METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE - metoprolol succinate and hydrochlorothiazide tablet METOPROLOL SUCCINATE AND HY

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Solubiomix

INN:

METOPROLOL SUCCINATE

composition:

METOPROLOL TARTRATE 25 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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

leaflet_short:

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.)

authorization_status:

New Drug Application

SPC

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)