Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Amdipharm UK Limited, Regency House, Miles Gray Road, Basildon, Essex, SS14 3AF, United Kingdom
Owing to the danger of cardiac arrest, a calcium antagonist of the verapamil type must not be administered intravenously to the patient already receiving treatment with a beta-blocker.
As beta-blockers increase the AV conduction time, beta-blockers should only be given with caution to patients with first degree AV block.
Beta-blockers should not be used in patients with untreated congestive heart failure.
This condition should first be stabilised.
As with all beta-blockers, oxprenolol should be used with caution in patients with a recent myocardial infarction.
Beta-blockers may unmask myasthenia gravis.
Caution is advised in patients with psoriasis, as oxprenolol can worsen this condition (see section 4.8).
If the patient develops increasing bradycardia less than 50-55 beats per minute at rest and the patient experiences symptoms related to bradycardia, the dosage should be reduced or gradually withdrawn (see section 4.3).
Beta-blockers are liable to affect carbohydrate metabolism. Diabetic patients, especially those dependent on insulin, should be warned that beta-blockers can mask symptoms of hypoglycaemia (e.g. tachycardia) (see section 4.5). Hypoglycaemia, producing loss of consciousness in some cases, may occur in non-diabetic individuals who are taking beta-blockers, particularly those who undergo prolonged fasting or severe exercise. The concurrent use of beta-blockers and anti-diabetic medication should always be monitored to confirm that diabetic control is well maintained.
Beta-blockers may mask certain clinical signs (e.g. tachycardia) of hyperthyroidism and the patient should be carefully monitored.
Beta-blockers may reduce liver function and thus affect the metabolism of other drugs.
Like many beta-blockers oxprenolol undergoes substantial first-pass hepatic metabolism. In the presence of liver cirrhosis the bioavailability of oxprenolol may be increased leading to higher plasma concentrations (see section 5.2).
In patients with renal impairment, the elimination half-life for unchanged oxprenolol is not expected to be significantly different from the subjects with normal renal function (see section 5.2). Creatinine clearance, urea and electrolytes should be monitored in patients with renal impairment since they might be more susceptible to the effects of antihypertensive drugs due to haemodynamic effects particularly patients with severe renal failure (see section 4.3).
In patients with peripheral circulatory disorders (e.g. Raynaud’s disease or syndrome, intermittent claudication), beta-blockers should be used with great caution as aggravation of these disorders may occur (see section 4.3).
As with all antihypertensive agents, a cautious dosage schedule is indicated in patients with severe coronary or cerebral arteriosclerosis.
In patients with phaeochromocytoma a beta-blocker should only be given together with an alpha-blocker, (see section 4.3).
Owing to the danger of cardiac arrest, a calcium antagonist of the verapamil type must not be administered intravenously to the patient already receiving treatment with a beta-blocker. Furthermore, since beta-blockers may potentiate the negative-inotropic and dromotropic effects of calcium antagonists, like verapamil or diltiazem, any oral co-medication (e.g. in angina pectoris) requires close clinical control (see also section 4.5).
Anaphylactic reactions precipitated by other agents may be particularly severe in patients taking beta-blockers, especially non-selective drugs, and may require higher than normal doses of adrenaline for treatment. Whenever possible, beta-blockers should be discontinued in patients who are at increased risk for anaphylaxis.
Especially in patients with ischaemic heart disease, treatment should not be discontinued suddenly. The dosage should gradually be reduced, i.e. over 1-3 weeks, if necessary, at the same time initiating alternative therapy, to prevent exacerbation of angina pectoris.
If a patient receiving oxprenolol requires anaesthesia, the anaesthetist should be informed of the use of the medication prior to the use of general anaesthetic to permit him to take the necessary precautions. The anaesthetic selected should be one exhibiting as little inotropic activity as possible, e.g. halothane/nitrous oxide During treatment with oxprenolol, patients should not undergo anaesthesia with agents causing myocardial depression (e.g. cyclopropane, trichloroethylene, ether, chloroform). If on the other hand, inhibition of sympathetic tone during the operation is regarded as undesirable, the betablocker should be withdrawn gradually at least 48 hours prior to surgery.
The full development of the “oculomucocutaneous syndrome”, as previously described with practolol has not been reported with oxprenolol. However some features of this syndrome have been noted such as dry eyes alone or occasionally associated with skin rash. In most cases the symptoms cleared after withdrawal of the treatment.
Discontinuation of oxprenolol should be considered, and a switch to another antihypertensive drug might be advisable, see advice on discontinuation above.
Oxprenolol use may give falsely high fluorometric readings in urine cortisol determinations.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Suitable for people with coeliac disease. Patients with wheat allergy (different from coeliac disease) should not take this medicine.
The antihypertensive effect of oxprenolol is enhanced by concomitant treatment with other antihypertensives.
Calcium channel blockers: Oxprenolol should not be used with calcium-channel blockers with negative inotropic effects e.g. verapamil and to a lesser extent diltiazem.
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 (see section 4.3 and 4.4).
Class I anti-arrhythmic drugs and amiodarone: Drugs like disopyramide, quinidine and amiodarone may increase atrial-conduction time and induce negative inotropic effect when administered concomitantly with beta-blockers.
Sympathomimetic drugs: Non-cardioselective beta-blockers such as oxprenolol enhance the pressor response to sympathomimetic drugs such as adrenaline, noradrenaline, isoprenaline, ephedrine and phenylephrine (e.g. local anaesthetics in dentistry, nasal and ocular drops), resulting in hypertension and bradycardia.
Beta-blockers may decrease the clearance of theophylline.
