Hyoscyamine 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, Anticholinergic
Pharmacologic Class
Muscarinic acetylcholine receptor antagonist
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hyoscyamine is a medication that helps relax muscles in your stomach, intestines, and bladder. It works by blocking certain natural chemicals in your body that cause spasms. It's often used to relieve cramps, pain, and discomfort from conditions like irritable bowel syndrome or bladder problems.
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, ask your pharmacist for guidance.
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 medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, ask your pharmacist about the best disposal method or check if there are 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 regular schedule. Do not take two doses at the same time or 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, ask your pharmacist for guidance.
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 medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, ask your pharmacist about the best disposal method or check if there are 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 regular schedule. Do not take two doses at the same time or extra doses. If you use this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Take exactly as prescribed. Do not take more than the recommended dose.
- Place the tablet under your tongue and allow it to dissolve completely. Do not chew or swallow it whole.
- This medication can cause dry mouth; sugar-free candy or gum, or sips of water may help.
- Avoid activities requiring mental alertness, such as driving or operating machinery, until you know how this medication affects you, as it can cause dizziness or blurred vision.
- Avoid overheating in hot weather or during exercise, as this medication can decrease sweating and increase the risk of heatstroke.
- Report any severe or persistent side effects to your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
0.125 mg to 0.25 mg sublingually every 4 hours as needed
Dose Range:
0.125 - 0.25 mg
Condition-Specific Dosing:
maximumDailyDose:
Not to exceed 1.5 mg in 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for sublingual formulation; oral forms have weight-based dosing. Use with extreme caution due to increased sensitivity to anticholinergic effects.
Adolescent:
0.125 mg to 0.25 mg sublingually every 4 hours as needed, not to exceed 1.5 mg in 24 hours (similar to adult dosing, but with caution)
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, significant risk of accumulation and increased anticholinergic effects. Contraindicated in obstructive uropathy.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Use with caution, monitor for increased anticholinergic effects.
Severe:
Use with caution, monitor for increased anticholinergic effects.
Pharmacology
Mechanism of Action
Hyoscyamine is a belladonna alkaloid that acts as a non-selective muscarinic acetylcholine receptor antagonist. It competitively inhibits the action of acetylcholine at postganglionic parasympathetic neuroeffector sites, leading to a reduction in smooth muscle spasm, gastric acid secretion, and various glandular secretions (salivary, bronchial, sweat). Its effects are dose-dependent and include relaxation of smooth muscles in the gastrointestinal tract, urinary tract, and biliary tract, as well as mydriasis, cycloplegia, and increased heart rate.
Pharmacokinetics
Absorption:
Bioavailability:
High (rapid and complete from sublingual route)
Tmax:
Approximately 30-60 minutes (sublingual)
FoodEffect:
Not applicable for sublingual administration, as it bypasses GI absorption.
Distribution:
Vd:
Not available
ProteinBinding:
Not available
CnssPenetration:
Yes (crosses blood-brain barrier, leading to CNS effects at higher doses)
Elimination:
HalfLife:
Approximately 3.5 to 13 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily)
Unchanged:
Approximately 13-30% excreted unchanged in urine
Pharmacodynamics
OnsetOfAction:
Rapid (within 15-30 minutes for sublingual)
PeakEffect:
Approximately 30-60 minutes
DurationOfAction:
Approximately 4-6 hours
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 experience 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
Fast or abnormal heartbeat
Erectile dysfunction
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness
Blurred vision
Constipation
Dry mouth
Dry eyes
Headache
Nausea or vomiting
Stomach pain
Changes in taste
Feeling nervous or excitable
* Feeling full
Reporting Side Effects
This is not a comprehensive list of all possible 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 experience 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
Fast or abnormal heartbeat
Erectile dysfunction
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness
Blurred vision
Constipation
Dry mouth
Dry eyes
Headache
Nausea or vomiting
Stomach pain
Changes in taste
Feeling nervous or excitable
* Feeling full
Reporting Side Effects
This is not a comprehensive list of all possible 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 or difficulty swallowing
- Blurred vision or eye pain
- Difficulty urinating or inability to urinate
- Severe constipation
- Fast or irregular heartbeat
- Confusion, hallucinations, or unusual thoughts/behavior
- Severe dizziness or fainting
- Skin rash or itching
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
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
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
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
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, wait until you understand how this medication affects you.
Consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
There is a risk of heat stroke associated with this medication, particularly in hot weather or during physical activity. Therefore, exercise caution in these situations.
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, use this medication with caution, as you may be more susceptible to side effects.
Note that different brands of this medication may be suitable for children of varying ages. Before administering this medication to a child, consult with their doctor. Additionally, when giving this medication to a child, use it with caution, as the risk of certain side effects may be higher in this population.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
Before operating a vehicle or engaging in any activity that requires alertness and clear vision, wait until you understand how this medication affects you.
Consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
There is a risk of heat stroke associated with this medication, particularly in hot weather or during physical activity. Therefore, exercise caution in these situations.
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, use this medication with caution, as you may be more susceptible to side effects.
