TENORMIN TABLET 50 MG [SIN00348P]

Product Info

TENORMIN TABLET 50 MG

[SIN00348P]

4.1 Therapeutic indications

1. Hypertension.

2. Angina pectoris.

3. Cardiac arrhythmias.

4. Myocardial infarction. Early and late intervention.

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.

Adults

Hypertension

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 TENORMIN with other antihypertensive agents. For example, co-administration of TENORMIN with a diuretic, provides a highly effective and convenient antihypertensive therapy.

Angina

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

Cardiac Arrhythmias

TENORMIN therapy should be initiated at 2.5 mg (5 ml) injection over a 2.5 minute period (i.e. 1 mg/minute). This may be repeated at 5 minute intervals until a response is observed, up to a maximum dosage of 10 mg. If TENORMIN is given by infusion, 0.15 mg/kg bodyweight 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 TENORMIN, a suitable oral maintenance dosage is 50–100 mg daily, given as a single dose.

Myocardial Infarction

Early intervention after acute myocardial infarction: For patients suitable for treatment with intravenous beta-blockade and presenting within 12 hours of the onset of chest pain, TENORMIN 5–10 mg should be given by slow intravenous injection (1 mg/minute) followed by TENORMIN 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, TENORMIN should be discontinued.

Late intervention after acute myocardial infarction: For patients who present some days after suffering an acute myocardial infarction an oral dose of TENORMIN (100 mg daily) is recommended for long-term prophylaxis of myocardial infarction.

Elderly

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

Children

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

Renal Failure

Since TENORMIN is excreted via the kidneys the dosage should be reduced in cases of severe impairment of renal function.

No significant accumulation of TENORMIN 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 <15 ml/min/1.73 m² (equivalent to serum creatinine of >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.

4.3 Contraindications

TENORMIN, as with other beta-blockers, should not be used in patients with any of the following: known hypersensitivity to the active substance, or any of the excipients; bradycardia (<45bpm); cardiogenic shock; hypotension; metabolic acidosis; severe peripheral arterial circulatory disturbances; second or third degree heart block; sick sinus syndrome; untreated phaeochromocytoma; uncontrolled heart failure.