PRODUCT INFORMATION

INDICATIONS AND USAGE:  Anaspaz® is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome (irritable colon, spastic colon, mucous colitis), acute entercolitis and other functional gastrointestinal disorders. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. Anaspaz is indicated (along with appropriate analgesics) in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis.

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; severe ulcerative colitis; toxic megacolon; myasthenia gravis; myocardial ischemia.

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, Anaspaz may produce drowsiness 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.

Anticholinergic psychosis has been reported in sensitive individuals given anticholinergic drugs. CNS signs and symptoms include confusion, disorientation, short term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve 12 to 48 hours after drug discontinuation.

Elderly patients may react with excitement, agitation, drowsiness, and other unfavorable manifestations to even small doses of Anaspaz.

PRECAUTIONS:
General:  Use with caution and only when clearly indicated 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
Anaspaz may produce drowsiness, dizziness or blurred vision. Patients should observe caution before operating a motor vehicle or other machinery or performing other tasks requiring mental alertness.

Use of Anaspaz 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.

Anaspaz is gluten free

See Full Prescribing Information for Anaspaz Orally Disintegrating Tablet

AVAILABILITY
Anaspaz is available by prescription only.

Anaspaz is available through retail and mail order pharmacies.

OTHER ANASPAZ® INFORMATION
For questions about Anaspaz, contact us.

Anaspaz® is a registered trademark of B.F. Ascher & Co., Inc.

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