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Uses
Side effects
Interactions
Precautions
- ZEBETA is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.
- Safety data are available in more than 30,000 patients or volunteers.
- Frequency estimates and rates of withdrawal of therapy for adverse events were derived from two U.S. placebo-controlled studies. In Study A, doses of 5, 10, and 20 mg bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5, 10, and 40 mg of bisoprolol fumarate were administered for 12 weeks.
- A total of 273 patients were treated with 5-20 mg of bisoprolol fumarate; 132 received placebo.
- Withdrawal of therapy for adverse events was 3.3% for patients receiving bisoprolol fumarate and 6.8% for patients on placebo.
- Withdrawals were less than 1% for either bradycardia or fatigue/lack of energy.
- The following table presents adverse experiences, whether or not considered drug related, reported in at least 1% of patients in these studies, for all patients studied in placebo-controlled clinical trials (2.5-40 mg), as well as for a subgroup that was treated with doses within the recommended dosage range (5-20 mg).
- Of the adverse events listed in the table, bradycardia, diarrhea, asthenia, fatigue, and sinusitis appear to be dose related.
- ZEBETA should not be combined with other beta-blocking agents.
- Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added beta-adrenergic blocking action of ZEBETA may produce excessive reduction of sympathetic activity.
- In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that ZEBETA be discontinued for several days before the withdrawal of clonidine. ZEBETA should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.
- Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Concurrent use of rifampin increases the metabolic clearance of ZEBETA, resulting in a shortened elimination half-life of ZEBETA.
- However, initial dose modification is generally not necessary.
- Pharmacokinetic studies document no clinically relevant interactions with other agents given concomitantly, including thiazide diuretics, and cimetidine.
- There was no effect of ZEBETA on prothrombin time in patients on stable doses of warfarin.
- Risk of Anaphylactic Reaction: While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic.
- Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
- Impaired Renal or Hepatic Function Use caution in adjusting the dose of ZEBETA in patients with renal or hepatic impairment (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
