Methscopolamine Br 5mg Tablets

Manufacturer BAYSHORE Active Ingredient Methscopolamine(meth skoe POL a meen) Pronunciation meth-skoe-POL-a-meen BROE-mide
It is used to treat GI (gastrointestinal) ulcers.
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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
Jul 1951
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Methscopolamine bromide is a medication used to reduce stomach acid and slow down the movement of your gut. It helps relieve symptoms like stomach pain, cramping, and excessive acid production often associated with conditions like peptic ulcers or irritable bowel syndrome.
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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, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are drug take-back programs available in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is 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 a missed one.
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Lifestyle & Tips

  • Take this medication 30 minutes before meals and at bedtime for best results.
  • Drink plenty of water and increase fiber intake to help prevent constipation, a common side effect.
  • Avoid activities requiring mental alertness, such as driving or operating machinery, until you know how this medication affects you, as it can cause dizziness or blurred vision.
  • Avoid alcohol, as it can increase drowsiness.
  • Inform your doctor or dentist that you are taking this medication before any procedures, as it can affect certain tests or other medications.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 2.5 to 5 mg orally 30 minutes before meals and at bedtime
Dose Range: 10 - 20 mg

Condition-Specific Dosing:

pepticUlcer: 2.5 to 5 mg orally 30 minutes before meals and at bedtime
irritableBowelSyndrome: 2.5 to 5 mg orally 30 minutes before meals and at bedtime
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not recommended for children under 12 years of age
Adolescent: Not established (generally not recommended under 12)
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Dose Adjustments

Renal Impairment:

Mild: Adjustment needed (monitor for increased anticholinergic effects)
Moderate: Dose reduction recommended (e.g., 50% of standard dose), monitor closely
Severe: Use with extreme caution or avoid due to increased risk of toxicity
Dialysis: Not well-studied; likely not dialyzable due to molecular weight and protein binding. Avoid or use with extreme caution.

Hepatic Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended (minimal hepatic metabolism)
Severe: No specific adjustment recommended (minimal hepatic metabolism)

Pharmacology

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Mechanism of Action

Methscopolamine bromide is a quaternary ammonium anticholinergic agent that competitively antagonizes the action of acetylcholine at muscarinic receptors. This leads to inhibition of muscarinic effects, including reduction of gastrointestinal motility and secretion (e.g., gastric acid, salivary, bronchial, sweat gland secretions). Due to its quaternary ammonium structure, it has limited ability to cross the blood-brain barrier, resulting in fewer central nervous system effects compared to tertiary amines.
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Pharmacokinetics

Absorption:

Bioavailability: <10-25%
Tmax: 1-2 hours
FoodEffect: Food may delay absorption and reduce peak concentrations.

Distribution:

Vd: Not well-established (likely low due to poor absorption and limited tissue penetration)
ProteinBinding: Not well-established (likely low)
CnssPenetration: Limited

Elimination:

HalfLife: 4-8 hours (variable)
Clearance: Not well-established
ExcretionRoute: Primarily renal (urine) and fecal
Unchanged: Significant portion (up to 50% or more) excreted unchanged in urine
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Pharmacodynamics

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

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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 urinating
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

Other Possible Side Effects

Like all medications, this drug can cause side effects. While 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, contact your doctor for advice:

Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Headache
Constipation
Dry mouth
Changes in taste
Nausea or vomiting
Bloating
Reduced 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, don't hesitate to reach out to 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, blurred vision, or difficulty urinating.
  • Severe constipation or abdominal pain.
  • Rapid or irregular heartbeat.
  • Confusion, agitation, or hallucinations (though less common due to limited CNS penetration).
  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing).
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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
+ Urinary retention or difficulty passing urine
+ Ulcerative colitis

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

Your doctor will help you determine whether it is safe to take this medication with 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.

There is a risk of heat stroke associated with this medication, particularly in hot weather or during physical activity. Exercise caution and monitor your body's response.

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

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

If you are pregnant, planning 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
  • Blurred vision, dilated pupils
  • Hot, dry skin
  • Fever
  • Flushing
  • Difficulty swallowing
  • Urinary retention
  • Constipation
  • Tachycardia, palpitations
  • Dizziness, staggering gait
  • Restlessness, tremors, confusion, delirium, hallucinations, seizures (less common due to quaternary structure, but possible with very high doses)

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Physostigmine may be used in severe cases to reverse anticholinergic effects, but is rarely needed for methscopolamine bromide overdose due to its limited CNS penetration.

