Toprol XL

[Metoprolol]

PRECAUTIONS

General

TOPROL-XL should be used with caution in patients with impaired hepatic function. In patients with pheochromocytoma, an alpha-blocking agent should be initiated prior to the use of any beta-blocking agent.

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Worsening cardiac failure may occur during up-titration of TOPROL-XL. If such symp-toms occur, diuretics should be increased and the dose of TOPROL-XL should not be advanced until clinical stability is restored (see DOSAGE AND ADMINISTRATION). It may be necessary to lower the dose of TOPROL-XL or temporarily discontinue it. Such episodes do not preclude subsequent successful titration of TOPROL-XL.

Information for Patients

Patients should be advised to take TOPROL-XL regularly and continuously, as directed, preferably with or immediately following meals. If a dose should be missed, the patient should take only the next scheduled dose (without doubling it). Patients should not interrupt or discontinue TOPROL-XL without consulting the physician. Patients should be advised

(1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient's response to therapy with TOPROL-XL has been determined;

(2) to contact the physician if any difficulty in breathing occurs;

(3) to inform the physician or dentist before any type of surgery that he or she is taking TOPROL-XL.

Heart failure patients should be advised to consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.

Laboratory Tests

Clinical laboratory findings may include elevated levels of serum transaminase, alkaline phosphatase, and lactate dehydrogenase.

Pregnancy

Category C

Metoprolol tartrate has been shown to increase post-implantation loss and decrease neonatal survival in rats at doses up to 22 times, on a mg/ m 2 basis, the daily dose of 200 mg in a 60-kg patient. Distribution studies in mice confirm exposure of the fetus when metoprolol tartrate is administered to the pregnant animal. These studies have revealed no evidence of impaired fertility or teratogenicity. There are no adequate and well-controlled studies in pregnant women.

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