FDA approved Ziac (bisoprolol/hydrochlorothiazide) for HypertensionFDA approved Ziac, a new combination pill for high blood pressure.

FDA From the archive Source published March 26, 1993 Summary added July 29, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Ziac for hypertension when monotherapy with bisoprolol or hydrochlorothiazide is inadequate.

The FDA has approved Ziac (bisoprolol fumarate/hydrochlorothiazide) for the management of hypertension. The combination tablet combines a beta-blocker (bisoprolol) and a thiazide diuretic (hydrochlorothiazide) to provide additive antihypertensive effects. In clinical trials, the combination reduced systolic and diastolic blood pressure throughout a 24-hour period with once-daily dosing. The approval is based on two randomized, double-blind, placebo-controlled trials in patients with mild-to-moderate hypertension. In these studies, the combination produced significantly greater blood pressure reductions than placebo or either component alone, with effects consistent across age, race, and gender. Clinicians should note that therapy may be initiated with the lowest dose (2.5/6.25 mg) and titrated at 14-day intervals up to a maximum of 20/12.5 mg daily. The combination is intended for patients who have not achieved adequate blood pressure control with monotherapy or who experience electrolyte disturbances with hydrochlorothiazide alone.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Bisoprolol is a beta1-selective adrenoceptor blocking agent. Hydrochlorothiazide is a thiazide diuretic that increases urinary excretion of sodium and water. The antihypertensive effects of the combination are additive.

Indication & Patient Population

Ziac is indicated for the management of hypertension. It is appropriate for patients whose blood pressure is not adequately controlled with bisoprolol monotherapy (2.5-20 mg daily) or for patients controlled on hydrochlorothiazide 50 mg daily who experience significant potassium loss.

Dosing & Administration

Initial therapy: one 2.5/6.25 mg tablet once daily. Titration at 14-day intervals up to maximum 20/12.5 mg (two 10/6.25 mg tablets) once daily. Replacement therapy: may substitute for titrated individual components. Cessation: withdraw gradually over about 2 weeks. Caution in hepatic or renal impairment. No dosage adjustment needed for geriatric patients unless significant renal or hepatic dysfunction. No pediatric experience.

Key Clinical Trial Data

In two randomized, double-blind, placebo-controlled U.S. trials in patients with mild-to-moderate hypertension (baseline ~151/101 mmHg, 77 bpm), the combination reduced sitting systolic/diastolic blood pressure and heart rate at 24 hours post-dose. For example, in Study 1, bisoprolol 5 mg/hydrochlorothiazide 6.25 mg reduced BP by -15.8/-12.6 mmHg (drug effect -12.9/-8.7 mmHg) and HR by -6.9 bpm (drug effect -6.6 bpm). Blood pressure responses were seen within 1 week, with maximum effect at 2-3 weeks. Effects were consistent across age, race, and gender.

Warnings & Contraindications

Beta-blockers should generally be avoided in patients with overt congestive heart failure. Use cautiously in compensated cardiac failure. For complete warnings, see label.

Place in Therapy

Ziac is a fixed-dose combination for hypertension. It may be used as initial therapy or as replacement therapy in patients not controlled on monotherapy. The combination minimizes dose-dependent adverse effects of each component when low doses are used.

The FDA has approved a new drug called Ziac for treating high blood pressure, also known as hypertension. Ziac is a combination tablet that contains two different medicines: bisoprolol, a beta-blocker, and hydrochlorothiazide, a diuretic. These two drugs work together to lower blood pressure more effectively than either one alone. In clinical studies, Ziac reduced blood pressure throughout the day with just one daily dose.

Ziac is meant for people who have not been able to get their blood pressure under control using a single medicine. It may also be an option for those who have had side effects like electrolyte imbalances from taking hydrochlorothiazide alone. The approval was based on two large studies that showed Ziac lowered blood pressure significantly better than placebo or either component by itself. The effects were consistent across different ages, races, and genders.

Doctors can start patients on a low dose and increase it slowly, every two weeks, up to a maximum dose. This helps find the right balance between effectiveness and side effects. The approval gives healthcare providers another tool to help patients manage their blood pressure.

If you have high blood pressure, talk to your doctor about whether Ziac might be a good option for you. This approval does not mean the drug is right for everyone. Your doctor can help you understand the benefits and risks based on your personal health history.

What this means for you:

Ziac is a new combination pill for high blood pressure. Talk to your doctor to see if it is right for you.

Study Details

Study typeFda approval

PublishedMar 1993

View Original Abstract ↓

INDICATIONS AND USAGE Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.

FDA approved Ziac (bisoprolol/hydrochlorothiazide) for HypertensionFDA approved Ziac, a new combination pill for high blood pressure.

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