Label Changes for:
Dutoprol (metoprolol succinate extended release/hydrochlorothiazide) tablets
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
5.2 Heart Failure
- section edited...Worsening cardiac failure may occur during up-titration of beta-blockers. If such symptoms occur, increase diuretics and restore clinical stability (compensated heart failure) before advancing the dose of DUTOPROL [see Dosage and Administration (2)]. It may be necessary to lower the dose of DUTOPROL or temporarily discontinue it [see Boxed Warning.] Such episodes do not preclude subsequent successful titration of DUTOPROL.
5.13 Impaired Hepatic Function
- added...Consider initiating DUTOPROL therapy at doses lower than those recommended; gradually increase dosage to optimize therapy, while monitoring closely for adverse events.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
- section added...Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
6.2 Post-Marketing Experience
- section added...The following adverse reactions have been identified during post-approval use of metoprolol succinate extended release and/or hydrochlorothiazide Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Central Nervous System:
- added...anxiety/nervousness,hallucinations, paresthesia
- added...hepatitis, vomiting
- added...arthralgia, male impotence, reversible alopecia, agranulocytosis, dry eyes, worsening of psoriasis, Peyronie’s disease, sweating, photosensitivity, taste disturbance
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.