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Inderal LA (Propranolol Hydrochloride) - Indications and Dosage

 
 



PHARMACODYNAMICS AND CLINICAL EFFECTS

Hypertension

In a retrospective, uncontrolled study, 107 patients with diastolic blood pressure 110 to 150 mmHg received propranolol 120 mg t.i.d. for at least 6 months, in addition to diuretics and potassium, but with no other hypertensive agent. Propranolol contributed to control of diastolic blood pressure, but the magnitude of the effect of propranolol on blood pressure cannot be ascertained.

Four double-blind, randomized, crossover studies were conducted in a total of 74 patients with mild or moderately severe hypertension treated with Inderal LA 160 mg once daily or propranolol 160 mg given either once daily or in two 80 mg doses. Three of these studies were conducted over a 4-week treatment period. One study was assessed after a 24-hour period. Inderal LA was as effective as propranolol in controlling hypertension (pulse rate, systolic and diastolic blood pressure) in each of these trials.

Angina Pectoris

In a double-blind, placebo-controlled study of 32 patients of both sexes, aged 32 to 69 years, with stable angina, propranolol 100 mg t.i.d. was administered for 4 weeks and shown to be more effective than placebo in reducing the rate of angina episodes and in prolonging total exercise time.

Twelve male patients with moderately severe angina pectoris were studied in a double-blind, crossover study. Patients were randomized to either Inderal LA 160 mg daily or conventional propranolol 40 mg four times a day for 2 weeks. Nitroglycerine tablets were allowed during the study. Blood pressure, heart rate and ECG's were recorded during serial exercise treadmill testing. Inderal LA was as effective as conventional propranolol for exercise heart rate, systolic and diastolic blood pressure, duration of anginal pain and ST-segment depression before or after exercise, exercise duration, angina attack rate and nitroglycerine consumption.

In another double-blind, randomized, crossover trial, the effectiveness of propranolol LA 160 mg daily and conventional propranolol 40 mg four times a day were evaluated in 13 patients with angina. ECG's were recorded while patients exercised until angina developed. Inderal LA was as effective as conventional propranolol for amount of exercise performed, ST-segment depression, number of anginal attacks, amount of nitroglycerine consumed, systolic and diastolic blood pressures and heart rate at rest and after exercise.

Migraine

In a 34-week, placebo-controlled, 4-period, dose-finding crossover study with a double-blind randomized treatment sequence, 62 patients with migraine received propranolol 20 to 80 mg 3 or 4 times daily. The headache unit index, a composite of the number of days with headache and the associated severity of the headache, was significantly reduced for patients receiving propranolol as compared to those on placebo.

Hypertrophic Subaortic Stenosis

In an uncontrolled series of 13 patients with New York Heart Association (NYHA) class 2 or 3 symptoms and hypertrophic subaortic stenosis diagnosed at cardiac catheterization, oral propranolol 40-80 mg t.i.d. was administered and patients were followed for up to 17 months. Propranolol was associated with improved NYHA class for most patients.

INDICATIONS AND USAGE

Hypertension

Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies.

Angina Pectoris Due to Coronary Atherosclerosis

Inderal LA is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.

Migraine

Inderal LA is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.

Hypertrophic Subaortic Stenosis

Inderal LA improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.

DOSAGE AND ADMINISTRATION

General

Inderal® LA provides propranolol hydrochloride in a sustained-release capsule for administration once daily. If patients are switched from Inderal Tablets to Inderal LA Capsules, care should be taken to assure that the desired therapeutic effect is maintained. Inderal LA should not be considered a simple mg-for-mg substitute for Inderal. Inderal LA has different kinetics and produces lower blood levels. Retitration may be necessary, especially to maintain effectiveness at the end of the 24-hour dosing interval.

Hypertension

The usual initial dosage is 80 mg Inderal LA once daily, whether used alone or added to a diuretic. The dosage may be increased to 120 mg once daily or higher until adequate blood pressure control is achieved. The usual maintenance dosage is 120 to 160 mg once daily. In some instances a dosage of 640 mg may be required. The time needed for full hypertensive response to a given dosage is variable and may range from a few days to several weeks.

Angina Pectoris

Starting with 80 mg Inderal LA once daily, dosage should be gradually increased at three- to seven-day intervals until optimal response is obtained. Although individual patients may respond at any dosage level, the average optimal dosage appears to be 160 mg once daily. In angina pectoris, the value and safety of dosage exceeding 320 mg per day have not been established.

If treatment is to be discontinued, reduce dosage gradually over a period of a few weeks (see  “WARNINGS”).

Migraine

The initial oral dose is 80 mg Inderal LA once daily. The usual effective dose range is 160 to 240 mg once daily. The dosage may be increased gradually to achieve optimal migraine prophylaxis. If a satisfactory response is not obtained within four to six weeks after reaching the maximal dose, Inderal LA therapy should be discontinued. It may be advisable to withdraw the drug gradually over a period of several weeks depending on the patient's age, comorbidity, and dose of Inderal LA.

Hypertrophic Subaortic Stenosis

The usual dosage is 80 to 160 mg Inderal LA once daily.

HOW SUPPLIED

Inderal® LA Capsules (propranolol hydrochloride)

Each white/light-blue capsule, identified by 3 narrow bands, 1 wide band, and “INDERAL LA 60,” contains 60 mg of propranolol hydrochloride in bottles of 100 (NDC 0046‑0470‑81).

Each light-blue capsule, identified by 3 narrow bands, 1 wide band, and “INDERAL LA 80,” contains 80 mg of propranolol hydrochloride in bottles of 100 (NDC 0046-0471-81).

Each light-blue/dark-blue capsule, identified by 3 narrow bands, 1 wide band, and “INDERAL LA 120,” contains 120 mg of propranolol hydrochloride in bottles of 100 (NDC 0046-0473-81).

Each dark-blue capsule, identified by 3 narrow bands, 1 wide band, and “INDERAL LA 160,” contains 160 mg of propranolol hydrochloride in bottles of 100 (NDC 0046-0479-81).

The appearance of these capsules is a registered trademark of Wyeth Pharmaceuticals.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]

Protect from light, moisture, freezing, and excessive heat.

Dispense in a tight, light-resistant container as defined in the USP.

This product’s label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556.

Wyeth ®

Wyeth Pharmaceuticals Inc.
Philadelphia, PA 19101

W10478C009
ET01
Rev 11/07

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