amlodipine (Rx)

Brand and Other Names:Norvasc, Katerzia
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 2.5mg (Norvasc, generic)
  • 5mg (Norvasc, generic)
  • 10mg (Norvasc, generic)

oral suspension

  • 1mg/mL (Katerzia)

Hypertension

Indicated for hypertension, to lower blood pressure

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions

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

Adjust dosage according to blood pressure goals

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

Renal impairment

  • Pharmacokinetics of amlodipine are not significantly affected by renal impairment; therefore no dosage adjustment necessary

Hepatic impairment

  • Lower initial dose may be required for patients with hepatic impairment
  • Consider starting with 2.5 mg/day PO

Dosage Forms & Strengths

tablet

  • 2.5mg (Norvasc, generic)
  • 5mg (Norvasc, generic)
  • 10mg (Norvasc, generic)

oral suspension

  • 1mg/mL (Katerzia)

Hypertension

<6 years: Safety and efficacy not established

6-17 years

  • Indicated for hypertension, to lower blood pressure
  • Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions
  • 2.5-5 mg/day PO; doses above 5 mg/day have been studied

Dosage Modifications

Renal impairment

  • Pharmacokinetics of amlodipine are not significantly affected by renal impairment; therefore no dosage adjustment necessary

Hepatic impairment

  • Lower initial dose may be required for patients with hepatic impairment
  • Consider starting with 2.5 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%)

            <1%

            Cardiovascular: Arrhythmia (eg, ventricular tachycardia, atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis

            Central and peripheral nervous system: Hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo

            Gastrointestinal: Anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia

            General: Allergic reaction, asthenia, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease

            Musculoskeletal system: Arthralgia, arthrosis, muscle cramps, myalgia

            Psychiatric: Sexual dysfunction (male and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization

            Respiratory system: dyspnea, epistaxis

            Skin and appendages: Angioedema, erythema multiforme, pruritus, rash, rash erythematous, rash maculopapular

            Special senses: Abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus

            Urinary system: Micturition frequency, micturition disorder, nocturia

            Autonomic nervous system: Dry mouth, sweating increased

            Metabolic and nutritional: hyperglycemia, thirst

            Hemopoietic: leukopenia, purpura, thrombocytopenia

            Postmarketing Reports

            Extrapyramidal disorder

            Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis)

            Gynecomastia

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Symptomatic hypotension is possible, particularly with severe aortic stenosis; owing to 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

            Extensively metabolized by the liver and plasma elimination half-life is 56 hr in patients with hepatic impairment; titrate slowly when treating patients with severe hepatic impairment

            Drug interaction overview

            • Sildenafil: Monitor for hypotension when sildenafil is coadministered with amlodipine
            • CYP3A4 Inhibitors
              • Coadministration with moderate or strong CYP3A inhibitors may increase systemic exposure to amlodipine and may require dose reduction
              • Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors
            • CYP3A4 inducers
              • No information available on the quantitative effects of CYP3A4 inducers on amlodipine
              • Closely monitor blood pressure when amlodipine is coadministered with CYP3A4 inducers
            • Simvastatin
              • Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin
              • Limit simvastatin dose in patients on amlodipine 20 mg/day
            • Immunosuppressants
              • Amlodipine may increase systemic exposure of cyclosporine or tacrolimus when coadministered
              • Frequent monitoring trough blood levels of cyclosporine and tacrolimus and adjust dose when appropriate
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            Pregnancy & Lactation

            Pregnancy

            Limited available data based on postmarketing reports are insufficient to inform a drug-associated risk for major birth defects and miscarriage during pregnancy

            Clinical considerations

            • Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, postpartum hemorrhage)
            • Hypertension increases fetal risk for intrauterine growth restriction and intrauterine death
            • Carefully monitor pregnant women with hypertension and manage 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

            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

            Steady-state plasma levels are reached after 7-8 days of consecutive dosing

            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 (10% [parent]; 60% [inactive metabolites])

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            Administration

            Oral Administration

            Take with or without food

            Suspension: Shake well before using

            Storage

            Tablets: Store bottles at controlled room temperature, 15-30°C (59-86°F) and dispense in tight, light-resistant containers

            Oral suspension: Refrigerate at 2-8°C (36-46°F); avoid freezing and excessive heat; protect from light

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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.