Amlopin 10

• Essential hypertension - alone or in combination with other antihypertensive agents
• Chronic stable angina pectoris - alone or in combination with other antianginal agents
• Vasospastic angina (Prinzmetal's or variant angina) - as monotherapy or in combination with other antianginal drugs

Amlodipine Besilate is a dihydropyridine calcium-channel blocker with a long duration of action, used for the treatment of hypertension and angina pectoris. Amlodipine influences the myocardial cells, the cells within the specialized conducting system of the heart, and the cells of vascular smooth muscle.

Administration of amlodipine results primarily in vasodilation, with reduced peripheral resistance, blood pressure and afterload, increased coronary blood flow and a reflex increase in heart rate. This in turn results in an increase in myocardial oxygen supply and cardiac output.

Hypertension: 5 mg once daily (maximum 10 mg). Elderly and hepatic impairment patients may start with 2.5 mg once daily.

Angina (Chronic stable or Vasospastic): 5-10 mg daily (lower dose for elderly and hepatic impairment). Most patients require 10 mg.

Pediatric (6-17 years - hypertension): 2.5 mg once daily initial, up to 5 mg once daily after 4 weeks. Efficacy in children <6 years not established.

Hepatic Impairment: Severe hepatic impairment: start with 2.5 mg once daily and titrate slowly.

Renal Impairment: No dose adjustment needed (amlodipine is not dialyzable).

• Fatigue
• Ankle swelling
• Sleepiness
• Dizziness
• Flushing
• Headache
• Nausea
• Palpitations
• Edema
• Abdominal pain
• Increased micturition frequency
• Lethargy
• Eye pain
• Mental depression

Rare: Increased angina, excessive hypotension, cerebral or myocardial ischemia, transient blindness, rash, fever, liver function abnormalities

[CONSULT YOUR DOCTOR] Amlodipine may be unsafe during pregnancy (Category C). Animal studies have shown harmful effects on the developing baby. Use only if potential benefit justifies the risk.

Serious Precautions:

• Patients with severe obstructive coronary artery disease may develop increased angina or MI when starting calcium channel blocker therapy or increasing dose
• Caution in severe aortic stenosis, hepatic impairment
• Caution in severe left ventricular dysfunction, sick-sinus syndrome, hypertrophic cardiomyopathy
• Heart failure patients may have increased risk of pulmonary edema
• Caution during pregnancy - animal studies have shown fetal risk
• Blood pressure may drop suddenly - rise slowly from sitting or lying position
• Caution while driving or operating machinery - may cause dizziness

Symptoms: Excessive peripheral vasodilation, reflex tachycardia, severe and prolonged systemic hypotension, shock (may be fatal).

Management: Cardiovascular support (monitoring cardiac and respiratory function, elevation of extremities, monitoring fluid volume and urine output). Vasoconstrictors may be used. IV calcium gluconate may help reverse calcium channel blockade. Gastric lavage may be helpful. Dialysis is not effective as amlodipine is highly protein-bound.

Keep out of reach of children. Store in a cool and dry place, protected from light.