AstraZeneca Announces TOPROL-XL(R) (Metoprolol Succinate) is Now Available

* Reuters is not responsible for the content in this press release.

Mon May 18, 2009 9:01am EDT

WILMINGTON, Del., May 18 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN)
announced today that all wholesale ordering restrictions in place for
TOPROL-XL(R) (metoprolol succinate) extended release tablets have been removed
and that supply levels of TOPROL-XL are approaching near usual levels at all
points in the distribution chain.
 
AstraZeneca has been diligently working to help ensure adequate market supply
of TOPROL-XL and the authorized generic metoprolol succinate following
published reports that two generic companies had recalled or suspended
shipments of metoprolol succinate in late 2008 and early 2009.

"After the two generic manufacturers stopped supplying the market, it was
critical that we quickly boost our production to increase the supply available
for patients," said Kathy Monday, Vice President at AstraZeneca.

To help ensure equitable distribution of TOPROL-XL, AstraZeneca had initially
instituted a short-term order management system to wholesalers.  That system
has now been lifted as AstraZeneca is now manufacturing and distributing
enough TOPROL-XL and authorized generic metoprolol succinate to meet
historical demand levels.  The authorized generic is distributed and marketed
by Par Pharmaceutical.

"TOPROL-XL and metoprolol succinate should now be available for patients in
all regions across the country," said Monday.  

AstraZeneca has been manufacturing TOPROL-XL for the US market since 1992 and
is making significant investments in order to help ensure that supply is
available to meet the needs of patients in the US, while not impacting supply
available to patients in the rest of the world.

TOPROL-XL and metoprolol succinate patients should always consult with their
health care professional if they have concerns about their medication. 
Patients should never disrupt or change their TOPROL-XL or metoprolol
succinate dosing without consulting their health care professional first.

Important Safety Information About TOPROL-XL(R) (metoprolol succinate)
Extended-Release Tablets
 
TOPROL-XL is a beta(1)-selective (cardioselective) adrenoceptor-blocking
agent, for oral administration, available as extended-release tablets.
TOPROL-XL has been formulated to provide a controlled and predictable release
of metoprolol for once-daily administration.
 
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 heart failure patients already receiving ACE inhibitors, diuretics,
and, in the majority of cases, digitalis.

TOPROL-XL is contraindicated in severe bradycardia, heart block greater than
first degree, cardiogenic shock, decompensated cardiac failure, and sick sinus
syndrome (unless a permanent pacemaker is in place) and in patients who are
hypersensative 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, in some cases, myocardial infraction 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 TOPROL-XL. 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 TOPROL-XL(R) (metoprolol succinate) 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 tartate 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, serious adverse events and adverse events
leading to discontinuation of study medication in MERIT-HF at an incidence
greater than or equal to 1% in the group receiving TOPROL-XL 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%).

For full Prescribing Information for TOPROL-XL including boxed WARNING
regarding abrupt cessation of therapy, call 1-800-236-9933 or visit
www.astrazeneca-us.com

About AstraZeneca
AstraZeneca is engaged in the research, development, manufacturing and
marketing of meaningful prescription medicines and in the supply of healthcare
services. 

AstraZeneca is one of the world's leading pharmaceutical companies with global
healthcare sales of $ 31.6 billion and is a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infectious disease
medicines.  In the United States, AstraZeneca is a $13.5 billion dollar
healthcare business.  

For more information about AstraZeneca in the US or our AZ&Me(TM) Prescription
Savings programs, please visit: www.astrazeneca-us.com.

SOURCE  AstraZeneca

Blair Hains of AstraZeneca, +1-302-885-1813, blair.hains@astrazeneca.com
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.