INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
ADCO-ATENOLOL TABLETS 50 mg
ADCO-ATENOLOL TABLETS 100 mg

SCHEDULING STATUS:
S3

PROPRIETARY NAME:
(and dosage form)

ADCO-ATENOLOL TABLETS 50 mg
ADCO-ATENOLOL TABLETS 100 mg

COMPOSITION:
ADCO-ATENOLOL TABLETS 50 mg contain 50 mg atenolol.
ADCO-ATENOLOL TABLETS 100 mg contain 100 mg atenolol.

PHARMACOLOGICAL CLASSIFICATION:
A 5.2 Adrenolytics (Sympathicolytics)

PHARMACOLOGICAL ACTION:
Atenolol (ADCO-ATENOLOL TABLETS) is a beta-adrenoceptor blocking agent which acts preferentially on beta-adrenergic receptors in the myocardium. It has no intrinsic activity and minimal membrane stabilizing properties. Atenolol does not cross the blood : brain barrier to a significant extent.

INDICATIONS:
Management of angina pectoris and hypertension.

CONTRA-INDICATIONS:
ADCO-ATENOLOL TABLETS should not be used:

1.	In the presence of second or third degree heart block.
2.	With myocardial depressant agents such as quinidine, procainamide or lignocaine which may enhance the effects of the atenolol. With verapamil, neither medicines should be administered within several days of discontinuing the other.
	Particular caution should be exercised with patients suffering from the following; asthma, bronchitis, chronic respiratory diseases, bradycardia less than 50 per minute, peripheral vascular diseases and Raynaud's phenomenon.
3.	After prolonged fasting.
4.	In patients with metabolic acidosis (eg. in diabetes).
5.	In cardiac failure, unless or until signs of failure are controlled with digitalis and/or diuretics.

The normal dose of ADCO-ATENOLOL should be reduced in elderly patients or in patients suffering from renal dysfunction.
In the peri-operative period it is generally unwise to reduce the dosage of ADCO-ATENOLOL therapy to which the patient is accustomed, as there may be danger of aggravation of angina pectoris or of hypertension during the surgical period. A patients normal tachycardiac response to hypovolaemia or blood loss may be obscurred during or after surgery by ADCO-ATENOLOL therapy. Particular caution should be taken in this regard.
Pregnancy:
The administration of ADCO-ATENOLOL to pregnant mothers shortly before birth or during labour has resulted in new-born infants being born hypotonic, collapsed and hypoglycaemic.
Lactation:
Atenolol is excreted into breast milk. Consult your physician.

