Hyoscyamine 0.125mg Tablets

Manufacturer NOBLE PHARMACEUTICALS Active Ingredient Hyoscyamine Tablets(hye oh SYE a meen) Pronunciation hye oh SYE a meen
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.
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Drug Class
Anticholinergic, Antispasmodic
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Pharmacologic Class
Muscarinic Antagonist
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Hyoscyamine is a medication that helps to relax the muscles in your stomach and intestines, and reduce the amount of acid and other fluids your body produces. It's used to treat conditions like irritable bowel syndrome (IBS), stomach cramps, and other digestive problems.
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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 local drug take-back programs.

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, be sure not to use it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Avoid overheating in hot weather or during exercise, as this medication can decrease sweating and increase body temperature.
  • Stay well-hydrated to help manage dry mouth and prevent constipation.
  • Avoid alcohol, as it can worsen side effects like dizziness and drowsiness.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause blurred vision or dizziness.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.125 mg to 0.25 mg (1 to 2 tablets) orally every 4 hours as needed
Dose Range: 0.125 - 0.25 mg

Condition-Specific Dosing:

Maximum Daily Dose: Not to exceed 1.5 mg in 24 hours
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Pediatric Dosing

Neonatal: Not established (generally avoided)
Infant: Not established (generally avoided, use with extreme caution if necessary, weight-based dosing)
Child: Children 2 to 12 years: 0.0625 mg to 0.125 mg orally every 4 hours as needed, not to exceed 0.75 mg in 24 hours
Adolescent: Adolescents 12 years and older: Same as adult dosing
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Dose Adjustments

Renal Impairment:

Mild: Use with caution, monitor for increased side effects
Moderate: Use with caution, consider lower doses and extended intervals, monitor closely
Severe: Use with caution, significant dose reduction may be necessary, monitor closely for toxicity
Dialysis: Not well-studied, likely not dialyzable due to protein binding and volume of distribution; use with extreme caution and monitor for anticholinergic effects

Hepatic Impairment:

Mild: Use with caution
Moderate: Use with caution, consider lower doses
Severe: Use with caution, consider lower doses, monitor closely

Pharmacology

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Mechanism of Action

Hyoscyamine is a belladonna alkaloid that acts as a competitive antagonist at muscarinic acetylcholine receptors. It inhibits the action of acetylcholine at postganglionic parasympathetic neuroeffector sites, leading to decreased gastrointestinal motility and secretions, relaxation of smooth muscle, and dilation of pupils. Its antispasmodic effects are due to direct action on smooth muscle and inhibition of parasympathetic stimulation.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90-100%
Tmax: 30-60 minutes (oral)
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Approximately 2-4 L/kg
ProteinBinding: Approximately 50%
CnssPenetration: Yes (crosses blood-brain barrier)

Elimination:

HalfLife: Approximately 3.5-13 hours (highly variable)
Clearance: Primarily renal clearance
ExcretionRoute: Renal (urine)
Unchanged: Approximately 50-70%
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Pharmacodynamics

OnsetOfAction: 20-30 minutes (oral)
PeakEffect: 1-2 hours
DurationOfAction: 4-6 hours

Safety & Warnings

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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
Lack of sweating 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 experience no side effects or only mild ones. If you notice any of the following side effects, or if they bother you or persist, contact your doctor:

Dizziness, drowsiness, fatigue, or 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dry mouth that interferes with speaking or swallowing
  • Difficulty urinating or inability to urinate
  • Severe constipation
  • Blurred vision or eye pain, especially with redness around the eyes (could be a sign of glaucoma)
  • Rapid or irregular heartbeat
  • Confusion, agitation, or hallucinations
  • Skin rash or allergic reaction
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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 obstruction
+ Bleeding disorders
+ Diarrhea
+ Enlarged colon
+ Glaucoma
+ Heart problems
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ Abnormalities of the esophagus
+ Ulcerative colitis
+ Urinary retention or difficulty passing urine

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 and 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. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.
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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, using marijuana or other cannabis products, or taking 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 drug.

To manage dry mouth, practice good oral hygiene, suck on sugar-free hard candies, or chew 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. Before administering this drug 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 pediatric patients.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe dry mouth and throat
  • Dilated pupils (large pupils)
  • Blurred vision
  • Hot, dry, flushed skin
  • Fever
  • Rapid and weak pulse
  • Rapid breathing
  • Dizziness, staggering, or clumsiness
  • Confusion, disorientation, agitation, or excitement
  • Hallucinations
  • Seizures
  • Coma

What to Do:

If you suspect an overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and may include gastric lavage, activated charcoal, and in severe cases, physostigmine as an antidote.

