Levsin 0.125mg Sublingual Tabs
It is used to slow the speed in the stomach and GI (gastrointestinal) tract.It is used to treat diarrhea.It is used to treat GI (gastrointestinal) ulcers.It is used to treat irritable bowel syndrome.It is used to treat muscle spasms of the GI (gastrointestinal) tract, gallbladder system, or urinary system.It is used to treat a runny nose.It is used to treat Parkinson's disease.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antispasmodic
Pharmacologic Class
Anticholinergic; Muscarinic Antagonist
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hyoscyamine is a medication used to treat various stomach and intestinal problems, such as cramps, spasms, and irritable bowel syndrome. It works by relaxing the muscles in your digestive system and reducing the amount of acid and other fluids your body makes. The sublingual tablet dissolves quickly under your tongue for fast relief.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication 30 to 60 minutes before meals. It's essential to avoid taking antacids at the same time as this medication. If you have questions about taking antacids with this medication, consult your doctor.
To take the medication, place the tablet under your tongue and let it dissolve. Some tablets can also be chewed or swallowed whole. If you're unsure about the best way to take your medication, check with your pharmacist.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.
Missing a Dose
If you take this medication regularly, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal schedule. Do not take two doses at the same time or take extra doses. If you use this medication as needed, do not take it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication 30 to 60 minutes before meals. It's essential to avoid taking antacids at the same time as this medication. If you have questions about taking antacids with this medication, consult your doctor.
To take the medication, place the tablet under your tongue and let it dissolve. Some tablets can also be chewed or swallowed whole. If you're unsure about the best way to take your medication, check with your pharmacist.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.
Missing a Dose
If you take this medication regularly, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal schedule. Do not take two doses at the same time or take extra doses. If you use this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Stay hydrated to help with dry mouth.
- Avoid activities requiring mental alertness (e.g., driving) until you know how the medication affects you, as it can cause dizziness or drowsiness.
- Be cautious in hot weather or during exercise, as this medication can reduce sweating and increase the risk of heatstroke.
- Avoid alcohol, as it can increase drowsiness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.125 mg sublingually every 4 hours as needed
Dose Range:
0.125 - 0.25 mg
Condition-Specific Dosing:
maximumDailyDose:
1.5 mg (12 tablets) in 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Dosing should be individualized based on weight and response, typically 0.031-0.0625 mg every 4 hours as needed, not to exceed 0.75 mg/24 hours for children 2-12 years.
Adolescent:
0.125 mg sublingually every 4 hours as needed, not to exceed 1.5 mg/24 hours.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for increased anticholinergic effects.
Moderate:
Use with caution, monitor for increased anticholinergic effects. Consider lower doses or extended intervals.
Severe:
Use with extreme caution or avoid due to increased risk of adverse effects and accumulation.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific adjustment recommended, monitor for increased anticholinergic effects.
Moderate:
Use with caution, monitor for increased anticholinergic effects. Consider lower doses or extended intervals.
Severe:
Use with extreme caution or avoid due to increased risk of adverse effects and accumulation.
Confidence:
Medium
Pharmacology
Mechanism of Action
Hyoscyamine is a belladonna alkaloid that acts as a competitive antagonist of acetylcholine at peripheral muscarinic receptors. It inhibits the muscarinic actions of acetylcholine on smooth muscles, secretory glands, and the central nervous system. This leads to decreased gastrointestinal motility and spasm, reduced gastric acid secretion, and decreased salivary and bronchial secretions.
Pharmacokinetics
Absorption:
Bioavailability:
High (rapid and complete after sublingual administration)
Tmax:
15-30 minutes (sublingual)
FoodEffect:
Not significantly affected by food for sublingual formulation, as it bypasses GI absorption.
Distribution:
Vd:
Not available (widely distributed throughout the body)
ProteinBinding:
Not available (low to moderate)
CnssPenetration:
Limited at therapeutic doses, but can cross the blood-brain barrier, especially at higher doses or in sensitive individuals, leading to CNS effects.
