Indications

Patients with essential hypertension; Patients with angina pectoris & hypertension as co-existing diseases; In post MI patients; In patients with refractory angina pectoris where nitrate therapy has failed.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.

Pharmacology

This is a fixed-dose combination of amlodipine and atenolol. Amlodipine is a dihydropyridine calcium antagonist, which can inhibit calcium ions from transmembrane into vascular smooth muscle and myocardium; its effect on vascular smooth muscle is greater than that on myocardium. Amlodipine is a peripheral vasodilator that directly acts on vascular smooth muscle, resulting in lower peripheral vascular resistance and lower blood pressure. Amlodipine reduces tension by reducing afterload, reduces coronary vascular reactivity, and reduces cardiac requirements.

Atenolol is a cardiac selective beta-blocker. Cardiac selectivity is related to dose. Atenolol lowers blood pressure by reducing cardiac output, plasma renin activity, and central nervous system sympathetic output. Atenolol also reduces myocardial oxygen demand due to its negative muscle strength and negative time-changing effects.

Dosage & Administration

The recommended dosage is Fixocard or Fixocard 25 one tablet daily. If necessary, the dosage may be increased to two tablets daily or as advised by the physicians. The dosage however should be individualized.

Interaction

Disopyramide: Atenolol reduces the clearance of disopyramide by 20%. Additive negative inotropic effects on the heart may be produced. Ampicillin: at doses of 1 gm and above may reduce Atenolol levels. Oral antidiabetics and insulin: 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. 

Contraindications

Hypersensitivity to any component, sinus bradycardia, heart block grade 2 and higher, cardiogenic shock, hypotension, congestive heart failure, and poor left ventricular function.

Side Effects

The combination of Amlodipine and Atenolol is well tolerated. Overall side-effects include fatigue, headache, edema, nausea drowsiness, anxiety and depression.

Pregnancy & Lactation

Pregnancy: The combination should be used during pregnancy only if the expected benefit outweighs the potential fetal risk.

Nursing Mother: The combination should not be used by nursing mothers. If its use is considered necessary, breast-feeding should be stopped.

Precautions & Warnings

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.

Drug withdrawal: Since coronary heart disease may exist without being recognized, patients should be warned against stopping the drug suddenly. Any discontinuation should be gradual and under observation.

Therapeutic Class

Combined antihypertensive preparations

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Generic

Amlodipine Besilate + Atenolol