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