Hyosyne
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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. 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.
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
HYOSYNE ORAL DROPS (Hyoscyamine Sulfate Oral Solution) contain 0.125 mg hyoscyamine sulfate per
mL with 5% v/v alcohol for oral administration.
HYOSYNE ELIXIR (Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with
20% v/v alcohol for oral administration.
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:
HYOSYNE ORAL DROPS also contain as inactive ingredients: Alcohol, citric acid, FD&C red #40, FD&C yellow #6, flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water.
HYOSYNE ELIXIR also contain as inactive ingredients: Alcohol, citric acid, FD&C red #40, FD&C yellow #6, flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose.
Sources
Hyosyne Manufacturers
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Silarx Pharmaceuticals, Inc
![Hyosyne (Hyoscyamine Sulfate) Elixir [Silarx Pharmaceuticals, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hyosyne | Silarx Pharmaceuticals, Inc
HYOSYNE ORAL DROPS
(Hyoscyamine Sulfate Oral Solution)Dosage may be adjusted according to the conditions and severity of symptoms. Measuredosage very carefully.
Body Weight Usual Dose Do Not Exceed
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.
In 24 Hours 3.4 kg (7.5 lb.)
4 drops
24 drops
5 kg (11 lb.)
5 drops
30 drops
7 kg (15 lb.)
6 drops
36 drops
10 kg (22 lb.)
8 drops
48 drops
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:
Approximate Equivalent Amount
Marking on Dropper Hyoscyamine Sulfate Oral Drops Solution (mL)
Hyoscyamine Sulfate (mg)
3 DROPS
0.08 mL
0.01 mg
4 DROPS
0.11 mL
0.01375 mg
5 DROPS
0.14 mL
0.0175 mg
0.25 mL
0.25 mL
0.03125 mg
HYOSYNE ELIXIR
Body Weight
(Hyoscyamine Sulfate Elixir)
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 teaspoonfuls every four hours or as needed. Do not exceed 12 teaspoonfuls in 24 hours.
Pediatric patients 2 to under 12 years of age: Please see the following dosage guide is based on body weight. The doses may be repeated every four hours or as needed. Do not exceed 6teaspoonfuls in 24 hours.
Usual Dose 10 kg (22 lb.)
1/4 teaspoon (1.25 mL)
20 kg (44 lb.)
1/2 teaspoonful (2.5 mL)
40 kg (88 lb.)
3/4 teaspoonful (3.75 mL)
50 kg (110 lb.)
1 teaspoonful (5 mL)
-
Silarx Pharmaceuticals, Inc
Hyosyne | Silarx Pharmaceuticals, Inc
HYOSYNE ORAL DROPS
(Hyoscyamine Sulfate Oral Solution)Dosage may be adjusted according to the conditions and severity of symptoms. Measuredosage very carefully.
Body Weight Usual Dose Do Not Exceed
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.
In 24 Hours 3.4 kg (7.5 lb.)
4 drops
24 drops
5 kg (11 lb.)
5 drops
30 drops
7 kg (15 lb.)
6 drops
36 drops
10 kg (22 lb.)
8 drops
48 drops
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:
Approximate Equivalent Amount
Marking on Dropper Hyoscyamine Sulfate Oral Drops Solution (mL)
Hyoscyamine Sulfate (mg)
3 DROPS
0.08 mL
0.01 mg
4 DROPS
0.11 mL
0.01375 mg
5 DROPS
0.14 mL
0.0175 mg
0.25 mL
0.25 mL
0.03125 mg
HYOSYNE ELIXIR
Body Weight
(Hyoscyamine Sulfate Elixir)
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 teaspoonfuls every four hours or as needed. Do not exceed 12 teaspoonfuls in 24 hours.
Pediatric patients 2 to under 12 years of age: Please see the following dosage guide is based on body weight. The doses may be repeated every four hours or as needed. Do not exceed 6teaspoonfuls in 24 hours.
Usual Dose 10 kg (22 lb.)
1/4 teaspoon (1.25 mL)
20 kg (44 lb.)
1/2 teaspoonful (2.5 mL)
40 kg (88 lb.)
3/4 teaspoonful (3.75 mL)
50 kg (110 lb.)
1 teaspoonful (5 mL)
![Hyosyne (Hyoscyamine Sulfate) Solution/ Drops [Silarx Pharmaceuticals, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=38f12473-08e0-4970-a6ef-a825cc7de8d8&name=carton.jpg)
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