Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
DUTOPROL is contraindicated in patients with:
- Cardiogenic shock or decompensated heart failure.
- Sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place.
- Hypersensitivity to metoprolol succinate or hydrochlorothiazide or to other sulfonamide-derived drugs.
WARNINGS AND PRECAUTIONS
Revised section 5.2, 5.3:
5.2 Heart Failure
New Section 5.4:
- Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Dutoprol. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders (including Wolff-Parkinson-White) may be at increased risk. The concomitant use of beta adrenergic blockers and non-dihydropyridine calcium channel blockers (e.g., verapamil and diltiazem), digoxin or clonidine increases the risk of significant bradycardia. Monitor heart rate and rhythm in patients receiving Dutoprol. If severe bradycardia develops, reduce or stop Dutoprol.
Revised sectionS 5.7, 5.8, 5.10, 5.11, 5.12, 5.13, 5.14:
5.7 Electrolyte and Metabolic Effects
- Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels.
5.8 Renal Impairment
5.10 Increased Blood Pressure in Patients with Pheochromocytoma
5.11 Thyrotoxicosis after Discontinuation in Patients with Hyperthyroidism
5.12 Reduced Effectiveness of Epinephrine in Treating Anaphylaxis
5.13 Acute Myopia and Secondary Angle-Closure Glaucoma
5.14 Exacerbation of Systemic Lupus Erythematosus
Revised Sections 6.1, 6.2:
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
Major Surgery (revised)
- Avoid initiation of high-dose regimen of extended release metoprolol in patients undergoing noncardiac surgery since such use in patients with cardiovascular risk factors has been associated with bradycardia, hypotension, stroke and death.
- Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
Hydrochlorothiazide -Acute Myopia and Secondary Angle-Closure Glaucoma (new)
- Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Drug Interactions (revised)
- Digitalis glycosides, clonidine, diltiazem and verapamil slow atrioventricular conduction and decrease heart rate. Concomitant use with beta-blockers can increase the risk of bradycardia.