ATEHEXAL Film-coated tablet Ref.[49798] Active ingredients: Atenolol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: HEXAL AG, Industriestraße 25, D-83607 Holzkirchen Telephone: +49 (0) 80 24/908-0 Telefax: +49 (0) 80 24/908-1290 e-mail: service@hexal.de Distributor in Cyprus: P.T.Hadjigeorgiou Co Ltd, P.O.Box 53158-3301, ...

4.1. Therapeutic indications

Atehexal 50:

  • myocardial infarction. Early intervention in the acute phase.
  • chronic stable angina pectoris or instable angina pectoris (if tachycardia or hypertension concurrently exist)
  • supraventricular arrhythmias
  • adjuvant therapeutic measure in case of sinus tachycardia due to thyreotoxicosis
  • paroxysmal supraventricular tachycardia
  • atrial fibrillation and flutter (in case of insufficient response to high-dose therapy with cardiac glycosides)
  • ventricular arrhythmias
  • ventricular extrasystoles in so far as extrasystoles are caused by increased activity of the sympathicus (physical stress, induction phase of anaesthesia, anaesthesia with halothane and administration of exogenous sympathomimetic drugs)0,
  • ventricular tachycardias and ventricular fibrillation (only as prophylaxis, especially when ventricular arrhythmias are caused by increased activity of the sympathicus)
  • arterial hypertension
  • Management of myocardial infarction
  • cardiac arrhythmias.

Atehexal 100:

  • chronic stable angina pectoris or instable angina pectoris (if tachycardia or hypertension concurrently exist)
  • arterial hypertension
  • Management of myocardial infarction
  • cardiac arrhythmias

4.2. Posology and method of administration

The dosage should be determined on an individual basis – above all, according to the therapeutical success.Myocardial infarction:see attachment. The following dosage directions apply: - myocardial infraction: for patients suitable for treatment with intravenous beta-adrenoceptor blockade and presenting within 12 hours of the onset of chest pain, “Atenolol” 5-10mg should be given by slow intravenous injection (1mg/minute) followed by “Atenolol” 50mg orally about 15 minutes later, provided no untoward effects occur from the intravenous dose. This should be followed by a further 50mg orally 12 hours after the intravenous dose and then 12 hours later by 100mg orally to be given once daily. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, “Atenolol” should be discontinued.

Atehexal 50

Chronic stable angina pectoris or instable angina pectoris

50-100 mg atenolol once daily (corresponding to 1-2 film-coated tablets of Atehexal 50)

Arterial hypertension

Treatment is to be started with 50 mg atenolol once daily (corresponding to 1 film-coated tablet of Atehexal 50). If necessary, the daily dose may be increased to 100 mg atenolol (corresponding to 2 film-coated tablets of Atehexal 50) after one week.

Supraventricular and ventricular arrhythmias

50 mg once to twice daily or 100 mg atenolol once daily (corresponding to 1 film-coated tablet of Atehexal 50 once to twice daily, or 2 film-coated tablets of Atehexal 50 once daily)

Atehexal 100

Chronic stable angina pectoris or instable angina pectoris

50-100 mg atenolol once daily (corresponding to ½-1 film-coated tablet of Atehexal 100)

Arterial hypertension

Treatment is to be started with 50 mg atenolol once daily (corresponding to ½ film-coated tablet of Atehexal 100). If necessary, the daily dose may be increased to 100 mg atenolol (corresponding to 1 film-coated tablet of Atehexal 100) after one week.

Cardiac arrhythmias

Angina: usually 100mg daily or 50mg twice daily.

Following control with intravenous atenolol, a suitable oral maintenance dosage is 50-100mg daily, given as a single dose.

Myocardial Infraction

Following treatment with intravenous atenolol, oral atenolol 50mg may be given approximately 15 minutes later, provided no untoward effects occur from the intravenous dose. This should be followed by a further 50mg orally 12 hours after the intravenous dose and subsequent dosage maintained, after a further 12 hours, with 100mg daily. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, atenolol should be discontinued.

Comment

In patients with impaired renal function, the dosage of atenolol should correspond to the renal clearance: If creatinine clearance is reduced to values between 10-30 ml/min (serum creatinine less than 1.2-5 mg/dl), it is recommended to reduce the dose by half. If creatinine clearance is less than 10 ml/min (serum creatinine > 5 mg/dl), it is recommended to reduce the standard dose to a quarter.

Children

it is not recommended for use in children.

Elderly Patients

Dosage requirements may be reduced especially in patients with impaired renal function.

Method and Duration of Administration

The film-coated tablets are to be taken unchewed with a sufficient quantity of liquid before meals.

If longer-term therapy with Atehexal is to be interrupted or discontinued, the dosage should be decreased slowly and gradually in principle, since abrupt withdrawal may lead to cardiac ischaemia with exacerbation of angina pectoris or to cardiac infarction or to exacerbation of hypertension.

4.9. Overdose

Symptoms of Intoxication

The clinical picture is mainly determined by cardiovascular and central nervous symptoms in dependence of the degree of intoxication. Overdosage may cause severe hypotension, bradycardia up to cardiac arrest, cardiac insufficiency and cardiogenic shock

General treatment should include

Close supervision; treatment in an intensive care ward; the use of gastric lavage; activated charcoal and a laxative to prevent absorption of any drug still present in the gastrointestinal tract; the use of plasma or plasma substitutes to treat hypotension and shock. The possible uses of haemodialysis or haemoperfusion may be considered.

Excessive bradycardia can be countered with atropine 1–2 mg intravenously and/or a cardiac pacemaker. If necessary, this may be followed by a bolus dose of glucagon 10 mg intravenously. If required, this may be repeated or followed by an intravenous infusion of glucagon 1–10 mg/hour depending on response. If no response to glucagon occurs or if glucagon is unavailable, a beta-adrenoceptor stimulant such as dobutamine 2.5 to 10 micrograms/kg/minute by intravenous infusion may be given. Dobutamine, because of its positive inotropic effect could also be used to treat hypotension and acute cardiac insufficiency. It is likely that these doses would be inadequate to reverse the cardiac effects of beta-blockade if a large overdose has been taken. The dose of dobutamine should therefore be increased if necessary to achieve the required response according to the clinical condition of the patient.

Bronchospasm can usually be reversed by bronchodilators.

6.3. Shelf life

The shelf life is 5 years.

This medication should not be used after the expiry date printed on the package.

6.4. Special precautions for storage

Protect tablets from light and moisture!

6.5. Nature and contents of container

Original packages containing 10 and 20 film-coated tablets.

6.6. Special precautions for disposal and other handling

None.

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