UPDATE: TOPROL-XL and generic metoprolol succinate*—all 4 strengths widely available
Dear Doctor,
We are pleased to provide you with follow-up information to our recent letter regarding the availability of TOPROL-XL
and its generic equivalent, metoprolol succinate extended-release tablets.
Over the last several weeks, a significant quantity of TOPROL-XL and generic metoprolol succinate has been delivered to the US market. Because we are shipping TOPROL-XL and its generic metoprolol succinate to our wholesaler and distribution partners in quantities that exceed historical levels, we expect no more shortages at retail pharmacies across the country.
If you have found it necessary to switch any of your hypertensive patients to the immediate-release formulation, metoprolol tartrate, please be assured that the once-daily extended-release is widely available, both as branded TOPROL-XL and as TOPROL-XL and metoprolol succinate are available in 4 dosages to suit individual patient needs: 25 mg, 50 mg, 100 mg, and TOPROL-XL, a beta1–selective (cardioselective) adrenoceptor blocking agent for oral administration is available as extended-release tablets. TOPROL-XL is a once-a-day beta-blocker indicated for the treatment of hypertension, alone or in combination with other antihypertensive agents.
TOPROL-XL is contraindicated in severe bradycardia, heart block of greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some
cases, myocardial infarction have occurred. When discontinuing chronical y administered TOPROL-XL, particularly in
patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1–2 weeks and the
patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, TOPROL-XL
administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management
of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without
the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to
discontinue TOPROL-XL therapy abruptly even in patients treated only for hypertension.
In clinical trials of patients with hypertension and angina pectoris the most common adverse events reported with immediate- release metoprolol tartrate are tiredness (10%), dizziness (10%), depression (5%), diarrhea (5%), pruritus or rash (5%), shortness of breath (3%), and bradycardia (3%).
Please see accompanying full Prescribing Information, including boxed WARNING regarding abrupt cessation of therapy.
We want to thank you again for your patience and understanding during this process.
If you have any questions, please call the AstraZeneca Information Center at 1-800-236-9933, between the hours of 8:00 am and 6:00 Pm EST, Monday through Friday.
*Manufactured for Par Pharmaceutical Companies, Inc. by AstraZeneca AB, Södertälje, Sweden. TOPROL-XL is a registered trademark of the AstraZeneca group of companies.
2009 AstraZeneca LP. All rights reserved. 281671 5/09


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