Drug Interactions

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Contraindicated Interactions

  • Other anticholinergics (additive effects)
  • Potassium chloride (wax matrix formulations - increased risk of GI lesions)
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Major Interactions

  • Opioids (additive constipation, urinary retention)
  • Tricyclic antidepressants (additive anticholinergic effects)
  • Phenothiazines (additive anticholinergic effects)
  • Monoamine Oxidase Inhibitors (MAOIs) (additive anticholinergic effects)
  • Amantadine (additive anticholinergic effects)
  • Disopyramide (additive anticholinergic effects)
  • Quinidine (additive anticholinergic effects)
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Moderate Interactions

  • Antacids (may decrease absorption if taken concurrently; administer hyoscyamine before meals and antacids after meals)
  • Adsorbent antidiarrheals (e.g., kaolin-pectin, attapulgite - may decrease absorption of hyoscyamine)
  • Metoclopramide (antagonistic effect on GI motility)
  • Nitrates/Nitrites (may enhance hypotensive effects)
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Minor Interactions

  • Not many specific minor interactions beyond general additive effects with other drugs that have anticholinergic properties.

Monitoring

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Baseline Monitoring

Gastrointestinal symptoms

Rationale: To assess baseline severity and monitor treatment efficacy.

Timing: Prior to initiation of therapy

Urinary function

Rationale: To assess for pre-existing urinary retention or prostatic hypertrophy, which are contraindications or require caution.

Timing: Prior to initiation of therapy

Ocular pressure (if risk factors for glaucoma)

Rationale: Anticholinergics can precipitate acute narrow-angle glaucoma.

Timing: Prior to initiation of therapy

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Routine Monitoring

Anticholinergic side effects (e.g., dry mouth, blurred vision, urinary retention, constipation, tachycardia)

Frequency: Regularly, especially during dose titration and initial therapy

Target: Minimize to tolerable levels

Action Threshold: If severe or persistent, consider dose reduction or discontinuation

Effectiveness of symptom control

Frequency: Ongoing, as needed

Target: Reduction in GI spasms/pain

Action Threshold: If symptoms persist or worsen, re-evaluate diagnosis or treatment plan

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Urinary hesitancy or retention
  • Constipation
  • Tachycardia (rapid heartbeat)
  • Dizziness
  • Confusion or disorientation (especially in elderly)
  • Eye pain or redness (signs of acute glaucoma)

Special Patient Groups

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Pregnancy

Hyoscyamine is Pregnancy Category C. It should be used during pregnancy 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.

Trimester-Specific Risks:

First Trimester: Potential for fetal tachycardia; use with caution.
Second Trimester: Potential for fetal tachycardia; use with caution.
Third Trimester: Potential for fetal tachycardia; use with caution. May inhibit uterine contractions.
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Lactation

Hyoscyamine is excreted into breast milk. Use with caution in nursing mothers. It may cause anticholinergic effects in the infant (e.g., sedation, constipation) and may decrease milk production.

Infant Risk: Low to moderate risk. Monitor infant for signs of anticholinergic effects (e.g., drowsiness, constipation, dry mouth) and monitor maternal milk supply.
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Pediatric Use

Use with caution, especially in 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 for younger children. Not recommended for infants under 2 years unless specifically directed by a physician.

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Geriatric Use

Elderly patients are more susceptible to the anticholinergic side effects of hyoscyamine, including confusion, disorientation, urinary retention, constipation, and increased risk of falls. Start with lower doses and titrate carefully. Avoid in elderly patients with cognitive impairment or prostatic hypertrophy.

Clinical Information

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Clinical Pearls

  • Hyoscyamine can cause significant dry mouth; advise patients to use sugar-free candies, gum, or artificial saliva.
  • Patients should be warned about potential blurred vision and dizziness, and advised to avoid driving or operating machinery until they know how the medication affects them.
  • Contraindicated in patients with narrow-angle glaucoma, myasthenia gravis, paralytic ileus, toxic megacolon, obstructive uropathy (e.g., prostatic hypertrophy), and severe ulcerative colitis.
  • Often used as an adjunctive therapy for functional bowel disorders rather than a sole treatment.
  • Advise patients to take hyoscyamine before meals if they are also taking antacids, as antacids can interfere with absorption.
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Alternative Therapies

  • Dicyclomine (another anticholinergic antispasmodic)
  • Atropine (another anticholinergic)
  • Scopolamine (another anticholinergic)
  • Belladonna alkaloids (e.g., belladonna extract)
  • Mebeverine (direct smooth muscle relaxant)
  • Alverine (direct smooth muscle relaxant)
  • Peppermint oil (natural antispasmodic for IBS)
  • Tricyclic antidepressants (low dose for visceral pain in IBS)
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Cost & Coverage

Average Cost: Varies, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet; consult with your pharmacist to determine if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with 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 detailed information, including the name of the medication taken, the quantity, and the time it was taken.