Navigation Links
AstraZeneca Announces TOPROL-XL(R) (Metoprolol Succinate) is Now Available
Date:5/18/2009

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
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Ingenuity Systems Announces Multi-Year Deal With AstraZeneca
2. Court Grants AstraZeneca Temporary Restraining Order Against Apotex in PULMICORT RESPULES Patent Litigation
3. FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site
4. AstraZenecas David Brennan Elected PhRMA Board Chairman
5. Video: Astrazeneca Calls on All Americans to Join US AGAINST ATHERO to Fight the Nations Number One Killer
6. AstraZeneca Applauds Appointment of New FDA Commissioner
7. AstraZeneca Announces SEROQUEL XR is Now Available to Treat Bipolar Depression
8. Palatin Technologies Announces Receipt of $4.1 Million from AstraZeneca
9. AstraZeneca Helped More Than 440,000 Patients Save $612 Million on Medicines in 2008
10. AstraZeneca Licenses Novel Antidepressant Compounds Discovered by Mayo Clinic and Virginia Tech Collaboration
11. MAP Pharmaceuticals Announces Expiration of Hart-Scott-Rodino Waiting Period for Unit Dose Budesonide Collaboration with AstraZeneca
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... ... ... Gout is like no other joint pain. It strikes suddenly, like flicking on ... redness. It is triggered by the crystallization of uric acid within the joints. It ... to the February 2016 issue of Harvard Men's Health Watch. , The large joint ...
(Date:2/10/2016)... ... February 10, 2016 , ... AHRA: The Association for ... speaker Jan Fox will serve as keynote speaker at the organization’s 2016 Spring ... tools to more effectively communicate with their own organizational staff and leadership. ...
(Date:2/10/2016)... , ... February 10, 2016 , ... ... will attend the Ohio Safety Congress and Expo event March 9-11, 2016. Hosted ... Greater Columbus Convention Center. , As the longest running and largest worker's ...
(Date:2/10/2016)... , ... February 10, 2016 , ... ... biocompatible columns and accessories. These PEEK-lined stainless steel (PLS) columns combine the strength ... solution that ensures the integrity of biological samples while operating at ultra-high pressures ...
(Date:2/10/2016)... CA (PRWEB) , ... February 10, 2016 , ... Workrite ... based company that has evolved from humble beginnings to being an internationally recognized leader ... company that we are today”, said Charlie Lawrence, President of Workrite. “Workrite recognized ...
Breaking Medicine News(10 mins):
(Date:2/9/2016)... Blood Monitoring & Cardiac Monitoring Devices Market Assessment & Forecast: 2015-2019" ... market for blood monitoring & cardiac monitoring devices was valued at ... 24,830.1 million by 2019 at a CAGR of 6.8% from 2015 ... Europe , Asia-Pacific , Latin ... Africa . The three major factors determining growth of the ...
(Date:2/9/2016)... , Feb. 9, 2016 The life of Dr. ... Center, has been anything but ordinary.  Twists of fate, combined ... War II and the constraints of communist Czechoslovakia to ... he would go on to make history by playing a ... best-selling drugs in the world, Remicade.  Dr. Vilcek brings readers ...
(Date:2/9/2016)... KONG , Feb. 9, 2016 Athenex, Inc. ... Athenex as Vice President of Corporate Strategy and Business Development ... MSc, MBA has joined as Senior Director and Deputy Head of Clinical ... . Simon Pedder stated, "Athenex has ... for a while. Coupled together with their unique business model ...
Breaking Medicine Technology: