Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

amlodipine/atorvastatin

tablet

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

Prevention of Cardiovascular Disease, Hypertension/Angina & Hyperlipidemia

Dosage must be individualized for each individual component for treatment of hypertension, angina, and/or hyperlipidemia; amlodipine dose may be titrated after 1-2 weeks and the atorvastatin dose after 2-4 weeks; not to exceed 10 mg amlodipine or 80 mg atorvastatin

2.5-10 mg amlodipine; 10-80 mg atorvastatin PO qDay

Renal Impairment

Dose adjustment not necessary

Hepatic Impairment

Contraindicated in active liver disease

Dosage Forms & Strengths

amlodipine/atorvastatin

tablet

  • 2.5/10mg
  • 2.5/20mg
  • 5/10mg
  • 5/20mg

Hypertension & Heterozygous Familial Hypercholesterolemia

Dosage must be individualized for each individual component for treatment of hypertension/hyperlipidemia; amlodipine dose may be titrated after 1-2 weeks and the atorvastatin dose after 2-4 weeks; not to exceed 5 mg amlodipine or 20 mg atorvastatin

<10 years: Safety and efficacy not established

≥10 years: 2.5-5 mg amlodipine; 10-20 mg atorvastatin PO qDay

Consider initiating amlodipine dose at lower end of the spectrum due to possible decrease in renal or hepatic clearance

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Interactions

Interaction Checker

and amlodipine/atorvastatin

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    Contraindicated

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            Adverse Effects

            >10%

            Amlodipine

            • Peripheral edema (2-15%)

            Atorvastatin

            • Arthralgia (4-12%)
            • Diarrhea (5-14%)
            • Nasopharingitis (4-13%)

            1-10%

            Amlodipine

            • Palpitation (1-5%)
            • Dizziness (1-3%)
            • Flushing (1-5%)
            • Somnolence (1-2%)
            • Rash (1-2%)
            • Fatigue (5%)
            • Pruritus (1-2%)
            • Male sexual dysfunction (1-2%)
            • Nausea (3%)
            • Dyspepsia (1-2%)
            • Dyspnea (1-2%)
            • Weakness (1-2%)

            Atorvastatin

            • Nausea (4-7%)
            • Dyspepsia (3-6%)
            • Increased transaminases (2-3% with 80 mg/day)
            • Urinary tract infection (4-8%)
            • Insomnia (1-5%)
            • Myalgia (3-8%)
            • Musculoskeletal pain (2-5%)
            • Respiratory pharyngeal pain (1-4%)

            <1%

            Amlodipine

            • Abnormal vision
            • Arthralgia
            • Chest pain
            • Abnormal dreams
            • Increased apetite
            • Acute interstitial nephritis
            • Alopecia
            • Conjunctivitis
            • Cough
            • Depression
            • Dysphagia
            • Flatulence

            Atorvastatin

            • Amnesia
            • Alopecia
            • Anorexia
            • Colitis
            • Confusion
            • Bullous rash
            • Biliary pain
            • Anemia
            • Cholestatic jaundice
            • Duodenal ulcer

            Postmarketing reports

            Myositis

            Extrapyramidal disorder

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            Warnings

            Contraindications

            Hypersensitivity to amlodipine or atorvastatin

            Active liver disease, or unexplained elevated transminases

            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 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 have 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 >3x ULN develops

            Use in patients with recent stroke or TIA: SPARCL study observed 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 diagnosed or suspected
            • Therapy should be temporarily withheld in any patient experiencing an acute or serious condition predisposing to development of renal failure secondary to rhabdomyolysis, eg, sepsis; hypotension; dehydration; major surgery; trauma; severe metabolic, endocrine, and electrolyte disorders; or uncontrolled epilepsy
            • Consider risk of IMNM carefully prior to 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 risk of IMNM carefully prior to initiation of a different statin
            • If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM

