Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)
RedHill announced in January 2017 that it had entered into an exclusive co-promotion agreement with Concordia Pharmaceuticals Inc. granting RedHill certain U.S. promotion rights for Donnatal®.
Under the terms of the Agreement, RedHill will be responsible for certain promotional activities related to Donnatal®. Concordia will continue to be responsible for the manufacturing and supply of Donnatal® in all territories. The initial term of the co-promotion agreement with Concordia is for three years. RedHill expects to initiate gradual promotion of Donnatal® in the coming months.
Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal® slows the natural movements of the gut by relaxing the muscles in the stomach and intestines and acts on the brain to produce a calming effect. Donnatal® comes in two formulations: immediate release Donnatal® Tablets, and immediate release Donnatal® Elixir, a fast acting liquid.
Important Safety information:
Donnatal® is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal®. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting, and allergic reactions which may be severe.
Further information, including prescribing information, can be found on www.donnatal.com
Please see the following website for important safety information about Donnatal®: http://www.donnatal.com/professionals/important-safety-information/