Tenocab®

Atenolol + Amlodipine

Prescribing Details



Description
Tenocab ® 25 and Tenocab ® 50 are fixed-dose combinations of amlodipine and atenolol. 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 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 cellsthan 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 b1 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.

Uses
No Data

Indications
Hypertension, Angina pectoris & hypertension as co-existing diseases, Post MI, Refractory angina pectoris where nitrate has failed.

Dosage and administration
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 individualised.

Use in pregnancy & lactation
Pregnancy: The combination should be used during pregnancy only if the expected benefit outweighs the potential foetal risk.

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

Geriatric use
No Data

Precautions
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. Bronchospasm: The combinationshould be used with caution in patients with airway obstruction.

Drug withdrawal:
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.

Side effects
The combination of amlodipine and atenolol is well tolerated. Side effects include headache, palpitations, flushing, edema, depression.

Contraindications
Hypersensitivity to either component.

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 g and above may reduce atenolol levels. Oral antidiabetics and insulin: b-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.

Overdose
No Data

Preparation
No Data

Pharmaceutical precautions
Store in a cool dry place. Protect from light.

Presentation
Tenocab ® 25 Tablets: White, round, scored and embossed with 'ACI' on one side and the other side plain tablet. Each tablet contains Atenolol BP 25 mg and Amlodipine 5 mg as Besilate BP.
Tenocab ® 50 Tablets: White, round, scored and embossed with 'ACI' on one side and the other side plain tablet. Each tablet contains Atenolol BP 50 mg and Amlodipine 5 mg as Besilate BP.

Package quantities
Tenocab ® 25 Tablets: Cartons of 50 tablets in Alu-PVC blister.
Tenocab ® 50 Tablets: Cartons of 50 tablets in Alu-PVC blister.