Levsin

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Levsin

What is Levsin? (Hyoscyamine Sulfate)

Property Description
Active ingredient Hyoscyamine Sulfate
Form Tablet (oral, sublingual, extended-release), Oral Solution
Pharmacological class Anticholinergic Agent, Gastrointestinal Antispasmodic
General purpose Relieves spasms, cramps, and excessive visceral movement
Origin Derived from natural tropane alkaloids

What is Levsin and What Type of Drug is it?

Levsin is a recognized trade name for the active substance Hyoscyamine Sulfate, which is primarily classified as a potent anticholinergic agent and a gastrointestinal antispasmodic. This medication is the highly active levo-isomer of atropine, with a structure demonstrating high affinity for muscarinic receptors. The drug is considered a prescription-only medicine, often used alongside equivalent generic formulations.


Composition, Origin, and Available Forms

The therapeutic substance is Hyoscyamine Sulfate, which originates as a tropane alkaloid naturally found in plants of the Solanaceae family. It is supplied as a single-ingredient product, offering several differentiating dosage forms beyond the standard oral tablet. These preparations include liquid oral solutions and the fast-acting sublingual tablet (SL), which is designed to dissolve rapidly for quick systemic absorption, facilitating flexible routes of administration.


What is the General Purpose of Hyoscyamine Sulfate?

The overall purpose of Hyoscyamine Sulfate is to achieve smooth muscle relaxation and control symptoms of functional disturbances where involuntary activity is excessive. By acting as an antimuscarinic agent, the drug's general function is to reduce the exaggerated contractions responsible for cramping and discomfort, such as easing the spasms associated with visceral hyperactivity. This action also extends to diminishing the production of various glandular secretions throughout the body, including excessive saliva and gastric fluids.

Regulatory References

  1. DailyMed Product Information

What side effects are possible with Levsin?

Possible Side Effects and Safety Information

Levsin (hyoscyamine sulfate) is associated with adverse reactions primarily related to its anticholinergic properties. The majority of reported effects are generally unclassified by frequency (incidence not known) in regulatory documents, although common effects include dry mouth, constipation, decreased sweating, and blurred vision.

Adverse reactions are grouped by the affected body system (System-Organ Class):

System Documented Adverse Reactions
Nervous System Drowsiness, dizziness, headache, confusion, nervousness, insomnia.
Ophthalmic (Eye) Mydriasis (dilated pupils), cycloplegia, increased ocular tension.
Gastrointestinal Constipation, loss of taste, nausea, vomiting, bloated feeling.
Cardiovascular Tachycardia (fast heartbeat), palpitations.
Genitourinary Urinary hesitancy or retention, impotence.

Serious Adverse Reactions and Safety Constraints

Official labeling documents highlight rare but serious adverse reactions and high-level safety constraints:

  • Central Nervous System (CNS) Effects: Reports of psychosis, hallucinations, and confusion, particularly in sensitive individuals. These symptoms generally resolve within 12 to 48 hours after the medication is stopped.
  • Heat Prostration Risk: Decreased sweating can occur, posing a risk of fever or heat stroke when exposed to high environmental temperatures or in febrile patients.
  • Intestinal Obstruction: Diarrhea in patients with an ileostomy or colostomy may signal incomplete intestinal obstruction, making continued use inappropriate.
  • Impaired Alertness: Due to the risk of drowsiness or blurred vision, engaging in activities requiring mental alertness, such as operating heavy machinery or driving, is restricted while using this medication.

Population-Specific Safety Notes

The product label includes specific safety considerations for vulnerable groups. Caution is advised when administering Levsin to nursing mothers as the drug is excreted in human milk. Elderly or debilitated patients are noted to be more susceptible to anticholinergic effects, such as confusion, and should use the medication with caution.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documents for Hyoscyamine Sulfate (Levsin) define overdose risk by the potential for severe anticholinergic toxicity, requiring immediate medical intervention.

Documented Overdose Presentations

Domain Official Regulatory Statements (Label-Derived)
Clinical Manifestations Symptoms include signs of central nervous system (CNS) stimulation, such as headache, confusion, excitement, and dizziness. Peripheral effects include dry mouth, nausea, vomiting, blurred vision, and dilated pupils (mydriasis).
Severe Outcomes Overdose may progress to CNS depression, respiratory muscle paralysis, and coma. Cardiovascular effects such as tachycardia are documented, along with potential fever and hot, dry skin.
Population-Specific Notes The risk of toxic reactions may be greater in patients with impaired renal function due to the drug’s substantial renal excretion.

