PROPRANOLOL HYDROCHLORIDE
Propranolol hydrochloride is a non-selective beta-adrenergic blocker indicated for the management of hypertension, angina pectoris, and atrial fibrillation (specifically to control ventricular rate). It is utilized to reduce cardiovascular mortality in clinically stable survivors of the acute phase of myocardial infarction. Additionally, it is indicated for the prophylaxis of common migraine headaches, the management of familial or hereditary essential tremor, and the improvement of functional class in symptomatic hypertrophic subaortic stenosis. It is also indicated as an adjunct to alpha-adrenergic blockade in the management of pheochromocytoma to control blood pressure and symptoms.
How PROPRANOLOL HYDROCHLORIDE Works
Propranolol is a non-selective beta-adrenergic receptor antagonist that competitively blocks both beta-1 and beta-2 receptors. It lacks intrinsic sympathomimetic activity. By blocking beta-1 receptors in cardiac tissue, it decreases heart rate, myocardial contractility, and cardiac output, which reduces myocardial oxygen demand. Its antihypertensive mechanism involves a reduction in cardiac output, decreased plasma renin activity, and a reduction in sympathetic outflow from the central nervous system. In essential tremor, it acts by blocking peripheral beta-2 receptors in skeletal muscle. For migraine prophylaxis, the mechanism likely involves the modulation of cerebral vasodilation and the inhibition of central beta-receptors.
Details
- Status
- Prescription
- First Approved
- 1967-11-13
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, CAPSULE, EXTENDED RELEASE, SOLUTION, INJECTABLE
Companies
PROPRANOLOL HYDROCHLORIDE Approval History
What PROPRANOLOL HYDROCHLORIDE Treats
6 indicationsPROPRANOLOL HYDROCHLORIDE is approved for 6 conditions since its original approval in 1967. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Angina Pectoris
- Atrial Fibrillation
- Myocardial Infarction
- Migraine
- Essential Tremor
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROPRANOLOL HYDROCHLORIDE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Hypertension Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride tablets are indicated to control ventricular rate in patients w...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.