Methscopolamine Br 2.5mg Tablets

Manufacturer BAYSHORE PHARMACEUTICALS Active Ingredient Methscopolamine(meth skoe POL a meen) Pronunciation meth skoe POL a meen
It is used to treat GI (gastrointestinal) ulcers.
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Drug Class
Anticholinergic, Antispasmodic
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Pharmacologic Class
Muscarinic Acetylcholine Receptor 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?

Methscopolamine is a medication that helps reduce stomach acid and muscle spasms in the digestive system. It's often used to treat conditions like stomach ulcers or irritable bowel syndrome by slowing down the gut and reducing secretions.
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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 medication 30 minutes before meals and at bedtime, unless your doctor has given you different instructions.

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, check with your pharmacist for guidance on the best disposal method or explore drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take this medication 30 minutes before meals and at bedtime as directed.
  • Drink plenty of fluids to help with dry mouth and prevent constipation.
  • Avoid activities requiring mental alertness, such as driving or operating machinery, until you know how this medication affects you, as it can cause blurred vision or dizziness.
  • Be cautious in hot weather or during exercise, as this medication can decrease sweating and increase the risk of heatstroke.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 2.5 mg orally 30 minutes before meals and 2.5-5 mg at bedtime
Dose Range: 2.5 - 12.5 mg

Condition-Specific Dosing:

pepticUlcer: 2.5 mg orally 30 minutes before meals and 2.5-5 mg at bedtime, maximum 10-12.5 mg/day
irritableBowelSyndrome: Individualized based on response and tolerance, typically 2.5 mg 3-4 times daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (safety and efficacy not established)
Adolescent: Not established (safety and efficacy not established)
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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.
Severe: Contraindicated or use with extreme caution; significant dose reduction likely required due to renal excretion.
Dialysis: Not well-studied; likely not dialyzable due to molecular weight. Avoid use if possible.

Hepatic Impairment:

Mild: Use with caution; monitor for increased anticholinergic effects.
Moderate: Use with caution; monitor for increased anticholinergic effects.
Severe: Use with caution; monitor for increased anticholinergic effects.

Pharmacology

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Mechanism of Action

Methscopolamine is a quaternary ammonium anticholinergic agent that competitively antagonizes the action of acetylcholine at muscarinic receptors. This leads to a reduction in gastrointestinal motility and gastric acid secretion. Due to its quaternary structure, it does not readily cross the blood-brain barrier, resulting in fewer central nervous system side effects compared to tertiary anticholinergics.
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Pharmacokinetics

Absorption:

Bioavailability: Low (poorly absorbed orally, typically <10%)
Tmax: 1-2 hours
FoodEffect: Food may delay absorption and reduce peak concentrations.

Distribution:

Vd: Not well-established, but generally limited due to quaternary structure
ProteinBinding: Not well-established
CnssPenetration: Limited

Elimination:

HalfLife: Not precisely defined, but relatively short (likely 2-4 hours for elimination phase)
Clearance: Primarily renal
ExcretionRoute: Renal (urine)
Unchanged: Significant portion (up to 50% or more of absorbed dose)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 1-2 hours
DurationOfAction: 4-6 hours
Confidence: Medium

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
Fast or abnormal heartbeat
Feeling confused
Diarrhea
Difficulty passing urine
Inability to sweat during physical activity or in warm temperatures
Muscle weakness
Severe constipation or stomach pain, which may indicate a serious bowel problem
Erectile dysfunction (inability to get or keep an erection)

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 experience any of the following side effects, or if they bother you or persist, contact your doctor:

Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Headache
Constipation
Dry mouth
Changes in taste
Upset stomach or vomiting
Bloating
Decreased sweating
Sleep disturbances
* Feeling nervous or excitable

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. 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 or persistent dry mouth
  • Significant blurred vision or eye pain
  • Inability to urinate or severe difficulty urinating
  • Severe constipation or abdominal distension
  • Fast or irregular heartbeat
  • Confusion or unusual thoughts (less common due to limited CNS penetration, but possible in sensitive individuals)
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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 and its symptoms.
Certain health conditions, including:
+ Bleeding problems
+ Bowel blockage
+ Enlarged colon
+ Glaucoma
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ Difficulty urinating
+ Ulcerative colitis

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor. Please disclose all the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Your doctor needs this information to determine the safety of taking this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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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 cause drowsiness or impair your reactions.

