Hypertension

TOPROL-XL is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Angina Pectoris

TOPROL-XL is indicated in the long-term treatment of angina pectoris.

Heart Failure

TOPROL-XL is indicated for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, TOPROL-XL decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure.

TOPROL-XL is an extended release tablet intended for once daily administration. For treatment of hypertension and angina, when switching from immediate release metoprolol to TOPROL-XL, the same total daily dose of TOPROL-XL should be used. Dosages of TOPROL-XL should be individualized and titration may be needed in some patients.

TOPROL-XL tablets are scored and can be divided; however, the whole or half tablet should be swallowed whole and not chewed or crushed.

Hypertension

The usual initial dosage is 25 to 100 mg daily in a single dose, whether used alone or added to a diuretic. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy. Dosages above 400 mg per day have not been studied.

Pediatric Hypertensive Patients ≥ 6 Years of age

A pediatric clinical hypertension study in patients 6 to 16 years of age did not meet its primary endpoint (dose response for reduction in SBP), however some other endpoints demonstrated effectiveness (see PRECAUTIONS, Pediatric Use).

If selected for treatment, the recommended starting dose of TOPROL-XL is 1.0 mg/kg once daily however, the maximum initial dose should not exceed 50 mg once daily. The minimum available dose is one half of the 25 mg TOPROL-XL tablet. Dosage should be adjusted according to blood pressure response. Doses above 2.0 mg/kg (or in excess of 200 mg) once daily have not been studied in pediatric patients. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.)

TOPROL-XL is not recommended in pediatric patients < 6 years of age (see CLINICAL PHARMACOLOGY, Pharmacokinetics and PRECAUTIONS, Pediatric Use.)

Angina Pectoris

The dosage of TOPROL-XL should be individualized. The usual initial dosage is 100 mg daily, given in a single dose. The dosage may be gradually increased at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, the dosage should be reduced gradually over a period of 1–2 weeks (see WARNINGS).

Heart Failure

Dosage must be individualized and closely monitored during up-titration. Prior to initiation of TOPROL-XL, the dosing of diuretics, ACE inhibitors, and digitalis (if used) should be stabilized. The recommended starting dose of TOPROL-XL is 25 mg once daily for two weeks in patients with NYHA Class II heart failure and 12.5 mg once daily in patients with more severe heart failure. The dose should then be doubled every two weeks to the highest dosage level tolerated by the patient or up to 200 mg of TOPROL-XL. If transient worsening of heart failure occurs, it may be treated with increased doses of diuretics, and it may also be necessary to lower the dose of TOPROL-XL or temporarily discontinue it. The dose of TOPROL-XL should not be increased until symptoms of worsening heart failure have been stabilized. Initial difficulty with titration should not preclude later attempts to introduce TOPROL-XL. If heart failure patients experience symptomatic bradycardia, the dose of TOPROL-XL should be reduced.

Tablets containing metoprolol succinate equivalent to the indicated weight of metoprolol tartrate, USP, are white, biconvex, film-coated, and scored.

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

TOPROL-XL is a trademark of the AstraZeneca group of companies. Rev 07/07
Manufactured for: AstraZeneca LP, Wilmington, DE 19850. By: AstraZeneca AB., S-151 85 Södertälje, Sweden
FDA rev date: 7/18/2007

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