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Important Safety Information and Indication
Important Safety Information and Indication
CADUET® (amlodipine besylate/atorvastatin calcium) tablets are contraindicated in patients with a known hypersensitivity to any component of this medication; in patients with active liver disease or unexplained persistent elevations of hepatic transaminases, and in women who are or may become pregnant or who are nursing.
Rare cases of rhabdomyolysis have been reported with the atorvastatin component of CADUET and with other statins. Tell patients to promptly report muscle pain, tenderness, or weakness. Predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment. Patients with a history of renal impairment merit closer monitoring. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued.
The concomitant use of higher doses of the atorvastatin component of CADUET with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis. Lower doses of atorvastatin should be considered. Physicians should carefully monitor patients for signs or symptoms of myopathy early during therapy and when titrating the dose of either drug.
It is recommended that liver function tests be performed prior to the initiation of CADUET therapy and repeated as clinically indicated thereafter. Titrate slowly when administering to patients with severe hepatic impairment. Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of the amlodipine component of CADUET, particularly in patients with severe obstructive coronary artery disease. Symptomatic hypotension is also possible, particularly in patients with severe aortic stenosis. Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including the atorvastatin component of CADUET.
Most common side effects are edema, fatigue, somnolence, abdominal pain, diarrhea, nausea, dizziness, flushing, arrhythmia, palpitations, nasopharyngitis, arthralgia, pain in extremity, and urinary tract infection. These were similar to those reported previously with amlodipine and/or atorvastatin.
In a post hoc analysis of the SPARCL study in patients without CHD who had a stroke or TIA within the preceding 6 months, a higher incidence of hemorrhagic stroke was seen in the atorvastatin 80mg group compared with placebo (2.3% vs. 1.4%). Some baseline characteristics, including hemorrhagic and lacunar stroke on study entry, were associated with a higher incidence of hemorrhagic stroke in the atorvastatin group.
CADUET tablets are a combination of two medications, NORVASC® (amlodipine besylate) tablets and LIPITOR® (atorvastatin calcium) tablets, and are indicated in patients for whom treatment with both NORVASC and LIPITOR is appropriate.
NORVASC® (amlodipine besylate) is indicated for the treatment of hypertension. NORVASC is also indicated for three forms of Coronary Artery Disease (CAD): symptomatic treatment of chronic stable angina; treatment of confirmed or suspected vasospastic angina (Prinzmetal’s or Variant Angina); and to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure in angiographically documented CAD patients without heart failure or an ejection fraction <40%.
LIPITOR® (atorvastatin calcium) is indicated as an adjunct to diet to reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adult patients with multiple risk factors but without clinically evident coronary heart disease (CHD); to reduce the risk of MI and stroke in patients with type 2 diabetes and without clinically evident CHD, but with multiple risk factors; to reduce the risk of nonfatal MI, fatal and nonfatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adult patients with clinically evident CHD.
LIPITOR, as an adjunct to diet, is also indicated to reduce elevated total-C, LDL-C, apo B, and TG levels; and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.
*Terms and Conditions
By using the CADUET Cares Card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
- The Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico [formerly known as “La Reforma De Salud”])
- The Card is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs that reimburse you for the entire cost of your prescription drugs
- Patients must be 18 or older
- By using the Card, patients will pay a minimum of $4 per refill and receive savings of up to $150 per refill. The Card is good for a maximum savings of $1800 per calendar year
- You must deduct the value received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
- The Card is not valid for Massachusetts residents whose prescriptions are covered in whole or in part by third-party insurance, or where otherwise prohibited by law
- The Card cannot be combined with any other rebate or coupon, free trial, or similar offer for the specified prescription
- The Card will be accepted only at participating pharmacies
- The Card is not health insurance
- This offer is good only in the United States and Puerto Rico
- The Card is limited to one per person during this offering period and is not transferable
- Pfizer reserves the right to rescind, revoke, or amend the Card without notice
- The Card expires on December 31, 2016. No membership fees apply
For help with the CADUET Cares Card, call 1-877-CADUET-4 (1-877-223-8384), visit www.caduet.com, or write: Pfizer, Attn: CADUET, PO Box 2169, Morrisville, PA 19067-0669.
For reimbursement when using a non-participating pharmacy/mail order:
Pay for your CADUET prescription and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: Pfizer, ATTN: CADUET, PO Box 2169, Morrisville, PA 19067-0669. Be sure to include a copy of the front of your CADUET Cares Card, your name, and mailing address. Please expect up to 4 to 6 weeks for reimbursement.