Indications

This is indicated in-

• Patients with essential hypertension
• Patients with angina pectoris & hypertension as co-existing diseases
• ln post Ml patients
• ln patients with refractory angina pectoris where nitrate therapy has failed.

Pharmacology

This is a fixed-dose combination of Amlodipine and Atenolol. Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle; it has a greater effect on vascular smooth muscle than on cardiac muscle. Amlodipine is a peripheral vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Amlodipine reduces tone, decreases coronary vasoreactivity, and lowers cardiac demand by reducing afterload.

Atenolol is a cardioselective beta-blocker. The cardio-selectivity is dose-related. Atenolol causes a reduction in blood pressure by lowering cardiac output, decreasing the plasma renin activity and sympathetic outflow from CNS. Atenolol also causes a reduction in myocardial oxygen demand by virtue of its negative inotropic and negative chronotropic effects.

Dosage & Administration

Adult: This therapy is initiated with a single dose of this preparation depending upon the therapeutic response, titration of the dosage is recommended.

In elderly patients: It is advisable to initiate the therapy with ½ tablet of fixed-dose combination of Amlodipine & Atenolol, i.e., 2.5 mg of Amlodipine & 25 mg Atenolol.

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 either component, sinus bradycardia, second and higher degrees of heart block, cardiogenic shock, hypotension, congestive heart failure, poor left ventricular function.

Side Effects

Fixocard 50 is well tolerated. Overall side-effects include
fatigue, headache, edema, nausea, drowsiness, anxiety, and depression.

Pregnancy & Lactation

The combination should be used during pregnancy only if the expected benefit outweighs the potential fetal risk. The combination should not be used by nursing mothers. If its use is considered necessary, breastfeeding 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 a possible reduction in the excretion of unchanged Atenolol.

Hepatic impairment: Caution may be necessary for the use of the combination in patients with severe liver damage because of the 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

Antihypertensive medications in combination

Storage Conditions

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

Pharmaceuticals name

Incepta  Pharmaceuticals Ltd.

Generic

Amlodipine Besilate + Atenolol

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