|Manufacturer:||Forest Pharmaceuticals Inc.|
(see CLINICAL PHARMACOLOGY, Pharmacokinetics)No dose adjustments are necessary for patients who are CYP2D6 poor metabolizers.
The clinical effect and safety profile observed in poor metabolizers were similar to those of extensive metabolizers.
BYSTOLIC is indicated for the treatment of hypertension.
BYSTOLIC may be used alone or in combination with other antihypertensive agents.
-- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.
BYSTOLIC is contraindicated in patients with severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), or severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.
-- Impaired conduction of cardiac impulse that can occur anywhere along the conduction pathway, such as between the SINOATRIAL NODE and the right atrium (SA block) or between atria and ventricles (AV block). Heart blocks can be classified by the duration, frequency, or completeness of conduction block. Reversibility depends on the degree of structural or functional defects.
-- Shock resulting from diminution of cardiac output in heart disease.
Sick Sinus Syndrome
-- A condition caused by dysfunctions related to the SINOATRIAL NODE including impulse generation (CARDIAC SINUS ARREST) and impulse conduction (SINOATRIAL EXIT BLOCK). It is characterized by persistent BRADYCARDIA, chronic ATRIAL FIBRILLATION, and failure to resume sinus rhythm following CARDIOVERSION. This syndrome can be congenital or acquired, particularly after surgical correction for heart defects.
-- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.
Patients with coronary artery disease treated with BYSTOLIC should be advised against abrupt discontinuation of therapy.
Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with ?-blockers.
Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of the angina pectoris.
Even patients without overt coronary artery disease should be cautioned against interruption or abrupt discontinuation of therapy.
As with other ?-blockers, when discontinuation of BYSTOLIC is planned, patients should be carefully observed and advised to minimize physical activity.
BYSTOLIC should be tapered over 1 to 2 weeks when possible.
If the angina worsens or acute coronary insufficiency develops, it is recommended that BYSTOLIC be promptly reinstituted, at least temporarily.
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