Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Medochemie Ltd., 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Heart failure: patients with controlled heart failure, under therapywith betaxolol should be under strict medical supervision; very low and slow increasing of doses should be administered.
Bradycardia: The dose must be reduced if the heart rate of patients is 50-55 Bpm and the patient is bradycardic and has associated symptoms.
AV-block grade 1: Because of the negative dromotropic effect of beta-blockers, patients should use betaxolol with caution. Patients with renal dysfunction (see section 4.2): The dose should be adjusted according to the serum creatinine levels and creatinine clearance.
Patients with diabetes mellitus (see sections 4.5 and 4.8): Betaxolol does not inhibit the recovery from insulin induced hypoglycaemia (like non selective beta-blockers do), as a result it is unlikely to interfere with glucose metabolism in insulin-treated diabetics. However caution is advised when treating such patients. Diabetes patients should monitor more often their the blood sugar level, because the symptoms of hypoglycemia, such as tachycardia, palpitation and sweating may be masked.
Psoriasis (see section 4.8): In patients with psoriasis in personal or family history, the use of beta blockers will be made only after careful benefit- risk assessment.
Ophthalmology: beta blockade reduces the intraocular pressure .The ophthalmologist should be informed about betaxolol treatment of the patients.
Thyrotoxicosis: beta-blockers mask the cardiovascular symptoms of thyrotoxicosis.
Pheochromocytoma: The use of beta blockers for the treatment of hypertension in patients with untreated pheochromocytoma should only be done under accurate blood pressure monitoring.
Asthma and chronic obstructive pulmonary disease: Although β1 (selective) blockers do not influence pulmonary function as the non-selective beta-blockers do, their use should be avoided in patients with asthma or chronic obstructive pulmonary disease, unless there are compelling clinical reasons for their use. In such patients betaxolol should be administered at a dose of 10 mg daily. Before starting the therapy lung function tests are recommended.
Allergic reactions: Beta-blockers increase the sensitivity to allergens and severe anaphylactic reactions (like acute allergic systemic reactions).
In patients at risk of severe anaphylactic reaction, irrespective of origin, particularly with floctafenin (see section 4.5) or during desensitizing treatment, beta-blocker treatment may lead to a worsening of the reaction and its resistance to treatment with usual doses of epinephrine.
Concurrent administration of betaxolol and a myocardial depressant inhibitor of AV conduction (such as calcium antagonists of the verapamil type) must be carried out under close supervision, especially in case of iv administration.
Discontinuation of treatment with beta-blockers is sometimes followed by secondary sympathetic hyperactivity. Even though betaxolol plasma levels decrease slowly, care should be exercised during treatment withdrawal, especially in patients with ischaemic heart disease. If necessary, at the same time a replacement therapy can be initiated to prevent deterioration the symptoms of angina.
As sympathetic stimulation may be essential for the circulatory function of patients with a history of cardiac failure, cardiomyopathy or cardiomegaly; such patients should be monitored closely when a beta-blocker is administered. Betaxolol should be used with caution when the PR interval is prolonged.
General anesthesia: Concomitant administration of betaxolol and narcotics results in an increased blood pressure. The negative inotropic effect of anesthetics and betaxolol can add up. The neuromuscular blockade by peripheral muscle relaxants (eg suxamethoniumhalogenid, Tubocurarine) may be strengthened or extended through the inhibition of beta receptors. In case of surgery, the patient should notify the anaesthetist of betaxolol therapy.
If discontinuation of treatment is necessary, for 48-hour sensitivity to the to catecholamines is guaranteed again. In patients with severe ischaemic heart disease, the risk/benefit of continuation of treatment has to be evaluated.
If treatment is to be continued, the use of anaesthetics such as ether, cyclopropane and trichloroethylene must be done with caution.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
In animal studies, no teratogenic effects were detected. So far there is no evidence of teratogenic effects in humans. Beta-blockers reduce the placental blood flow resulting in intrauterine fetal death, miscarriage or premature birth. Furthermore, they can lead to the occurrence of side effects especially hypoglycaemia and bradycardia the fetus.
The use of betaxolol in the pregnancy should be done only if mandatory and after careful risk-benefit evaluation.
Newborn period: maternal beta-blocker treatment could have an effect on the newborn for several days after birth. The newborn has an increased risk of cardiac and pulmonary complications in the postnatal period. If heart failure occurs in the new born, admission in intensive care unit is recommended (see section 4.9).
Because of the risk of acute pulmonary edema, the use of plasma expanders should be avoided.
Bradycardia, respiratory depression and hypoglycemia have also been reported. Intensified monitoring of the newborn heart rate and blood sugar within the first 3-5 days of life is recommended.
Betaxolol is excreted to milk. Since hypotension or bradycardia may appear to the nursing infant, discontinuation of breast feeding is advisable.
There are no studies on the effects of betaxolol on ability to drive or use machines.
Occasionally dizziness and fatigue can occur.
Betaxolol is generally well tolerated. Side effects rarely demand discontinuation of the drug.
The following undesirable effects were classified by using the MedDRA frequency convention: 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: hypoglycemia, hyperglycemia.
Common: weakness, insomnia.
Rare: depressive disorders.
Very rare: hallucinations, confusion, nightmares.
Common: dizziness, headache.
Very rare: distal paresthesia. Eye disorders
Very rare: blurred vision.
Common: marked bradycardia sometimes.
Rare: heart failure, hypotension, decrease in AV conduction and strengthening of a preexisting AV block.
Common: cold sensation in the limbs.
Rare: Raynaud’s syndrome, strengthening of intermittent claudication.
Rare: bronchospasm.
Common: abdominal pain, diarrhea, nausea, vomiting.
Rare: skin reactions including psoriatiforme eruptions or exacerbation of psoriasis
Common: impotence.
Rare: In rare cases, the occurrence of antinuclear antibodies was detected. Only in exceptional cases, clinical symptoms (as in patients with systemic Lupus erythematosus) were detectable.
Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs Fax: +357 22608649.
None known.
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