Hyosyne .125 mg/5mL

Hyoscyamine Sulfate · ELIXIR · Lannett Company, Inc.

No Recall History

Plain English

Hyosyne is a elixir containing hyoscyamine sulfate at .125 mg/5mL, taken oral. Manufactured by Lannett Company, Inc..

Key Facts

Brand Name: Hyosyne
Generic Name: Hyoscyamine Sulfate
NDC Code (Product): 54838-511
Manufacturer: Lannett Company, Inc.
Strength: .125 mg/5mL
Dosage Form: ELIXIR
Route: ORAL
Marketing Status
Marketing Start: 11/01/1997

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea162 reports

diarrhoea144 reports

headache139 reports

pain133 reports

fatigue132 reports

dizziness122 reports

drug ineffective91 reports

product dose omission issue91 reports

dyspnoea90 reports

vomiting88 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 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 a…

Dosage & Administration

DOSAGE AND ADMINISTRATION HYOSYNE ORAL DROPS (Hyoscyamine Sulfate Oral Solution) Dosage may be adjusted according to the conditions and severity of symptoms. Measuredosage 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. Body Weight Usual Dose Do Not Exceed 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.…

Warnings

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, 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.

Contraindications

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 in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

Adverse Reactions

ADVERSE REACTIONS All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating.

Frequently Asked Questions

What is Hyosyne used for?

Hyosyne contains Hyoscyamine Sulfate. It is a elixir taken oral. Consult your doctor for specific uses.

Is Hyosyne a controlled substance?

Hyosyne is not classified as a controlled substance by the DEA.

What is the generic name for Hyosyne?

The generic name for Hyosyne is Hyoscyamine Sulfate. There are 12 other brand versions of Hyoscyamine Sulfate.

What is the NDC code for Hyosyne .125 mg/5mL?

The NDC (National Drug Code) for Hyosyne .125 mg/5mL is 54838-511, listed by Lannett Company, Inc..

Product NDC

54838-511

Package NDC

54838-511-80

Other Hyoscyamine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)