NADOLOL

Adults:

Dosage should be titrated gradually with at least a week between increments to assess response; individuals show considerable variation in their response to beta-adrenergic blockade. Nadolol may be given in a once daily dosage without regard to meals.

73 m2. If Nadolol is to be discontinued, reduce dosage over a period of at least two weeks (see warnings).

Angina pectoris:

Initially 40 mg once daily. This may be increased at weekly intervals until an adequate response is obtained or excessive bradycardia occurs. Most patients respond to 160 mg or less daily. The value and safety of daily doses exceeding 240 mg have not been established.

Hypertension:

Initially 80 mg once daily. This may be increased by a weekly increment of 80 mg or less until an optimum response is obtained. Many patients respond to 80 mg daily, and most patients respond to 240 mg or less, daily, but higher doses have been required for a few patients.

In some patients it is necessary to administer a diuretic, peripheral vasodilator and/or other antihypertensive agents in conjunction with nadolol in order to achieve satisfactory response. Treatment of hypertension associated with phaeochromocytoma may require the addition of an alpha-blocking agent.

Cardiac tachyarrhythmias:

Initially 40 mg once daily. This may be increased if necessary to 160 mg once daily. If bradycardia occurs dosage should be reduced to 40 mg once daily.

Migraine:

The initial dose of nadolol is 40 mg once daily. Dosage may be gradually increased in 40 mg increments until optimum migraine prophylaxis is achieved. The usual maintenance dose is 80 to 160 mg administered once daily. After 4 to 6 weeks at the maximum dose if a satisfactory response is not obtained, therapy with nadolol should be withdrawn gradually.

Thyrotoxicosis:

The dosage range is 80-160 mg once daily. It has been found that most patients require a dose of 160 mg once daily. Nadolol may be used together with conventional anti-thyroid treatment. For the preparation of patients for partial thyroidectomy, nadolol should be administered in conjunction with potassium iodide for a period of 10 days prior to operation.

01%; Unknown (cannot be estimated from available data) Most adverse effects have been mild and transient and have rarely required withdrawal of therapy. The percentages given below were based on a population of 1440 patients taking nadolol in clinical trials.

5%) The events listed below have also occurred with nadolol and/or other beta-adrenergic blocking agents; however, no causal relationship to nadolol was established: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypertensive reaction in patients with pheochromocytoma Blood and lymphatic system disorders Agranulocytosis and thrombocytopenic purpura.

Psychiatric disorders Reversible depression progressing to catatonia; hallucinations; an acute reversible syndrome characterised by disorientation for time and place, emotional lability, and decreased performance on neuropsychologic tests; sleep disturbances.

Nervous system disorders An acute reversible syndrome characterised by short term memory loss and slightly clouded sensorium. Eye disorders Visual disturbances. Vascular disorders Mesenteric arterial thrombosis. Gastrointestinal disorders Ischaemic colitis.

Reproductive system and breast disorders Peyronie's disease. Skin and subcutaneous tissue disorders Non-thrombocytopenic purpura; pemphigoid rash. General disorders and administration site conditions Fever combined with aching. Investigations Elevated liver enzymes.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4 Special warnings and precautions for use Warnings Exacerbation of Ischaemic Heart Disease Following Abrupt Withdrawal Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina, hypertension, and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy.

When discontinuing chronically administered nadolol, particularly in patients with ischaemic heart disease, the dosage should be gradually reduced over a period of one to two weeks, and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, nadolol administration should be re-instituted promptly (at least temporarily), and other measures appropriate for the management of unstable angina should be taken.

Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognised, it may be prudent not to discontinue nadolol therapy abruptly, even in patients under treatment for hypertension alone.

Patients with a History of Cardiac Failure Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and beta-blockade may worsen failure. Although beta-blockers including nadolol should be avoided in overt congestive heart failure, they can be cautiously used, if necessary, in patients with a history of heart failure who are well compensated (usually with digitalis and diuretics).

Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle. Patients Without a History of Heart Failure Continued depression of the myocardium with beta-blockade over a period of time can, in some cases, lead to cardiac failure.

At the first sign or symptom of impending heart failure, the patient should be fully digitalised and/or treated with diuretics, and the response observed closely. If cardiac failure continues despite adequate digitalisation and diuresis, Nadolol should be withdrawn (gradually, if possible).

1 • Bronchial asthma or a history of asthma • Sinus bradycardia • Greater than first degree atrioventricular conduction block • Cardiogenic shock • Right ventricular failure secondary to pulmonary hypertension • Overt cardiac failure (see section