Hyoscyamine Sulfate Extended-release
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Questions & Answers
Side Effects & Adverse Reactions
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, 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, 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Hyoscyamine Sulfate Extended-Release Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, 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). Hyoscyamine Sulfate Extended-Release Tablets are 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.
History
There is currently no drug history available for this drug.
Other Information
Hyoscyamine Sulfate Extended-Release Tablets contain 0.375 mg hyoscyamine sulfate in a formulation designed for oral b.i.d. dosage.
Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2•H2SO4•2H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:
Each tablet also contains as inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose.
Sources
Hyoscyamine Sulfate Extended-release Manufacturers
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American Health Packaging
![Hyoscyamine Sulfate Extended-release Tablet [American Health Packaging]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hyoscyamine Sulfate Extended-release | American Health Packaging
Dosage may be adjusted according to the conditions and severity of symptoms.
Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every 12 hours. Do not crush or chew tablets. Do not exceed 4 tablets in 24 hours.
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County Line Pharmaceuticals, Llc
Hyoscyamine Sulfate Extended-release | County Line Pharmaceuticals, Llc
Dosage may be adjusted according to the conditions and severity of symptoms.
Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every 12 hours. Do not crush or chew tablets. Do not exceed 4 tablets in 24 hours.
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Aidarex Pharmaceuticals Llc
Hyoscyamine Sulfate Extended-release | Aidarex Pharmaceuticals Llc
Dosage may be adjusted according to the conditions and severity of symptoms.
Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every 12 hours. Do not crush or chew tablets. Do not exceed 4 tablets in 24 hours.
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Carilion Materials Management
Hyoscyamine Sulfate Extended-release | Carilion Materials Management
Dosage may be adjusted according to the conditions and severity of symptoms.
1 to 2 tablets every 12 hours. Do not crush or chew tablets. Do not exceed 4 tablets in 24 hours. Adults and pediatric patients 12 years of age and older:
![Hyoscyamine Sulfate Extended-release Tablet [County Line Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d2b55db1-be5f-4fe0-b31d-21bbe85a34f1&name=d2b55db1-be5f-4fe0-b31d-21bbe85a34f1-02.jpg)
![Hyoscyamine Sulfate Extended-release Tablet [Aidarex Pharmaceuticals Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4c2b85b3-0f7a-4832-9d53-bc026116a1e6&name=hyoscyamine-sulf-er-0-375mg-for-county-line-2.jpg)
![Hyoscyamine Sulfate Extended-release Tablet [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2bf8d44e-e1b2-4a1d-9914-00bb7ef1293e&name=68151-5182.jpg)
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