amlodipine (Rx)

Brand and Other Names:Norvasc
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 2.5mg
  • 5mg
  • 10mg
more...

Hypertension

5 mg/day PO initially; may be increased by 2.5 mg/day every 7-14 days; not to exceed 10 mg/day PO; maintenance: 5-10 mg/day PO

Coronary Artery Disease

Treatment of chronic stable angina and vasospastic angina (Prinzmetal or variant angina) and angiographically documented coronary artery disease (CAD) in patients without heart failure or ejection fraction (EF) <40%

5-10 mg/day PO initially; maintenance: 10 mg/day PO

Angina

5-10 mg/day PO; maintenance: 10 mg/day PO

Dosage Modifications

Hepatic insufficiency: Consider starting with 2.5 mg/day PO

Severe hepatic impairment: Titrate slowly

Dosing Considerations

Also given in combination with benazepril (Lotrel), atorvastatin (Caduet), olmesartan (Azor), telmisartan (Twynsta), and valsartan (Exforge)

Dosage Forms & Strengths

tablet

  • 2.5mg
  • 5mg
  • 10mg
more...

Hypertension

<6 years: Safety and efficacy not established

≥6 years: 2.5-5 mg/day PO

Start dosing at low end of dosing range; elderly patients have greater frequency of decreased renal, hepatic or cardiac function

Hypertension

2.5-5 mg/day PO initially; may be increased by 2.5 mg/day every 7-14 days; not to exceed 10 mg/day PO; maintenance: 5-10 mg/day PO

Coronary Artery Disease

Treatment of chronic stable angina and vasospastic angina (Prinzmetal or variant angina) and angiographically documented CAD in patients without heart failure or EF <40%

2.5-10 mg/day PO initially; maintenance: 10 mg/day PO

Angina

2.5-10 mg/day PO; maintenance: 10 mg/day

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Interactions

Interaction Checker

and amlodipine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Edema (1.8-10.8%)

            Pulmonary edema (7-15%)

            1-10%

            Headache (7.3%)

            Fatigue (4.5%)

            Palpitations (0.7-4.5%)

            Dizziness (1.1-3.4%)

            Nausea (2.9%)

            Flushing (0.7-2.6%)

            Abdominal pain (1.6%)

            Somnolence (1.4%)

            Male sexual disorder (1-2%)

            Drowsiness (1%)

            Pruritus (1-2%)

            Skin rash (1-2%)

            Muscle cramps (1-2%)

            Muscle weakness (1-2%)

            Postmarketing Reports

            Extrapyramidal disorder

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Congestive heart failure (CHF)

            Persistent progressive dermatologic reactions

            Symptomatic hypotension with or without syncope possible, particularly with severe aortic stenosis; because of gradual onset of action, acute hypotension unlikely

            Worsening of angina and acute myocardial infarction (MI) can develop after dose is started or increased, particularly with severe obstructive CAD

            Peripheral edema may develop within 2-3 weeks of starting therapy

            Use with caution in patients with hypertrophic cardiomyopathy; reduction in afterload may worsen symptoms associated with this condition

            May reduce coronary perfusion and result in ischemia in patients with severe aortic stenosis; use caution

            Extensively metabolized by liver; titrate dose slowly with severe hepatic impairment

            Initiate at lower dose in the elderly

            Titrate dose every 7-14 days on a given dose; peak antihypertensive effect is delayed

            Co-administration 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

            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

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            Pregnancy & Lactation

            Pregnancy

            The limited available data based on post-marketing reports are not sufficient to inform a drug-associated risk for major birth defects and miscarriage during pregnancy; there are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy

            Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly

            Lactation

            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 infant reported; 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

            Inhibits transmembrane influx of extracellular calcium ions across membranes of myocardial cells and vascular smooth muscle cells without changing serum calcium concentrations; this inhibits cardiac and vascular smooth muscle contraction, thereby dilating main coronary and systemic arteries

            Increases myocardial oxygen delivery in patients with vasospastic angina

            Absorption

            Bioavailability: 64-90%

            Onset: 24-96 hr

            Duration: 24 hr (antihypertensive effect)

            Peak plasma time: 6-12 hr

            Distribution

            Protein bound: 93-98%

            Vd: 21 L/kg

            Metabolism

            Extensively metabolized in liver by CYP3A4

            Metabolites: Pyridine analogue (inactive)

            Elimination

            Half-life: 30-50 hr

            Excretion: Urine (70%)

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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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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