VASCOTEN Film-coated tablet Ref.[28198] Active ingredients: Atenolol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

  • Management of hypertension.
  • Management of angina pectoris.
  • Management of cardiac arrhythmias.
  • Early intervention in the acute phase of myocardial infarction.

4.2. Posology and method of administration

Posology

Adults

Hypertension

Usual dose is 100mg once a day, to which most patients will respond. Some patients will respond to 50mg given as a single daily dose. It takes one to two weeks to establish the full effect.

Blood pressure may be further reduced by concomitant administration of another hypertensive agent such as a diuretic.

Angina pectoris

The majority of patients respond to a daily dose of 100mg, given either as a single dose of 100mg or a twice daily dose of 50mg. An increase of the dose is unlikely to bring additional benefit.

Arrhythmias

Following initial control of the arrhythmias, maintenance can be achieved by a single daily dose of 50mg-100mg, titrated to the patient’s response.

Myocardial infarction

Following control of the early acute phase, 100mg once a day. If bradycardia and/or hypotension needing treatment, or other adverse effects occur, treatment should be discontinued.

Elderly

Dosage reduction may be necessary, especially in patients with renal function impairment.

Renal failure

Atenolol is excreted via the kidneys, thus dosage must be adjusted in the case of severe renal impairment.

Atenolol does not significantly accumulate in patients with creatinine clearance greater than 35ml/min/1.73m² (the normal range is 100-150ml/min/1.73m²).

With creatinine clearance of 15-35ml/min/1.73m², equivalent to serum creatinine of 300-600mol/L, dose should be 50mg daily.

With creatinine clearance of less than 15ml/min/1.73m², equivalent to serum creatinine of more than 600mol/L, dose should be 25mg daily or 50mg every other day.

Haemodialysis

A dose of 50mg after each dialysis session is recommended; this should be done under close supervision as severe falls in blood pressure can happen.

Hepatic failure

Atenolol is not significantly metabolized in the liver, thus no dosage alteration is necessary in patients with hepatic disease.

Paediatric population

There is no experience in children; Atenolol is not recommended in children.

Method of administration

For oral administration only

4.9. Overdose

Symptoms

These may include bradycardia, hypotension, bronchospasm and acute cardiac insufficiency.

Management

In general terms it requires close supervision and hospitalization. Drug absorption should be minimized or prevented by gastric lavage, activated charcoal slurry and a laxative. Hypotension and shock should be treated with plasma or plasma substitutes. Consideration may be given to the use of haemodialysis or haemoperfusion.

Excessive bradycardia may be treated with atropine (1-2mg) via the i.v route; if necessary a bolus of 10mg glucagon i.v. may follow. The glucagon dose may be repeated if required. If there is no response to glucagon, dobutamine (2.5-10g/kg/min) by i.v. infusion can be given. Dobutamine may also treat hypotension and acute cardiac insufficiency. In the case of a large overdose, the dobutamine dosage may need to be increased to achieve a clinical response.

Bronchodilators are usually sufficient to reverse bronchospasm.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C in the original package, in order to protect from light.

6.5. Nature and contents of container

Polyvinylchloride film and aluminium foil blisters of ten tablets.

Packs of Packs of 20, 30 or 100 tablets are available with a patient information leaflet are available.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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