Tensolol "Film Coated Tablet"



Composition:
Each tablet contains:
Atenolol                                 100 mg

Pharmacological Properties:
Tensolol is a beta1-selective (cardioselective) adrenergic receptor blocking agent without membrane stabilizing or intrinsic sympathomimetic (partial agonist) activities. Beta-adrenoreceptor blocking activity of Tensolol has been demonstrated by reduction in heart rate and cardiac output, reduction of systolic and diastolic blood pressure at rest and on exercise and also reduction in reflex orthostatic tachycardia.

Pharmacokinetics:
An oral dose of Tensolol is rapidly and consistently absorbed. About 50% of an oral dose is absorbed from the gastrointestinal tract and the remainder is excreted unchanged in the feces. Peak blood levels are reached between 2 and 4 hours after ingestion. Tensolol tablet undergoes little or no metabolism by the liver and the absorbed portion is eliminated primarily by renal excretion. The elimination half-life of oral Tensolol is approximately 6-7 hours. Only a small amount is bound to proteins in the plasma.

Indications:
- Hypertension.
- Angina pectoris due to coronary atherosclerosis.
- Acute myocardial infarction.

Contraindications:
Tensolol is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock and overt cardiac failure.
Tensolol is contraindicated in patients with a history of hypersensitivity to atenolol or any other component of the drug.

Warnings:
- Avoid abrupt discontinuation of Tensolol therapy.
- Patients with bronchospastic disease should, in general, not receive beta blockers.    
- Tensolol should not be given to patients with untreated pheochromocytoma.

Precautions:
- Tensolol may aggrevate peripheral arterial circulatory disorders.
- Tensolol should be used with caution in patients with impaired renal function and in diabetic patients as it may mask tachycardia occuring with hypoglycemia.
- Tensolol may mask certain clinical signs (e. g, tachycardia) of hyperthyroidism.
Besides, abrupt withdrawal of Tensolol might precipitate a thyroid storm in Patients suspected of developing thyrotoxicosis.

Pregnancy:
Atenolol can cause fetal harm when administered to a pregnant woman.

Lactation:
Atenolol is excreted in human breast milk, caution should be exercised when Tensolol is administered to a nursing woman. Premature infants or infants with impaired renal function, may be more likely to develop adverse effects.

Drug interactions:
- Calcium channel blockers may have an additive effect when given with Tensolol.
- Tensolol may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.
- Concomitant use of prostaglandin synthase inhibiting drugs such as Indomethacin, may decrease the hypotensive effects of beta blockers.

Side effects:
Most adverse effects are mild and transient. They include nausea, diarrhea, cold extremities, dizziness and fatigue.

Overdosage:
- Symptoms reported following tensolol overdose are lethargy, disorder of respiratory drive, wheezing, sinus pause, bradycardia, congestive heart failure, hypotension, bronchospasm and/or hypoglycemia.
- Treatment of overdose should be directed to the removal of any unabsorbed drug by induced emesis, gastric lavage, or administration of activated charcoal, Tensolol can be removed from the general circulation by hemodialysis.
Other treatment modalities should be employed at the physician´s discretion.

Dosage and administration:
In the treatment of hypertension and angina pectoris:
The initial dose of Tensolol is 50 mg given daily either alone or added to diuretic therapy.
If an optimal response is not achieved, the dosage should be increased to 100 mg given as one tablet a day.

Therapeutic category: Antihypertensive.

Legal category: Prescription only medicine.

Storage:
Store at a temperature below 30° C, protect from light.

Package: Box containing 20 tablets.

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.