Tenobis Plus

Bisoprolol Fumarate USP + Hydrochlorothiazide USP

Composition : Tenobis Plus 2.5 : Bisoprolol Fumarate USP 2.5 mg + Hydrochlorothiazide USP 6.25 mg Tablet

Tenobis Plus 5 : Bisoprolol Fumarate USP 5 mg + Hydrochlorothiazide USP 6.25 mg Tablet &

Tenobis Plus 10 : Bisoprolol Fumarate USP 10 mg + Hydrochlorothiazide USP 6.25 mg Tablet.

Indication : It is indicated in the management of hypertension.

Dosage and administration : Bisoprolol is an effective treatment of hypertension in once-daily doses of 2.5 to 40 mg, while hydrochlorothiazide is effective in doses of 12.5 to 50 mg . In clinical trials of bisoprolol/hydrochlorothiazide combination therapy using bisoprolol doses of Tenobis Plus 2.5 to 20 mg and hydrochlorothiazide doses of 6.25 to 25 mg, the antihypertensive effects increased with increasing doses of either component. Initial Therapy : Antihypertensive therapy may be initiated with the lowest dose of one 2.5/6.25 mg tablet once daily. Subsequent titration (14 day intervals) may be carried out with Tenobis Plus up to the maximum recommended dose 20/12.5 mg once daily, as appropriate. Replacement Therapy : The combination may be substituted for the titrated individual components. Therapy Guided by Clinical Effect : A patient whose blood pressure is not adequately controlled with 2.5-20 mg bisoprolol daily may instead be given Tenobis Plus. Patients whose blood pressures are adequately controlled with 50mg of hydrochlorothiazide daily, but who experience significant potassium loss with this regimen, may achieve similar blood pressure control without electrolyte disturbance if they are switched to Tenobis Plus. Or, as directed by the registered physician.

Use in pregnancy and lactation : Pregnancy Category C : There are no adequated and wellcontrolled studies in pregnant women. Bisoprolol fumarate and hydrochlorothiazide combination should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Nursing mothers : Bisoprolol fumarate alone or in combination with HCTZ has not been studied in nursing mothers. Thiazides are excreted in human breast milk. Small amounts of bisoprolol fumarate have been detected in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking in to account the importance of the drug to the mother.