Product Information
INDICATIONS AND USAGE: Levsin® (hyoscyamine sulfate) is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Levsin® (hyoscyamine sulfate) is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.
CONTRAINDICATIONS: Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.
WARNINGS:
In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, Levsin® (hyoscyamine sulfate) may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug.
Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, shortterm memory loss, hallucinations, dysarthria, ataxia, euphoria, 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.
PRECAUTIONS:
General:
Use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hypertension, and renal disease. Investigate any tachycardia before giving any anticholinergic drug since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.
Information for Patients:
Like other anticholinergic agents, Levsin® (hyoscyamine sulfate) may produce drowsiness, dizziness, or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug.
Use of Levsin ® (hyoscyamine sulfate) may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution.
About This Disease
For more information on the conditions treated by Levsin,
please visit www.webmd.com.
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Please See Full Prescribing Information PDF
Levsin® (hyoscyamine sulfate) Tablets
Levsin® (hyoscyamine sulfate) Sub-Lingual Tablet
Levsin® (hyoscyamine sulfate) for Injection
Levbid® (hyoscyamine sulfate, 0.375 mg) extended-release tablets
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Availability
Levsin® (hyoscyamine sulfate) is available by prescription only.
Ask your doctor if Levsin®(hyoscyamine sulfate) is right for you.
IMPORTANT INFORMATION ABOUT LEVSIN®(hyoscyamine sulfate)
All Levsin® (hyoscyamine sulfate) and Levbid® (hyoscyamine sulfate, 0.375 mg) products are available through normal distribution channels including retail and mail order pharmacies.
Please see the complete list of order numbers for use when obtaining product from a distributor. Check back.
Thank you for your interest in the Levsin® (hyoscyamine sulfate) family of products and your patience as we work to increase our supply to meet demand.
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Reference Library
For questions about Levsin® (hyoscyamine sulfate), please contact:
Levsin® (hyoscyamine sulfate), Levbid® (hyoscyamine sulfate, 0.375 mg), are registered trademarks of Alaven® Pharmaceutical LLC.
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