e made aware that both alcohol and PDE5 inhibitors including STENDRA act as vasodilators.
When vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Physicians should inform patients that substantial consumption of alcohol (e.g., greater than 3 units) in combination with STENDRA may increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness and headache.
Physicians should inform patients not to take STENDRA with other PDE5 inhibitors as the safety and efficacy of these combinations have not been
studied.
Use of STENDRA offers no protection against sexually transmitted diseases, including the human immunodeficiency virus (HIV); therefore, physicians should consider counseling their patients about protective measures.
The most common side effects of STENDRA were headache (5.6%), flushing (3.5%), nasopharyngitis (3.4%) and nasal congestion (2.1%).http://www.stendra.com/assets/pdf/STENDRA-avanafil-tablets-full-PI.pdf
MOUNTAIN VIEW, Calif., Sept. 18, 2012 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced the U.S. market availability of Qsymia™ (pronounced Kyoo sim ee' uh). Qsymia is FDA-approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight
management in adult patients with an initial body mass index (BMI) of 30 or greater (obese), or 27 or greater (overweight) in the presence of at
least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol (dyslipidemia). It is the first FDA-approved once daily combination therapy – and the first new medication available in 13 years – for the treatment of obesity.
VIVUS is formally introducing Qsymia to medical professionals this week at The Obesity Society's Annual Scientific Meeting in San Antonio, Texas.
"VIVUS is proud to be leading the way in the treatment of obesity, a disease with very serious health consequences," said Peter Tam, President of VIVUS. "Qsymia is the first ever combination treatment made available, and today's introduction marks a new beginning for many patients who struggle with obesity. We are excited about making this new treatment option available to patients because Qsymia is the first FDA-approved oral
medication that has been shown to achieve an average weight loss of 10% in obese patients when used in conjunction with a lifestyle modification
program."
To help ensure healthcare providers and patients are properly educated, VIVUS is emphasizing the Qsymia Risk eva luation and Mitigation Strategy
(REMS) program, which includes a Medication Guide, healthcare provider training, patient brochure and other education tools. As part of the REMS program, Qsymia is available only through certified mail order pharmacies that are part of the Qsymia Home Delivery Network including CVS Pharmacy and Walgreens.
"The battle against obesity can seem hopeless, yet given the health consequences, it is absolutely critical that people who are at risk improve their weight," said Donna Ryan, M.D., associate executive director for clinical research at Pennington Biomedical Research Center in Baton
Rouge, La., and former president of The Obesity Society. "It is time that healthcare professionals have a new medical treatment option allo
