METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

から入手可能:

Physicians Total Care, Inc.

INN（国際名）:

METOPROLOL TARTRATE

構図:

METOPROLOL TARTRATE 50 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the management of hypertension. This fixed-combination drug is not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient's needs, therapy with the fixed combination may be more convenient than with the separate components. Metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS). Hypersensitivity to metoprolol tartrate and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross sensitivity between beta-blockers can occur). Sick-sinus syndrome. Severe peripheral arterial circulatory disorders. Hydrochlorothiazide is contraindicated in patients with anuria or hypersensitivity to this or other sulfonamide-derived drugs (see WARNINGS).

製品概要:

Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP are available containing 50 mg/25 mg, 100 mg/25 mg of metoprolol tartrate, USP and hydrochlorothiazide, USP. The 50 mg/25 mg tablets are peach, round, scored tablets debossed with M above the score and 424 below the score on one side of the tablet and blank on the other side. They are available as follows: The 100 mg/25 mg tablets are peach, oval, scored tablets debossed with M to the left of the score and 434 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED APRIL 2010 MPHCTZ:R3 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK       74146

認証ステータス:

Abbreviated New Drug Application

製品の特徴

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE - METOPROLOL TARTRATE AND
HYDROCHLOROTHIAZIDE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
_ISCHEMIC HEART DISEASE_
Following abrupt cessation of therapy with certain beta-blocking
agents, exacerbations of angina
pectoris and in some cases, myocardial infarction have been reported.
Even in the absence of
overt angina pectoris, when discontinuing therapy, metoprolol should
not be withdrawn abruptly,
and patients should be cautioned against interruption of therapy
without the physician's advice (see
PRECAUTIONS: Information for Patients).
DESCRIPTION
Metoprolol tartrate and hydrochlorothiazide tablets, USP have the
antihypertensive effect of metoprolol
tartrate, a selective beta -adrenoreceptor blocking agent, and the
antihypertensive and diuretic actions of
hydrochlorothiazide. It is available as tablets for oral
administration. The 50 mg/25 mg tablets contain
50 mg of metoprolol tartrate, USP and 25 mg of hydrochlorothiazide,
USP; the 100 mg/25 mg tablets
contain 100 mg of metoprolol tartrate, USP and 25 mg of
hydrochlorothiazide, USP; and the 100 mg/50
mg tablets contain 100 mg of metoprolol tartrate, USP and 50 mg of
hydrochlorothiazide, USP.
Metoprolol tartrate, USP is (±)-
1-Isopropylamino-3-[_p_-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-
tartrate (2:1) salt, and its structural formula is:
Metoprolol tartrate, USP is a white, crystalline powder. It is very
soluble in water; freely soluble in
methylene chloride, in chloroform, and in alcohol; slightly soluble in
acetone; and insoluble in ether. Its
molecular weight is 684.82.
Hydrochlorothiazide is 6-chloro-3,
4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide,
and its structural formula is:
Hydrochlorothiazide, USP is a white, or practically white, practically
odorless, crystalline powder. It
is freely soluble in sodium hydroxide solution, in _n_-butylamine, and
in dimethylformamide; sparingly
soluble in methanol; slightly soluble in water; and insoluble in
ether, in chloroform, and in dilute mineral