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Tracleer ( Bosentan ) Receives New Indication In Patients With Systemic Sclerosis And Active Digital Ulcer Disease Tenormin in our life. Delivery options for Tenormin My Medicines - This Brochure Can be a Lifesaver. My Medicines, the title of a brochure offered by FDA's Office of Women's Health, can play a vital role in the medical treatment you receive during an emergency. Health tips and advises for everybody.
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Tracleer ( Bosentan ) Receives New Indication In Patients With Systemic Sclerosis And Active Digital Ulcer Disease

Tenormin in our life.

uses of Tenormin Tenormin is a beta-blocker used to treat chest pain ( angina ) and high blood pressure. It's also used after an acute heart attack to improve survival. High blood pressure reduction helps prevent strokes, heart attacks and kidney problems.

Tenormin works by blocking action of certain natural chemicals in your body such as epinephrine on heart and blood vessels. This results in a lowering of the heart rate, blood pressure, and strain on heart.

how to use of Tenormin Take Tenormin by mouth, usually once daily; or as directed by your doctor. Use Tenormin regularly in order to get most benefit from it. To help we remember, use it at same time each day.

Tenormin isn't effective if we use it only when chest pain or a migraine headache occurs. It's very important to take this medication regularly as prescribed to help prevent these conditions.

The dosage is based on your medical condition and response to therapy. It may take one or two weeks before full benefit of Tenormin takes effect. It's important to continue taking Tenormin even if we feel well. Most people with high blood pressure don't feel sick.

Don't suddenly stop taking Tenormin without consulting your doctor. Your condition may become worse when drug is suddenly stopped. Refer to the Warning section.

other used of Tenormin This section contains uses of Tenormin that aren't listed in the approved professional labeling for drug but that may be prescribed by your health care professional. Use Tenormin for a condition that's listed in this section only if it has been so prescribed by your health care professional.

Tenormin may also be used for irregular heartbeats, heart failure, migraine headache prevention, tremors and other conditions as determined by your doctor.

side effects of Tenormin We may experience dizziness, lightheadedness, drowsiness, tiredness, nausea, diarrhea, unusual dreams, leg pain, or vision problems as your body adjusts to medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Tenormin may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

Remember that your doctor has prescribed Tenormin because he or she has judged that benefit to we is greater than risk of side effects. Many people using Tenormin do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur:

In the unlikely event you have an allergic reaction to Tenormin, seek medical attention immediately. Symptoms of an allergic reaction include:

This is not a complete list of possible side effects. If we notice other effects not listed above, contact your doctor or pharmacist.

precautions of Tenormin Before taking Tenormin, tell your doctor or pharmacist if we are allergic to it; or to other beta-blockers ( e. g. , metoprolol, propranolol ) ; or if we have any other allergies.

Tenormin shouldn't be used if we have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

Before using Tenormin, tell your doctor or pharmacist your medical history, especially of:

Before having surgery, tell your doctor or dentist that we are taking Tenormin.

If you have diabetes, Tenormin may mask the fast/pounding heartbeat you'd usually feel when your blood sugar level falls too low ( hypoglycemia ) . Other symptoms of a low blood sugar level such as dizziness or sweating are unaffected by Tenormin.

Tenormin may make we dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Tenormin should be used only when clearly needed during pregnancy. Discuss risks ( e. g. , low birth weight ) and benefits with your doctor.

Tenormin passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

interactions of Tenormin Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring we for it. Don't start, stop or change dosage of any medicine before checking with them first.

Before using Tenormin, tell your doctor or pharmacist of all prescription and nonprescription products we may use, especially of:

Check labels on all your medicines ( e. g. , cough-and-cold products, diet aids ) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products.

