Management of hypertension.
Dosage & 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 2.5 to 20 mg and Hydrochlorothiazide doses of 6.25 to 25 mg, the antihypertensive effects increased with increasing doses of either component.
Antihypertensive therapy may be initiated with the lowest dose of Betacor HZ, one 2.5/6.25 mg tablet once daily. Subsequent titration (14 day intervals) may be carried out with Betacor HZ tablets up to the maximum recommended dose 20/12.5 mg once daily, as appropriate.
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 Betacor HZ. Patients whose blood pressures are adequately controlled with 50 mg 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 Betacor HZ.
Use in Pregnancy and Lactation
Use in Pregnancy:
US-FDA Pregnancy Category C. There are no adequate and wellcontrolled studies in pregnant women. Betacor HZ should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
Use in Nursing Mothers:
Bisoprolol Fumarate alone or in combination with Hydrochlorothiazide 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 into account the importance of the drug to the mother.
Hyperuricemia or acute gout may be precipitated in certain patients receiving thiazide diuretics. Warning signs or symptoms of fluid and electrolyte imbalance include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting.
Hypokalemia may develop.
If withdrawal of this combination therapy is planned, it should be achieved gradually over a period of about 2 weeks. Patients should be carefully observed.