Emergency Actions and Regulatory Mandates

Classification Domain Official Regulatory Statements (Label-Derived)
When immediate medical help is required Individuals must seek immediate medical attention or contact a poison control center for any suspected overdose.
Antidote and Support Management procedures explicitly documented are stomach lavage, symptomatic treatment for fever (e.g., hypothermic blanket), and the administration of Physostigmine injection to counteract central toxicity. If respiratory muscle paralysis occurs, artificial respiration must be instituted.

Connection to the overall overdose profile: Regulatory documents define the Hyoscyamine Sulfate overdose profile by the necessity of immediate action due to the life-threatening progression of anticholinergic effects across multiple physiological systems. This profile mandates that individuals must seek urgent professional assistance and dictates specific procedural steps, including gastric decontamination and the use of the centrally acting agent, Physostigmine.

Therapeutic Uses of Levsin

Levsin is commonly used to help with symptoms related to heightened physiological activity across multiple body systems and is considered relevant in contexts involving heightened systemic burden. It is generally applied in settings where additional symptomatic support is needed to address discomfort. The medication is considered relevant for easing acute discomfort and managing symptom clusters that may become intense or disruptive.

The medication is commonly used to help with symptoms that interfere with daily functioning in the gastrointestinal tract, such as in conditions like Irritable Bowel Syndrome, and symptoms linked to organ-specific functional stress in the urinary and biliary systems. It also assists with managing problems with excessive body fluids, such as drooling, sweating, and nasal discharge.

“This provides support that helps ease the overall symptom burden, particularly during episodes where symptoms become more noticeable.”

This contributes to improved comfort during symptomatic periods by addressing physical strain and helps maintain a sense of stability when symptoms interfere with routine activities.


Quick Fact: Relief for Physical Discomfort and Excessive Fluids

Regulatory References

  1. FDA DailyMed official prescribing information

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Levsin — Official Regulatory Information

The eligibility profile for Levsin (hyoscyamine sulfate) is defined by a series of official regulatory statements that prohibit or restrict its use based on a patient's existing medical conditions or physiological status.


Classification Statement
Contraindicated Populations Use is prohibited for patients with glaucoma, myasthenia gravis, unstable cardiovascular status in acute hemorrhage, and known hypersensitivity to the drug.
Contraindicated Conditions The medicine must not be used in the presence of obstructive uropathy (e.g., prostatic hypertrophy), obstructive gastrointestinal disease (e.g., paralytic ileus, toxic megacolon), intestinal atony, or severe ulcerative colitis.

Condition-Specific and Age-Related Rules

Population/Status Regulatory Status
Restricted/Conditional Use Use with caution is required for patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hypertension, renal disease, and hiatal hernia with reflux esophagitis.
Age-Group Rules Geriatric patients require cautious dose selection due to common decreases in organ function. Use in children under 12 years of age is not generally recommended for some formulations.
Pregnancy/Lactation Classified as Pregnancy Category C; the drug should be given to a pregnant woman only if clearly needed. Caution is advised for nursing mothers as the drug is excreted in human milk.

This framework ensures the medicine is restricted where its potent activity could exacerbate pre-existing conditions, defining a strict boundary for patient eligibility.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Levsin (Hyoscyamine Sulfate) identifies interactions across two primary domains: additive pharmacodynamic effects and pharmacokinetic absorption interference.

Additive Pharmacodynamic Effects

Co-administration with several classes of medications may lead to additive adverse effects resulting from intensified cholinergic blockade, as documented in regulatory labeling. Interacting categories include other antimuscarinics, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, and certain antihistamines. Specific medicines such as amantadine and haloperidol are also noted to carry this risk.

Pharmacokinetic Interference and Timing Rules

Interactions that modify drug exposure are also documented. Antacids may interfere with the absorption of Hyoscyamine Sulfate, which could decrease its overall systemic exposure. To manage this effect, official labeling includes a mandatory timing restriction: Hyoscyamine Sulfate should be administered before meals, with antacids administered after meals.

Furthermore, Hyoscyamine’s regulatory-documented effect of decreasing gastrointestinal motility and delaying gastric emptying may, in turn, decrease the absorption of other co-administered oral medications.

Substance and Population Notes

The consumption of alcohol is noted to potentially worsen certain effects, such as drowsiness. Population-specific cautions are also included, indicating an increased potential for toxic reactions in geriatric patients and those with impaired renal function due to the drug’s primary route of renal excretion.

