Propranolol Hydrochloride

What it is and how it works

Mechanism of Action The mechanism of the antihypertensive effect of propranolol has not been established. Factors that may contribute to the antihypertensive action include: decreased cardiac output, inhibition of renin release by the kidneys, and diminution of tonic sympathetic nerve outflow from vasomotor centers in the brain. Although total peripheral resistance may increase initially, it readjusts to or below the pretreatment level with chronic use of propranolol. Effects of propranolol on plasma volume appear to be minor and somewhat variable.

Indications

INDICATIONS AND USAGE Hypertension Propranolol hydrochloride tablets, USP 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 tablets, USP are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride tablets, USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride tablets, USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction Propranolol hydrochloride tablets, USP are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine Propranolol hydrochloride tablets, USP are indicated for the prophylaxis of common migraine headache.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION General Because of the variable bioavailability of propranolol, the dose should be individualized based on response. Hypertension The usual initial dosage is 40 mg propranolol hydrochloride twice daily, whether used alone or added to a diuretic. Dosage may be increased gradually until adequate blood pressure control is achieved. The usual maintenance dosage is 120 mg to 240 mg per day. In some instances a dosage of 640 mg a day may be required. The time needed for full antihypertensive response to a given dosage is variable and may range from a few days to several weeks.

Contraindications

CONTRAINDICATIONS Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.

Warnings and precautions

WARNINGS Angina Pectoris There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. Therefore, when discontinuance of propranolol is planned, the dosage should be gradually reduced over at least a few weeks and the patient should be cautioned against interruption or cessation of therapy without the physician's advice.

Pregnancy

Pregnancy In a series of reproductive and developmental toxicology studies, propranolol hydrochloride was given to rats by gavage or in the diet throughout pregnancy and lactation.

Storage and supply

HOW SUPPLIED Propranolol Hydrochloride Tablets, USP, 20 mg are blue, round, flat faced, beveled edge, scored tablets, debossed “54” bisect “83” on one side and debossed “V” on the reverse side. They are available as follows: Bottles of 1000: 63629-2277-1 Store at 20° to 25°C (68° to 77°F) .

Source: Propranolol Hydrochloride (Propranolol Hydrochloride) — US FDA prescribing information, 2024-10-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.