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Dutoprol

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Dutoprol

DUTOPROL®
(metoprolol succinate extended release/ hydrochlorothiazide) Tablets

WARNING

CARDIAC ISCHEMIA AFTER ABRUPT DISCONTINUATION

Following abrupt discontinuation of therapy with beta adrenergic blockers, exacerbations of angina pectoris and myocardial infarction have occurred.

When discontinuing chronically administered DUTOPROL, particularly in patients with ischemic heart disease, gradually reduce the dose over a period of 1–2 weeks and monitor the patient. If angina markedly worsens or acute coronary insufficiency develops, promptly resume therapy, at least temporarily, and take other measures appropriate for the management of unstable angina. Warn patients against interruption or discontinuation of therapy without the physician's advice.

Because coronary artery disease is common and may be unrecognized, avoid abrupt discontinuation of DUTOPROL therapy even in patients treated only for hypertension [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

DUTOPROL™ (metoprolol succinate extended release/hydrochlorothiazide) combines a beta adrenoceptor blocker and a thiazide diuretic.

Metoprolol succinate is chemically described as (±)1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:

Metoprolol succinate - Structural Formula Illustration

Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water, soluble in methanol, sparingly soluble in ethanol, slightly soluble in dichloromethane and 2-propanol, and practically insoluble in ethyl-acetate, acetone, diethylether and heptane.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is:

Hydrochlorothiazide - Structural Formula Illustration

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

DUTOPROL is for oral administration in 3 tablet strengths of metoprolol succinate extended release and hydrochlorothiazide.

DUTOPROL 25/12.5 contains 23.75 mg of metoprolol succinate extended release, equivalent to 25 mg of metoprolol tartrate, and 12.5 mg of hydrochlorothiazide. DUTOPROL 50/12.5 contains 47.5 mg of metoprolol succinate extended release, equivalent to 50 mg of metoprolol tartrate, and 12.5 mg of hydrochlorothiazide. DUTOPROL 100/12.5 contains 95 mg of metoprolol succinate extended release, equivalent to 100 mg of metoprolol tartrate, and 12.5 mg of hydrochlorothiazide. The inactive ingredients of the tablets are silicon dioxide, ethylcellulose, hydroxypropyl cellulose, cornstarch, microcrystalline cellulose, polyvinyl pyrrolidone, sodium stearyl fumarate, hydroxypropyl methylcellulose, polyethylene glycol 6000, titanium dioxide, iron oxide (yellow), iron oxide (red) and paraffin.

Last reviewed on RxList: 11/3/2014
This monograph has been modified to include the generic and brand name in many instances.

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