Hyoscyamine Sulfate 0.125mg Tablets
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
Anticholinergic; Antispasmodic
Pharmacologic Class
Muscarinic Acetylcholine Receptor Antagonist
Pregnancy Category
Category C
FDA Approved
Aug 1975
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hyoscyamine is a medication that helps to relax the muscles in your stomach and intestines, reducing cramps, spasms, and pain. It also helps to dry up excess body fluids like saliva and stomach acid. It's often used for conditions like irritable bowel syndrome (IBS) or other digestive problems.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication 30 to 60 minutes before meals. It's essential to avoid taking antacids at the same time as your medication. If you have questions about taking antacids with your medication, consult your doctor 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, check with your pharmacist for the best disposal method or explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you take your 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 your medication as needed, follow your doctor's instructions and do not use it more frequently than recommended.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication 30 to 60 minutes before meals. It's essential to avoid taking antacids at the same time as your medication. If you have questions about taking antacids with your medication, consult your doctor 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, check with your pharmacist for the best disposal method or explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you take your 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 your medication as needed, follow your doctor's instructions and do not use it more frequently than recommended.
Lifestyle & Tips
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how the medication affects you, as it can cause dizziness or blurred vision.
- Avoid overheating and strenuous exercise in hot weather, as this medication can decrease sweating and increase the risk of heatstroke.
- Stay hydrated by drinking plenty of fluids to help with dry mouth and prevent constipation.
- Avoid alcohol, as it can increase drowsiness and other side effects.
- Inform your doctor or dentist that you are taking hyoscyamine before any medical procedures or surgeries.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
0.125 mg to 0.25 mg orally every 4 hours as needed
Dose Range:
0.125 - 0.25 mg
Condition-Specific Dosing:
maximumDailyDose:
1.5 mg (12 tablets of 0.125 mg)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
0.0625 mg to 0.125 mg orally every 4 hours as needed (dosing based on weight/age, consult specific product labeling)
Adolescent:
0.125 mg to 0.25 mg orally every 4 hours as needed
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for increased anticholinergic effects.
Moderate:
Use with caution, consider lower doses and extended intervals. Monitor for increased anticholinergic effects.
Severe:
Use with extreme caution or avoid. Significant risk of accumulation and exaggerated anticholinergic effects.
Dialysis:
Not well studied; likely not dialyzable. Avoid or use with extreme caution.
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. Hepatic metabolism is not the primary elimination route, but severe impairment could affect overall drug handling.
Pharmacology
Mechanism of Action
Hyoscyamine is a belladonna alkaloid that inhibits the action of acetylcholine at postganglionic parasympathetic neuroeffector sites, thereby exerting anticholinergic (antimuscarinic) effects. It competitively blocks the action of acetylcholine at muscarinic receptors, leading to decreased gastrointestinal motility and spasm, reduced gastric acid secretion, and decreased salivary and bronchial secretions. It also has effects on the heart, eyes, and urinary tract.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90-100% (oral)
Tmax:
20-60 minutes (oral tablet)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
Not precisely quantified, but widely distributed throughout the body.
ProteinBinding:
Approximately 50%
CnssPenetration:
Yes, crosses the blood-brain barrier, especially at higher doses, leading to CNS effects.
Elimination:
HalfLife:
3.5 to 13 hours (variable, average 3.5 hours for immediate release)
Clearance:
Not precisely quantified.
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 30-50% excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
20-30 minutes (oral)
PeakEffect:
1-2 hours
DurationOfAction:
4-6 hours (immediate release)
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 immediately or seek emergency 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. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 immediately or seek emergency 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. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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, difficulty swallowing or speaking
- Severe blurred vision or eye pain
- Difficulty or inability to urinate
- Severe constipation or abdominal distension
- Confusion, agitation, hallucinations, or unusual behavior
- Rapid or irregular heartbeat
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 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
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 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
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 drug 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, especially in hot weather or during physical activity. Therefore, it is crucial to 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 drug may be suitable for children of various ages. Before administering this medication to a child, consult with their doctor to ensure the correct brand and dosage are used. Additionally, when giving this drug to a child, exercise caution, as the risk of certain side effects may be higher in pediatric patients.
If you are pregnant, plan to become pregnant, or are breastfeeding, 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, ensure you understand how this drug 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, especially in hot weather or during physical activity. Therefore, it is crucial to 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 drug may be suitable for children of various ages. Before administering this medication to a child, consult with their doctor to ensure the correct brand and dosage are used. Additionally, when giving this drug to a child, exercise caution, as the risk of certain side effects may be higher in pediatric patients.
