Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
METOPROLOL SUCCINATE (UNII: TH25PD4CCB) (METOPROLOL - UNII:GEB06NHM23), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Solubiomix
METOPROLOL SUCCINATE
METOPROLOL TARTRATE 25 mg
ORAL
PRESCRIPTION DRUG
Metoprolol Succinate Extended Release/Hydrochlorothiazide is a combination tablet of metoprolol succinate, a beta adrenoceptor blocking agent and hydrochlorothiazide, a diuretic. Metoprolol Succinate Extended Release/Hydrochlorothiazide 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 Na
Metoprolol Succinate Extended Release/Hydrochlorothiazide 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.)
New Drug Application
METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE - METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE TABLET METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE - METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE TABLET SOLUBIOMIX ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METOPROLOL SUCCINATE EXTENDED RELEASE/HYDROCHLOROTHIAZIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METOPROLOL SUCCINATE EXTENDED RELEASE/HYDROCHLOROTHIAZIDE. METOPROLOL SUCCINATE EXTENDED RELEASE/HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2006 WARNING: CARDIAC ISCHEMIA AFTER ABRUPT DISCONTINUATION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ FOLLOWING ABRUPT CESSATION OF THERAPY WITH BETA-BLOCKERS, EXACERBATIONS OF ANGINA PECTORIS AND MYOCARDIAL INFARCTION HAVE OCCURRED. WARN PATIENTS AGAINST INTERRUPTION OR DISCONTINUATION OF THERAPY WITHOUT THE PHYSICIAN’S ADVICE (5.1) INDICATIONS AND USAGE Metoprolol Succinate Extended Release/Hydrochlorothiazide 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 May worsen congestive heart failure. (5.2) Bronchospasm: Avoid beta-blockers. (5.3) Διαβάστε το πλήρες έγγραφο