Classes
DEA Class; Rx
Common Brand Names; Norvasc, Katerzia, Norliqva
- Antianginal Agents;
- Calcium Channel Blockers, Dihydropyridine
Description
Oral dihydropyridine calcium channel blocker; potent peripheral vasodilator
Used for hypertension and angina
Once daily dosing due to long half-life
Indications
Indicated for the treatment of hypertension.
Contraindications
Hypersensitivity
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
10 mg/day PO.
10 mg/day PO.
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.
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.
Safety and efficacy have not been established.
How supplied
Amlodipine besylate
tablet
2.5mg (Norvasc, generic)
5mg (Norvasc, generic)
10mg (Norvasc, generic)
oral suspension
1mg/mL (Katerzia)
oral solution
1mg/mL (Norliqva)