If you are pregnant, plan to become pregnant, or are breastfeeding, 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, nose, throat
- Blurred vision, dilated pupils, sensitivity to light
- Hot, dry, flushed skin
- Fever
- Rapid, weak pulse
- Difficulty urinating
- Abdominal distension, decreased bowel sounds
- Confusion, disorientation, agitation, hallucinations, delirium
- Ataxia (loss of coordination)
- Seizures
- Coma
What to Do:
Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention. Treatment is supportive and may include physostigmine for severe anticholinergic toxicity.
Drug Interactions
Major Interactions
- Other anticholinergics (e.g., atropine, scopolamine, tricyclic antidepressants, phenothiazines, antihistamines, quinidine, disopyramide): Potentiation of anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation, CNS effects).
- Opioid analgesics: Increased risk of severe constipation and paralytic ileus.
Moderate Interactions
- Antacids: May interfere with absorption of hyoscyamine; administer hyoscyamine at least 1 hour before antacids.
- Potassium chloride (solid oral dosage forms): Increased risk of GI lesions due to delayed GI transit.
- Drugs that slow GI motility (e.g., loperamide, diphenoxylate): Increased risk of severe constipation or paralytic ileus.
- MAO inhibitors: May enhance anticholinergic effects.
Monitoring
Baseline Monitoring
Baseline vital signs (heart rate, blood pressure)
Rationale: To establish a baseline and monitor for anticholinergic effects like tachycardia or orthostatic hypotension.
Timing: Prior to initiation of therapy.
Assessment for pre-existing conditions (e.g., glaucoma, prostatic hypertrophy, urinary retention, paralytic ileus)
Rationale: Hyoscyamine is contraindicated or requires extreme caution in these conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Anticholinergic side effects (dry mouth, blurred vision, constipation, urinary hesitancy/retention, tachycardia, CNS effects)
Frequency: Regularly, especially during dose titration or initiation.
Target: Minimize discomfort while achieving therapeutic effect.
Action Threshold: If severe or intolerable, consider dose reduction or discontinuation.
Bowel function
Frequency: Daily/regularly
Target: Maintain regular bowel movements.
Action Threshold: If severe constipation develops, consider laxatives or dose adjustment.
Urinary output
Frequency: Regularly
Target: Maintain adequate urinary flow.
Action Threshold: If urinary retention occurs, discontinue or reduce dose and seek medical attention.
Symptom Monitoring
- Dry mouth
- Blurred vision
- Difficulty urinating (urinary hesitancy or retention)
- Constipation
- Dizziness or lightheadedness
- Tachycardia (fast heart rate)
- Nervousness or excitement (especially in sensitive individuals or overdose)
- Headache
- Nausea/vomiting
Special Patient Groups
Pregnancy
Hyoscyamine is Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data; use only if clearly needed.
Second Trimester:
Potential for fetal harm based on animal data; use only if clearly needed.
Third Trimester:
Potential for fetal harm based on animal data; use only if clearly needed. May inhibit uterine contractions.
Lactation
Hyoscyamine is excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants (e.g., anticholinergic effects like sedation, constipation, or decreased milk production), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderate risk) - Potential for anticholinergic effects in infant (sedation, constipation, dry mouth, urinary retention). May also decrease milk supply.
Pediatric Use
Use with caution in children, especially infants and young children, as they may be more susceptible to the toxic effects of anticholinergic agents. Dosing must be carefully calculated based on weight and age. Not recommended for use in infants under 2 years of age unless specifically directed by a physician.
Geriatric Use
Geriatric patients are more likely to experience adverse anticholinergic effects (e.g., confusion, memory impairment, hallucinations, constipation, urinary retention, dry mouth, orthostatic hypotension) due to increased sensitivity. Use the lowest effective dose and monitor closely. Avoid in elderly patients with cognitive impairment or prostatic hypertrophy.
Clinical Information
Clinical Pearls
- Hyoscyamine is a potent anticholinergic; counsel patients on common side effects like dry mouth, blurred vision, and constipation.
- Advise patients to avoid activities requiring mental alertness until they know how the drug affects them.
- Warn patients about the risk of heatstroke due to decreased sweating, especially in hot environments or during exercise.
- It can be taken with or without food, but if antacids are used, take hyoscyamine at least 1 hour before.
- Often used as an 'as needed' medication for acute GI spasms rather than continuous therapy.
- Consider alternative therapies in patients with glaucoma, prostatic hypertrophy, or significant cardiac disease due to anticholinergic effects.
Alternative Therapies
- Dicyclomine (another anticholinergic/antispasmodic)
- Belladonna alkaloids (e.g., atropine, scopolamine)
- Peppermint oil (for IBS symptoms)
- Antispasmodics (e.g., mebeverine, alverine - not available in US)
- Tricyclic antidepressants (low dose for IBS pain modulation)
- SSRIs (for IBS with anxiety/depression)
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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.