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CADUET® (amlodipine besilate, atorvastatin calcium) Highlights

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
(mg daily)
Maximum dose
(mg daily)
*
Start small adults or children, fragile, or elderly patients, or patients with hepatic insufficiency on 2.5 mg once daily (2)
Start patients requiring large LDL-C reduction (> 45%) at 40 mg once daily (2)
Amlodipine5*10
Atorvastatin10–2080

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).

CONTRAINDICATIONS

  • 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).

ADVERSE REACTIONS

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

DRUG INTERACTIONS

Increased Risk of Myopathy/Rhabdomyolysis (2, 5.1, 7, 12.3)
Cyclosporine, tipranavir plus ritonavir, glecaprevir plus pibrentasvir, letermovir when co-administered with cyclosporineAvoid atorvastatin
Clarithromycin, itraconazole, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovirDo not exceed 20 mg atorvastatin daily
NelfinavirDo not exceed 40 mg atorvastatin daily
Lopinavir plus ritonavir, simeprevir, fibric acid derivatives, erythromycin, azole antifungals, lipid-modifying doses of niacin, colchicineUse 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.

Revised: 9/2020

What's New

No Current Announcements.

Contact Pfizer Medical

Report an Adverse Event
1-800-438-1985

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