Be cautious when exposed to high temperatures or engaging in physical activity, as this medication can increase the risk of heat stroke.

If you need to take antacids while using this medication, discuss this with your doctor first.

If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects.

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:

  • Exaggerated anticholinergic effects: severe dry mouth, dilated pupils (mydriasis), blurred vision, hot and dry skin, fever, flushing, rapid and irregular pulse, urinary retention, constipation, central nervous system stimulation (restlessness, excitement, delirium, hallucinations, convulsions, coma in severe cases).

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and symptomatic. Physostigmine may be considered in severe cases of central anticholinergic toxicity.

Drug Interactions

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Major Interactions

  • Potassium chloride (solid oral dosage forms): Increased risk of GI lesions due to delayed GI transit.
  • Other anticholinergics (e.g., tricyclic antidepressants, antihistamines, phenothiazines, quinidine, disopyramide): Potentiation of anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation, tachycardia).
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Moderate Interactions

  • Antacids: May interfere with absorption of methscopolamine if taken concurrently (separate dosing by at least 1-2 hours).
  • Drugs requiring specific pH for absorption (e.g., ketoconazole, digoxin): Methscopolamine may alter GI transit time, potentially affecting absorption.
  • Opioid analgesics: Additive constipating effects.

Monitoring

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Baseline Monitoring

Gastrointestinal symptoms (e.g., pain, spasms)

Rationale: To assess baseline severity and monitor treatment efficacy.

Timing: Prior to initiation of therapy

Baseline vital signs (heart rate, blood pressure)

Rationale: To monitor for potential anticholinergic effects like tachycardia.

Timing: Prior to initiation of therapy

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Routine Monitoring

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

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.

Gastrointestinal symptom relief

Frequency: Periodically, to assess therapeutic response

Target: Reduction in pain/spasms

Action Threshold: Lack of efficacy may warrant re-evaluation of therapy.

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Difficulty urinating or decreased urine output
  • Constipation
  • Dizziness
  • Tachycardia (fast heart rate)
  • Headache
  • Nervousness

Special Patient Groups

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Pregnancy

Methscopolamine is classified as 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 not been conducted, and there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential risk not well-established; use only if clearly indicated.
Second Trimester: Potential risk not well-established; use only if clearly indicated.
Third Trimester: Potential risk not well-established; use only if clearly indicated. Anticholinergics near term could theoretically affect fetal heart rate or GI motility.
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Lactation

Methscopolamine is excreted in breast milk in small amounts. Anticholinergics can inhibit lactation by suppressing prolactin and reducing milk production. Use with caution in nursing mothers, and monitor the infant for anticholinergic effects (e.g., constipation, dry mouth).

Infant Risk: Low to moderate. Potential for decreased milk supply and anticholinergic effects in the infant.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.

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Geriatric Use

Elderly patients are more susceptible to the anticholinergic effects of methscopolamine, including dry mouth, constipation, urinary retention, blurred vision, and central nervous system effects (e.g., confusion, delirium). Use with caution, starting with lower doses and titrating slowly. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Methscopolamine is a quaternary ammonium compound, meaning it has limited penetration into the central nervous system, leading to fewer CNS side effects (e.g., sedation, confusion) compared to tertiary anticholinergics like scopolamine.
  • It is primarily used as adjunctive therapy for peptic ulcer disease and irritable bowel syndrome to reduce gastric acid secretion and GI motility.
  • Patients should be advised to take the medication 30 minutes before meals to optimize its effect on gastric acid secretion.
  • Common side effects are typical anticholinergic effects: dry mouth, blurred vision, constipation, and urinary retention. Patients should be educated on how to manage these.
  • Due to its renal excretion, caution is advised in patients with renal impairment, and dose adjustments may be necessary in severe cases.
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Alternative Therapies

  • Other anticholinergics/antispasmodics (e.g., dicyclomine, hyoscyamine, glycopyrrolate)
  • Proton pump inhibitors (PPIs) for peptic ulcer disease (e.g., omeprazole, pantoprazole)
  • H2-receptor antagonists (H2RAs) for peptic ulcer disease (e.g., famotidine, ranitidine)
  • Antidepressants (e.g., TCAs, SSRIs) for irritable bowel syndrome with pain predominance
  • Fiber supplements or laxatives for constipation associated with IBS
  • Antidiarrheals for diarrhea-predominant IBS
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Cost & Coverage

Average Cost: Varies widely, typically low cost per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this 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 occurred.