Hyoscyamine Sul 0.125/ml Or Drp20ml

Manufacturer CHARTWELL RX Active Ingredient Hyoscyamine Liquid(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 is used to treat infant belly pain.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, intestines, and bladder. It can reduce spasms, cramping, and pain, and also decrease stomach acid and other body secretions. It's often used for conditions like irritable bowel syndrome (IBS) or bladder spasms.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, take it exactly as directed by your doctor. 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 also important to avoid taking antacids at the same time as your medication. If you have questions about taking antacids with your medication, be sure to ask your doctor. When taking the liquid form of this medication, measure your dose carefully using the measuring device that comes with it. If you don't have a measuring device, ask your pharmacist for one.

Storing and Disposing of Your Medication

To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.

What to Do If You Miss a Dose

If you take your medication on a regular schedule, 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 return to your regular schedule. Do not take two doses at the same time or take extra doses. If you take your medication as needed, do not use it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how this medication affects you, as it can cause drowsiness or blurred vision.
  • Avoid alcohol, as it can increase drowsiness.
  • Stay hydrated to help manage dry mouth and prevent constipation.
  • Be cautious in hot weather or during exercise, as this medication can reduce sweating and increase the risk of heat stroke.
  • Inform your doctor or dentist that you are taking hyoscyamine before any medical procedures.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

maximumDailyDose: Not to exceed 1.5 mg (12 mL) in 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: 0.033 mg to 0.0625 mg (0.26 mL to 0.5 mL) orally every 4 hours as needed, not to exceed 0.75 mg (6 mL) in 24 hours (for infants under 2 years)
Child: 0.0625 mg to 0.125 mg (0.5 mL to 1 mL) orally every 4 hours as needed, not to exceed 0.75 mg (6 mL) in 24 hours (for children 2 to 12 years)
Adolescent: 0.125 mg to 0.25 mg (1 mL to 2 mL) orally every 4 hours as needed, not to exceed 1.5 mg (12 mL) in 24 hours (for adolescents 12 years and older)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor for increased anticholinergic effects.
Moderate: Use with caution; consider dose reduction and monitor closely for increased anticholinergic effects.
Severe: Use with caution; consider significant dose reduction and monitor closely for increased anticholinergic effects. Contraindicated in severe renal disease if urinary retention is a risk.
Dialysis: Not specifically studied; likely not dialyzable due to protein binding and volume of distribution. Use with extreme caution.

Hepatic Impairment:

Mild: Use with caution; monitor for increased anticholinergic effects.
Moderate: Use with caution; consider dose reduction and monitor closely for increased anticholinergic effects.
Severe: Use with caution; consider significant dose reduction and monitor closely for increased anticholinergic effects.

Pharmacology

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Mechanism of Action

Hyoscyamine is a belladonna alkaloid that acts as a competitive antagonist of acetylcholine at peripheral muscarinic receptors. It inhibits the action of acetylcholine on smooth muscles, secretory glands, and the central nervous system. Its anticholinergic effects lead to decreased gastrointestinal motility and secretions, relaxation of smooth muscles in the urinary tract and gallbladder, and reduction of salivary, bronchial, and sweat gland secretions.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Not readily available, 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: Approximately 3.5 hours
Clearance: Not readily available
ExcretionRoute: Renal (urine)
Unchanged: 13-30%
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Pharmacodynamics

OnsetOfAction: 20-30 minutes (oral)
PeakEffect: 30-60 minutes
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
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 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 bother 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

Reporting Side Effects

This is not an exhaustive list of 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe constipation or inability to pass stool
  • Difficulty urinating or inability to urinate
  • Severe blurred vision or eye pain
  • Confusion, hallucinations, or unusual thoughts/behavior
  • Fast or irregular heartbeat
  • Severe dizziness or fainting
  • Skin rash or itching
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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. Describe the allergic reaction you experienced, including the 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

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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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, 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. Exercise caution and take necessary precautions to stay cool.

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 various ages. Before administering this medication to a child, consult with their doctor to ensure the correct brand and dosage are used.

When giving this medication 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 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, nose, throat
  • Dilated pupils, blurred vision
  • Hot, dry skin
  • Fever
  • Rapid, weak pulse
  • Rapid breathing
  • Dizziness, staggering
  • Confusion, disorientation, hallucinations
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Overdose treatment may involve gastric lavage, activated charcoal, and physostigmine as an antidote.

