AstraZeneca Launches Dutoprol (metoprolol succinate extended release/hydrochlorothiazide) Tablets for High Blood Pressure in U.S.

  • 1st and only once-daily combination containing the active ingredient of TOPROL-XL® (metoprolol succinate) ER tablets plus low-dose hydrochlorothiazide, offers the dual efficacy of a beta blocker and a diuretic1,2
  • Competitively priced with the generics of TOPROL-XL and hydrochlorothiazide tablets, regardless of insurance coverage3
  • DUTOPROL is the 1st AZ brand to take a novel launch approach utilizing a direct-to-patient program

WILMINGTON, Del.--(BUSINESS WIRE)--Apr 12, 2012 - AstraZeneca (NYSE: AZN) today announced the availability of DUTOPROL™ (metoprolol succinate extended release/hydrochlorothiazide) Tablets, the first and only once-daily antihypertensive agent that contains the active ingredient of TOPROL-XL® (metoprolol succinate) plus a low-dose diuretic (also known as a water pill) that provides proven blood pressure lowering at 24 hours.1,2

“One in three US adults have high blood pressure, and of these patients whom are treated, approximately 36% remain uncontrolled,” said Steve Davis, Executive Director, Foundation Brands, AstraZeneca.4 “DUTOPROL may provide another treatment option for patients with hypertension. We have launched DUTOPROL so patients now have the option to receive a branded combination medicine, in a convenient, once-a-day tablet.”

Instead of a traditional payer contracting strategy, AstraZeneca has taken a novel approach in launching DUTOPROL at a wholesale acquisition price ($15.90) that's competitive to the generics of TOPROL-XL and hydrochlorothiazide tablets, with or without insurance coverage.

AstraZeneca has created DUTOPROL Direct, a direct-to-patient mail-order program, which may offer additional savings to patients beyond the retail pharmacy price so they can fill their prescription for $18.33 per month, with free shipping and handling, when they order a 90-day supply. However, for patients who wish to use their local pharmacies, AstraZeneca has also created a retail pharmacy program.

With DUTOPROL, AstraZeneca builds upon the hypertension legacy of TOPROL-XL, which has been in use for 20 years as a treatment for hypertension and was among the nation's top-ten most-prescribed medicines for the five years prior to the introduction of generic versions of TOPROL-XL at all dosage strengths.5

About DUTOPROL Direct

DUTOPROL Direct is an option that allows eligible patients with a valid prescription for DUTOPROL to have it shipped directly to their home by Express Scripts pharmacy services, for under $20 a month for a 90-day supply.

DUTOPROL Direct does not require a qualification process, nor is a coupon or savings card needed. The program is open to most patients with a valid prescription for DUTOPROL who elect to receive and pay for DUTOPROL on their own. Prescription coverage cannot be used for any type of reimbursement. DUTOPROL Direct is not valid for prescriptions purchased under Medicaid or similar assistance programs.

Patients can submit their enrollment information in two different ways: patients may download the enrollment form from http://www.dutoprol.com/ and then mail in their prescription and enrollment information, or their physician can fax the enrollment form and prescription to 1-800-698-3759.

Patients or physicians with questions can call 1-800-637-3616 to contact DUTOPROL Customer Service between 8:00 AM and 6:00 PM ET, Monday through Friday, excluding holidays.

Approved Use for DUTOPROL™ (metoprolol succinate extended release/hydrochlorothiazide) Tablets

DUTOPROL is approved to lower high blood pressure. Lowering high blood pressure helps reduce the risk of certain heart-related problems such as stroke and heart attack. It's good for you to know more about your medical condition and the medicine you are taking for it. Talk to your doctor about high blood pressure and DUTOPROL.

Important Safety Information about DUTOPROL

Because of the possibility of serious side effects, such as chest pain or a heart attack, you should not stop taking DUTOPROL suddenly. If your doctor decides you should stop taking DUTOPROL, you may be instructed to slowly reduce your dose over a period of time before stopping it completely.

DUTOPROL may not be right for everyone, especially people who have the following health conditions:

 

  • Extreme slowing of the heart rate
  • Sudden and severe drop in blood pressure and blood flow through the body because the heart is not pumping normally
  • Uncontrolled heart failure
  • Slowdown of the heart's electrical signal causing a slower heart rate
  • Damage to the heart's natural pacemaker that affects the heart's rhythm unless one has a pacemaker device
  • Any allergies to DUTOPROL or its ingredients

It is important to take your medications every day as directed by your doctor.

Patients who have asthma or asthma-like lung disease should, in general, not take DUTOPROL.

Your doctor may not want you to take DUTOPROL if you are currently taking certain types of high blood pressure medicine or lithium, or have adrenal gland tumors, diabetes, low blood sugar, overactive thyroid disease, hardening of the arteries in the arms or legs, kidney disease, or liver disease.

