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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

Metoprolol succinate extended release /hydrochlorothiazide

The metoprolol succinate extended release and hydrochlorothiazide combination was evaluated for safety in 891 patients treated for hypertension in clinical trials. In a placebo-controlled trial, 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). Overall, the incidence of adverse experiences reported with the combination was comparable to placebo. Adverse events, whether or not attributed to treatment, occurring in greater than 1% of patients treated with DUTOPROL and at a rate equal to or greater than with placebo were: nasopharyngitis (3.4% vs 1.3%), fatigue (2.6% vs 0.7%), dizziness (2.6% vs 2.6%), back pain (1.7% vs 1.3%), and nausea (1.4% vs 0.7%). Adverse experiences were usually mild and transient in nature and infrequently required discontinuation of therapy (2.7% vs 2.6% with placebo).

Metoprolol

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

Central Nervous System: Tiredness and dizziness have occurred in about 10 of 100 patients. Depression has been reported in about 5 of 100 patients. Mental confusion and short-term memory loss have been reported. Headache, somnolence, nightmares, and insomnia have also been reported.

Cardiovascular: Shortness of breath and bradycardia have occurred in approximately 3 of 100 patients. Cold extremities; arterial insufficiency, usually of the Raynaud type; palpitations; congestive heart failure; peripheral edema; syncope; chest pain; and hypotension have been reported in about 1 of 100 patients (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).

Respiratory: Wheezing (bronchospasm) and dyspnea have been reported in about 1 of 100 patients (see WARNINGS).

Gastrointestinal: Diarrhea has occurred in about 5 of 100 patients. Nausea, dry mouth, gastric pain, constipation, flatulence, digestive tract disorders, and heartburn have been reported in about 1 of 100 patients.

Hypersensitive Reactions: Pruritus or rash have occurred in about 5 of 100 patients. Worsening of psoriasis has also been reported.

Miscellaneous: Peyronie's disease has been reported in fewer than 1 of 100,000 patients. Musculoskeletal pain, blurred vision, decreased libido, and tinnitus have also been reported.

There have been rare reports of reversible alopecia, agranulocytosis, and dry eyes. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable. The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with metoprolol.

Potential Adverse Reactions

In addition, there are a variety of adverse reactions not listed above, which have been reported with other beta-adrenergic blocking agents 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, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics.

Cardiovascular: Intensification of AV block (see CONTRAINDICATIONS).

Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.

Hypersensitive Reactions: Fever combined with aching and sore throat, laryngospasm, and respiratory distress.

Post-Marketing Experience

In addition, the following adverse reactions have been reported with metoprolol succinate in worldwide post-marketing use, regardless of causality:

Cardiovascular: 2nd and 3rd degree heart block.

Gastrointestinal: hepatitis, vomiting.

Hematologic: thrombocytopenia.

Musculoskeletal: arthralgia.

Nervous System/Psychiatric: anxiety/nervousness, hallucinations, paresthesia.

Reproductive, male: impotence.

Skin: increased sweating, photosensitivity, urticaria.

Special Sense Organs: taste disturbances.

Hydrochlorothiazide

Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, are listed below:

Body As A Whole: weakness; Cardiovascular: hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs); Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia; Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia; Hypersensitivity: anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura; Metabolic: electrolyte imbalance, glycosuria; Musculoskeletal: muscle spasm; Nervous System/Psychiatric: Vertigo, paresthesias, dizziness, headache, restlessness; Renal: renal failure, renal dysfunction, interstitial nephritis; Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia; Special Senses: transient blurred vision, xanthopsia; Urogenital: impotence.

Laboratory Test Findings

In controlled clinical trials, clinically important changes in standard laboratory parameters were infrequently associated with the administration of DUTOPROL. The laboratory test findings with metoprolol or hydrochlorothiazide or their combination may include:

Creatinine, Blood Urea Nitrogen-Minor increases in blood urea nitrogen (BUN) . (See WARNINGS, Renal Disease.)

Serum Electrolytes-Declines in serum potassium, sodium, chloride, magnesium. Increases in serum calcium and uric acid. (See PRECAUTIONS).

Glucose-Increase in serum or blood glucose. (See PRECAUTIONS, General, Hydrochlorothiazide.)

Lipids-Increase in serum total cholesterol, triglycerides. Decreases in high density lipoprotein (HDL).

Liver Function Tests-Increases in liver enzymes and/or serum bilirubin.

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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