Hyosyne 0.125mg/5ml Elixir

Manufacturer SILARX 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
Antispasmodic, Anticholinergic
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Pharmacologic Class
Antimuscarinic, Belladonna Alkaloid
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Pregnancy 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 medicine that helps relax the muscles in your stomach, intestines, and bladder. It can reduce cramps, spasms, and pain related to conditions like irritable bowel syndrome (IBS) or bladder problems. It also helps reduce stomach acid and body secretions like saliva and sweat.
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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.
Do not take antacids at the same time as your medication. If you have questions about taking antacids with this medication, consult your doctor.

When taking the liquid form of this medication, it's essential to measure your dose accurately.
Use the measuring device that comes with your medication.
If a measuring device is not provided, ask your pharmacist for one to ensure you're taking the correct dose.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best disposal methods, as there may be drug take-back programs available 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.
If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses.

If you use this medication as needed:
Do not use it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Avoid overheating: This medication can reduce sweating, making you more prone to heatstroke, especially in hot weather or during exercise. Stay in cool places and drink plenty of fluids.
  • Avoid alcohol: Alcohol can increase drowsiness and other side effects.
  • Be cautious with activities requiring alertness: This medication can cause dizziness or blurred vision. Do not drive or operate machinery until you know how it affects you.
  • Manage dry mouth: Sip water, chew sugar-free gum, or suck on sugar-free candies.
  • Prevent constipation: Drink plenty of fluids, eat fiber-rich foods, and engage in regular physical activity.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 0.125 to 0.25 mg (5-10 mL) orally every 4 hours as needed
Dose Range: 0.125 - 0.25 mg

Condition-Specific Dosing:

maximumDailyDose: Not to exceed 1.5 mg (60 mL) in 24 hours
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Pediatric Dosing

Neonatal: Not established, generally avoided due to increased sensitivity and risk of hyperthermia.
Infant: 0.031 to 0.0625 mg (1.25-2.5 mL) orally every 4 hours as needed, not to exceed 0.375 mg (15 mL) in 24 hours.
Child: 0.0625 to 0.125 mg (2.5-5 mL) orally every 4 hours as needed, not to exceed 0.75 mg (30 mL) in 24 hours.
Adolescent: 0.125 to 0.25 mg (5-10 mL) orally every 4 hours as needed, not to exceed 1.5 mg (60 mL) in 24 hours.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, use with caution.
Moderate: Use with caution, monitor for increased anticholinergic effects; dose reduction may be necessary.
Severe: Use with extreme caution, significant dose reduction likely required or avoid due to increased sensitivity and accumulation.
Dialysis: Considerations: Not dialyzable. Use with extreme caution, monitor closely for anticholinergic effects.

Hepatic Impairment:

Mild: No specific dose adjustment, use with caution.
Moderate: Use with caution, monitor for increased anticholinergic effects.
Severe: Use with caution, monitor for increased anticholinergic effects; dose reduction may be necessary.

Pharmacology

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Mechanism of Action

Hyoscyamine is a belladonna alkaloid that functions as a competitive antagonist of muscarinic acetylcholine receptors. It inhibits the action of acetylcholine at postganglionic parasympathetic neuroeffector sites, leading to decreased smooth muscle spasm, reduced gastric acid secretion, and diminished salivary, bronchial, and sweat gland secretions. It also has effects on the heart (tachycardia) and eyes (mydriasis, cycloplegia).
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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: 2-4 L/kg
ProteinBinding: Approximately 50%
CnssPenetration: Limited at therapeutic doses, but can cross the blood-brain barrier, especially at higher doses or in sensitive individuals.

Elimination:

HalfLife: Approximately 3.5 hours
Clearance: Not readily available as a specific rate, but primarily renal elimination.
ExcretionRoute: Renal
Unchanged: 13-50% (excreted unchanged in urine)
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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
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 any other unusual 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

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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 or abdominal bloating
  • Significantly blurred vision or eye pain
  • Rapid or irregular heartbeat
  • Confusion, disorientation, or hallucinations
  • Fever or hot, dry skin (signs of heatstroke)
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
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 medications, health problems, and concerns with your doctor and pharmacist. This includes:

All 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. Never start, stop, or adjust 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 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, especially in hot weather or during physical activity. Therefore, exercise caution in these situations.

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, 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.