Drug Interactions

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Major Interactions

  • Potassium chloride (solid dosage forms): Increased risk of GI lesions due to delayed GI transit.
  • Other anticholinergics (e.g., atropine, dicyclomine, hyoscyamine): Additive anticholinergic effects, increasing risk of side effects.
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Moderate Interactions

  • Antacids: May decrease absorption of methscopolamine if given concurrently. Administer methscopolamine at least 1 hour before antacids.
  • Drugs that prolong QT interval: Theoretical risk of additive QT prolongation, though less significant than with other anticholinergics.
  • Drugs with anticholinergic properties (e.g., tricyclic antidepressants, phenothiazines, antihistamines, MAOIs, disopyramide): Increased risk of anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation).
  • Opioid analgesics: Increased risk of severe constipation and paralytic ileus due to additive reduction in GI motility.
  • Digoxin: May increase digoxin levels due to increased absorption from reduced GI motility.
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Minor Interactions

  • Corticosteroids: May increase intraocular pressure in patients with narrow-angle glaucoma.

Monitoring

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Baseline Monitoring

Baseline vital signs (heart rate, blood pressure)

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

Timing: Prior to initiation of therapy

Assessment of GI symptoms (e.g., abdominal pain, cramping, hyperacidity)

Rationale: To evaluate the effectiveness of therapy.

Timing: Prior to initiation of therapy

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

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

Timing: Prior to initiation of therapy

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Routine Monitoring

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

Frequency: Daily, especially during initial therapy and dose adjustments

Target: Minimize severity while achieving therapeutic effect

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

Heart rate

Frequency: Periodically, especially in patients with cardiac conditions

Target: Within normal limits or patient's baseline

Action Threshold: Significant tachycardia (e.g., >100 bpm or significant increase from baseline) may warrant dose adjustment or discontinuation.

Bowel movements

Frequency: Daily

Target: Regular, comfortable bowel movements

Action Threshold: Persistent constipation (e.g., >3 days without a bowel movement) may require intervention or dose adjustment.

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Constipation
  • Urinary retention
  • Dizziness
  • Drowsiness
  • Nausea
  • Headache
  • Tachycardia
  • Palpitations
  • Nervousness
  • Difficulty swallowing

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 developmental abnormalities, though human data are limited.
Second Trimester: Potential for fetal anticholinergic effects (e.g., decreased fetal heart rate variability, decreased fetal movement).
Third Trimester: Potential for fetal anticholinergic effects, including decreased GI motility in the neonate.
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Lactation

L3 (Moderately Safe). Methscopolamine bromide is excreted into breast milk. It may decrease milk production due to its anticholinergic effects on prolactin and mammary glands. Monitor the infant for anticholinergic effects (e.g., constipation, urinary retention, drowsiness). Use with caution.

Infant Risk: Low to moderate risk of anticholinergic effects (e.g., constipation, drowsiness, dry mouth) and potential for decreased milk supply in the mother.
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Pediatric Use

Safety and efficacy have not been established in children under 12 years of age. Use is generally not recommended due to increased susceptibility to anticholinergic side effects and lack of specific dosing guidelines.

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Geriatric Use

Elderly patients are more susceptible to the anticholinergic side effects of methscopolamine bromide, including dry mouth, constipation, urinary retention, blurred vision, and central nervous system effects (e.g., confusion, delirium, memory impairment), even at therapeutic doses. Use with caution, starting with the lowest effective dose and titrating slowly. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Methscopolamine bromide is a quaternary ammonium compound, which means it has limited ability to cross the blood-brain barrier, leading to fewer CNS side effects (like confusion or sedation) compared to tertiary anticholinergics (e.g., atropine, scopolamine).
  • Its primary use is for gastrointestinal conditions requiring reduced motility or acid secretion, such as peptic ulcer disease or irritable bowel syndrome.
  • Due to its poor oral absorption, higher doses may be needed to achieve therapeutic effects, but this also increases the risk of peripheral anticholinergic side effects.
  • Advise patients to take the medication 30 minutes before meals to optimize its effect on gastric secretion and motility during digestion.
  • Patients should be educated on managing common anticholinergic side effects like dry mouth (sugar-free candy/gum, sips of water) and constipation (increased fluid and fiber intake).
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Alternative Therapies

  • Dicyclomine (anticholinergic/antispasmodic)
  • Hyoscyamine (anticholinergic/antispasmodic)
  • Glycopyrrolate (anticholinergic, quaternary ammonium)
  • Proton Pump Inhibitors (for acid reduction, e.g., omeprazole, pantoprazole)
  • H2 Receptor Blockers (for acid reduction, e.g., famotidine, ranitidine)
  • Antacids (for symptomatic relief of hyperacidity)
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Cost & Coverage

Average Cost: Typically $10-$30 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'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 taken, the amount, and the time it occurred.