DOSAGE AND DIRECTIONS FOR USE:
Angina Pectoris:
Most patients with angina pectoris will respond to a dose of 100 mg daily. This is most conveniently administered as a single 100 mg tablet once daily, which may if desired be given in the form of one 50 mg tablet twice daily. It is unlikely that any additional benefit will be gained by increasing the dose.
Hypertension:
Most patients will respond to a dose of 100 mg once daily. This is most conveniently administered as a single 100 mg tablet once daily. It is unlikely that any additional benefit will be gained by increasing the dosage.
In refractory cases a further reduction of blood pressure may be achieved by combining ADCO-ATENOLOL TABLETS with other anti-hypertensive agents. ADCO-ATENOLOL TABLETS may be combined with a diuretic.
Patients can be transferred to ADCO-ATENOLOL TABLETS from other anti-hypertensive treatments. Caution should be excercised when transferring a patient from clonidine. The withdrawal of clonidine may result in the release of large amounts of catecholamines which may give rise to a hypertensive crisis. If ADCO-ATENOLOL TABLETS are administered in these circumstances, the unopposed alpha-receptor stimulation may potentiate this effect.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effects are nausea, vomiting, diarrhoea, fatigue and dizziness. Cardiovascular effects include bradycardia, congestive heart failure, heart block, hypotension, cold extremities, Raynaud's phenomenon and paraesthesia. Central nervous system effects include depression, hallucinations and disturbances of sleep (sleeplessness, vivid dreams, nightmares) and vision. Bronchospasms may occur particularly in patients suffering from asthma, bronchitis and other chronic pulmonary diseases. Blood disorders, dry eyes and skin rashes may also occur. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable.
Anaesthesia:
The anaesthetist should be made aware of ADCO-ATENOLOL therapy in patients due to undergo general anaesthesia. Anaesthetic agents such as ether, chloroform, cyclopropane and trichloroethylene should be avoided.
It can be dangerous to administer ADCO-ATENOLOL concomitantly with the following medicines; hypoglycaemic agents, phenothiazines and various anti-arrhythmic agents.
Please Note: Such drug reactions can have life-threatening consequences.
ADCO-ATENOLOL should never be given to patients with phaeochromocytoma without concomitant alpha-adrenoceptor blocking therapy.
Special Note: Digitalisation of certain patients receiving long-term ADCO-ATENOLOL therapy can be valuable, particularly those patients in whom congestive cardiac failure is likely to develop. This combination can be considered despite the potentiation of the negative chronotropic effect of the two medicines. Careful control of dosages and of the individual patients response and notably the pulse rate is essential in this situation.
Abrupt discontinuation of therapy may cause exacerbation of angina pectoris in patients suffering from ischaemic heart disease. Discontinuation of therapy with ADCO-ATENOLOL should be gradual rather than abrupt, and patients should be advised to limit the extent of their physical activity during the period that the medicine is being discontinued.
Treatment with ADCO-ATENOLOL may be associated with exacerbation of peripheral vascular disease, the development of Raynaud's phenomenon (due to unopposed arteriolar alpha-sympathetic activity), sexual impotence, hypoglycaemia, skeletal muscle weakness and gastro-intestinal disturbances. Severe peripheral vascular disease and even peripheral gangrene may be precipitated.
Safety during long-term administration has not yet been demonstrated.
Note: Adverse reactions to ADCO-ATENOLOL are more common in patients with renal decompensation; and in patients who receive the drug intravenously.
If ADCO-ATENOLOL TABLETS and clonidine are given concurrently, the clonidine should not be discontinued until several days after the withdrawal of the ADCO-ATENOLOL, as severe rebound hypertension may occur.
Interactions:
The effects of other myocardial depressant agents such as quinidine, procainamide or lignocaine may also be enhanced by ADCO-ATENOLOL. The effects of ADCO-ATENOLOL are diminished by beta-adrenergic stimulating agents, the hypotensive effects of ADCO-ATENOLOL may be dangerously reversed and the peripheral vasoconstrictor effects enhanced by alpha-adrenergic stimulating agents such as nor-adrenaline or those with mixed alpha- and beta-adrenergic stimulating properties such as adrenaline. Bradycardia may also occur.
The effects of ADCO-ATENOLOL may be enhanced by adrenergic neurone blocking agents such as guanethidine, bethanidine, or reserpine, and the hypotensive effects by diuretics.
ADCO-ATENOLOL may enhance some of the cardiac effects of digitalis and diminish others.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may induce bradycardia and severe hypotension. Bronchospasm and heart failure may be induced in certain individuals. Bradycardia associated with severe hypotension should be treated with atropine 1 to 2 mg intravenously, followed if necessary by a slow infusion of isoprenaline 25 micrograms or orciprenaline 500 micrograms intravenously. Bronchospasm should be treated by intravenous aminophylline, and heart failure with digitalis and diuretics.

IDENTIFICATION:
ADCO-ATENOLOL TABLETS 50 mg: White, round, coated tablets with a diameterof 8,1mm.
ADCO-ATENOLOL TABLETS 100 mg: Orange, round coated tablets with a diameter of 10,5 mm.

PRESENTATION:
ADCO-ATENOLOL TABLETS 50 mg:
Securitainers of 28, 30 tablets and 250 tablets.
Blister packs of 30's.
ADCO-ATENOLOL TABLETS 100 mg:
Securitainers of 28, 30 tablets and 250 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture. Keep out of reach of children.

REGISTRATION NUMBER:
ADCO-ATENOLOL TABLETS 50 mg: W/5.2/115
ADCO-ATENOLOL TABLETS 100 mg: W/5.2/116

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Ave
Bryanston
2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 1990

New addition to this site: April 2004
Source: Pharmaceutical Industry
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