavir||Do not exceed 40 mg atorvastatin daily|
|Lopinavir plus ritonavir, simeprevir, fibric acid derivatives, erythromycin, azole antifungals, lipid-modifying doses of niacin, colchicine||Use with caution and lowest dose necessary|
- Other Lipid-Lowering Medications: Increased risk of myopathy (7).
- Rifampin: Take at same time as CADUET (7.9).
- Digoxin: Monitor digoxin levels (7.10).
- Oral Contraceptives: Norethindrone and ethinyl estradiol may be increased (7.11).
USE IN SPECIFIC POPULATIONS
- Hepatic Impairment: Plasma concentrations of atorvastatin markedly increased in patients with active liver disease (8.6, 12.3).
- Females of reproductive potential: Advise females of reproductive potential to use effective contraception during treatment with CADUET (8.3).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.