This document doesn't contain all possible interactions. Therefore, before using Tenormin, tell your doctor or pharmacist of all the products we use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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Tracleer ( Bosentan ) Receives New Indication In Patients With Systemic Sclerosis And Active Digital Ulcer Disease

Tracleer ( Bosentan ) Receives New Indication In Patients With Systemic Sclerosis And Active Digital Ulcer Disease Tenormin in our life. Delivery options for Tenormin My Medicines - This Brochure Can be a Lifesaver. My Medicines, the title of a brochure offered by FDA's Office of Women's Health, can play a vital role in the medical treatment you receive during an emergency. Health tips and advises for everybody.

Actelion Pharmaceuticals UK Ltd announced that Tracleer ( bosentan ) , a dual endothelin receptor antagonist, has been approved in UK and Ireland for reduction of number of new digital ulcers ( DUs ) in patients with systemic sclerosis ( SSc ) and ongoing DU disease. 1

DUs are a frequent, extremely painful and disabling complication of SSc2, caused by a reduced blood flow to the fingers and toes. DUs can result in difficult to heal open sores and adversely affect the ability to perform work and daily activities, particularly those associated with fingertip function. In severe cases, infection can lead to osteomyelitis and gangrene, where surgery and even amputation may be required. 3

SSc affects at least 7, 000 people in UK, 4 and research indicates that up to 50% of SSc patients develop DUs. 2 Until now there have been no licensed therapies for reduction of new DUs in SSc patients with ongoing DU disease. Tracleer targets underlying vasculopathy in SSc by blocking damaging effects of endothelin. The new indication extends the previous licence of Tracleer for treatment of pulmonary arterial hypertension ( PAH ) .

Dr Arianne Herrick, Reader of Rheumatology at the University of Manchester, added: " Digital ulcers can be severely disabling as well as extremely painful, affecting peoples ability to undertake activities of everyday living and interfering with their working and social lives. We know that digital ulcers can be slow to heal and may lead to serious complications, such as infection ( sometimes involving underlying bone ) and gangrene. This new indication offers a valuable therapy for patients with scleroderma and ongoing digital ulceration, to help reduce number of new ulcers. "

Results from two randomised, placebo-controlled, double-blind studies, RAPIDS-1 and RAPIDS-2, supported the licence approval. Tracleer compared to placebo significantly reduced the mean occurrence of new DUs in patients with SSc and ongoing DU disease by 48% ( 1. 4 versus 2. 7; p=0. 0083 ) and by 30% ( 1. 9 versus 2. 7; p=0. 035 ) in RAPIDS-1 and RAPIDS-2 respectively. Although new DUs were prevented, no improvement in ulcer healing with Tracleer was observed. In both trials safety profile was consistent with that seen in previous trials of Tracleer in pulmonary arterial hypertension with Gastrointestinal reflux disease, infected ulcers, peripheral oedema ( including worsening ) and abnormal raised liver function tests being the most common side effects. 5, 6

A survey of 1, 050 SSc patients conducted by Raynaud's and Scleroderma Association in October 2007 found that 86% of those with DUs were affected by pain and 53% by some loss of function, both of which were negatively impacting on their ability to carry out everyday tasks such as cooking, dressing, driving and washing. 7

A disease registry has also been set up to collect and analyse data on this poorly characterised patient population where currently little information is available. The registry will provide further insights into DUs, their disabling manifestations and response to treatments across a range of patients with systemic sclerosis and ongoing DU disease.

About RAPIDS-1

RAPIDS-1 ( RAndomized Placebo-controlled Investigation of Digital ulcers in Scleroderma ) was a placebo-controlled double-blind clinical trial that evaluated the prevention of ischaemic digital ulcers ( DUs ) in 122 patients with systemic sclerosis ( SSc ) at 17 centres in Europe and North America. RAPIDS-1 was first specifically designed study to look at prevention of ulcer formation. Furthermore study is among very few to demonstrate clinical efficacy in SSc. 5 Patients with SSc who had either a history of at least one DU over the past 12 months or active DUs at the time of enrolment, were treated with either bosentan ( 62. 5mg bid for four weeks, then 125mg bid for the next 12 weeks ) or placebo. The total number of new ulcers during the treatment period was 1. 4 for patients on bosentan versus 2. 7 for patients on placebo ( p=0. 0083 ) representing a 48% reduction in the number of new DUs. 5

