Caduet 10 mg/1
amlodipine and atorvastatin · TABLET, FILM COATED · Pfizer Laboratories Div Pfizer Inc
Caduet is a prescription tablet that combines amlodipine (a blood pressure-lowering medication) and atorvastatin (a cholesterol-lowering medication) in a single dose. It is used to help manage high blood pressure and high cholesterol together.
Key Facts
- Brand Name
- Caduet
- Generic Name
- amlodipine and atorvastatin
- NDC Code (Product)
0069-7810- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA021540
- Marketing Start
- 06/06/2022
Recall History
Pfizer Inc.
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Pfizer Inc.
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. CADUET is a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a HMG-CoA-reductase inhibitor (statin), indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate ( 1 ). Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. Amlodipine is indicated for the treatment of Coronary Artery Disease ( 1 ). Atorvastatin is indicated ( 1 ): • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in ad…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Usual starting dose (mg daily) Maximum dose (mg daily) Amlodipine 5 Start small adults or children, fragile, or elderly patients, or patients with hepatic insufficiency on 2.5 mg once daily ( 2 ). 10 Atorvastatin 10–20 Start patients requiring large LDL-C reduction (> 45%) at 40 mg once daily ( 2 ). 80 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 amlodipine and atorvastatin independently. CADUET may be substituted for its individually titrated components. Patients may be given the equivalent dose of CADUET or a dose of CADUET with increased amounts of amlodipine, atorvastatin, or both for additional antianginal effects, blood pressure lowering, or lipid-lowering effect. CADUET may be used to provide additional therapy for patients already on one of its components. CADUET may be used to initiate treatment in patients with hyperlipidemia and either hypertension or angina. Important Dosage Information Take CADUET orally once daily at any time of the day, with or without food. Amlodipine The usual initia…
Contraindications
4 CONTRAINDICATIONS • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . • Hypersensitivity to amlodipine, atorvastatin or any excipients in CADUET. Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported [see Adverse Reactions (6.2) ] . • Acute liver failure or decompensated cirrhosis ( 4 ). • Hypersensitivity to amlodipine, atorvastatin or any excipient in CADUET ( 4 ).
Drug Interactions
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. The effect of amlodipine on the pharmacokinetics of atorvastatin showed no effect on the C max : 91% (90% confidence interval: 80 to 103%), but the AUC of atorvastatin increased by 18% (90% confidence interval: 109 to 127%) in the presence of amlodipine, which is not clinically meaningful. No drug interaction studies have been conducted with CADUET and other drugs, although studies have been conducted in the individual amlodipine and atorvastatin components, as described below: • See full prescribing information for details regarding concomitant use of CADUET with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis ( 2.5 , 7.3 ). • Rifampin: May reduce atorvastatin plasma concentrations. Administer simultaneously with atorvastatin ( 7.4 ). • Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive ( 7.5 ). • Digoxin: May increas…
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] • Hepatic Dysfunction [see Warnings and Precautions (5.3) ] • Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.6) ] Most common adverse reaction to amlodipine is edema which occurred in a dose related manner ( 6.1 ). Most common adverse reactions (incidence ≥ 5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection to atorvastatin ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. CADUET CADUET (amlodipine/atorvastatin) has been evaluated for safety in 1092 patients in double-blind p…
Frequently Asked Questions
What is Caduet used for?
Caduet is a prescription tablet that combines amlodipine (a blood pressure-lowering medication) and atorvastatin (a cholesterol-lowering medication) in a single dose. It is used to help manage high blood pressure and high cholesterol together.
Is Caduet a controlled substance?
Caduet is not classified as a controlled substance by the DEA.
What is the generic name for Caduet?
The generic name for Caduet is amlodipine and atorvastatin. There are 11 other brand versions of amlodipine and atorvastatin.
What is the NDC code for Caduet 10 mg/1?
The NDC (National Drug Code) for Caduet 10 mg/1 is 0069-7810, listed by Pfizer Laboratories Div Pfizer Inc.
Other Caduet Dosages
Other Amlodipine Brands
See all →- Amlodipine and Atorvastatin5 mg/172162-2093
- Amlodipine and Atorvastatin10 mg/146708-764
- Amlodipine and Atorvastatin2.5 mg/166993-264
- Amlodipine and Atorvastatin5 mg/166993-266
- Amlodipine and Atorvastatin10 mg/166993-271
- Amlodipine and atorvastatin10 mg/10378-4518
- Amlodipine and Atorvastatin5 mg/146708-758
- Amlodipine and Atorvastatin5 mg/146708-761
- Amlodipine and Atorvastatin10 mg/146708-765
- Amlodipine and Atorvastatin5 mg/166993-269
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)