Item Number: ATENOLOL
White to off white, circular, flat faced beveled edge, uncoated tablets with inscription “AA” on one side and breakline on the other side.
4.1 Therapeutic indications
a. Management of hypertension.
b. Management of angina pectoris.
c. Management of cardiac dysrhythmias.
d. Management of myocardial infarction. Early intervention in the acute phase and long term prophylaxis after recovery from myocardial infarction
4.2 Posology and method of administration
The dose must always be adjusted to individual requirements of the patients, with the lowest possible starting dosage. The following are guidelines:
One tablet daily. 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 tablets with other antihypertensive agents. For example, co-administration of Atenolol tablets with a diuretic provides a highly effective and convenient antihypertensive therapy.
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.
Having controlled the dysrhythmias with intravenous atenolol a suitable maintenance dosage is 50 mg – 100 mg daily, given as single dose.
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.
Dosage requirements may be reduced, especially in patients with impaired renal function.
There is no paediatric experience with Atenolol and for this reason it is not recommended for use in children.
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.
• Atenolol, as with other beta-blockers, should not be used in patients with any of the following:
• Cardiogenic shock
• Uncontrolled heart failure
• Sick sinus syndrome (including sino-atrial block)
• Second-or third-degree heart block
• Untreated phaeochromocytoma
• Metabolic acidosis
• Bradycardia (< 45 bpm)
• Known hypersensitivity to the active substance, or any of the excipients listed in section 6.1
• Severe peripheral arterial circulatory disturbances
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