Mechanism of Action

Receptor-Level Blockade: Antimuscarinic Action

Levsin (hyoscyamine) acts as a non-selective competitive antagonist at muscarinic acetylcholine receptors (mAChRs), including subtypes M1, M2, and M3, located on postganglionic effector cells. This molecular interaction interrupts the transmission of cholinergic signals within the peripheral parasympathetic nervous system.

Modulation of Visceral Smooth Muscle Tone

The primary mechanistic action occurs on visceral smooth muscles in the gastrointestinal (GI) and urinary tracts. By blocking the acetylcholine signals that stimulate contraction, the mechanism leads to a rapid relaxation of the muscle tone, which directly suppresses the involuntary contractions characteristic of heightened motility.

Suppression of Secretory Gland Output

Simultaneously, the blockade of mAChRs on exocrine glands regulates secretory processes, including those responsible for producing saliva, gastric acid, and sweat. This mechanistic domain results in an antisecretory physiological adjustment, leading to a reduction in the output of various bodily fluids.

Dosage and Administration Information

Levsin (Hyoscyamine Sulfate) administration is defined by its specific dosage form and approved route. Official routes include oral (for tablets, solutions, and drops), sublingual (for fast-dissolving forms), and parenteral (intramuscular, intravenous, or subcutaneous) for the injection solution. The medicine is available as 0.125 mg immediate-release (IR) tablets and 0.375 mg extended-release (ER) tablets.

The adult dosing regimen for the immediate-release forms is generally 0.125 mg to 0.25 mg per dose, which may be taken every four hours as needed, with a total daily dose not to exceed 1.5 mg. The extended-release tablets are scheduled for twice-daily dosing, approximately every twelve hours. For effective use, the extended-release tablet must be swallowed whole and should not be crushed, split, or chewed to maintain its controlled-release mechanism.

Timing of administration is crucial: oral IR and sublingual forms are directed to be taken 30 to 60 minutes prior to meals and at bedtime. Separation from antacids is recommended, as they may hinder absorption; Hyoscyamine should be taken before meals, and antacids taken after meals, or at least one hour later. Dose selection for older adults should be cautious and typically initiated at the low end of the prescribed range. Pediatric patients (ages 2 to under 12) have a specific lower maximum daily dose of 0.75 mg.

Recent Clinical Evidence

Levsin (Hyoscyamine): Recent Clinical Evidence

Research on hyoscyamine, an anticholinergic agent, has focused primarily on its antispasmodic role in gastrointestinal (GI) and urinary tract disorders. The drug functions by blocking muscarinic acetylcholine receptors, thereby reducing smooth muscle spasms and certain secretions.

Clinical Efficacy Research

Studies have investigated hyoscyamine as an adjunctive therapy for conditions characterized by functional spasms. Findings across multiple trials have explored its role in:

  • Irritable Bowel Syndrome (IBS): Meta-analyses have supported the use of antispasmodic agents, including hyoscyamine, for short-term symptomatic relief of global symptoms and abdominal pain in cohorts with IBS. Evidence generally remains limited for its long-term, continuous use.
  • Acute Spasm/Colic: Studies have examined rapid-release formulations of hyoscyamine for immediate symptom management in acute scenarios, such as biliary or renal colic, suggesting a rapid onset of effect via sublingual administration.
  • Other Indications: The medication is also investigated for use in other conditions involving spasms, including diverticulitis, pancreatitis, and certain types of bladder dysfunction.

Comparative and Safety Considerations

In comparative trials, hyoscyamine's efficacy for pain reduction has been compared to other agents, such as non-steroidal anti-inflammatory drugs (NSAIDs) for ureteral colic, with varied outcomes. Its use is limited in certain patient populations due to its anticholinergic properties.

Condition Studied Primary Research Focus General Findings (Summary)
IBS Short-term relief of pain and spasms Supported symptomatic relief in several trials.
Ureteral Colic Acute pain management Demonstrated pain reduction, but efficacy varies compared to other analgesics.

Note on Use: Due to its mechanism of action (slowing GI motility), hyoscyamine is typically not recommended for patients experiencing constipation, as this symptom may be exacerbated by anticholinergic effects.

Frequently Asked Questions (FAQ)

Common questions about Levsin (FAQ)


Q: Are there any serious side effects associated with Levsin?

