Each coated tablet contains:

Active ingredient: Atenolol – 50mg;

For a full list of excipients, see section 6.1.

Posology

The dose must always be adjusted to individual requirements of the patients, with the lowest possible starting dosage. The following are guidelines:

Adults

Hypertension

Most patients respond to 100 mg daily given orally as a single dose. Some patients, however, will respond to 50 mg given as a single daily dose. The effect will be fully established after one to two weeks. A further reduction in blood pressure may be achieved by combining atenolol with other antihypertensive agents. For example co-administration of atenolol with a diuretic, as in Tenoretic (atenolol and chlorthalidone), provides a highly effective and convenient antihypertensive therapy.

Anginapectoris

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.

Cardiac arrhythmias

A suitable initial dose of atenolol is 2.5 mg (5 ml) injected intravenously over a 2.5 minute period (i.e. 1 mg/minute). (See also prescribing information for atenolol Injection.) This may be repeated at 5 minute intervals, until a response is observed up to a maximum dosage of 10 mg. If atenolol is given by infusion, 0.15 mg/kg body weight may be administered over a 20 minute period. If required, the injection or infusion may be repeated every 12 hours. Having controlled the arrhythmias with intravenous atenolol, a suitable oral maintenance dosage is 50–100 mg daily, given as a single dose.

Myocardial infarction

For patients suitable for treatment with intravenous beta-blockade and presenting within 12 hours of the onset of chest pain, atenolol 5–10 mg should be given by slow intravenous injection (1 mg/minute) followed by atenolol 50 mg orally about 15 minutes later, provided no untoward effects have occurred from the intravenous dose. This should be followed by a further 50 mg orally 12 hours after the intravenous dose, and then 12 hours later by 100 mg orally, once daily. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, atenolol should be discontinued.

Older population

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

Paediatric population

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

Renal failure

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 and the intravenous dose should be 10 mg once every two days.

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 and the intravenous dose should be 10 mg once every four 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 administration by the oral route.

Pharmacotherapeutic group: Beta-blocking agents, plain, selective,

ATC code: CO7A B03.

List of excipients

Tablet core:

microcrystalline cellulose,

maize starch,

povidone,

talc purified,

sodium starch glycolate,

ethylcellulose,

sodium lauryl sulfate;

Tablet coating:

talc purified,

hypromellose,

titanium dioxide,

propylene glycol,

color yellow E-110,

color red E-129.

For more detailed information about the drug, click: http://pharm.cals.am/pharm/data/drug_134482/1734095746965.pdf