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
  • Hot, dry, flushed skin
  • Fever
  • Rapid and/or irregular heartbeat (tachycardia)
  • Dizziness or lightheadedness
  • Confusion
  • Agitation
  • Hallucinations
  • Seizures
  • Coma

What to Do:

If you suspect an overdose, seek immediate medical attention. Call 911 or your local emergency number. You can also contact a poison control center at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Narrow-angle glaucoma
  • Obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy)
  • Obstructive gastrointestinal disease (e.g., achalasia, pyloroduodenal stenosis)
  • Paralytic ileus
  • Intestinal atony of elderly or debilitated patients
  • Severe ulcerative colitis
  • Toxic megacolon complicating ulcerative colitis
  • Myasthenia gravis (relative contraindication, may worsen symptoms)
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Major Interactions

  • Other anticholinergics (e.g., atropine, scopolamine, dicyclomine, benztropine, trihexyphenidyl): Additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation, CNS effects).
  • Opioid analgesics: Increased risk of severe constipation and/or paralytic ileus.
  • Phenothiazines (e.g., chlorpromazine, thioridazine): Additive anticholinergic effects, increased risk of CNS depression.
  • Tricyclic antidepressants (TCAs) (e.g., amitriptyline, imipramine): Additive anticholinergic effects, increased risk of CNS depression.
  • Monoamine Oxidase Inhibitors (MAOIs): May potentiate anticholinergic effects.
  • Potassium chloride (solid oral dosage forms): Increased risk of gastrointestinal lesions due to delayed transit.
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Moderate Interactions

  • Antacids: May decrease absorption of hyoscyamine if administered concurrently. Separate administration by at least 1-2 hours.
  • Digoxin: May increase serum digoxin levels due to delayed gastric emptying.
  • Metoclopramide: Antagonizes the prokinetic effects of metoclopramide.
  • Amantadine: Additive anticholinergic effects.
  • Antihistamines (first-generation, e.g., diphenhydramine): Additive anticholinergic effects.
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Minor Interactions

  • Not many specific minor interactions; most are additive effects with other drugs possessing anticholinergic properties.

Monitoring

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Baseline Monitoring

Assessment for contraindications (e.g., glaucoma, urinary retention, GI obstruction)

Rationale: To ensure safe use and prevent serious adverse events.

Timing: Prior to initiation of therapy.

Baseline vital signs (heart rate, blood pressure)

Rationale: To establish a baseline and monitor for anticholinergic effects like tachycardia.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Symptom control (e.g., reduction in spasms, pain)

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

Target: Optimal symptom relief with minimal side effects.

Action Threshold: If symptoms persist or worsen, reassess diagnosis and treatment plan.

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

Frequency: Regularly, especially during dose titration and in vulnerable populations (elderly, children).

Target: Absence or mild, tolerable side effects.

Action Threshold: If severe or intolerable side effects occur, consider dose reduction or discontinuation.

Fluid intake and hydration status

Frequency: Regularly, especially in hot environments or with prolonged use.

Target: Adequate hydration.

Action Threshold: Signs of dehydration or heat prostration require immediate intervention.

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Dilated pupils
  • Constipation
  • Urinary hesitancy or retention
  • Tachycardia (rapid heart rate)
  • Dizziness
  • Drowsiness
  • Confusion or disorientation (especially in elderly)
  • Nausea
  • Headache
  • Nervousness
  • Decreased sweating (leading to hyperthermia)

Special Patient Groups

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Pregnancy

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, but there are no adequate and well-controlled studies in humans.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, though human data is limited. Avoid if possible.
Second Trimester: Use with caution, monitor for fetal effects.
Third Trimester: Use with caution. May inhibit uterine contractions and cause fetal tachycardia.
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Lactation

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

Infant Risk: L3 (Moderate risk). Possible risk of anticholinergic effects in the infant and potential for decreased milk supply in the mother.
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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, including hyperthermia (fever) due to suppressed sweating. Dosing must be carefully calculated based on weight/age.

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Geriatric Use

Elderly patients are more susceptible to the anticholinergic side effects of hyoscyamine, including confusion, memory impairment, urinary retention, constipation, and increased risk of falls. Use the lowest effective dose and monitor closely. Included in the Beers Criteria as a potentially inappropriate medication in older adults due to high anticholinergic burden.

Clinical Information

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Clinical Pearls

  • Hyoscyamine is often used as an adjunctive therapy for various gastrointestinal and genitourinary conditions, not as a sole treatment.
  • Patients should be advised about the potential for heat prostration (heatstroke) due to decreased sweating, especially in hot environments or during physical activity.
  • The liquid formulation allows for flexible and precise dosing, which is particularly useful in pediatric patients or those with difficulty swallowing pills.
  • Caution patients about performing tasks requiring mental alertness, such as driving or operating machinery, until they know how the medication affects them.
  • Monitor for signs of urinary retention, especially in men with prostatic hypertrophy, and constipation, particularly in the elderly.
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Alternative Therapies

  • Dicyclomine (another anticholinergic antispasmodic)
  • Mebeverine (direct smooth muscle relaxant)
  • Peppermint oil (for IBS symptoms)
  • Proton pump inhibitors (for acid reduction in peptic ulcer disease)
  • H2 receptor antagonists (for acid reduction)
  • Laxatives (for constipation, if not due to obstruction)
  • Alpha-blockers (for bladder outlet obstruction symptoms)
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Cost & Coverage

Average Cost: Varies widely, generally inexpensive per 120 mL bottle
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'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 details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.