ZIAC Film-coated tablet (2024)

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Teva Women's Health, Inc.

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1. Description

ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta<sub>1</sub>-selective ...

2. Clinical Pharmacology

Bisoprolol fumarate and HCTZ have been used individually and in combination for the treatment of hypertension. The antihypertensive effects of these agents are additive; HCTZ 6.25 mg significantly increases ...

3. Indications and Usage

ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.

4. Contraindications

ZIAC is contraindicated in patients in cardiogenic shock, overt cardiac failure (see WARNINGS), second or third degree AV block, marked sinus bradycardia, anuria, and hypersensitivity to either component ...

5. Warnings

Cardiac Failure In general, beta-blocking agents should be avoided in patients with overt congestive failure. However, in some patients with compensated cardiac failure, it may be necessary to utilize ...

6. Precautions

Bisoprolol Fumarate Concurrent use of rifampin increases the metabolic clearance of bisoprolol fumarate, shortening its elimination half-life. However, initial dose modification is generally not necessary. ...

6.1. General

Electrolyte and Fluid Balance Status Although the probability of developing hypokalemia is reduced with ZIAC because of the very low dose of HCTZ employed, periodic determination of serum electrolytes ...

6.2. Information for Patients

Warn patients, especially those with coronary artery disease, against discontinuing use of ZIAC without a physicians supervision. Patients should also be advised to consult a physician if any difficulty ...

6.4. Drug Interactions

ZIAC may potentiate the action of other antihypertensive agents used concomitantly. ZIAC should not be combined with other beta-blocking agents. Patients receiving catecholamine-depleting drugs, such as ...

6.5. Drug/Laboratory Test Interactions

Based on reports involving thiazides, ZIAC (bisoprolol fumarate and hydrochlorothiazide) may decrease serum levels of protein-bound iodine without signs of thyroid disturbance. Because it includes a thiazide, ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis ZIAC Long-term studies have not been conducted with the bisoprolol fumarate/hydrochlorothiazide combination. Bisoprolol Fumarate Long-term studies were conducted with oral bisoprolol fumarate ...

6.7. Pregnancy

Teratogenic Effects ZIAC In rats, the bisoprolol fumarate/hydrochlorothiazide (B/H) combination was not teratogenic at doses up to 51.4 mg/kg/day of bisoprolol fumarate in combination with 128.6 mg/kg/day ...

6.9. 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 (<2% of the dose) have been ...

6.10. Pediatric Use

Safety and effectiveness of ZIAC in pediatric patients have not been established.

6.11. Geriatric Use

In clinical trials, at least 270 patients treated with bisoprolol fumarate plus HCTZ were 60 years of age or older. HCTZ added significantly to the antihypertensive effect of bisoprolol in elderly hypertensive ...

7. Adverse Reactions

ZIAC Bisoprolol fumarate/HCTZ 6.25 mg is well tolerated in most patients. Most adverse effects (AEs) have been mild and transient. In more than 65,000 patients treated worldwide with bisoprolol fumarate, ...

9. Overdosage

There are limited data on overdose with ZIAC. However, several cases of overdose with bisoprolol fumarate have been reported (maximum: 2000 mg). Bradycardia and/or hypotension were noted. Sympathomimetic ...

10. 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 ...

11. How Supplied

ZIAC 2.5 mg/6.25 mg Tablets (bisoprolol fumarate 2.5 mg and hydrochlorothiazide 6.25 mg): Yellow, round, film-coated, unscored tablets. Debossed with stylized b within an engraved heart shape on one side ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

13. Clinical Studies

In controlled clinical trials, bisoprolol fumarate/hydrochlorothiazide 6.25 mg has been shown to reduce systolic and diastolic blood pressure throughout a 24-hour period when administered once daily. The ...