Amlodipine Besylate INN & Atenolol BP

To be submitted at the time of inclusion.

TABLET.
Each tablet contains Amlodipine Besylate INN equivalent to Amlodipine 5 mg & Atenolol BP 25 mg.

This combination drug is indicated for the treatment of hypertension and chronic stable angina.

The recommended dosage is one tablet once daily. If necessary, the dosage may be increased to two tablets daily. The dosage however should be individualized.

Hypersensitivity to any component of the product, sinus bradycardia, second and higher degrees of heart block, cardiogenic shock, hypotension, congestive heart failure, poor left ventricular function.

This combination of Amlodipine and Atenolol is well tolerated. Side effects include headache, palpitations, flushing, oedema, depression, dizziness, dyspepsia, dyspnoea, muscle cramps, fatigue, cold extremities and bradycardia.

The combination should be used with caution in patients with airway obstruction.
This combination can be used in patients with renal impairment. However, caution may be necessary if the creatinine clearance is less than 30 ml/min because of possible reduction in the excretion of unchanged Atenolol.
Caution may be necessary in the use of this combination drug in patients with severe liver damage because of prolongation of the elimination half-life of Amlodipine.
Since coronary heart disease may exist without being recongnised, patients should be warned against stopping the drug suddenly. Any discontinuation should be gradual and under observation.
Excessive fall of blood pressure can occur in some patients especially the elderly.

There is no information on the use of Aceclofenac during pregnancy and the secretion of Aceclofenac to breast milk. The use of Aceclofenac should therefore be avoided in pregnancy and lactation unless the potential benefits to the mother outweigh the possible risks to the fetus.

Atenolol reduces the clearance of disopyramide by 20%. Additive negative inotropic effects on the heart may be produced. Ampicillin at doses of 1 g and above may reduce Atenolol levels. Beta-blockers may decrease tissue sensitivity to insulin and inhibit insulin secretion e.g. in response to oral antidiabetics. Atenolol has less potential for these actions. The heart rate may not be reliable as an early warning of hypoglycaemia. .

Though not documented, hypotension and less frequently congestive cardiac failure may occur in cases of overdosage.
Unabsorbed drugs may be removed by gastric lavage or administration of activated charcoal. Symptomatic treatment is suggested.

Safety & effectiveness in paediatric patients have not been established.

• Store in a cool & dry place.
• Keep out of the reach of children.

Box containing 10 X 10 Tablets in blister pack.