Note that different brands of this medication may be suitable for children of varying ages. Before administering this medication to a child, consult with their doctor. Additionally, when giving this medication to a child, use it with caution, as the risk of certain side effects may be higher in this population.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe dry mouth and throat
- Dilated pupils (large pupils)
- Blurred vision
- Flushing of the skin
- Fever
- Rapid and weak pulse
- Rapid breathing
- Dizziness
- Restlessness, excitement, nervousness
- Confusion, delirium, hallucinations
- Ataxia (loss of coordination)
- Convulsions
- Coma
- Respiratory depression
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and may include gastric lavage, activated charcoal, and physostigmine for severe anticholinergic toxicity.
Drug Interactions
Major Interactions
- Potassium chloride (solid oral dosage forms): Increased risk of GI lesions due to delayed GI transit.
- Other anticholinergics (e.g., atropine, scopolamine, dicyclomine): Additive anticholinergic effects, increasing risk of severe side effects (e.g., paralytic ileus, urinary retention, severe dry mouth, CNS toxicity).
Moderate Interactions
- Tricyclic antidepressants (TCAs): Additive anticholinergic effects.
- Phenothiazines: Additive anticholinergic effects.
- MAO inhibitors: May enhance anticholinergic effects.
- Antihistamines (H1-blockers with anticholinergic properties, e.g., diphenhydramine): Additive anticholinergic effects.
- Disopyramide: Additive anticholinergic effects.
- Amantadine: Additive anticholinergic effects.
- Antacids: May interfere with absorption if taken concurrently (separate administration by at least 1 hour).
- Drugs requiring specific pH for absorption (e.g., ketoconazole, digoxin): Hyoscyamine may alter GI motility and pH, affecting absorption.
Minor Interactions
- Opioid analgesics: May cause additive constipation and urinary retention.
Monitoring
Baseline Monitoring
Patient history (glaucoma, obstructive uropathy, GI obstruction, myasthenia gravis, cardiac conditions)
Rationale: To identify contraindications or conditions requiring caution.
Timing: Prior to initiation
Baseline vital signs (heart rate, blood pressure)
Rationale: To establish baseline and monitor for anticholinergic effects (e.g., tachycardia).
Timing: Prior to initiation
Routine Monitoring
Symptom relief (e.g., reduction in GI spasms, bladder urgency)
Frequency: Ongoing, with each dose
Target: Patient-reported improvement
Action Threshold: Lack of efficacy may require dose adjustment or alternative therapy.
Anticholinergic side effects (e.g., dry mouth, blurred vision, urinary retention, constipation, tachycardia, CNS effects)
Frequency: Regularly, especially during dose titration or initiation
Target: Minimal to tolerable side effects
Action Threshold: Severe or intolerable side effects warrant dose reduction or discontinuation.
Urinary output
Frequency: As needed, especially in patients at risk for urinary retention (e.g., BPH)
Target: Normal urinary flow
Action Threshold: Decreased output or difficulty voiding requires immediate assessment.
Symptom Monitoring
- Dry mouth
- Blurred vision
- Difficulty urinating
- Constipation
- Dizziness
- Drowsiness
- Confusion (especially in elderly)
- Palpitations or rapid heart rate
- Headache
- Nausea/vomiting
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. 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.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects, but human data are limited.
Second Trimester:
Potential for adverse effects, but human data are limited.
Third Trimester:
Potential for adverse effects, including decreased fetal heart rate variability and uterine contractions. May also affect the neonate with anticholinergic effects.
Lactation
Hyoscyamine is excreted into breast milk. It may decrease milk production due to its anticholinergic effects. Use with caution in nursing mothers. Monitor the infant for anticholinergic effects (e.g., constipation, urinary retention, sedation).
Infant Risk:
Low to moderate risk. Potential for anticholinergic effects in the infant and reduction in milk supply.
Pediatric Use
Use with extreme caution, especially in infants and young children, due to increased sensitivity to anticholinergic effects and potential for paradoxical excitement. Sublingual formulation dosing is not well-established for very young children. Overdose can be particularly dangerous in this population.
Geriatric Use
Elderly patients are more susceptible to the anticholinergic side effects of hyoscyamine, including confusion, memory impairment, hallucinations, urinary retention, and constipation. Start with the lowest effective dose and titrate slowly. Avoid use in patients with dementia or cognitive impairment. Monitor closely for CNS effects.
Clinical Information
Clinical Pearls
- Hyoscyamine sublingual offers rapid onset of action, making it suitable for acute spasm relief.
- Educate patients about common anticholinergic side effects (dry mouth, blurred vision, constipation, urinary retention) and when to seek medical attention.
- Caution patients about the risk of heat prostration due to decreased sweating, especially in hot environments or during exercise.
- In elderly patients, consider lower starting doses and monitor closely for CNS effects and urinary retention.
- This medication is for symptomatic relief and does not treat the underlying cause of the condition.
Alternative Therapies
- Antispasmodics (e.g., dicyclomine, peppermint oil for IBS)
- Antidiarrheals (e.g., loperamide)
- Laxatives (for constipation)
- Alpha-blockers (for urinary retention due to BPH)
- Beta-3 agonists (for overactive bladder)
- Tricyclic antidepressants (low dose for functional GI disorders)
- SSRIs (for functional GI disorders)
Cost & Coverage
Average Cost:
Varies, typically $10-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.