Hyoscyamine Sulfate Sl
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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, 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.
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 Sublingual Tablets, USP are effective as adjunctive therapy in the treatment of peptic ulcer. They 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 distrubances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine Sulfate Sublingual Tablets, USP 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 Sublingual Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for sublingual administration. However, the tablets may be chewed or taken orally.
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: FD&C blue #1, lactose monohydrate, magnesium stearate, mannitol, starch and stearic acid.
Sources
Hyoscyamine Sulfate Sl Manufacturers
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Franklin Pharmaceutical Llc
![Hyoscyamine Sulfate Sl (Hyoscyamine Sulfate) Tablet, Soluble [Franklin Pharmaceutical Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hyoscyamine Sulfate Sl | Franklin Pharmaceutical Llc
Dosage may be adjusted according to the conditions and severity of symptoms. The tablets may be taken sublingually, orally or chewed.
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Virtus Pharmaceuticals
Hyoscyamine Sulfate Sl | Virtus Pharmaceuticals
Dosage may be adjusted according to the conditions and severity of symptoms. Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg must be placed under the tongue when it will dissolve in seconds, then swallow with saliva. Administering with liquid is not necessary.
Adults and pediatric patients 12 years of age and older1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.
Pediatric patients 2 to under 12 years of age½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.
![Hyoscyamine Sulfate Sl (Hyoscyamine Sulfate) Tablet [Virtus Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c9623ab9-ead1-4ae5-94d8-e18384b1e30c&name=hyoscyamine-02.jpg)
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