Fixocard Tablet 5mg+50mg

PRESENTATION

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

Fixocard 25 tablet: Each tablet contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg and Atenolol BP 25 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 & 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.

SIDE EFFECTS

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

drowsiness, anxiety and depression.

PRECAUTIONS

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.

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.

DRUG 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.

OVER DOSE

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 50 tablet: Each box contains 5 blister strips of 10 tablets.

Fixocard 25 tablet: Each box contains 5 blister strips of 10 tablets.