Your doctor may not want you to start taking DUTOPROL™ (metoprolol succinate extended release/hydrochlorothiazide) Tablets if you are about to have any type of surgery.

DUTOPROL may cause eye problems, or cause or worsen lupus erythematosus (a disease of the body's immune system). Your doctor will monitor you for fluid imbalance or changes in substances that indicate how your body is working.

If you have a history of serious allergic reactions, the usual dose of epinephrine (adrenaline) may not work as well if you are taking DUTOPROL.

If you take non-steroidal anti-inflammatory drugs (also called NSAIDs), DUTOPROL may not work as well.

Until you know how you will react to DUTOPROL, avoid activities that require alertness.

Contact your doctor if you have any difficulty in breathing.

The most common side effects were sore throat, tiredness, dizziness, back pain, and nausea. If you experience any of these side effects, contact your doctor.

Click here for the accompanying full Prescribing Information, including Boxed WARNING about suddenly stopping therapy with DUTOPROL.

Approved Use for TOPROL-XL® (metoprolol succinate)

TOPROL-XL is approved for the treatment of high blood pressure. It may be used alone or in combination with other medications to treat high blood pressure. It's good for you to know more about your medical condition and the medicine you are taking for it, so talk to your doctor about high blood pressure and TOPROL-XL.

Important Safety Information about TOPROL-XL

Because of the possibility of serious side effects, such as chest pain or a heart attack, you should not stop taking TOPROL-XL suddenly. If your doctor decides you should stop taking TOPROL-XL, you may be instructed to slowly reduce your dose over a period of time before stopping it completely.

TOPROL-XL may not be right for everyone, especially people who have the following health conditions:

 

  • Extreme slowing of the heart rate
  • Sudden and severe drop in blood pressure and blood flow through the body because the heart is not pumping normally
  • Uncontrolled heart failure
  • Slowdown of the heart's electrical signal causing a slower heart rate
  • Damage to the heart's natural pacemaker that affects the heart's rhythm unless one has a pacemaker device
  • Any allergies to TOPROL-XL® (metoprolol succinate) or its ingredients

It is important to take your medications every day as directed by your doctor.

Patients who have asthma or asthma-like lung disease should, in general, not take TOPROL-XL.

Your doctor may not want you to take TOPROL-XL if you are currently taking certain types of high blood pressure medicine, or have adrenal gland tumors, diabetes, low blood sugar, liver damage, overactive thyroid disease, or hardening of the arteries in the arms or legs.

Your doctor may not want you to start taking TOPROL-XL if you are about to have any type of surgery.

If you have a history of serious allergic reactions, the usual dose of epinephrine (adrenaline) may not work as well if you are taking TOPROL-XL.

Until you know how you will react to TOPROL-XL, avoid activities that require alertness.

Contact your doctor if you have any difficulty in breathing.

In patients with high blood pressure, the most common side effects were tiredness, dizziness, depression, diarrhea, itching or rash, shortness of breath, and slow heart rate. If you experience any of these or other side effects, contact your doctor.

Click here for the accompanying full Prescribing Information, including Boxed WARNING about suddenly stopping therapy with TOPROL-XL.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

About Hypertension

Hypertension, or high blood pressure, is dangerous because it makes the heart work too hard and contributes to atherosclerosis (hardening of the arteries). It increases the risk of heart disease and stroke, which are the first and third leading causes of death among Americans. High blood pressure can also result in other conditions, such as congestive heart failure, kidney disease, and blindness.6

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information about AstraZeneca in the U.S. or our AZ&Me™ Prescription Savings programs, please visit www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).

DUTOPROL is a trademark and TOPROL-XL is a registered trademark of the AstraZeneca group of companies.

_______________________________

1 DUTOPROL Prescribing Information, AstraZeneca, LP, Wilmington, DE.
2 Data on File, 1593807, AstraZeneca Pharmaceuticals LP
3 Fingertip Formulary, Walmart Retail Prescription Program Drug List, and Drugstore.com data as of 2/9/12.
4 Roger VL, Go AS, Lloyd-Jones DM et al. Heart disease and stroke statistics – 2012 update: A report from the American Heart Association. Circulation. 2012; Pgs. 98-100.
5 IMS Health, IMS National Prescription Audit PLUSTM, 3/2007. http://www.imshealth.com/imshealth/Global/Content/Document/Top-Line%20Industry%20Data/2006%20Top%2010%20Products%20by%20U.S.%20Dispensed%20Prescriptions.pdf. Accessed Feb. 29, 2012.
6 NIH Heart, Lung and Blood Institute. Your Guide to Lowering Blood Pressure. http://www.nhlbi.nih.gov/hbp/hbp/whathbp.htm. Accessed 02/20/12.

1747900 3/12

Contact: AstraZeneca
Anna Padula, 302-885-3332
Cell: 215-760-2928
anna.padula@astrazeneca.com

 

 

Posted: April 2012


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