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Amlodipine

    Brands

    DEA Class; Rx

    Common Brand Names; Norvasc, Katerzia, Norliqva

    • Antianginal Agents; 
    • Calcium Channel Blockers, Dihydropyridine

    Oral dihydropyridine calcium channel blocker; potent peripheral vasodilator
    Used for hypertension and angina
    Once daily dosing due to long half-life

    Indicated for the treatment of hypertension.

    For the treatment of coronary artery disease (CAD), including chronic stable angina, variant angina (Prinzmetal angina), and angiographically documented CAD without heart failure or ejection fraction less than 40%.
    For the treatment of pulmonary hypertension.

    Hypersensitivity

    • Edema (1.8-10.8%)
    • 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%)
    • Asthenia (1-2%)
    • Pruritus (1-2%)
    • Skin rash (1-2%)
    • Muscle cramps (1-2%)
    • Male sexual dysfunction (1-2%)
    • 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

    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

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

    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

    Adults

    10 mg/day PO.

    Geriatric

    10 mg/day PO.

    Adolescents

    5 mg/day PO is the maximum dosage per FDA-approved labeling; however, doses up to 0.6 mg/kg/day PO (usually not exceeding adult max: 10 mg/day) have been reported.

    Children

    6 to 12 years: 5 mg/day PO is the maximum dosage per FDA-approved labeling; however, doses up to 0.6 mg/kg/day PO (usually not exceeding adult max: 10 mg/day) have been reported.
    1 to 5 years: Safety and efficacy have not been established; however, doses up to 0.6 mg/kg/day PO have been reported off-label.

    Infants

    Safety and efficacy have not been established.

    Amlodipine besylate

    tablet

    • 2.5mg (Norvasc, generic)

    • 5mg (Norvasc, generic)

    • 10mg (Norvasc, generic)

    oral suspension

    • 1mg/mL (Katerzia)

    oral solution

    • 1mg/mL (Norliqva)