BETAC Film-coated tablet Ref.[28143] Active ingredients: Betaxolol

Posology

In mild hypertension, therapy should be initiated with 10 mg betaxolol daily .If necessary the dose may be increased to 20 mg daily after 7 to 14 days of treatment, which is the standard dose.

In moderate hypertension, the standard dose is 20mg daily.

Doses more than 20 mg daily have been shown to produce no significant additional antihypertensive effect, although they are well tolerated. Withdrawal of therapy must be performed gradually over a period of about 2 weeks. Patients should be carefully observed during that period.

Renal failure

In case of renal dysfunction (creatinine clearance up to 30 ml/min) dosage adjustments are not usually required.

However the clinical monitoring of these patients is recommended. In patients with severe renal failure (creatinine clearance less than 30 ml/min), including those undergoing dialysis, the clearance of betaxolol is decreased. The recommended dose is 10 mg once a day.

Hepatic failure

In case of liver insufficiency, no dose adjustment is necessary, but clinical supervision is recommended at therapy initiation.

Elderly patients-Patients with a history of bronchospasm

Geriatric patients are more susceptible to bradycardia, one of the adverse reactions of betaxolol. If there is an increased risk for the appearance of bradycardia therapy must be initiated with 10 mg betaxolol daily.

Paediatric population

Children: Safety and efficacy of the drug in children has not been established. Betaxolol is not recommended for pediatric use.

Method of administration

Betaxolol is administered once a day. Food does not affect the behavior of the drug.

Symptoms

In case of overdose the most common effects expected are bradycardia, hypotension, congestive heart failure, bronchospasm, hypoglycaemia, vomiting, disturbances of consciousness, occasionally also generalized convulsive seizures.

Overdose can lead to severe hypotension, bradycardia, cardiac arrest, heart failure and cardiogenic shock. In addition, difficulty breathing, bronchospasm, vomiting, disturbances of consciousness, and occasionally generalized convulsive seizures were reported.

Management

In case of life threatening hypotension or bradycardia the treatment with betaxolol should be stopped. In addition to general measures of primary removal of betaxolol should be started and the vital signs should be monitored and corrected if necessary.

As an antidote it can be used:

• Atropine (for the management of bradycardia): 1 to 2 mg i.v as a bolus.
• Glukagon: Initial 1-10 mg i.v, then 2 to 2.5 mg/h in continuous infusion.
• Sympathomimetics: dopamine, dobutamine, isoprenaline, orciprenaline and adrenaline (for the management of hypotension).

For bronchospasm, beta-2 agonists as aerosol (in case of insufficient effect also i.v) or aminophylline i.v. can be used.

For generalized seizures slow i.v. administration of diazepam is recommended.

In hemodialysis or peritoneal dialysis betaxolol and its metabolites are eliminated in a small extent.

In the newborn babies from beta blocker-treated mothers, in case of cardiac decompensation, it is recommended:

• Glucagon 0.3 mg/kg
• Hospitalization in intensive care
• Isoprenaline and dobutamine (prolonged treatment and usually high doses require special monitoring).

36 months.

This medicinal product does not require any special temperature storage conditions.

Store in the original package in order to protect from light.

10 betaxolol tablets are folded into PVC-Al blister.

Boxes of 10, 20, 28 and 30 film-coated tablets are available.

Not all pack sizes may be marketed.

No special requirements.