Betac Special Precautions

Asthma and chronic obstructive pulmonary disease: Beta-blockers may only be administered in mild forms of these conditions, using a beta-1 selective blocker at an initially low dose. It is recommended to have pulmonary function tests performed before beginning treatment. In case of an attack while undergoing treatment, beta-mimetic bronchodilators may be used.
Cardiac Insufficiency: In patients with cardiac insufficiency which is controlled with treatment, when necessary betaxolol should be administered at very low doses and then progressively increased under strict medical monitoring. Bradycardia: If the heart rate decreases to less than 50-55 beats per minute at rest and the patient exhibits bradycardia-related symptoms, the dosage should be reduced.
First-degree atrioventricular block: Given the negative dromotropic effect of beta-blockers, betaxolol should only be administered with caution to patients with first-degree atrioventricular block.
Prinzmetal's angina: Beta-blockers can increase the number and duration of anginal episodes in patients with Prinzmetal's angina. The use of beta-1 cardioselective beta-blocker is possible in mild and related forms, provided that it is administered concomitantly with a vasodilator.
Peripheral arterial disorders: In patients with peripheral arterial disorders (Raynaud's disease or phenomenon, arteritis or chronic obliterating arteriopathies of lower limbs), the use of beta-blockers can worsen these conditions. In these situations, it is advisable to use a cardio-selective beta-blocker with partial agonist potential, which shall be administered with caution.
Pheochromocytoma: The use of beta-blockers in the treatment of hypertension due to treated pheochromocytoma requires close monitoring of the arterial blood pressure. Diabetic patients: Instruct the patient and reinforce the self-monitoring of blood glucose at the start of treatment. The warning signs of hypoglycaemia may be masked, particularly with tachycardia, palpitations and sweats.
Psoriasis: As exacerbations of the disorder have been reported with the use of beta-blockers, the indication of use should be carefully considered.
Allergic reactions: In patients with a risk of any severe anaphylactic reaction, particularly to floctafenine or in those receiving drug sensitization treatments, treatment with beta-blockers may lead to an exacerbation of the reaction and resistance to its treatment with adrenaline at the usual doses.
General anaesthesia: Beta-blockers result in a reduction of reflex tachycardia and an increased risk of hypotension. Continuation of treatment with beta-blockers reduces the risk of arrhythmias, myocardial ischaemia and hypertensive episodes. It is advisable to inform the anaesthetist that the patient is being treated with beta-blockers.
If the discontinuation of treatment is deemed necessary, a 48-hours interruption is considered sufficient to restore catecholamine sensitivity.
Beta-blocker treatment may not be interrupted in certain cases: In patients with coronary insufficiency, it is advisable to continue treatment until the intervention, given the risks involved with the sudden withdrawal of beta-blockers.
In case of emergency or the possibility of stopping treatment, the patient should be protected from a predominant vagal reaction by sufficient premedication with atropine, repeated as necessary. The anaesthetist should use products with as little myocardial depressant effects as possible and blood loss should be compensated for.
The anaphylactic risk should be taken into account.
Thyrotoxicosis: Beta-blockers may mask the cardiovascular signs.
Athletes: Athletes should take note of the fact that this product contains an active substance which may induce a positive reaction in tests performed during anti-doping controls.
Also it should be noted that systemic effects of oral and ophthalmic administered beta-blockers are additive.
Use in Pregnancy: Betaxolol crosses the placenta barrier. The drug was found to cause foetal abnormalities in animals when administered in doses up to 600 times the maximum recommended human dose. Since there are no well-controlled studies in pregnant women, betaxolol should no be administered during pregnancy unless the potential benefits outweigh the hazard to the foetus.
Use in Lactation: Betaxolol is excreted to milk. Since hypotension or bradycardia may appear to the nursing infant, discontinuation of breastfeeding is advisable.
Neonatal aspect: In neonates of treated mothers, the beta-blocking action persists for several days after birth. Though this residual effect may have no clinical consequence, it is nevertheless possible that cardiac failure may occur. This would require hospitalisation in intensive care, in which replacement fluids should be avoided (risk of acute pulmonary oedema). In addition, bradycardia, respiratory distress and hypoglycaemia have been reported, therefore careful monitoring of the neonate (cardiac rate and serum glucose during the first 3 to 5 days of life) is recommended in a specialised setting.