            Drug interaction overview

            • Risk of myopathy increased by coadministration with CYP3A4 inhibitors (eg, fibrates, niacin, cyclosporine, macrolides, azole antifungals); therapy should be discontinued if myopathy 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 need for dose adjustment
            • Clarithromycin, itraconazole, HIV and HCV protease inhibitors (saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir) may increase risk of myopathy/rhabdomyolysis; do not exceed 20 mg atorvastatin
            • Amlodipine may increase systemic exposure of cyclosporine or tacrolimus when co-administered; frequent monitoring of trough blood levels of cyclosporine and tacrolimus recommended; adjust dose when appropriate
            • Atorvastatin is a substrate of hepatic transporters; inhibitors of OATP1B1 (e.g., cyclosporine) can increase 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
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            Pregnancy & Lactation

            Pregnancy

            Atorvastatin

            • Owing to HMG-CoA reductase inhibitors decrease 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 request 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 female 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
            • Animal data
              • There was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times MRHD; respectively; however for rats, litter size was significantly decreased (by about 50%) and number of intrauterine deaths was significantly increased (about 5-fold); amlodipine has been shown to prolong both gestation period and duration of labor in rats at this dose

            Contraception

            • Females of reproductive potential: Use effective contraception during treatment

            Lactation

            There is no available information on effects of drug on breastfed infant or on 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 request to remove the contraindication against HMG-CoA reductase inhibitors in pregnant females
              • Breastfeeding is still not recommended if taking statins; drug may still pass through milk and pose a risk 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 estimated median relative infant dose of 4.2%; no adverse effects of amlodipine on breastfed infant observed; there is no available information on effects of amlodipine on milk production

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Amlodipine: Ca channel blocker: inhibits extracellular Ca ions across the membranes of myocardial cells and vascular smooth muscle cells, without changing serum calcium concentrations, resulting in inhibition of cardiac & vascular smooth muscle contraction, thereby dilating the main coronary and systemic arteries

            Atorvastatin: HMG-CoA reductase inhibitor, inhibits rate-limiting step in cholesterol biosynthesis by competitively inhibiting HMG-CoA reductase

            Pharmacogenomics

            SLCO1B1 (OATP1B1) CC genotype significantly increases AUCs of parent drug and metabolites compared with the CT or TT genotypes

            This polymorphism is proposed to reduced transport into the liver, the main site of statin metabolism and elimination, resulting in elevated plasma concentrations

            SLCO1B1 polymorphism is thought to have a lesser effect on the more hydrophilic statins (eg, rosuvastatin, fluvastatin) compared with more those that are more lipophilic (eg, atorvastatin, pravastatin, simvastatin)

            Other genetic polymorphisms of elimination (eg, CYP450, P-glycoprotein) for each individual drug must also be considered to explain variability for statin clearance among patients that exhibit SCLO1B1 polymorphism

            SLCO1B1 CC genotype is most common in Caucasians and Asians (15%)

            Risk of myopathy is 2.6- to 4.3-fold higher if the C allele is present and 16.9-fold higher in CC homozygotes compared with TT homozygotes

            Genetic testing laboratories

            • Optivia Biotechnology, Inc (http://optiviabio.com/index.html)

            Pharmacokinetics

            Amlodipine

            • Duration: 24 hr (antihypertensive effects)
            • Vd: 21 L/kg
            • Bioavailability: 64-90%
            • Half-life: 30-50 hr
            • Metabolism: Liver (>90%)
            • Protein binding: 93-98%
            • Peak plasma time: 6-12 hr
            • Excretion: Urine (70%)

            Atorvastatin

            • Bioavailability: 30 %
            • Vd: 381 L
            • Protein binding: >98%
            • Half-life: 14 hr (parent drug); 20-30 hr (active metabolites)
            • Peak plasma time: 1-2 hr
            • Onset of action: 3-5 days
            • Excretion: Bile; urine (< 2% as unchanged drug)
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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.