DUTOPROL- metoprolol succinate and hydrochlorothiazide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METOPROLOL SUCCINATE (UNII: TH25PD4CCB) (METOPROLOL - UNII:GEB06NHM23), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Concordia Pharmaceuticals Inc.

INN (International Name):

METOPROLOL SUCCINATE

Composition:

METOPROLOL TARTRATE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DUTOPROL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes

Product summary:

DUTOPROL is supplied as circular, biconvex, film-coated tablets engraved on one side. Store at 25°C (77°F). Excursions permitted to 15-30°C (59‑86°F). (See USP Controlled Room Temperature.)

Authorization status:

New Drug Application

Summary of Product characteristics

DUTOPROL - METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE TABLET
CONCORDIA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DUTOPROL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DUTOPROL.
DUTOPROL® (METOPROLOL SUCCINATE EXTENDED RELEASE/HYDROCHLOROTHIAZIDE)
TABLETS, FOR ORAL
USE.
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
DUTOPROL is the combination tablet of metoprolol succinate, a beta
adrenoceptor blocker and
hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the
treatment of hypertension, to lower blood
pressure. Lowering blood pressure reduces the risk of fatal and
nonfatal cardiovascular events, primarily
strokes and myocardial infarctions. (1)
DOSAGE AND ADMINISTRATION
Usual dose range: Hydrochlorothiazide 12.5 to 25 mg and metoprolol
succinate 25 to 200 mg dosed
once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets (metoprolol succinate/HCTZ mg): 25/12.5 mg, 50/12.5 mg,
100/12.5 mg. (3)
CONTRAINDICATIONS
Hypersensitivity to metoprolol succinate or hydrochlorothiazide or
other sulfonamide-derived drugs. (4)
Cardiogenic shock or decompensated heart failure. (4)
Sinus bradycardia, sick sinus syndrome, and greater than first-degree
block unless a permanent
pacemaker is in place. (4)
Anuria. (4)
WARNINGS AND PRECAUTIONS
Abrupt cessation may exacerbate myocardial ischemia. (5.1)
May worsen congestive heart failure. (5.2)
Bronchospasm: Avoid beta-blockers. (5.3)
Bradycardia.(5.4)
Avoid discontinuing therapy prior to major surgery.(5.5)
May mask symptoms of hypoglycemia.(5.6)
Monitor serum electrolytes and creatinine periodically. (5.7)
Peripheral vascular disease: Can aggravate symptoms of arterial
insufficiency. (5.9)
Pheochromocytoma: First initiate therapy with an alpha blocker. (5.10)
Abrupt withdrawal in thyrotoxicosis might precipitate a thyroid
storm.(5.11)
ADVERSE REACTIONS
Adverse events which occurred greater than 1% more frequently in
patients treated with DUTOPROL than
placebo were: