| Drug Name |
ATENOLOL |
| Active Ingredient(s) |
ATENOLOL |
Form(s) and
Strength(s) Available |
TABLET; ORAL:100MG ;25MG ;50MG |
Product Information / Press Release COMPOSITION:
Each tablet contains 50 or 100 mg of Atenolol
PHARMACOLOGICAL CLASSIFICATION:
A 5.2 Medicines affecting Autonomic functions: Adrenolytics (Sympathicolytics)
PHARMACOLOGICAL ACTION:
Atenolol is a beta 1 selective beta-blocker without intrinsic sympathomimetic and membrane stabilising activity. Absorption of atenolol following oral dosing is consistent but incomplete (approximately 40-50%) with peak plasma concentrations occurring 2-4 hours after dosing. There is no significant hepatic metabolism of atenolol and more than 90% of that absorbed reaches the systemic circulation unaltered. The plasma half-life is about 6 hours but this may rise in severe renal impairment since the kidney is the major route of elimination. Atenolol penetrates tissues poorly due to its low lipid solubility and its concentration in brain tissue is low. Plasma protein binding is low (approximately 3%).
INDICATIONS:
APO-ATENOLOL is indicated in patients with mild or moderate hypertension.
APO-ATENOLOL is indicated in the management of angina pectoris.
CONTRA-INDICATIONS:
APO-ATENOLOL should not be used in the following instances:
1. Hypersensitivity to any of the ingredients.
2. Patients with bronchospasm or asthma, or patients with a history of obstructive airways disease.
3. In the presence of second degree or third degree heart block.
4. In patients with cardiogenic shock.
5. After prolonged fasting.
6. In patients with metabolic acidoses (e.g. in diabetes).
7. Special care should be taken with patients whose cardiac reserve is poor. Atenolol should be avoided in cardiac failure, unless or until signs of failure are controlled with digitalis or diuretics.
8. Uncontrolled cardiac failure, excluding that due to hypertrophic obstructive cardiomyopathy.
9. Pregnancy: Atenolol crosses the placental barrier and appears in cord blood. Administration to pregnant women has been associated with intra-uterine growth retardation. Administration of atenolol to pregnant mothers shortly before giving birth, or during labour may result in the newborn infants being born hypotonic, collapsed and hypoglycaemic.
10. There is significant accumulation in breast milk. Breastfeeding patients must not take atenolol.
11. Atenolol is not recommended for the emergency treatment of hypertensive crises.
WARNINGS:
While taking atenolol, patients with a history of anaphylactic reactions to a variety of allergens, may have a more severe reaction on repeated challenge. Such patients may be unresponsive to the usual dose of adrenaline used to treat allergic reactions. Particular caution should be exercised with patients suffering from the following:
Bradycardia of less that 50 pulse beats a minute
Peripheral vascular disease
Raynaud's phenomenon
The normal dose should be reduced in elderly patients, or in patients suffering from renal dysfunction. Elderly patients may not respond as well to atenolol as younger patients.
In the perioperative period it is generally unwise to reduce the dosage to which the patient is accustomed, as there may be danger of aggravation of angina pectoris or of hypertension. A patients normal tachycardic response to hypovolemia or blood loss may be obscured during or after surgery. Particular caution should be taken in this regard.
DOSAGE AND DIRECTIONS FOR USE:
Hypertension:
50-100 mg daily, given orally as a single dose. It is unlikely that additional benefit will be gained by increasing the dose.
Atenolol is compatible with diuretics and other hypotensive agents. In refractory cases a further reduction of blood pressure may be achieved by combining atenolol with other antihypertensive agents for example, co-administration of a diuretic.
Atenolol may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two medicines are co-administered, the atenolol should be withdrawn several days before discontinuing clonidine. If replacing clonidine by Atenolol therapy, the introduction of the latter should be delayed for several days after clonidine administration has stopped.
Angina Pectoris:
The usual dose is 100 mg daily given as a single or divided dose. Additional benefit is not obtained from higher doses.
Patients with Renal Impairment:
Since atenolol is eliminated predominantly via the kidneys, dosage should be adjusted in patients with severe renal impairment. Significant accumulation of atenolol occurs when creatinine clearance falls below 35 mL/min/1,73 m² (normal range is 100-150 mL/min/1,73 m²). The following maximum dosages are recommended for patients with renal impairment:
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