Fixocard Tablet
Amlodipine 5 mg plus Atenolol 50 mg tablet
 

Presentation

Fixocard tablet: Each tablet contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Atenolol BP 50 mg.

Description

Fixocard 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 after load. Atenolol is a cardio selective 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.

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.

Dosage and Administration

The therapy is initiated with a single dose of Amlodipine 5 mg plus Atenolol 50 mg. 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.

Side-effects

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

Contraindications

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

Use in 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.

Precaution

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.

Drug Interactions

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.

Overdosage

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.

Commercial pack

Fixocard  tablet: Each box contains 3 blister strips of 10 tablets.