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Dutoprol (Metoprolol Succinate / Hydrochlorothiazide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Hypertension

DUTOPROL is indicated for the management of hypertension. The fixed-dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION

Dosing must be individualized considering baseline and target blood pressure as well as experience with individual agents.

The side effects (see WARNINGS) of metoprolol succinate extended release are a mixture of dose-dependent phenomena (primarily bradycardia and fatigue); those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of metoprolol succinate extended release and hydrochlorothiazide will be associated with both sets of dose independent side effects. To minimize the known dose-related tolerability and safety-related effects of the individual agents, consideration should be given to initiating treatment at less than their maximum doses.

DUTOPROL may be administered with other antihypertensive agents.

DUTOPROL may be administered with or without food.

DUTOPROL is administered once daily.

Hydrochlorothiazide is effective in doses of 12.5 mg to 50 mg once daily.

Patients usually do not require doses in excess of 50 mg hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.

The usual initial dose of metoprolol succinate extended release is 25 to 100 mg daily in a single dose.

Metoprolol succinate extended release doses greater than 400 mg have not been studied.

Replacement Therapy

DUTOPROL may be substituted for treatment with individual components.

Dose Titration by Clinical Effect

Use the dose necessary based on patient response once the need for combination product is established. Response rates are greater at higher doses.

Patients with insufficient blood pressure effects with metoprolol succinate extended release or hydrochlorothiazide alone may be switched to DUTOPROL.

The lowest DUTOPROL tablet available is 25/12.5 mg. A 50/6.25 mg dose can be achieved by splitting the 100/12.5 mg tablet. Subsequently titration may be carried out every 2 weeks up to a maximum of 200/25 mg (two DUTOPROL 100/12.5 mg tablets).

Patients with Renal Impairment

The usual regimens of therapy with DUTOPROL may be followed as long as the patient’s creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so DUTOPROL is not recommended.

Patients with Hepatic Impairment

The usual regimens of therapy with DUTOPROL may be followed in patients with mild hepatic impairment. In patients with moderate hepatic impairment, consideration should be given to initiation of TOPROL-XL with lower doses of hydrochlorothiazide.

HOW SUPPLIED

DUTOPROL 25/12.5 (NDC 0186-1087-05) yellow, circular, biconvex, film-coated tablet engraved with “A” above “IH” on one side, are supplied in bottles of 100.

DUTOPROL 50/12.5 (NDC 0186-1095-05) light orange, circular, biconvex, film-coated tablet engraved with “A” above “IK” on one side, are supplied in bottles of 100.

DUTOPROL 100/12.5 (NDC 0186-1097-05) yellow, circular, biconvex, film-coated tablet engraved with “A” above “IL” on one side and scored on the other side, are supplied in bottles of 100.

Storage:

Store at 25°C (77°F). Excursions permitted to 15-30°C (59–86°F). (See USP Controlled Room Temperature.)

All trademarks are the property of the AstraZeneca group of companies

©AstraZeneca 2006

Rev 08/06

Manufactured for: AstraZeneca LP Wilmington, DE 19850

By: AstraZeneca AB S-151 85 Södertälje, Sweden

Made in Sweden

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