Elimination:
HalfLife:
3.5-13 hours (highly variable)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as unchanged drug and metabolites)
Unchanged:
Approximately 13-50% (variable)
Pharmacodynamics
OnsetOfAction:
5-20 minutes (sublingual)
PeakEffect:
30-60 minutes
DurationOfAction:
4-6 hours
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Diarrhea
Confusion
Mood changes
Changes in behavior
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Trouble sleeping
Changes in speech
Changes in balance
Changes in eyesight, eye pain, or severe eye irritation
Difficulty urinating
Inability to sweat during physical activity or in warm temperatures
Fever
Flushing
Abnormal or rapid heartbeat
Erectile dysfunction
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Constipation
Dry mouth
Dry eyes
Headache
Nausea or vomiting
Stomach pain
Changes in taste
Nervousness or excitability
Feeling full or bloated
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Diarrhea
Confusion
Mood changes
Changes in behavior
Hallucinations (seeing or hearing things that are not there)
Memory problems or loss
Trouble sleeping
Changes in speech
Changes in balance
Changes in eyesight, eye pain, or severe eye irritation
Difficulty urinating
Inability to sweat during physical activity or in warm temperatures
Fever
Flushing
Abnormal or rapid heartbeat
Erectile dysfunction
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Constipation
Dry mouth
Dry eyes
Headache
Nausea or vomiting
Stomach pain
Changes in taste
Nervousness or excitability
Feeling full or bloated
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dry mouth that interferes with speaking or swallowing
- Severe blurred vision or eye pain
- Difficulty or inability to urinate
- Severe constipation
- Fast or irregular heartbeat
- Confusion, hallucinations, or unusual thoughts/behavior
- Skin rash or hives
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bowel blockage
+ Bleeding problems
+ Diarrhea
+ Enlarged colon
+ Glaucoma
+ Heart problems
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ Abnormalities of the esophagus
+ Ulcerative colitis
+ Difficulty urinating
Please note that this list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, inform your doctor and pharmacist about all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Bowel blockage
+ Bleeding problems
+ Diarrhea
+ Enlarged colon
+ Glaucoma
+ Heart problems
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ Abnormalities of the esophagus
+ Ulcerative colitis
+ Difficulty urinating
Please note that this list is not exhaustive, and it is crucial to discuss all your health problems with your doctor.
Additionally, inform your doctor and pharmacist about all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in any activity that requires alertness and clear vision, ensure you understand how this medication affects you.
Consult your doctor before consuming alcohol, marijuana, or other cannabis products, as well as prescription or over-the-counter medications that may impair your reactions.
Be cautious of heat stroke, particularly in hot weather or during physical activity, as this condition has been reported in individuals taking this medication.
To manage dry mouth, practice good oral hygiene, and consider sucking on hard, sugar-free candy or chewing sugar-free gum. Regular dental check-ups are also recommended.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
Note that different brands of this medication may be suitable for children of various ages. Therefore, it is crucial to consult with your doctor before administering this medication to a child. Additionally, when using this medication in children, be aware that the risk of certain side effects may be increased.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
Before operating a vehicle or engaging in any activity that requires alertness and clear vision, ensure you understand how this medication affects you.
Consult your doctor before consuming alcohol, marijuana, or other cannabis products, as well as prescription or over-the-counter medications that may impair your reactions.
Be cautious of heat stroke, particularly in hot weather or during physical activity, as this condition has been reported in individuals taking this medication.
To manage dry mouth, practice good oral hygiene, and consider sucking on hard, sugar-free candy or chewing sugar-free gum. Regular dental check-ups are also recommended.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
Note that different brands of this medication may be suitable for children of various ages. Therefore, it is crucial to consult with your doctor before administering this medication to a child. Additionally, when using this medication in children, be aware that the risk of certain side effects may be increased.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe dry mouth and throat
- Dilated pupils (large pupils)
- Blurred vision
- Flushing and hot, dry skin
- Fever
- Rapid and weak pulse
- Rapid breathing
- Dizziness, staggering, or unsteadiness
- Confusion, disorientation, hallucinations
- Excitement, nervousness, restlessness
- Seizures
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment may involve activated charcoal, gastric lavage, and supportive care. Physostigmine may be used as an antidote in severe cases.
