Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Generics [UK] Limited, T/A Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, untreated cardiac failure, atrioventricular block, cardiogenic shock, pronounced bradycardia, second and third degree heart block, obstructive pulmonary disease, bronchial asthma and history of bronchospasm, history of cor pulmonale, metabolic acidosis, prolonged fasting, severe renal failure, sick sinus syndrome, Prinzmetals angina, untreated phaeochromocytoma, speripheral circulatory disturbances.
Pindolol should not be taken in conjunction with agents which inhibit calcium transport e.g. verapamil.
Patients with a poor cardiac reserve should be stabilised with digitalis before treatment with pindolol to prevent impairment of myocardial contractility.
As for other beta blockers, and especially in patients with ischaemic heart disease, therapy should not be discontinued suddenly. The dosage should gradually be reduced, i.e. over 1-2 weeks, if necessary at the same time initiating replacement therapy, to prevent exacerbation of angina pectoris.
Patients with psoriasis should take beta-blockers only after careful consideration
As with all beta-blockers, pindolol should be used with caution in patients with a history of bronchial asthma, non-asthmatic chronic obstructive lung disease or recent myocardial infarction. Caution must be exercised when beta-blocking agents are administered to patients with spontaneous hypoglycaemia or diabetes under treatment with insulin or oral hypoglycaemic agents, since hypoglycaemia may occur during prolonged fasting and some of its symptoms (tachycardia, tremor) may be masked. Beta-blockers may also mask the symptoms of thyrotoxicosis.
During treatment with pindolol, patients should not undergo anaesthesia with agents causing myocardial depression (e.g. halothane, cyclopropane, trichloroethylene, ether, chloroform). Pindolol should be gradually withdrawn before elective surgery. In emergency surgery or cases where withdrawal of pindolol would cause deterioration in cardiac condition, atropine sulphate 1 to 2 mg intravenously should be given to prevent severe bradycardia.
If a beta-blocker is indicated in a patient with a phaeochromocytoma it must always be given in conjunction with an alpha-blocker. Pre-existing peripheral vascular disorders may be aggravated by beta-blockers.
In severe renal failure a further impairment of renal function following beta blockade has been reported in a few cases.
There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenoceptor blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when treatment is withdrawn. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable.
Cessation of therapy with a beta-blocker should be gradual.
Beta-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions.
The label will state ‘do not use this medicine if you have a history of wheezing or asthma’.
During treatment with pindolol patients should not undergo anaesthesia with agents causing myocardial depression (e.g. halothane, cyclopropane, trichlorethylene, ether, chloroform). Pindolol should be gradually withdrawn before elective surgery. In emergency surgery or cases where withdrawal of pindolol would cause deterioration in cardiac condition, atropine sulphate 1 to 2 mg intravenously should be given to prevent severe bradycardia.
Calcium-channel blocking agents: pindolol should not be used with calcium-channel blockers with negative inotropic effects e.g. verapamil and to a lesser extent diltiazem as combined use can lead to an exaggeration of their effects, particularly in patients with impaired ventricular function and/or sino-atrial or atrio-ventricular abnormalities. This may result in severe hypotension, bradycardia and cardiac failure. The concomitant use of oral beta-blockers and calcium antagonists of the dihydropyridine type can be useful in hypertension or angina pectoris. However, because of their potential effect on the cardiac conduction system and contractility, the i.v. route must be avoided. The concomitant use with dihydropyridines e.g. nifedipine may increase the risk of hypotension. In patients with cardiac insufficiency, treatment with beta-blocking agents may lead to cardiac failure.
Use of digitalis glycosides, in association with beta-adrenoceptor blocking drugs, may increase atrio-ventricular conduction time.
Clonidine: when therapy is discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blockers should be gradually discontinued several days before clonidine is discontinued, in order to reduce the potential risk of a clonidine withdrawal hypertensive crisis.
MAO inhibitors: concurrent use with beta-blockers is not recommended. Possibly significant hypertension may theoretically occur up to 14 days following discontinuation of the MAO inhibitor.
Caution should be exercised in the concurrent use of beta-blocking agents with class 1 antiarrhythmics (e.g. disopyramide, quinidine) and amiodarone.
Concomitant use of beta-blockers may intensify the blood sugar lowering effect of insulin and other antidiabetic drugs since hypoglycaemia may occur during prolonged fasting. Use of beta-blockers may prevent appearance of the signs of hypocalcaemia (tachycardia).
Cimetidine, hydralazine and alcohol may induce increased plasma levels of hepatically metabolised beta-blockers.
Prostaglandin synthetase inhibiting drugs (e.g. Non-steroidal anti-inflammatory drugs – NSAIDs) may decrease the hypotensive effects of beta-blockers.
Sympathomimetics with beta-adrenergic stimulant activity and xanthines: concurrent use with beta-blockers may result in mutual inhibition of therapeutic effects; in addition, beta-blockers may decrease theophylline clearance.
Concomitant use of beta-blockers with tricyclic antidepressants, barbiturates and phenothiazines as well as other antihypertensive agents may increase the blood pressure lowering effect.
Reserpine: concurrent use may result in an additive and possibly excessive beta-adrenergic blockade.
Pindolol is contraindicated in pregnancy.
Pindolol passes in small quantities into breast milk Breast-feeding is therefore not recommended following administration.
Because dizziness or fatigue may occur during the initial phase of treatment with beta-adrenoceptor blocking drugs, patients driving vehicles or operating machinery should exercise caution until their individual response to treatment has been determined.
The following undesirable effects have been observed with the following frequencies: not known (frequency cannot be estimated from the available data).
Not known: Beta-blockers may mask the signs of thyrotoxicosis or hypoglycaemia.
Not known: Hallucinations, psychoses, sleep disturbances, insomnia, depression, nightmares.
Not known: Fatigue, headaches, paraesthesia of the extremities, dizziness, confusion, tremor
Not known: Impaired vision, dry eyes.
Not known: Bradycardia, a slowed AV-conduction or increase of an existing AV-block, hypotension, heart failure, cold and cyanotic extremities, Raynaud’s phenomenon, increase of an existing intermittent claudication.
Not known: Bronchospasm in patients with bronchial asthma or a history of asthmatic complaints.
Not known: Gastrointestinal disturbances (including epigastric pain, diarrhoea, nausea and vomiting).
Not known: Muscle cramps.
Not known: Disorders of the skin including allergic skin reactions, especially rashes.
Not known: Impotence.
Not known: An increase in ANA (anti nuclear antibodies) has been observed with the use of beta-blockers, although the clinical relevance of this is not clear.
Depression, diarrhoea, nausea, insomnia, headaches, sleep disturbance, epigastric pain, fatigue, dizziness, muscle cramps, tremors, hypotension are usually transient and disappear if dosage is reduced.
The reported incidence of skin rashes and/or dry eyes associated with the use of beta-adrenoceptor blocking drugs is small and in most cases the symptoms have cleared when treatment was withdrawn. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable. Cessation of therapy with a beta-blocker should be gradual.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.
Not applicable.
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