Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Physicians Total Care, Inc.
METOPROLOL TARTRATE
METOPROLOL TARTRATE 50 mg
ORAL
PRESCRIPTION DRUG
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).
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
Abbreviated New Drug Application
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 Lees het volledige document