Amneal Launches Generic Lotronex
Alosetron HCl, a 5-HT3 receptor antagonist, is indicated to treat women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have chronic IBS symptoms (generally lasting 6 months or longer) and have had anatomic or biochemical abnormalities of the GI tract excluded, and not responded adequately to conventional therapy. It is restricted to patients for whom the benefit-to-risk balance is most favorable.
Activation of ligand-gated cation channels and the resulting neuronal depolarization affect the regulation of visceral pain, colonic transit and gastrointestinal secretions, which are processes that relate to the pathophysiology of IBS.
Amneal's generic version was approved under a Risk Evaluation and Mitigation Strategy (REMS) known as the Alosetron REMS Program, ensuring that the benefits of a drug outweigh the risk of adverse gastrointestinal reactions.
Alosetron HCl is available in 0.5mg and 1mg strengths in 30-count bottles. The product has started shipping to distributors on January 30.
For more information call (877) 835-5472 or visit Amneal.com.