Clonidine: When clonidine is used in conjunction with non-selective beta-blockers, such as oxprenolol, treatment with clonidine should be continued for some time after beta-blocker has been discontinued to reduce the danger of rebound hypertension.
Catecholamine-depleting drugs: e.g. guanethidine, reserpine, may have an additive effect when administered concomitantly with beta-blockers. Patients should be closely observed for hypotension.
Monoamine oxidase 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. Blood pressure and heart rate should be monitored more closely in patients taking this medicine with a MAO inhibitor.
Beta-blockers may modify blood glucose concentrations in patients being treated with insulin and oral antidiabetic drugs and may alter the response to hypoglycaemia by prolonging the recovery (blood glucose rise) from hypoglycaemia, causing hypotension and blocking tachycardia. In diabetic patients receiving beta-blockers hypoglycaemic episodes may not result in the expected tachycardia but hypoglycaemia-induced sweating will occur and may even be intensified and prolonged. (see section 4.4). During concurrent therapy with antidiabetics a close watch should therefore be kept on carbohydrate metabolism, and the dosage of hypoglycaemic medication may have to be readjusted (see section 4.4).
Non-steroidal anti-inflammatory drugs (NSAIDs): Non-steroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, can reduce the hypotensive effect of beta blockade.
Cimetidine: Hepatic metabolism of beta-blockers may be reduced resulting in increased plasma levels of beta-blocker and prolonged serum half-life. Marked bradycardia may occur.
Ergot alkaloids: Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids.
Anaesthetic drugs: Beta-blockers and certain anaesthetics (e.g. halothane) are additive in their cardiodepressant effect. However, continuation of beta-blockers reduces the risk of arrhythmia and hypertension during anaesthesia (see section 4.4).
Digitalis glycosides: Beta-blockers and digitalis glycosides may be additive in their depressant effect on myocardial conduction, particularly through the atrioventricular node, resulting in bradycardia or heart block.
Lidocaine: Concomitant administration with beta-blockers may increase lidocaine blood concentrations and potential toxicity; patients should be closely monitored for increased lidocaine effects.
Alcohol and beta-blocker effects on the central nervous system have been observed to be additive and it is possible that symptoms such as dizziness may be exaggerated if alcohol and Trasicor Tablets are taken together (see also section 4.4).
Barbiturates and rifampicin can increase the metabolism of some beta-blockers (resulting in reduced plasma levels).
Hydralazine can decrease the metabolism of some beta-blockers (resulting in increased plasma levels).
Antimalarials such as mefloquine can cause arrhythmias and caution is necessary if used with beta-blockers.
Concomitant use of beta-blockers with phenothiazines may increase the blood pressure lowering effect.
Excessive caffeine and nicotine intake may oppose the beneficial effects of oxprenolol.
The hypotensive effects of tricyclic antidepressants may be exacerbated in patients receiving beta-blockers.
Concomitant administration of sulfinpyrazone with oxprenolol may reduce or abolish its antihyperntensive effect.
Oxprenolol should not be given during pregnancy unless there are no safer alternatives. As in the case of any form of drug therapy, oxprenolol should be employed with caution during pregnancy, especially in the first 3 months.
Beta-blockers may reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. Use the lowest possible dose. If possible, discontinue beta-blocker therapy at least 2 to 3 days prior to delivery to avoid the effects on uterine contractility and possible adverse effects, especially bradycardia and hypoglycaemia, in the foetus and neonate.
Oxprenolol is excreted into breast milk (see section 5.2). However, although the estimated daily infant dose derived from breast-feeding is likely to be very low, breast feeding is not recommended.
Patients receiving oxprenolol should be warned that dizziness, fatigue or visual disturbances (see section 4.8) may occur, in which case they should not drive, operate machinery or do anything else requiring alertness, particularly if they also consume alcohol.
Frequency estimate: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Very rare: Thrombocytopenia sometimes with purpura.
Not known: Agranulocytosis.
Not known: Diabetes mellitus, hypoglycaemia, hyperglycaemia.
Common: Depression, libido disorder.
Uncommon: Sleep disorder, nightmares.
Rare: Hallucinations.
Not known: Psychosis, confusional state.
Common: Headache, dizziness.
Uncommon: Visual impairment (vision blurred, vision abnormal).
Rare: Dry eyes, keratoconjunctivitis.
Common: Cardiac failure.
Uncommon: Bradycardia, cardiac conduction disorders.
Not known: Complete atrioventricular block, cardiac arrhythmia.
Common: Hypotension, peripheral vascular disorders (e.g. peripheral coldness, paraesthesia).
Rare: Raynaud’s phenomenon.
Not known: Necrotising vasculitis, intermittent claudication.
Common: Dyspnoea, bronchospasm (see section 4.3 and 4.4).
Very common: Dry mouth, constipation.
Common: Nausea.
Uncommon: Diarrhoea, vomiting, flatulence.
Not known: Abdominal discomfort, retroperitoneal fibrosis, dyspepsia.
Not known: Myalgia, arthralgia, muscle cramps, myasthenia gravis.
Uncommon: Dermatitis allergic.
Rare: Worsening of psoriasis.
Not known: Rash, toxic epidermal necrolysis, cutaneous lupus erythematosus like lesions, reactivation of cutaneous lupus erythematosus, pruritus, hyperhidrosis.
Common: Erectile dysfunction.
Not known: Glycosuria.
Common: Fatigue.
Rare: Exertional tiredness.
Not known: Hyperpyrexia.
Not known: An increase in ANA (anti-nuclear antibodies) has been seen; its clinical relevance is not clear.
Chronic treatment with oxprenolol increases very low density lipoprotein and decreases high density lipoprotein, which may have an adverse effect on the risk of cardiovascular events.
Beta-blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia.
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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