TENSIG

What it is

TENSIG contains atenolol. TENSIG tablets contain 50 mg atenolol. TENSIG tablets are white to off-white, circular biconvex film coated tablets with "50" embossed on one side and break line on other side.

Approved indications

TENSIG is indicated in the management of all grades of hypertension, including hypertension of renal origin. — Frequent disabling angina without evidence of cardiac failure. — Cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias including those associated with acute myocardial infarction). — Myocardial infarction: Late intervention (beta-blocker class effect greater than 12 hours after onset of chest pain).

Dosing overview

For hypertension, therapy should be initiated with 50 mg of atenolol daily, which may be increased each week in daily doses of 50 mg up to a maximum of 200 mg. Doses of 50 to 100 mg daily may be given once daily, whilst doses above 100 mg daily should be given on a divided basis. For angina pectoris, therapy should be initiated with 50 mg of atenolol daily, which may be increased if required to 100 mg daily given as a single or divided dose. For cardiac dysrhythmias, after controlling dysrhythmias with other intravenous agents, atenolol given orally at a dosage of 50 to 100 mg daily will help maintain control. Following acute myocardial infarction, maintenance oral therapy of 50 mg daily of atenolol is recommended for 1 to 3 years, beginning after early intervention with other agents, or immediately in those patients who present more than 12 hours after suffering an acute myocardial infarction.

Key safety warnings

Care should be taken if beta-blockers have to be discontinued abruptly in patients with coronary artery disease, as severe exacerbation of angina and precipitation of myocardial infarction and ventricular arrhythmias have occurred following abrupt discontinuation. Therefore, it is recommended that the dosage be reduced gradually over a period of about 8 to 14 days during which time the patient's progress should be reassessed. Beta-blockade depresses myocardial contractility and may precipitate cardiac failure in some patients with a history of cardiac failure, chronic myocardial insufficiency or unsuspected cardiomyopathy. In patients without a history of cardiac failure, continuing depression of the myocardium may lead to cardiac failure. Beta-blockers affect glucose metabolism and may mask some important premonitory signs of acute hypoglycaemia, such as tachycardia. In patients with insulin or non-insulin dependent diabetes, especially labile diabetes, or with a history of spontaneous hypoglycaemia, beta-blockade may result in the loss of diabetic control and delayed recovery from hypoglycaemia. Patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge whilst taking beta-adrenoreceptor blocking drugs, and such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions.

Contraindications

Beta-blockers are contraindicated in any patient with a history of airways obstruction or tendency to bronchospasm. TENSIG is contraindicated in congestive heart failure. TENSIG is contraindicated in sick sinus syndrome, sinus bradycardia (less than 45 to 50 beats/minute), and second and third-degree A-V block. TENSIG is contraindicated in shock (including cardiogenic and hypovolaemic shock). TENSIG is contraindicated in hypersensitivity to the drug, hypotension, metabolic acidosis, and severe peripheral arterial circulatory disturbances. TENSIG is contraindicated in untreated phaeochromocytoma. TENSIG is contraindicated in pregnancy and lactation.

Regulatory history

TENSIG atenolol 50 mg tablet in bottle form was first listed on the ARTG on 1 February 2001, and TENSIG atenolol 50 mg tablet in blister pack form was first listed on 31 March 2008.