Drugplain

Levsin .125 mg/1

hyoscyamine sulfate · TABLET · Viatris Specialty LLC

1 Recall on Record
Plain English

Levsin (hyoscyamine sulfate) is an oral tablet used to treat symptoms caused by muscle spasms in the digestive tract, such as cramping and abdominal pain. It works by relaxing the muscles in your stomach and intestines to help relieve discomfort.

Key Facts

Brand Name
Levsin
Generic Name
hyoscyamine sulfate
NDC Code (Product)
68220-112
Manufacturer
Viatris Specialty LLC
Strength
.125 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Marketing Start
06/01/1955

Recall History

1 Recall on Record
Class II05/25/2023

Viatris Inc

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

nausea341 reports
diarrhoea308 reports
pain280 reports
fatigue257 reports
headache244 reports
vomiting216 reports
dizziness212 reports
abdominal pain199 reports
drug ineffective185 reports
dyspnoea168 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Levsin ® 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). Levsin ® 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.

Dosage & Administration

DOSAGE AND ADMINISTRATION 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 four hours or as needed. Do not exceed 12 tablets in 24 hours. Pediatric patients 2 to under 12 years of age: ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

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, Levsin ® 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.

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.

Drug Interactions

Drug Interactions Additive adverse effects resulting from cholinergic blockade may occur when Levsin ® is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines. Antacids may interfere with the absorption of Levsin ® . Administer Levsin ® before meals; antacids after meals.

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 Levsin used for?

Levsin (hyoscyamine sulfate) is an oral tablet used to treat symptoms caused by muscle spasms in the digestive tract, such as cramping and abdominal pain. It works by relaxing the muscles in your stomach and intestines to help relieve discomfort.

Is Levsin a controlled substance?

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

What is the generic name for Levsin?

The generic name for Levsin is hyoscyamine sulfate. There are 12 other brand versions of hyoscyamine sulfate.

What is the NDC code for Levsin .125 mg/1?

The NDC (National Drug Code) for Levsin .125 mg/1 is 68220-112, listed by Viatris Specialty LLC.

Product NDC

68220-112

Package NDC

68220-112-10

Other Hyoscyamine Brands

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

Data from openFDA · Public domain (CC0 1.0)