A: Official labeling documents state that rare but serious adverse reactions have been reported. These include central nervous system effects such as psychosis (hallucinations and confusion). The official information also describes the documented risk of heat prostration (fever or heat stroke) due to the drug’s potential to decrease sweating, and the risk of incomplete intestinal obstruction is noted for patients with certain conditions.


Q: Does Levsin interact with over-the-counter pain relievers like ibuprofen?

A: The official product label lists several drug classes that may lead to additive adverse effects when taken with Levsin, such as antihistamines and tricyclic antidepressants. However, the official regulatory information for this drug does not explicitly detail an interaction with over-the-counter pain relievers such as ibuprofen.


Q: Can I take Levsin if I am already taking antidepressants?

A: Official documentation indicates that Levsin has known interactions with specific types of antidepressants, including tricyclic antidepressants and MAO inhibitors. Taking Levsin with these medications may lead to intensified side effects. For all other types of antidepressants, the decision regarding use is determined by the healthcare provider.


Q: What is the official recommendation regarding driving while taking Levsin?

A: Regulatory documents state that due to the potential for side effects like drowsiness, dizziness, or blurred vision, patients are officially cautioned not to engage in activities requiring mental alertness. This restriction includes operating a motor vehicle or other heavy machinery while using the medication.


Q: Does Levsin lose effectiveness over time?

A: Long-term studies on animals to determine the drug's potential for causing cancer or impairment of fertility have not been performed, according to regulatory documents. While official evidence regarding continuous effectiveness over long periods is generally limited, a history of marketing experience with hyoscyamine sulfate is noted, but the evidence regarding continuous effectiveness over long periods remains limited.


Q: Are there specific medicines that should not be taken with Levsin?

A: Yes, official documents document that combining Levsin with several drug classes carries a risk of additive side effects. These include other antimuscarinics, MAO inhibitors, phenothiazines, and tricyclic antidepressants. Additionally, official labeling includes a mandatory timing restriction for antacids, as they can interfere with Levsin's absorption.


Q: Can Levsin be crushed or chewed?

A: The extended-release tablet form is officially directed to be swallowed whole and should not be crushed, split, or chewed, because this would disrupt its controlled-release mechanism. The sublingual tablet form (Levsin SL) is designed to be dissolved under the tongue, but may also be chewed or swallowed orally as specified.


Q: What is the purpose of the extended-release version of Levsin?

A: The extended-release formulation is designed to provide a prolonged therapeutic effect. This design is intended to allow for a twice-daily dosing schedule, approximately every twelve hours, thereby aiming for a prolonged therapeutic effect.


Q: Can Levsin be used for bladder spasms?

A: Yes, official prescribing information lists Levsin as an adjunctive therapy for the treatment of certain disturbances in the urinary tract. These include conditions such as spastic bladder, cystitis, and issues related to the neurogenic bladder.


Q: What is the typical duration of action for Levsin?

A: The drug’s effect varies depending on the formulation. The standard oral and injection forms typically have a duration of action of up to 4 hours. The extended-release preparation is designed to provide effects lasting up to 12 hours.


Q: Do you take Levsin only when symptoms occur, or is it a daily medicine?

A: The usage depends on the specific formulation prescribed. Immediate-release forms are generally described as being taken 'as needed' when symptoms occur. In contrast, the extended-release tablets are scheduled for routine dosing, approximately every twelve hours.


Q: Is Levsin prescribed for children?

A: The FDA label addresses use in pediatric patients, including those ages 2 to under 12, for certain formulations. However, the label also states that the safety and effectiveness for use in all children have not been established for every dosage form.


Q: What happens if I miss a dose of Levsin?

A: Patient information provides general guidance regarding missed doses. This often includes instructions that if a dose is missed, it should be taken as soon as it is remembered, unless it is close to the time for the next scheduled dose, in which case the missed dose is typically skipped.


Q: Does taking Levsin affect how my body absorbs other medicines?

A: Yes, official documentation notes that one of Levsin’s regulatory documented effects is the potential to delay gastric emptying. This effect may, in turn, decrease the absorption of other oral medications taken at the same time.


Q: What does official research say about the long-term use of Levsin?

A: Official research and meta-analyses have supported the use of antispasmodic agents, like hyoscyamine, for short-term symptomatic relief of certain conditions. Evidence for its long-term, continuous use in specific functional disorders is noted in clinical literature as generally being limited.


Q: Are there different forms of Levsin available (e.g., tablet, liquid, extended-release)?

