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Dutoprol

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Dutoprol

Dutoprol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Dutoprol (metoprolol succinate extended release/hydrochlorothiazide) is used to treat hypertension, to lower blood pressure. Metoprolol is a beta1-selective (cardioselective) adrenoceptor-blocking agent, and hydrochlorothiazide is a diuretic. Common side effects include inflammation of the nose and throat, fatigue, dizziness, back pain, and nausea.

Dosing of Dutoprol is individualized considering baseline and target blood pressure and any experience with the individual drugs. The usual initial dose of metoprolol succinate extended release is 25 to 100 mg daily in a single dose. Hydrochlorothiazide is effective in doses of 12.5 mg to 50 mg once daily. Dutoprol may interact with cisapride, dofetilide, fingolimod, lithium, lumefantrine, quinidine, propafenone, SSRI antidepressants, St. John's wort, cough-and-cold products, diet aids, or NSAIDs. Tell your doctor all medications and supplements you use. During pregnancy, Dutoprol should be used only if prescribed. A small amount of metoprolol passes into breast milk. Thiazides pass into breast milk. Consult your doctor before breastfeeding.

Our Dutoprol (metoprolol succinate extended release/hydrochlorothiazide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Dutoprol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

Laboratory Abnormalities

Liver Enzyme Tests-Increases in liver enzymes or serum bilirubin.

Post-Marketing Experience

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.

Metoprolol

The following adverse reactions have been reported for immediate release metoprolol tartrate. Most adverse reactions have been mild and transient.

Central Nervous System: Confusion, short-term memory loss, headache, somnolence, nightmares, insomnia, anxiety/nervousness, hallucinations, paresthesia, dizziness

Cardiovascular: Shortness of breath, bradycardia, cold extremities; arterial insufficiency (usually of the Raynaud type), palpitations, peripheral edema, syncope, chest pain

Respiratory: Dyspnea

Gastrointestinal: Diarrhea, nausea, dry mouth, gastric pain, constipation, flatulence, heartburn, hepatitis, vomiting.

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.

Hydrochlorothiazide

Adverse reactions that have been reported with hydrochlorothiazide are listed below:

Body as a Whole: Weakness

Cardiovascular: Orthostatic hypotension

Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation, anorexia

Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia

Hypersensitivity Reactions: Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria

Metabolic: Glycosuria

Musculoskeletal: Muscle spasm

Nervous System/Psychiatric: Vertigo, paresthesias, restlessness

Renal: Interstitial nephritis

Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis

Special Senses: Transient blurred vision, xanthopsia

Read the entire FDA prescribing information for Dutoprol (Metroprolol) »

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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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