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CADUET®(amlodipine besilate, atorvastatin calcium)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

CADUET® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.

...
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2 DOSAGE AND ADMINISTRATION

CADUET

Dosage of CADUET must be individualized on the basis of both effectiveness and tolerance for each...

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3 DOSAGE FORMS AND STRENGTHS

CADUET tablets are formulated for oral administration in the following strength combinations:

...
Table 1
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4 CONTRAINDICATIONS

  • Active Liver Disease, Which May Include Unexplained Persistent Elevations in Hepatic Transaminase Levels
  • Pregnancy [...
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5 WARNINGS AND PRECAUTIONS

5.1 Myopathy and Rhabdomyolysis

CADUET may cause myopathy (muscle pain, tenderness,...

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6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

  • Myopathy and Rhabdomyolysis [see

    6.1 Clinical...

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7 DRUG INTERACTIONS

Data from a drug-drug interaction study involving 10 mg of amlodipine and 80 mg of atorvastatin in healthy subjects indicate that the pharmacokinetics of amlodipine are not altered when the drugs are co-...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

CADUET is contraindicated...

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10 OVERDOSAGE

There is no information on overdosage with CADUET in humans.

Amlodipine

Overdosage might be expected to...

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11 DESCRIPTION

CADUET (amlodipine and atorvastatin) tablets combine the calcium channel blocker amlodipine besylate with the HMG CoA-reductase inhibitor atorvastatin calcium.

Amlodipine besylate is chemically described...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

CADUET is a combination of two drugs, a dihydropyridine calcium channel blocker (amlodipine) and an HMG-CoA...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

14.1 Amlodipine for Hypertension

Adult Patients

The...

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16 HOW SUPPLIED/STORAGE AND HANDLING

CADUET® tablets contain amlodipine besylate and atorvastatin calcium equivalent to amlodipine and atorvastatin in the dose strengths described below.

CADUET...

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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Information for...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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