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Clinical Trials Experience
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.
Metoprolol Succinate Extended Release/Hydrochlorothiazide
The metoprolol succinate extended release and hydrochlorothiazide combination was evaluated for safety in 891 patients with hypertension in clinical trials. In a randomized, double-blind, placebo-controlled, factorial trial (Study 1), 843 patients were treated with various combinations of metoprolol succinate (doses of 25 to 200 mg) and hydrochlorothiazide (doses of 6.25 to 25 mg) [see Clinical Studies]. Adverse events which occurred more than 1% more frequently in patients treated with DUTOPROL than placebo were: nasopharyngitis (3.4% vs 1.3%) and fatigue (2.6% vs 0.7%).
The adverse reactions of metoprolol succinate extended release are a mixture of dose-dependent phenomena (primarily bradycardia and fatigue) and those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with DUTOPROL will be associated with both sets of dose independent reactions.
Liver Enzyme Tests—Increases in liver enzymes or serum bilirubin.
The following adverse reactions have been identified during post-approval use of DUTOPROL, 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 estimate their frequency reliably or establish a causal relationship to drug exposure.
The following adverse reactions have been reported for immediate release metoprolol tartrate. Most adverse reactions have been mild and transient.
Hypersensitivity Reactions: Pruritus, rash
Miscellaneous: Musculoskeletal pain, arthralgia, blurred vision, decreased libido, male impotence, tinnitus, reversible alopecia, dry eyes, worsening of psoriasis, Peyronie's disease, sweating, photosensitivity, taste disturbance, depression
Other Beta-Adrenergic Blockers
In addition, adverse reactions not listed above, that have been reported with other beta-adrenoceptor blockers and should be considered potential adverse reactions to DUTOPROL.
Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, emotional lability, clouded sensorium, and decreased performance on neuropsychometrics.
Hematologic: Non-thrombocytopenic purpura, thrombocytopenic purpura.
Hypersensitivity Reactions: Laryngospasm, and respiratory distress.
Adverse reactions that have been reported with hydrochlorothiazide are listed below:
Body as a Whole: Weakness
Cardiovascular: Orthostatic hypotension
Hypersensitivity Reactions: Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria
Musculoskeletal: Muscle spasm
Nervous System/Psychiatric: Vertigo, paresthesias, restlessness
Special Senses: Transient blurred vision, xanthopsia
Read the Dutoprol (metroprolol) Side Effects Center for a complete guide to possible side effects
Drug Interactions With Metoprolol
Reserpine, monoamine oxidase (MAO) inhibitors: The concomitant use of catecholamine-depleting drugs (e.g., reserpine, monoamine oxidase (MAO) inhibitors) with beta adrenergic blockers may have an additive affect and increase the risk of hypotension or bradycardia. Observe patients treated with DUTOPROL plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.
CYP2D6 Inhibitors: Drugs that inhibit CYP2D6 such as quinidine, fluoxetine, paroxetine, and propafenone are likely to increase metoprolol concentration [see CLINICAL PHARMACOLOGY].
Nondihydropyridine Calcium Channel Blockers: [See WARNINGS AND PRECAUTIONS].
Digoxin: Digitalis glycosides slow atrioventricular conduction and decrease heart rate. Concomitant use of digoxin with beta adrenergic blockers increases the risk of bradycardia.
Clonidine: Clonidine slows conduction and decrease heart rate. Concomitant use with beta adrenergic blockers increases the risk of bradycardia. If clonidine and DUTOPROL are to both be discontinued, withdraw DUTOPROL several days before the gradual withdrawal of clonidine to reduce the risk of rebound hypertension following the clonidine withdrawal. If a patient is to switch from clonidine to DUTOPROL, delay the introduction of DUTOPROL for several days after discontinuation of clonidine.
Epinephrine: [See WARNINGS AND PRECAUTIONS].
Drug Interactions With Hydrochlorothiazide
Antidiabetic drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required.
Ion exchange resins: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. Stagger the dosage of hydrochlorothiazide and ion exchange resins (e.g., cholestyramine and colestipol resins) such that hydrochlorothiazide is administered at least 4 hours before or 4-6 hours after the administration of resins to minimize the interaction.
Lithium: Diuretics reduce the renal clearance of lithium and increase the risk of lithium toxicity. Monitor serum lithium concentrations during concurrent use.
Read the Dutoprol Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 11/3/2014
Additional Dutoprol Information
- Dutoprol Drug Interactions Center: metoprolol su-hydrochlorothiaz oral
- Dutoprol Side Effects Center
- Dutoprol FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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