Amlodipine+Atenolol 5/25mg x100s Tablets (Amlopres AT)

AMLODIPINE / ATENOLOL combo tablet;

Description

This is a combination tablet of 5mg/Amlodipine + 25mg/Atenolol packed 100s Tablets per blister package.

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 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 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 Administrations

The therapy is initiated with a single dose of this combination. 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.

Drug Interactions

Amlodipine has been safely administered with thiazide diuretics, beta blockers, alpha blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual glyceryl trinitrate, non-steroidal anti-inflammatory agents, antibiotics, and oral hypoglycemic agents. In vitro data from studies with human plasma indicate that amlodipine has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin, or indomethacin).

Atenolol reduces the clearance of disopyramide by 20% .Additive negative inotropic effects on the heart may be produced. At doses of 1 gm and above Ampicillin 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.

Precautions

Brochospasm: 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 30ml/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:
The combination should be used during pregnancy only if the expected benefit outweighs the potential fetal risk.

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

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.

Pharmaceutical Precautions
Store in a cool dry place protected from light. Keep out of reach of children.