Hyoscyamine 0.125mg Oral Dis Tabs

Manufacturer KMR PHARMACEUTICALS Active Ingredient Hyoscyamine Orally Disintegrating 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
Antispasmodic, Anticholinergic
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Pharmacologic Class
Antimuscarinic
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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 used to treat various stomach, intestinal, and bladder problems by relaxing the muscles in these organs and reducing spasms. It can help with symptoms like cramping, pain, and overactive bladder. It works by blocking certain natural chemicals in your body.
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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 your dose 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 drug, consult your doctor.

To take this medication:

Place the tablet on your tongue and let it dissolve.
Some tablets can also be chewed, but check with your pharmacist if you're unsure about the correct method.

Remember not to swallow the tablet whole.

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, consult your pharmacist for guidance on the best disposal method or explore local drug take-back programs.

Missing a Dose

If you take this medication regularly and miss a dose, take it 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 extra doses. If you use this medication as needed, follow your doctor's instructions and avoid taking it more frequently than recommended.
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Lifestyle & Tips

  • Avoid activities requiring mental alertness or coordination (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.
  • Drink 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 or dental procedures.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.125 mg orally disintegrating tablet every 4 hours as needed
Dose Range: 0.125 - 0.375 mg

Condition-Specific Dosing:

maximumDailyDose: 0.75 mg in 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally not recommended for children under 2 years)
Child: Children 2-12 years: 0.0625 mg every 4 hours as needed, maximum 0.375 mg in 24 hours. Dosing may be weight-based for some formulations.
Adolescent: Adolescents >12 years: 0.125 mg every 4 hours as needed, maximum 0.75 mg in 24 hours.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor for increased anticholinergic effects.
Moderate: Use with caution; monitor for increased anticholinergic effects. Dose reduction may be necessary.
Severe: Use with extreme caution; contraindicated in some severe cases due to risk of accumulation and exaggerated anticholinergic effects.
Dialysis: Considerations: Not dialyzable. Use with extreme caution, if at all, due to potential for accumulation and adverse effects.

Hepatic Impairment:

Mild: Use with caution; monitor for increased anticholinergic effects.
Moderate: Use with caution; monitor for increased anticholinergic effects. Dose reduction may be necessary.
Severe: Use with extreme caution; contraindicated in some severe cases due to risk of accumulation and exaggerated anticholinergic effects.

Pharmacology

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Mechanism of Action

Hyoscyamine is a belladonna alkaloid that acts as a non-selective muscarinic acetylcholine receptor antagonist. It competitively blocks the action of acetylcholine at postganglionic parasympathetic neuroeffector sites, leading to inhibition of smooth muscle contraction, reduction of glandular secretions (salivary, gastric, bronchial, sweat), and relaxation of various muscles including those in the gastrointestinal tract, urinary tract, and eye. Its antispasmodic effect on the GI tract reduces motility and tone.
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Pharmacokinetics

Absorption:

Bioavailability: High (well absorbed orally)
Tmax: Approximately 30-60 minutes (for ODT formulation, may be faster)
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Not extensively reported, but widely distributed throughout the body.
ProteinBinding: Not extensively reported, generally low for similar compounds.
CnssPenetration: Yes (can cross the blood-brain barrier, leading to CNS effects)

Elimination:

HalfLife: Approximately 3.5 hours
Clearance: Not extensively reported
ExcretionRoute: Renal (urine)
Unchanged: Approximately 13-50% (excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Rapid (within 20-30 minutes for ODT)
PeakEffect: Approximately 30-60 minutes
DurationOfAction: Approximately 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
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, or if they persist or bother you, 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

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.
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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
  • Confusion, agitation, or hallucinations
  • Fast or irregular heartbeat
  • Skin rash or hives
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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 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. Do not initiate, stop, or modify the dose 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 activities that require 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.

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, planning to become pregnant, or 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
  • Dilated pupils (large pupils)
  • Blurred vision
  • Flushing (redness of skin)
  • Hot, dry skin
  • Fever
  • Rapid heartbeat (tachycardia)
  • Dizziness
  • Drowsiness or extreme tiredness
  • Restlessness, agitation, or nervousness
  • Confusion, disorientation, or hallucinations
  • Seizures
  • Loss of consciousness

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and may include activated charcoal, physostigmine (antidote for severe anticholinergic toxicity), and measures to control hyperthermia and agitation.

