Showing posts with label Oral Solution for Pediatric Patients. Show all posts
Showing posts with label Oral Solution for Pediatric Patients. Show all posts

Monday, May 8, 2017

FDA Approves Qbrelis (lisinopril) Oral Solution for Pediatric Patients 6 Years of Age and Older

We know that,  Lisinopril is a drug of the angiotensin-converting enzyme (ACE) inhibitor class used primarily in treatment of high blood pressure, heart failure, and after heart attacks. It is also used for preventing kidney and eye complications in people with diabetes. Its indications,contraindications, and side effects are as those for all ACE inhibitors.
Lisinopril was the third ACE inhibitor (after captopril and enalapril) and was introduced into therapy in the early 1990s. A number of properties distinguish it from other ACE inhibitors: It ishydrophilic, has a long half-life and tissue penetration, and is not metabolized by the liver.

Structural formula of lisinopril

Now Silvergate Pharmaceuticals, Inc., leader in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved Qbrelis (Lisinopril) Oral Solution, the first and only FDA-approved Lisinopril oral solution. Qbrelis is indicated for the treatment of hypertension (high blood pressure) in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults. 

“We are excited to launch our second product focused on pediatric patients and pediatric hypertension” said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. “Qbrelis provides a ready-to-use oral solution for these children with the additional assurance of an FDA approved medication. As a company, we continue to focus on pediatric medications that are safe, effective, and readily available.”
Qbrelis enables weight-based dosing for children 6 years of age and older who until now have relied on an adjusted adult dose. Qbrelis will be available through an extensive network of pharmacies and a qualified mail order service. For additional information on how to obtain Qbrelis, please call 1-855-379-0382.

About Qbrelis

Qbrelis delivers the trusted efficacy of lisinopril (an ACE inhibitor), the effectiveness of which has been well established in clinical trials.1 As a unique formulation of an oral solution, Qbrelis provides consistent potency and stability in each dose1, in addition to the quality of a product made in accordance with FDA regulations and requirements. People who have trouble swallowing lisinopril tablets may also benefit from Qbrelis.
Qbrelis reduces blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Control of high blood pressure should be part of a comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
More info @ https://www.drugs.com/history/qbrelis.html