SECTRAL Tablet

The agent alleviates some sympathetic effects on cardiovascular regulation. It is indicated for the following treatments:

- Hypertension;

- Treatment of certain rhythm disorders;

- Prevention of exertion angina attacks;

- Long courses of treatment after myocardial infarction.

Dosage

The dosage depends on the indicated treatments. Dosage adjustment is required in each patient.

Hypertension: The routine daily dose of acebutolol is 400mg, which is best given once daily in the morning or twice daily in the morning and evening. This dosage can be increased in cases of severe hypertension.

- Prevention of angina attacks, exertion angina, tachyarrythmias: The daily dose can vary from 400-800mg (mean dose: 600mg) starting with the lowest dose and then gradually increasing to give the right one for the clinical condition of EC.

- Long courses of treatment after myocardial infarction acebutolol therapy should start between 3-21 days after the acute infarction episode: dosage is 1 tablet twice daily.

Method of administration

Oral route.

The tablet should be swallowed with sufficient amount of water.

Duration of treatment

In most cases, treatment duration with beta-blockers requires several months to years and is determined by your physician.

This medication should never be used in the following circumstances;

- Asthma and severe forms of chronic obstructive bronchopneumopathies,

- Heart failure uncontrolled by the treatment,

- Cardiogenic shock,

- Second or third degree atrioventricular block not receiving pacemaker stimulation,

- Printzmetal angina (pure forms and during monotherapy),

- Sinus disease (including sinoatrial block),

- Bradycardia (<45-50 beats per minute),

- Raynaud’s phenomenon and severe forms of peripheral arterial disorders (i.e. the severe forms of symmetric circular digital disorders with numbness of the digits and peripheral arterial disorders),

- Untreated pheochromocytoma (a type of adrenal medulla tumor causing severe hypertension),

- Hypotension,

- Hypersensibility to acebutolol,

- Previous anaphylaxis,

- Lactation,

- Combinations with floctafenine, with sultopride,

- Gluten intolerance or allergy, due to the presence of wheat starch (gluten).

Relative contra-indication:

Combinations with amiodarone.

- The most frequently reported are: asthenia, cold extremities, bradycardia, gastrointestinal disorders, impotence.

- Much more rarely: bradycardia, cardiac insufficiency, asthmatic attack, hypoglycemia, Raynaud’s syndrome, worsening of existing intermittent claudication, diverse skin reactions including psoriasis-like rash or exacerbation of psoriasis.

- Exceptionally, lung disease of immunoallergic origin.

Pregnancy

If necessary, this medicinal product can be prescribed during pregnancy. If treatment has to be continued up to delivery, the neonate should be carefully monitored for the first few days of life.

Lactation

Breast-feeding is contraindicated during treatment with acebutolol since is passes extensively into breast milk

- Inform physician about your pregnancy, diabetes mellitus, hepatic impairment or renal failure, psoriasis, history of allergy or arterial disease (Raynaud syndrome).

- If surgery is required, inform the anesthetist about your current medication with this agent.

Beta blocker.

Acebutolol has the following three pharmacological properties:

- beta 1 selective beta blocker

- anti-arrhythmic effect

- partial agonist (mild intrinsic sympathomimetic activity)