Amlodipine Besylate

Generic Name: amlodipine besylate

Over-the-Counter (OTC)

Brand Names:

Amlodipine Besylate

Amlodipine besylate is a long-acting calcium channel blocker (dihydropyridine class). Available as tablets in 2.5, 5, or 10 mg strengths.

Overview

Amlodipine besylate is a long-acting calcium channel blocker (dihydropyridine class). Available as tablets in 2.5, 5, or 10 mg strengths.

Uses

Indicated for treatment of hypertension to lower blood pressure and reduce risk of cardiovascular events including strokes and myocardial infarctions. Also used for coronary artery disease including chronic stable angina, vasospastic angina (Prinzmetal's variant), and angiographically documented disease.

Dosage

Adults: usual initial dose 5 mg once daily, maximum 10 mg daily. Elderly or hepatically impaired patients start at 2.5 mg daily. For angina, 5-10 mg daily with most requiring 10 mg. Children ages 6-17: 2.5-5 mg once daily. Allow 7-14 days between dosage adjustments.

Side Effects

Most common adverse reaction is dose-related peripheral edema. Other frequent effects include fatigue, nausea, abdominal pain, and somnolence. Dose-related effects also include dizziness, flushing, and palpitations. Rare serious events include arrhythmias, angioedema, and gingival hyperplasia.

Interactions

CYP3A inhibitors increase systemic exposure; monitor and consider dose reduction. CYP3A inducers require blood pressure monitoring. Simvastatin dose limited to 20 mg daily with amlodipine. Cyclosporine and tacrolimus levels increase, requiring frequent monitoring.

Warnings

Symptomatic hypotension possible, particularly in severe aortic stenosis patients. Worsening angina and acute myocardial infarction can develop after starting or increasing dose, particularly in severe obstructive coronary artery disease. Titrate slowly in patients with severe hepatic impairment.

Pregnancy

Limited post-marketing data insufficient to determine drug-associated birth defect risk. Animal studies showed no teratogenicity at doses 10-20 times maximum recommended human dose. Risks to mother and fetus associated with uncontrolled hypertension in pregnancy.

Storage

Store at 20°C to 25°C (68°F to 77°F). Protect from light. Keep in tight, light-resistant, child-resistant containers.

Frequently Asked Questions

What is Amlodipine Besylate used for?

Indicated for treatment of hypertension to lower blood pressure and reduce risk of cardiovascular events including strokes and myocardial infarctions. Also used for coronary artery disease including chronic stable angina, vasospastic angina (Prinzmetal's variant), and angiographically documented disease.

What are the side effects of Amlodipine Besylate?

Most common adverse reaction is dose-related peripheral edema. Other frequent effects include fatigue, nausea, abdominal pain, and somnolence. Dose-related effects also include dizziness, flushing, and palpitations. Rare serious events include arrhythmias, angioedema, and gingival hyperplasia.

Can I take Amlodipine Besylate during pregnancy?

Limited post-marketing data insufficient to determine drug-associated birth defect risk. Animal studies showed no teratogenicity at doses 10-20 times maximum recommended human dose. Risks to mother and fetus associated with uncontrolled hypertension in pregnancy.

What are the important warnings for Amlodipine Besylate?

Symptomatic hypotension possible, particularly in severe aortic stenosis patients. Worsening angina and acute myocardial infarction can develop after starting or increasing dose, particularly in severe obstructive coronary artery disease. Titrate slowly in patients with severe hepatic impairment.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.