About RAPIDS-2

In late 2003, Actelion initiated a second pivotal Phase III clinical trial, RAPIDS-2 ( RAndomized Placebo-controlled Investigation of Digital ulcers in Scleroderma ) investigating bosentan in ischaemic DUs secondary to SSc. In contrast to earlier RAPIDS-1 trial, this study evaluated prevention and healing in a population with more severe forms of disease at the time of enrolment.

The treatment duration was longer and a withdrawal period was implemented in order to assess evolution of DUs after treatment interruption. The study enrolled a total of 188 patients in 41 centers worldwide. 6

Patients with SSc and at least one DU were treated with either bosentan ( 62. 5mg bid for four weeks, then 125mg bid for at least 20 weeks and up to 32 weeks ) or placebo. The total number of new ulcers over 24 weeks was 1. 9 ± 0. 2 for patients on bosentan versus 2. 7 ± 0. 3 for patients on placebo ( p=0. 035 ) representing a 30% reduction in number of new DUs. The reduction in DUs was more pronounced in patients with more than three active DUs at start of study. 6

About Tracleer in Pulmonary Arterial Hypertension ( PAH )

Tracleer is licensed in the UK for the treatment of PAH to improve exercise capacity and symptoms in patients with grade III functional status. Efficacy has been shown in primary ( idiopathic and familial ) PAH, PAH secondary to scleroderma without significant interstitial pulmonary disease and PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology. Tracleer is also indicated to reduce number of new digital ulcers in patients with systemic sclerosis and ongoing DU disease. 1

Attention required regarding two significant safety concerns

Potential for serious liver injury ( including rare cases of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring ) - liver monitoring of all patients is essential prior to initiation of treatment, 2 weeks after any dose increase and monthly thereafter. High potential for major birth defects - pregnancy must be excluded and prevented by two forms of birth control; monthly pregnancy tests should be obtained. Because of these risks, Tracleer is only supplied through a controlled distribution.

About Actelion Pharmaceuticals UK & Ireland Ltd " Actelion " is an independent biopharmaceutical company that focuses on discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion Pharmaceuticals UK & Ireland is a subsidiary of Actelion Ltd, which has its corporate headquarter in Allschwil/Basel, Switzerland. Actelion markets Tracleer, an orally available dual endothelin receptor antagonist, for pulmonary arterial hypertension ( PAH ) and Zavesca, a small molecule oral therapy for treatment of type 1 Gaucher's disease, both in UK and Ireland. Further information is available from http: //www. actelion. com.

References:

1. Actelion Pharmaceuticals UK Limited. Tracleer ( bosentan ) Summary of Product Characteristics. 15 May 2007.

2. Chung L, Fiorentino D. Digital ulcers in patients with systemic sclerosis. Autoimmun Rev 2006; 5 ( 2 ) : 125128.

3. Ford Jones N et al . Surgery for scleroderma of hand. J Hand Surg [Am] 1987; 12 ( 3 ) : 391400.

4. Raynaud's & Scleroderma Association. November 2007. Press Release - Scleroderma Survey. Viewed 20 December 2007.

5. Korn J. et al. Digital ulcers in systemic sclerosis: Prevention by treatment with bosentan, an oral endothelin receptor antagonist Arthritis Rheum 2004, Issue 12; 50: 3985-3993.

6. Seibold J. et al. Bosentan prevents occurrence but does not speed healing of digital ulcers in patients with systemic sclerosis ( SSc ) . ACR 2005. Poster presentation L2: 552.

7. Raynaud's & Scleroderma Association. Scleroderma Questionnaire. October 2007. Conducted by the Raynaud's & Scleroderma Association and sponsored by an educational grant from Actelion Pharmaceuticals UK Ltd.

http: //www. actelion. com


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