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Microsoft word - toprol physician letter 031609.doc
UPDATE: TOPROL-XL® (metoprolol succinate) now generally available
after AstraZeneca delivers significant supply across the US in
response to generic shortage
We are pleased to provide you with follow-up information to our letter of last month
regarding the availability of TOPROL-XL.
As you know, after published reportsi,ii that two generic manufacturers had recalled or
suspended their shipments of metoprolol succinate, AstraZeneca increased
manufacturing of TOPROL-XL to help meet the US market demand.
Over the last number of weeks, AstraZeneca has delivered a significant quantity of
TOPROL-XL to the US market in all strengths. Although outages at the retail pharmacy
may still occur, we expect such circumstances to be increasingly rare, as wholesaler
stocks have improved substantially.
AstraZeneca has been manufacturing TOPROL-XL for the US market since 1992 and
has made significant investments to increase our capacity to address this unexpected
change in the US market, while not adversely impacting supply available in the rest of
Metoprolol succinate is a beta1-selective (cardioselective) adrenoceptor blocking agent,
for oral administration, available as extended-release tablets. Following abrupt cessation of therapy with certain beta-blocking agents,
exacerbations of angina pectoris and, in some cases, myocardial infarction have
occurred. When discontinuing chronically 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.
Metoprolol succinate is a once-a-day beta-blocker indicated for the following:
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
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 contraindicated in severe bradycardia, heart block 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 component of this product. Please see accompanying full Prescribing Information, including boxed WARNING regarding abrupt cessation of therapy, and the attached Important Safety Information about TOPROL-XL® (metoprolol succinate) extended-release tablets. If you have any questions, or should you encounter difficulty in getting TOPROL-XL for your patients, please contact the AstraZeneca Information Center at 1-800-236-9933, between the hours of 8:00 am and 6:00 pm Eastern time, Monday through Friday. Sincerely, John McCarthy
Important Safety Information about TOPROL-XL® (metoprolol succinate) extended-release
TOPROL-XL is indicated for the treatment of hypertension, alone or in combination with other
antihypertensives; the long-term treatment of angina pectoris; and 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,
TOPROL-XL is contraindicated in severe bradycardia, heart block of greater than first degree,
cardiogenic shock, decompensated cardiac failure, and sick sinus syndrome (unless permanent
pacemaker is in place) and in patients who are hypersensitive to any component of this product.
Patients taking TOPROL-XL should avoid abrupt cessation of therapy. Following abrupt cessation of
therapy with certain beta-blocking agents, exacerbations of angina pectoris and, is some cases,
myocardial infarction have occurred. The dosage should be reduced gradually over a one-to-two-
week period, and the patient should be carefully monitored.
TOPROL-XL should be used with caution in patients who have bronchospastic disease, diabetes,
thyrotoxicosis, peripheral vascular disease, who are undergoing major surgery, or who take calcium
channel blockers of the verapamil and diltiazem type.
There is a risk of worsening cardiac failure during up-titration of the dose of metoprolol succinate
extended-release. Patients need to consult their physicians if they experience signs or symptoms of
worsening heart failure such as weight gain or increased shortness of breath.
Patients should be advised to (1) avoid operating automobiles and machinery or engaging in other
tasks requiring alertness until the patient’s response to therapy with metoprolol succinate extended-
release has been determined; (2) contact a physician if any difficulty in breathing occurs; (3) inform
the physician or dentist before any surgery that he or she is taking TOPROL-XL.
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%).
In patients with heart failure, adverse events at an incidence ≥1% in the group receiving TOPROL-XL
extended-release and greater than placebo by more than 0.5% were dizziness/vertigo (1.8% vs
1.0%), bradycardia (1.5% vs 0.4%), and accident and or injury (1.4% vs 0.8%).
Please see accompanying full Prescribing Information.
TOPROL-XL is a registered trademark of the AstraZeneca group of companies. 277202
i Sandoz Recall, http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01084.html, accessed March 12, 2009
ii KV ceases shipping tablets, http://www.kvpharmaceutical.com/news_center_article.aspx?articleid=276, http://www.fda.gov/oc/po/firmrecalls/kv12_08.html accessed March 12, 2009.
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