Hyoscyamine Sulfate 0.125 mg

INDICATIONS AND USAGE: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets are an anticholinergic agent used as adjunctive therapy for a range of gastrointestinal and genitourinary conditions. Hyoscyamine reduces gastrointestinal motility and secretions and relieves smooth muscle spasm. Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets may be used as adjunctive therapy in conditions such as: -Peptic ulcer disease -Irritable bowel syndrome and functional gastrointestinal disorders (e.g., spastic colon, mucous colitis) -Acute enterocolitis -Neurogenic bladder and bladder spasms -Biliary and renal colic (in combination with narcotic analgesics)

WARNINGS: Digenyx™ (Hyoscyamine Sulfate USP, 0.125 mg) tablets may cause drowsiness, dizziness, or blurred vision, so patients should avoid activities that require mental alertness, such as driving or operating machinery. It should be used with caution in individuals with heart disease, high blood pressure, hyperthyroidism, or enlarged prostate, and is not recommended for patients with narrow-angle glaucoma. In hot environments, the use of this drug may lead to heat prostration (fever, heat stroke due to decreased sweating). Diarrhea could be an early sign of incomplete intestinal obstruction, especially for patients with an ileostomy or colostomy, in which case using this product may be harmful. Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, anxiety, decreased anxiety, fatigue, insomnia, agitation and mannerisms and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.