Hyoscyamine Sulfate Solution/ Drops
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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, 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.
Not to be used by persons having glaucoma or excessive pressure within the eye, by elderly persons (where undiagnosed glaucoma or excessive pressure within the eye occurs most frequently), or by children under 6 years of age, unless directed by a physician. Discontinue use if blurring of vision, rapid pulse, or dizziness occurs. Do not exceed recommended dosage. Not for frequent or prolonged used. If dryness of the mouth occurs, decrease dosage. If eye pain occurs, discontinue use and see your physician immediately as this may indicate undiagnosed glaucoma.
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 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). 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.
History
There is currently no drug history available for this drug.
Other Information
(Hyoscyamine Sulfate Oral Solution)
Rx Only
DESCRIPTION:
Hyoscyamine Sulfate Oral Drops (hyoscyamine sulfate oral solution, USP) contain 0.125 mg hyoscyamine sulfate per mL with 5% v/v alcohol for oral administration.
Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C
17H
23NO
3)
2·H
2SO
4·2H
2O 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:
Hyoscyamine Sulfate Oral Drops also contain as inactive ingredients: Citric Acid, Ethyl Alcohol, FD&C Red #40, FD&C Yellow #10, Orange Flavor, Propylene Glycol, Purified Water, Sodium Citrate, and Sodium Saccharin.
Sources
Hyoscyamine Sulfate Solution/ Drops Manufacturers
-
Cypress Pharmaceutical, Inc.
![Hyoscyamine Sulfate Solution/ Drops [Cypress Pharmaceutical, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hyoscyamine Sulfate Solution/ Drops | Cypress Pharmaceutical, Inc.
Dosage may be adjusted according to the conditions and severity of symptoms. Measure dosage very carefully.
Adults and pediatric patients 12 years of age and older: 1 to 2 mL every four hours or as needed. Do not exceed 12 mL in 24 hours.
Pediatric patients 2 to under 12 years of age: 1/4 to 1 mL every four hours or as needed. Do not exceed 6 mL in 24 hours.
Pediatric patients under 2 years of age: The following dosage guide is based upon body weight. The doses may be repeated every four hours or as needed.
Package of Hyoscyamine Sulfate Oral Drops is accompanied with a dropper having markings of 3,4,5 DROPS, and 0.25 mL. The approximate equivalent amount of hyoscyamine sulfate drops (mL) and its equivalent amount of hyoscyamine sulfate (mg) for each marking are as follows:
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