Drug Interactions

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Contraindicated Interactions

  • Potassium chloride (solid dosage forms) - increased risk of GI lesions due to slowed motility.
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Major Interactions

  • Other anticholinergics (e.g., atropine, scopolamine, dicyclomine, tricyclic antidepressants, antihistamines, phenothiazines, quinidine, disopyramide, amantadine) - increased risk of additive anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation, CNS effects).
  • Opioid analgesics - increased risk of severe constipation and paralytic ileus.
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Moderate Interactions

  • Antacids - may decrease absorption of hyoscyamine if given concurrently; separate administration by at least 1 hour.
  • Digoxin - hyoscyamine may increase digoxin absorption due to slowed GI motility, potentially leading to digoxin toxicity.
  • Ketoconazole - hyoscyamine may decrease absorption of ketoconazole due to increased gastric pH.
  • Metoclopramide - antagonistic effects on GI motility.
  • Nitrates/Nitrites - may enhance hypotensive effects.

Monitoring

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Baseline Monitoring

Baseline GI symptoms (e.g., pain, cramping, diarrhea, constipation)

Rationale: To assess efficacy and differentiate drug effects from underlying condition.

Timing: Prior to initiation of therapy

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

Rationale: To identify risk factors for urinary retention, a common anticholinergic side effect.

Timing: Prior to initiation of therapy

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

Rationale: To identify contraindications or risk factors for acute angle-closure glaucoma.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy of symptom control (e.g., reduction in GI spasms, pain)

Frequency: Regularly, based on patient's condition and response

Target: Symptom improvement

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

Anticholinergic side effects (e.g., dry mouth, blurred vision, constipation, urinary retention, tachycardia, CNS effects like confusion/drowsiness)

Frequency: Regularly, 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: Daily/weekly

Target: Regular bowel movements

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

Urinary output/symptoms

Frequency: Daily

Target: Normal urination pattern

Action Threshold: Difficulty urinating or urinary retention requires immediate medical attention.

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Constipation
  • Urinary retention
  • Tachycardia
  • Dizziness
  • Drowsiness
  • Confusion (especially in elderly)
  • Headache
  • Nausea/vomiting
  • Nervousness
  • Palpitations

Special Patient Groups

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Pregnancy

Hyoscyamine is classified as 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; use with caution.
Third Trimester: Potential for fetal harm; use with caution. May inhibit uterine contractions and cause fetal tachycardia.
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Lactation

Hyoscyamine is excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants (e.g., sedation, anticholinergic effects like dry mouth, constipation, urinary retention), 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: Moderate to High (L3-L4). Potential for infant sedation, decreased milk supply, and anticholinergic effects.
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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. Paradoxical excitement may occur in children. Dosing must be carefully calculated based on age/weight.

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Geriatric Use

Elderly patients are more likely to experience anticholinergic side effects, particularly CNS effects (confusion, delirium, memory impairment), urinary retention, and constipation. Start with lower doses and titrate slowly. Avoid in elderly patients with cognitive impairment or benign prostatic hyperplasia (BPH) due to increased risk of urinary retention.

Clinical Information

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Clinical Pearls

  • Administer 30-60 minutes before meals for optimal effect on GI spasms.
  • Can be given sublingually for faster onset of action, though this formulation is oral drops.
  • Advise patients about potential for dry mouth; suggest sugar-free candy or gum.
  • Monitor for signs of heat prostration (fever, heat stroke) in hot environments, as hyoscyamine can inhibit sweating.
  • Caution patients about blurred vision and drowsiness, especially when driving or operating machinery.
  • Not effective for pain caused by organic disease unless it is due to spasm.
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Alternative Therapies

  • For Irritable Bowel Syndrome (IBS): Fiber supplements, peppermint oil, tricyclic antidepressants (TCAs), SSRIs, rifaximin, lubiprostone, linaclotide, eluxadoline.
  • For Bladder Spasms: Oxybutynin, tolterodine, solifenacin (other anticholinergics with more bladder selectivity).
  • For Peptic Ulcer Disease: Proton pump inhibitors (PPIs), H2-receptor antagonists, antacids.
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Cost & Coverage

Average Cost: Varies, typically $20-$50 per 20 mL bottle (0.125 mg/mL)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.