Drug Interactions

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Contraindicated Interactions

  • Potassium chloride (solid oral dosage forms) - increased risk of GI lesions due to delayed transit time.
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Major Interactions

  • Other anticholinergics (e.g., atropine, scopolamine, dicyclomine, tricyclic antidepressants, antihistamines, phenothiazines, quinidine, disopyramide, amantadine) - additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation, CNS effects).
  • Opioid analgesics - increased risk of severe constipation and paralytic ileus.
  • Digoxin - may increase digoxin levels due to delayed gastric emptying.
  • Ketoconazole, Itraconazole - decreased absorption of antifungals due to increased gastric pH.
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Moderate Interactions

  • Antacids - may interfere with absorption of hyoscyamine ODT; administer hyoscyamine at least 1 hour before or 2 hours after antacids.
  • Drugs that increase gastric pH (e.g., H2 blockers, PPIs) - may affect absorption of other drugs that require an acidic environment.
  • Metoclopramide - antagonistic effects (hyoscyamine decreases GI motility, metoclopramide increases it).
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Minor Interactions

  • Not specifically categorized as minor, but general caution with any drug affecting GI motility or CNS.

Monitoring

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Baseline Monitoring

Assessment of underlying condition (e.g., IBS symptoms, bladder spasm)

Rationale: To establish baseline severity and guide treatment.

Timing: Prior to initiation of therapy

Urinary function assessment (e.g., history of urinary retention)

Rationale: Hyoscyamine can exacerbate urinary retention.

Timing: Prior to initiation of therapy

Ocular examination (e.g., history of narrow-angle glaucoma)

Rationale: Hyoscyamine is contraindicated in narrow-angle glaucoma.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (symptom relief)

Frequency: Regularly during treatment, as needed

Target: Reduction in target symptoms (e.g., abdominal pain, spasms)

Action Threshold: Lack of efficacy may require dose adjustment or alternative therapy.

Anticholinergic side effects (dry mouth, blurred vision, constipation, urinary hesitancy/retention, CNS effects like confusion/drowsiness)

Frequency: Regularly during treatment, especially during dose titration

Target: Minimal to tolerable side effects

Action Threshold: Severe or intolerable side effects may require dose reduction or discontinuation.

Bowel habits

Frequency: Regularly

Target: Maintain regular bowel movements

Action Threshold: Significant constipation may require intervention or dose adjustment.

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Constipation
  • Urinary hesitancy or difficulty
  • Dizziness
  • Drowsiness
  • Confusion (especially in elderly)
  • Tachycardia
  • Flushing
  • Fever

Special Patient Groups

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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 data are limited.
Second Trimester: Potential for adverse effects, but data are limited.
Third Trimester: Potential for adverse effects, including decreased fetal heart rate variability and premature labor inhibition. May also affect the neonate with anticholinergic effects if used close to delivery.
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Lactation

Excreted into breast milk. Use with caution. May decrease milk production. Monitor infant for signs of anticholinergic effects (e.g., constipation, drowsiness, dry mouth).

Infant Risk: L3 (Moderately safe) - Possible adverse effects on the infant; use only if the potential benefit to the mother justifies the potential risk to the infant.
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Pediatric Use

Use with caution, especially in children under 2 years, as they may be more susceptible to the toxic effects of anticholinergic agents. Dosing must be carefully calculated based on age and weight. Risk of hyperthermia is increased in children.

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Geriatric Use

Increased sensitivity to anticholinergic effects (e.g., confusion, memory impairment, urinary retention, constipation, dry mouth, blurred vision). Start with lower doses and titrate slowly. Avoid in elderly patients with cognitive impairment or benign prostatic hyperplasia (BPH) with urinary retention.

Clinical Information

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Clinical Pearls

  • Hyoscyamine ODT offers rapid onset of action due to sublingual/buccal absorption, making it useful for acute spasm relief.
  • Patients should be instructed not to chew or crush the ODT, but to allow it to dissolve on the tongue.
  • Educate patients on common anticholinergic side effects and strategies to manage them (e.g., sugar-free candies/gum for dry mouth, increased fluid intake for constipation).
  • Caution patients about the risk of heatstroke due to decreased sweating, especially during exercise or in hot environments.
  • Hyoscyamine is often used as an adjunct therapy for conditions like IBS, peptic ulcer disease, and neurogenic bladder, rather than a sole treatment.
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Alternative Therapies

  • Dicyclomine (another anticholinergic antispasmodic)
  • Atropine (for specific indications)
  • Scopolamine (for specific indications, e.g., motion sickness)
  • Mebeverine (not available in US)
  • For IBS: Fiber supplements, antidiarrheals (loperamide), laxatives, tricyclic antidepressants (TCAs), SSRIs, rifaximin, lubiprostone, linaclotide, eluxadoline.
  • For overactive bladder: Oxybutynin, tolterodine, solifenacin, mirabegron.
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Cost & Coverage

Average Cost: Price varies widely by pharmacy and formulation per 30 tablets
Generic Available: Yes
Insurance Coverage: Generally Tier 1 or 2 (preferred generic) on most insurance formularies due to generic availability and long-standing use.
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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 this 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.