Amlodipine-Atorvastatin

Amlodipine-Atorvastatin is a combination of prescription medicines used for the prevention of cardiovascular disease, hypertension/angina, and hyperlipidemia. 

• Amlodipine-Atorvastatin  is available under the following different brand names: Caduet

Adult and pediatric dosage

Tablet

• 2.5/10 mg
• 2.5/20 mg
• 2.5/40 mg
• 5/10 mg
• 5/20 mg
• 5/40 mg
• 5/80 mg
• 10/10 mg
• 10/20 mg
• 10/40 mg
• 10/80 mg

Prevention of Cardiovascular Disease, Hypertension/Angina & Hyperlipidemia

Adult dosage

• 2.5-10 mg amlodipine; 10-80 mg atorvastatin orally every day
• Hypertension & Heterozygous Familial Hypercholesterolemia

Pediatric dosage

• Aged below 10 years: Safety and efficacy not established
• Aged above 10 years: 2.5-5 mg amlodipine; 10-20 mg atorvastatin orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Amlodipine-Atorvastatin include:

• swelling hands/ankles/feet,
• tiredness,
• flushing (warmth or redness in the face),
• headache,
• muscle pain,
• diarrhea,
• nausea,
• stomach pain,
• indigestion, or
• joint pain.

Serious side effects of Amlodipine-Atorvastatin include:

• fainting,
• fast or pounding heartbeat or fluttering in the chest,
• unexplained muscle pain
• tenderness or weakness,
• fever,
• unusual tiredness,
• dark-colored urine,
• weight gain,
• urinating less than usual or not at all,
• severe drowsiness,
• light-headedness,
• worsening chest pain,
• chest pain spreading to the arm or shoulder,
• sweating,
• general ill feeling,
• upper stomach pain,
• itching,
• loss of appetite,
• clay-colored stools, or
• jaundice (yellowing of the skin or eyes).

Rare side effects of Amlodipine-Atorvastatin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Amlodipine-Atorvastatin has severe interactions with the following drugs:
  • cyclosporine
  • dantrolene
  • gemfibrozil
• Amlodipine-Atorvastatin has serious interactions with at least 67 other drugs.
• Amlodipine-Atorvastatin has moderate interactions with at least 275 other drugs.
• Amlodipine-Atorvastatin has minor interactions with at least 51 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to amlodipine or atorvastatin
• Active liver disease, or unexplained elevated transaminases

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Amlodipine-Atorvastatin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Amlodipine-Atorvastatin?”

Cautions

• Hypotension with or without syncope is possible (particularly with severe aortic stenosis)
• Use caution in congestive heart failure
• Persistent progressive dermatologic reactions
• Exacerbation of angina and/or MI (during initiation of treatment, after a dose increase, or withdrawal of beta-blocker)
• Caution in liver impairment
• Heavy alcohol use, history of liver disease, renal failure
• Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with the atorvastatin
• Adverse reactions associated with atorvastatin therapy reported including anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), rhabdomyolysis, myositis, fatigue, tendon rupture, fatal and non-fatal hepatic failure, dizziness, depression, peripheral neuropathy, pancreatitis, and interstitial lung disease
• Withhold or discontinue if myopathy, renal failure, or transaminase levels more than 3 times the ULN develops
• Use in patients with recent stroke or TIA: SPARCL study observed a higher incidence of hemorrhagic stroke with atorvastatin 80 mg (compared with placebo)
• Increased HbA1c and fasting serum glucose levels reported with HMG-CoA reductase inhibitors
• Immune-mediated necrotizing myopathy
• Immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, reported with statin use
• IMNM is characterized by muscle biopsy showing necrotizing myopathy without significant inflammation improvement with immunosuppressive agents, proximal muscle weakness, and elevated serum creatine kinase, which persist despite discontinuation of statin treatment
• Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher drug dosage
• Treatment with immunosuppressive agents may be required
• Advice all patients starting therapy or whose dose is being increased, about the risk of myopathy, including rhabdomyolysis
• Patients should report promptly any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing therapy; additional neuromuscular and serologic testing may be necessary
• Therapy should be discontinued immediately if myopathy is diagnosed or suspected
• Discontinue therapy if markedly elevated creatine kinase (CK) levels occur or if myopathy is diagnosed or suspected
• Therapy should be temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis, e.g., sepsis; hypotension; dehydration; major surgery; trauma; severe metabolic, endocrine, and electrolyte disorders; or uncontrolled epilepsy
• Consider the risk of IMNM carefully before initiation of a different statin
• If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM
• Additional neuromuscular and serologic testing may be necessary
• Treatment with immunosuppressive agents may be required
• Consider the risk of IMNM carefully before initiation of a different statin
• If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM
• Drug interaction overview
  • The risk of myopathy increased by coadministration with CYP3A4 inhibitors (e.g., fibrates, niacin, cyclosporine, macrolides, azole antifungals); therapy should be discontinued if myopathy is diagnosed or suspected
  • Coadministration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction; monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment
  • Clarithromycin, itraconazole, HIV and HCV protease inhibitors (saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir) may increase the risk of myopathy/rhabdomyolysis; do not exceed 20 mg atorvastatin
  • Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered; frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended; adjust the dose when appropriate
  • Atorvastatin is a substrate of hepatic transporters; inhibitors of OATP1B1 (e.g., cyclosporine) can increase the bioavailability of atorvastatin
  • Concomitant administration of glecaprevir and pibrentasvir or elbasvir and grazoprevir may lead to increased plasma concentrations of atorvastatin and an increased risk of myopathy

Pregnancy & Lactation

• Atorvastatin
  • Owing to HMG-CoA reductase inhibitors decreasing cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, fetal harm may occur when administered to pregnant females; discontinue therapy as soon as pregnancy is recognized; limited published data are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage
• FDA MedWatch
  • On July 20, 2021, the FDA requested to remove the contraindication against HMG-CoA reductase inhibitors in pregnant females
  • Despite the changes, most females found to be pregnant should stop therapy
• Amlodipine
  • Limited available data based on postmarketing reports with use in pregnant females are not sufficient to inform a drug-associated risk for major birth defects and miscarriage
  • There are risks to mother and fetus associated with poorly controlled hypertension in pregnancy
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment.
• Lactation
  • There is no available information on the effects of drugs on breastfed infants or milk production
  • Unknown whether is present in human milk; it has been shown that drugs in this class pass into human milk and atorvastatin is present in rat milk
  • Not recommended during treatment
  • Atorvastatin
    • FDA MedWatch
    • On July 20, 2021, the FDA requested to remove the contraindication against HMG-CoA reductase inhibitors in pregnant females
    • Breastfeeding is still not recommended if taking statins; the drug may still pass through the milk and pose a risk to breastfed children
    • For patients with lower risk, temporarily stop statin therapy until breastfeeding ends
    • Patients who are at high risk of heart attack or stroke who require statins after delivery should not breastfeed and should use alternatives such as infant formula
  • Amlodipine
    • Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%; no adverse effects of amlodipine on breastfed infants are observed; there is no available information on the effects of amlodipine on milk production