Tenocab^®

Tenocab is the preparation of Amlodipine and Atenolol.
Mechanism of action: Amlodipine Besilate is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. The contractile process of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine Besilate inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. It acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Atenolol is phenylacetamide, a selective ßl blocker. It blocks the effects of adrenergic stimulation mediated through these receptors. 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.

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Tenocab is indicated for the treatment of hypertension, angina pectoris and hypertension as co-existing diseases, post MI, refractory angina pectoris where nitrate has failed.

Route of administration: Tenocab should be taken in oral route.
The recommended dosage is one tablet of Tenocab 25 and Tenocab 50 daily. If necessary, the dosage may be increased to two tablets daily. The dosage however should be individualized.

Patients with 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.

Patients with 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.

Pregnancy: This combination should be used during pregnancy only if the expected benefit outweighs the potential fetal risk.
Lactation: This combination should not be used by nursing mothers. If its use is considered necessary, breast feeding should be stopped.

Use in children and adolescents
Amlodipine (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years. Effect of amlodipine on blood pressure in patients less than 6 years of age is not known. Safety and effectiveness of atenolol in pediatric patients have not been established.

This combination should be used with caution in patients with airway obstruction. Since coronary heart disease may exist without being recognised, patients should be warned against stopping the drug suddenly. Any discontinuation should be gradual and under observation.

This combination of amlodipine and atenolol is well tolerated. Overall side effects include fatigue, headache, edema, nausea, drowsiness, anxiety and depression.

This combination is contraindicated in patients with known hypersensitivity to amlodipine and atenolol or any of the components of this product.

Drug interaction with medications: Atenolol reduces the clearance of disopyramide by 20%. Additive negative inotropic effects on the heart may be produced. Ampicillin at doses of 1 g and above may reduce atenolol levels. ß-blockers may decrease tissue sensitivity to insulin and inhibit insulin secretion e.g., in response to oral anti-diabetics. Atenolol has less potential for these actions.

Drug interaction with food and others: Not applicable.

Though not documented, hypotension and less frequently congestive cardiac failure may occur in cases of overdose. Unabsorbed drugs may be removed by gastric lavage or administration of activated charcoal. Symptomatic treatment is suggested.

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Store in a cool dry place. Protect from light.

Tenocab 25 tablet: Each tablet contains Atenolol BP 25 mg and Amlodipine 5 mg as Besilate BP.
Tenocab 50 tablet: Each tablet contains Atenolol BP 50 mg and Amlodipine 5 mg as Besilate BP.

Storage
Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.

Packing
Tenocab 25 tablet: Carton of 100 tablets in blister pack.
Tenocab 50 tablet: Carton of 50 tablets in blister pack.