A: Yes, according to official product information, the medication is supplied in several dosage forms. These include standard oral tablets, fast-acting sublingual tablets (SL), extended-release (ER) tablets, and various oral solutions or drops.


Q: How is Levsin classified by official drug agencies (e.g., anticholinergic)?

A: Levsin, which contains hyoscyamine sulfate, is officially classified as a potent Anticholinergic Agent. It is also classified as a Gastrointestinal Antispasmodic, reflecting its primary therapeutic use in controlling spasms.


Q: What is the difference between Levsin and Levsin SL?

A: Levsin is the general trade name, while Levsin SL refers to the sublingual tablet form. The key difference is that the SL tablet is formulated to dissolve rapidly under the tongue for quick systemic absorption, which is designed to facilitate a faster onset of action than standard oral tablets.


Q: Why is it important to tell my doctor all the medicines I take before starting Levsin?

A: It is important due to the documented risk of drug interactions. Levsin is documented to interact with several classes of drugs, which can lead to intensified anticholinergic side effects. Additionally, Levsin can interfere with the proper absorption of other oral medicines.


Q: Is there a generic version of Levsin available?

A: Official drug classification documents confirm that Levsin (hyoscyamine sulfate) is a prescription-only medicine that is often prescribed alongside equivalent generic formulations.


Q: Do official documents mention any effects of Levsin on the central nervous system?

A: Yes, official documents list effects on the Central Nervous System (CNS) among its adverse reactions. These include symptoms like drowsiness, dizziness, confusion, and nervousness. Reports of rare, more severe CNS effects such as psychosis are also noted in sensitive individuals.


Q: Are there food restrictions when taking Levsin?

A: Regulatory documents do not list specific foods that must be restricted. However, the administration of the oral immediate-release and sublingual forms is subject to specific timing relative to meals to optimize absorption.


Q: What should I do if my symptoms get worse after starting Levsin?

A: Official safety warnings indicate that for certain patients (those with an ileostomy or colostomy), worsening symptoms like diarrhea may signal an underlying incomplete intestinal obstruction, in which case continued use is inappropriate. Generally, patients with worsening symptoms, or those who experience any new or unusual problems, should seek further guidance from a healthcare provider.


Q: Does Levsin help with nausea and vomiting?

A: Nausea and vomiting are actually listed in the official adverse reactions section as potential side effects of the medication. The drug's indicated uses primarily relate to controlling spasms and hypermotility in the gastrointestinal and urinary tracts, not the treatment of nausea and vomiting itself.


Q: How is Levsin eliminated from the body?

A: Official clinical pharmacology information indicates that Levsin is substantially excreted by the kidney (renal excretion). The majority of the drug is eliminated in the urine, either unchanged or partly modified by the body, generally within 12 hours.


Q: What do official sources say about taking Levsin with high blood pressure?

A: Official prescribing information states that Levsin must be used with caution in patients with hypertension (high blood pressure). This classification indicates that the drug’s use in this population is subject to specific precautions outlined in the label.


Q: Does Levsin affect cognitive function in the elderly?

A: Yes, the official label notes that elderly patients are often more susceptible to the anticholinergic effects of the drug. These effects can include CNS symptoms such as confusion and temporary short-term memory loss.


Q: What are the signs of a potential overdose on Levsin?

A: Signs and symptoms of an overdose, as described in official documents, may include various effects such as headache, nausea, vomiting, blurred vision, dilated pupils, dryness of the mouth, difficulty in swallowing, and CNS stimulation (such as agitation or anxiety).


Q: Does Levsin contain any common allergens like gluten or lactose?

A: The official product description for some tablet forms lists lactose monohydrate as an inactive ingredient. The primary labeling documents confirm the presence of lactose but typically do not detail the presence or absence of other common allergens like gluten.

How should Levsin be stored and disposed of?

Storage Recommendations

Levsin (hyoscyamine sulfate) should be stored securely to maintain its effectiveness and prevent accidental ingestion. Keep the medication in its original, tightly closed container and out of sight and reach of children and pets.

Store Levsin at room temperature, typically between 59 F to 86 F (15 C to 30 C). It is crucial to protect the medication from excessive moisture and heat, which means you should not store it in a bathroom.

Disposal Guidelines

Do not dispose of Levsin by flushing it down the toilet or throwing it in the trash, as this can pose environmental and health risks. Unneeded or expired Levsin should be disposed of properly through a medicine take-back program.

If a take-back program is unavailable, consult your pharmacist or local waste disposal service for guidance on the safest disposal method in your area.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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