VELORIN Film-coated tablet Ref.[28201] Active ingredients: Atenolol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

  • Control of hypertension.
  • Management of angina pectoris.
  • Control of cardiac arrhythmias.
  • In early intervention in the acute phase of myocardial infraction and for long-term prophylaxis after recovery from myocardial infarction.

4.2. Posology and method of administration

Posology

Adults

Control of hypertension

Most patients respond to 50 mg daily given orally as a single dose. If necessary, the dose may be increased to 100 mg daily. The effect will be fully established after one to two weeks. A further reduction in blood pressure may be achieved by combining Velorin with other antihypertensive agents.

Management of angina pectoris

Most patients with angina pectoris will respond to 100 mg given orally once daily or 50 mg given twice daily. It is unlikely that additional benefit will be gained by increasing the dose.

Control of cardiac arrhythmias

An oral maintenance dose of Velorin is 50-100 mg, given once daily.

Early and lae intervention after myocardial infarction: Oral treatment with Velorin can be initiated in haemodynamically stable patients with 50 mg twice daily, and then 100 mg once daily. During the early phase of acute myocardial infarction, treatment with Velorin should be initiated in hospital under close monitoring. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, Velorin should be discontinued. Velorin 100 mg daily is recommended for long-term prophylaxis of myocardial infarction.

Paediatric population

There is no paediatric experience with Velorin and for this reason it is not recommended for use in children.

Elderly

The dosage requirements may be reduced in the elderly or in patients with impaired renal function.

Renal impairment

Since atenolol is excreted via the kidneys, the dosage should be adjusted in cases of severe impairment of renal function.

No significant accumulation of atenolol occurs in patients who have a creatinine clearance greater than 35 ml/min/1.73 m² (normal range is 100–150 ml/min/1.73 m²).

For patients with a creatinine clearance of 15–35 ml/min/1.73 m² (equivalent to serum creatinine of 300–600 micromol/litre), the oral dose should be 50 mg daily. For patients with a creatinine clearance of less than 15 ml/min/1.73 m² (equivalent to serum creatinine of greater than 600 micromol/litre), the oral dose should be 25 mg daily or 50 mg on alternate days.

Patients on haemodialysis should be given 50 mg orally after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.

Method of administration

For oral use.

4.9. Overdose

The symptoms of overdosage may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm.

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-adrenoceptor 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

5 Years.

6.4. Special precautions for storage

Store below 25°C. Protected from light and moisture.

6.5. Nature and contents of container

Velorin 25 mg film-coated tablets:

PVC/Aluminium blisters. Pack-sizes of 30 and 1000 film-coated tablets.

PP containers with PE closures. Pack-size of 1000 film-coated tablets.

Velorin 50 mg film-coated tablets:

PVC/Aluminium blisters. Pack-sizes of 30, 100 and 1000 film-coated tablets.

PP containers with PE closures. Pack-size of 1000 film-coated tablets.

Velorin 100 mg film-coated tablets:

PVC/Aluminium blisters. Pack-sizes of 14, 30,100 and 1000 film-coated tablets.

PP containers with PE closures. Pack-sizes of 100 and 1000 film-coated tablets.

Not all pack-sizes may be marketed.

6.6. Special precautions for disposal and other handling

Not applicable.

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