Betacal Tablet: Each uncoated tablet contains Amlodipine Besylate BP equivalent to Amlodipine BP 5 mg and Atenolol BP 50 mg.
Betacal is indicated for the treatment of hypertension and chronic stable angina.
Hypersensitivity to either component, sinus bradycardia, second and higher degrees of heart block, cardiogenic shock, hypotension, congestive heart failure, poor left ventricular function.
Dosage & Administration
The recommended dosage is one tablet of Betacal daily. If necessary, the dosage may be increased to two tablets daily. The dosage however should be individualized.
The combination of Amlodipine and Atenolol is well tolerated. Side effects include headache, palpitations, flushing, edema, depression, dizziness, dyspepsia, dyspnea, muscle cramps, fatigue, cold extremities and bradycardia.
BRONCHOSPASM: The combination should be used with caution in patients with airway obstruction.
RENAL IMPAIRMENT: The 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.
HEPATIC IMPAIRMENT: Caution may be necessary in the use of the combination in patients with severe liver damage because of prolongation of the elimination half-life of Amlodipine.
PREGNANCY: The combination should be used during pregnancy only if the expected benefit outweighs the potential fetal risk.
LACTATION: The combination should not be used by nursing mothers. If its use is considered necessary, breast feeding should be stopped.
DRUG INTERACTIONS: Disopyramide: Atenolol reduces the clearance of disopyramide by 20%. Additive negative inotropic effects on the heart may be produced. Ampicillin: Ampicillin at doses of 1 g and above may reduce atenolol levels. Oral Antidiabetics and Insulin: Beta-blockers may decrease tissue sensitivity to insulin and inhibit insulin secretion eg. in response to oral antidiabetics. Atenolol has less potential for these actions. The heart rate may not be reliable as an early warning of hypoglycemia.
HYPOTENSION: Excessive fall of blood pressure can occur in some patients especially the elderly.
AGGRAVATION OF ANGINA: Rarely patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy.