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Inderal (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 antihypertensive agent. Propranolol contributed to control of diastolic blood pressure, but the magnitude of the effect of propranolol on blood pressure cannot be ascertained.

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.

Atrial Fibrillation

In a report examining the long-term (5-22 months) efficacy of propranolol, 10 patients, aged 27 to 80, with atrial fibrillation and ventricular rate >120 beats per minute despite digitalis, received propranolol up to 30 mg t.i.d. Seven patients (70%) achieved ventricular rate reduction to <100 beats per minute.

Myocardial Infarction

The Beta-Blocker Heart Attack Trial (BHAT) was a National Heart, Lung and Blood Institute-sponsored multicenter, randomized, double-blind, placebo-controlled trial conducted in 31 U.S. centers (plus one in Canada) in 3,837 persons without history of severe congestive heart failure or presence of recent heart failure; certain conduction defects; angina since infarction, who had survived the acute phase of myocardial infarction. Propranolol was administered at either 60 or 80 mg t.i.d. based on blood levels achieved during an initial trial of 40 mg t.i.d. Therapy with Inderal, begun 5 to 21 days following infarction, was shown to reduce overall mortality up to 39 months, the longest period of follow-up. This was primarily attributable to a reduction in cardiovascular mortality. The protective effect of Inderal was consistent regardless of age, sex, or site of infarction. Compared with placebo, total mortality was reduced 39% at 12 months and 26% over an average follow-up period of 25 months. The Norwegian Multicenter Trial in which propranolol was administered at 40 mg q.i.d. gave overall results which support the findings in the BHAT.

Although the clinical trials used either t.i.d. or q.i.d. dosing, clinical, pharmacologic, and pharmacokinetic data provide a reasonable basis for concluding that b.i.d. dosing with propranolol should be adequate in the treatment of postinfarction patients.

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.

Essential Tremor

In a 2 week, double-blind, parallel, placebo-controlled study of 9 patients with essential or familial tremor, propranolol, at a dose titrated as needed from 40-80 mg t.i.d. reduced tremor severity compared to 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.

Pheochromocytoma

In an uncontrolled series of 3 patients with norepinephrine-secreting pheochromocytoma who were pretreated with an alpha adrenergic blocker (prazosin), perioperative use of propranolol at doses of 40-80 mg t.i.d. resulted in symptomatic blood pressure control.

INDICATIONS AND USAGE

Hypertension

Inderal 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 is not indicatedin the management of hypertensive emergencies.

Angina Pectoris Due to Coronary Atherosclerosis

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

Atrial Fibrillation

Inderal is indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.

Myocardial Infarction

Inderal is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.

Migraine

Inderal 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.

Essential Tremor

Inderal is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Inderal causes a reduction in the tremor amplitude, but not in the tremor frequency. Inderal is not indicated for the treatment of tremor associated with Parkinsonism.

Hypertrophic Subaortic Stenosis

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

Pheochromocytoma

Inderal is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.

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 Inderal 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.

While twice-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, some patients, especially when lower doses are used, may experience a modest rise in blood pressure toward the end of the 12-hour dosing interval. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. If control is not adequate, a larger dose, or 3‑times‑daily therapy may achieve better control.

Angina Pectoris

Total daily doses of 80 mg to 320 mg Inderal, when administered orally, twice a day, three times a day, or four times a day, have been shown to increase exercise tolerance and to reduce ischemic changes in the ECG. If treatment is to be discontinued, reduce dosage gradually over a period of several weeks. (See WARNINGS.)

Atrial Fibrillation

The recommended dose is 10 mg to 30 mg Inderal three or four times daily before meals and at bedtime.

Myocardial Infarction

In the Beta-Blocker Heart Attack Trial (BHAT), the initial dose was 40 mg t.i.d., with titration after 1 month to 60 mg to 80 mg t.i.d. as tolerated. The recommended daily dosage is 180 mg to 240 mg Inderal per day in divided doses. Although a t.i.d. regimen was used in the BHAT and a q.i.d. regimen in the Norwegian Multicenter Trial, there is a reasonable basis for the use of either a t.i.d. or b.i.d. regimen (see PHARMACODYNAMICS AND CLINICAL EFFECTS). The effectiveness and safety of daily dosages greater than 240 mg for prevention of cardiac mortality have not been established. However, higher dosages may be needed to effectively treat coexisting diseases such as angina or hypertension (see above).

Migraine

The initial dose is 80 mg Inderal daily in divided doses. The usual effective dose range is 160 mg to 240 mg per day. The dosage may be increased gradually to achieve optimum migraine prophylaxis. If a satisfactory response is not obtained within four to six weeks after reaching the maximum dose, Inderal therapy should be discontinued. It may be advisable to withdraw the drug gradually over a period of several weeks.

Essential Tremor

The initial dosage is 40 mg Inderal twice daily. Optimum reduction of essential tremor is usually achieved with a dose of 120 mg per day. Occasionally, it may be necessary to administer 240 mg to 320 mg per day.

Hypertrophic Subaortic Stenosis

The usual dosage is 20 mg to 40 mg Inderal three or four times daily before meals and at bedtime.

Pheochromocytoma

The usual dosage is 60 mg Inderal daily in divided doses for three days prior to surgery as adjunctive therapy to alpha-adrenergic blockade. For the management of inoperable tumors, the usual dosage is 30 mg daily in divided doses as adjunctive therapy to alpha-adrenergic blockade.

HOW SUPPLIED

Inderal®
(propranolol hydrochloride)

Tablets

INDERAL 10 —Each hexagonal-shaped, orange, scored tablet, embossed with an “I” and imprinted with “INDERAL 10,” contains 10 mg propranolol hydrochloride, in bottles of 100 (NDC 0046-0421-81) and 5,000 (NDC 0046-0421-95).

Store at controlled room temperature 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F).

Dispense in a well-closed container as defined in the USP.

INDERAL 20 —Each hexagonal-shaped, blue, scored tablet, embossed with an “I” and imprinted with “INDERAL 20,” contains 20 mg propranolol hydrochloride, in bottles of 100 (NDC 0046-0422-81).

Store at controlled room temperature 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F).

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

Protect from light.

Use carton to protect contents from light.

INDERAL 40 —Each hexagonal-shaped, green, scored tablet, embossed with an “I” and imprinted with “INDERAL 40,” contains 40 mg propranolol hydrochloride, in bottles of 100 (NDC 0046-0424-81) and 5,000 (NDC 0046-0424-95).

Store at controlled room temperature 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F).

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

Protect from light.

Use carton to protect contents from light.

INDERAL 60 —Each hexagonal-shaped, pink, scored tablet, embossed with an “I” and imprinted with “INDERAL 60,” contains 60 mg propranolol hydrochloride, in bottles of 100 (NDC 0046-0426-81).

Store at controlled room temperature 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F).

Dispense in a well-closed container as defined in the USP.

INDERAL 80 —Each hexagonal-shaped, yellow, scored tablet, embossed with an “I” and imprinted with “INDERAL 80,” contains 80 mg propranolol hydrochloride, in bottles of 100 (NDC 0046-0428-81).

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]

Dispense in a well-closed container as defined in the USP.

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

Wyeth ®

Wyeth Pharmaceuticals Inc.
Philadelphia, PA 19101

W10486C007
ET01
Rev 12/07

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