Drug Interactions
Major Interactions
- Potassium chloride (solid dosage forms): Increased risk of GI lesions due to delayed GI transit.
- Other anticholinergics (e.g., atropine, scopolamine, tricyclic antidepressants, phenothiazines, antihistamines): Additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation, CNS effects).
Moderate Interactions
- Opioid analgesics: May cause severe constipation and/or paralytic ileus due to additive effects on GI motility.
- Antacids: May interfere with absorption of hyoscyamine; administer hyoscyamine at least 1 hour before antacids.
- Drugs that prolong QT interval: Theoretical risk of additive QT prolongation, though not a primary effect of hyoscyamine.
- Drugs that affect gastric emptying (e.g., metoclopramide, domperidone): Hyoscyamine may antagonize their effects.
Monitoring
Baseline Monitoring
Baseline symptoms (e.g., abdominal pain, spasm)
Rationale: To assess efficacy of treatment.
Timing: Prior to initiation of therapy
Assessment for contraindications (e.g., glaucoma, prostatic hypertrophy, myasthenia gravis)
Rationale: To prevent serious adverse events.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (symptom relief)
Frequency: Ongoing, as needed
Target: Reduction in target symptoms (e.g., abdominal pain, spasm)
Action Threshold: Lack of efficacy may require dose adjustment or alternative therapy.
Anticholinergic adverse effects (e.g., dry mouth, blurred vision, urinary retention, constipation, tachycardia, CNS effects)
Frequency: Ongoing, with each dose
Target: Absence or mild, tolerable effects
Action Threshold: Severe or intolerable effects require dose reduction or discontinuation.
Symptom Monitoring
- Dry mouth
- Blurred vision
- Difficulty urinating (urinary retention)
- Constipation
- Dizziness
- Drowsiness
- Headache
- Nervousness
- Tachycardia (fast heart rate)
- Palpitations
- Flushing
- Photophobia (sensitivity to light)
Special Patient Groups
Pregnancy
Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Use only if clearly needed and the benefit outweighs the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental effects, though human data are limited.
Second Trimester:
Potential for anticholinergic effects on the fetus (e.g., decreased fetal heart rate variability, decreased fetal movement).
Third Trimester:
Potential for anticholinergic effects on the fetus and neonate (e.g., paralytic ileus, urinary retention, tachycardia).
Lactation
Hyoscyamine is excreted into breast milk. It can decrease milk production due to its anticholinergic effects. Use with caution. Monitor the infant for anticholinergic effects (e.g., drowsiness, constipation, dry mouth).
Infant Risk:
Moderate risk (L3). Potential for anticholinergic effects in the infant and reduction in milk supply.
Pediatric Use
Use with caution, especially in infants and young children, as they may be more susceptible to the toxic effects of anticholinergics. Dosing must be carefully individualized and monitored. Not recommended for neonates or infants due to lack of established safety and efficacy.
Geriatric Use
Elderly patients are more susceptible to the anticholinergic adverse effects of hyoscyamine, including dry mouth, constipation, urinary retention, blurred vision, and CNS effects (e.g., confusion, delirium). Use lower doses and titrate slowly. Avoid in elderly patients with cognitive impairment or those at high risk for falls.
Clinical Information
Clinical Pearls
- Sublingual formulation provides rapid onset of action, useful for acute spasms.
- Advise patients to let the tablet dissolve completely under the tongue and not to chew or swallow it whole.
- Warn patients about potential anticholinergic side effects, especially dry mouth, blurred vision, and urinary retention.
- Caution patients about heat intolerance due to decreased sweating.
- Hyoscyamine can worsen symptoms in patients with glaucoma, prostatic hypertrophy, or myasthenia gravis; it is generally contraindicated in these conditions.
- Monitor for signs of central anticholinergic syndrome, especially in overdose or sensitive individuals.
Alternative Therapies
- Dicyclomine (another anticholinergic antispasmodic)
- Peppermint oil (for IBS symptoms)
- Fiber supplements (for IBS-C)
- Loperamide (for IBS-D)
- Tricyclic antidepressants (low dose for IBS pain)
- SSRIs (for IBS with anxiety/depression)
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.