CADUET Film-coated tablet (2023)

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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. Amlodipine 1.1 Hypertension Amlodipine is indicated for the treatment ...

2. Dosage and Administration

CADUET Dosage of CADUET must be individualized on the basis of both effectiveness and tolerance for each individual component in the treatment of hypertension/angina and hyperlipidemia. Select doses of ...

3. Dosage Forms and Strengths

CADUET tablets are formulated for oral administration in the following strength combinations: <b>Table 1:</b>   Atorvastatin (mg) 10 20 40 80 Amlodipine (mg) 5 X X X X 10 X X X X Combinations ...

4. Contraindications

Active Liver Disease, Which May Include Unexplained Persistent Elevations in Hepatic Transaminase Levels Pregnancy [see Use in Specific Populations (8.1)] Lactation [see Use in Specific Populations (8.2)] ...

5. Warnings and Precautions

5.1 Myopathy and Rhabdomyolysis CADUET may cause myopathy (muscle pain, tenderness, or weakness with creatine kinase (CK) above ten times the upper limit of normal) and rhabdomyolysis (with or without ...

6. Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the label: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)] Liver enzyme abnormalities [see ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval of amlodipine and atorvastatin. Because these reactions are reported voluntarily from a population of uncertain size, it is not ...

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-administered. ...

8.1. Pregnancy

Risk Summary CADUET is contraindicated in women who are pregnant. Atorvastatin Atorvastatin is contraindicated for use in pregnant women since safety in pregnant women has not been established and there ...

8.2. Lactation

Risk Summary CADUET is contraindicated during breastfeeding. Atorvastatin Atorvastatin use is contraindicated during breastfeeding [see Contraindications (4)]. There is no available information on the ...

8.3. Females and Males of Reproductive Potential

Contraception Atorvastatin may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with CADUET [see Use in Specific ...

8.4. Pediatric Use

The safety and effectiveness of CADUET have not been established in pediatric populations. Amlodipine Amlodipine (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see ...

8.5. Geriatric Use

Safety and effectiveness of CADUET have not been established in geriatric populations. Amlodipine Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine ...

8.6. Hepatic Impairment

CADUET is contraindicated in patients with active liver disease which may include unexplained persistent elevations in hepatic transaminase levels [see Contraindications (4) and Clinical Pharmacology (12.3)]. ...

10. Overdosage

There is no information on overdosage with CADUET in humans. Amlodipine Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. ...

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 ...

12.1. Mechanism of Action

CADUET is a combination of two drugs, a dihydropyridine calcium channel blocker (amlodipine) and an HMG-CoA reductase inhibitor (atorvastatin). The amlodipine component of CADUET inhibits the transmembrane ...

12.2. Pharmacodynamics

Amlodipine Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation resulting in a reduction of supine and standing blood pressures. These decreases ...

12.3. Pharmacokinetics

Absorption <u>Amlodipine:</u> After oral administration of therapeutic doses of amlodipine alone, absorption produces peak plasma concentrations between 6 and 12 hours. Absolute bioavailability has been ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Amlodipine Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg amlodipine/kg/day, showed ...

14. Clinical Studies

14.1 Amlodipine for Hypertension Adult Patients The antihypertensive efficacy of amlodipine has been demonstrated in a total of 15 double-blind, placebo-controlled, randomized studies involving 800 patients ...

16.1. How Supplied

CADUET tablets contain amlodipine besylate and atorvastatin calcium equivalent to amlodipine and atorvastatin in the dose strengths described below. CADUET tablets are differentiated by tablet color/size ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Information for Patients Because of the risk of myopathy with statins, the drug class to which atorvastatin belongs, ...