Benztropine 1mg Tablets

Manufacturer LEADING PHARMA Active Ingredient Benztropine Tablets(BENZ troe peen) Pronunciation BENZ-troe-peen
It is used to treat Parkinson's disease.It is used to treat side effects caused by some other drugs.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antiparkinsonian agent; Anticholinergic
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Pharmacologic Class
Centrally acting anticholinergic; Muscarinic antagonist
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Pregnancy Category
Category C
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FDA Approved
Jan 1954
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Benztropine is a medication used to treat symptoms of Parkinson's disease, such as tremors and stiffness, and to control muscle spasms and movements caused by certain other medicines (drug-induced extrapyramidal symptoms). It works by helping to balance natural chemicals in the brain.
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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. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.

It's also important to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, 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 doctor or pharmacist. If you're unsure about the best way to dispose of your medication, consult with your pharmacist, who may be aware of drug take-back programs in your area.

What to Do If You Miss 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

  • Avoid alcohol and other CNS depressants as they can increase drowsiness.
  • Be cautious in hot weather or during exercise, as this medication can decrease sweating and increase the risk of heatstroke. Stay hydrated.
  • Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness or blurred vision.
  • To relieve dry mouth, chew sugarless gum, suck on hard candy, or use saliva substitutes.
  • To prevent constipation, increase fiber intake and drink plenty of fluids.

Dosing & Administration

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Adult Dosing

Standard Dose: Parkinsonism: 1-2 mg orally, 1-2 times daily. Drug-induced extrapyramidal disorders: 1-4 mg orally, 1-2 times daily.
Dose Range: 0.5 - 6 mg

Condition-Specific Dosing:

Parkinsonism (initial): 0.5-1 mg at bedtime, gradually increased to 4-6 mg daily in 1-2 divided doses.
Drug-induced extrapyramidal disorders (acute dystonia): 1-2 mg orally, then 1-2 mg 1-2 times daily as needed for maintenance. May be given parenterally (IM/IV) for acute dystonic reactions.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not recommended for children under 3 years. For older children (â‰Ĩ3 years) with drug-induced extrapyramidal disorders: 0.02-0.05 mg/kg/dose orally or IM/IV, up to 1-2 mg/dose, 1-2 times daily.
Adolescent: Similar to adult dosing for drug-induced extrapyramidal disorders, typically 1-2 mg orally 1-2 times daily.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution and monitor for adverse effects.
Severe: No specific adjustment recommended, use with caution and monitor closely for adverse effects. Consider lower initial doses.
Dialysis: Not well-studied. Use with caution, monitor for anticholinergic effects.

Hepatic Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution and monitor for adverse effects due to hepatic metabolism.
Severe: No specific adjustment recommended, use with caution and monitor closely for adverse effects. Consider lower initial doses.

Pharmacology

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Mechanism of Action

Benztropine is a centrally acting anticholinergic agent that possesses both anticholinergic and antihistaminic properties. It acts by blocking muscarinic acetylcholine receptors in the central nervous system, thereby helping to restore the balance between cholinergic and dopaminergic activity in the basal ganglia. This action reduces the excess cholinergic activity that contributes to the symptoms of Parkinson's disease and drug-induced extrapyramidal disorders.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified, but well absorbed orally.
Tmax: Approximately 1-2 hours (oral)
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Not precisely quantified, but widely distributed.
ProteinBinding: Not precisely quantified, but likely moderate.
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 6-10 hours (variable)
Clearance: Not precisely quantified
ExcretionRoute: Renal (metabolites and some unchanged drug)
Unchanged: Small percentage
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour (oral); within minutes (IM/IV)
PeakEffect: Approximately 2-4 hours (oral)
DurationOfAction: 6-10 hours (variable, can be up to 24 hours for some effects)

Safety & Warnings

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Side Effects

Urgent 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 or seek medical attention immediately:

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
New or worsening mental, mood, or behavior changes
Hallucinations (seeing or hearing things that are not there)
Feeling confused
Changes in eyesight, eye pain, or severe eye irritation
Difficulty swallowing or speaking
Decreased appetite
Weight loss
Trouble passing urine
Pain when passing urine
Rapid heartbeat
Enlarged pupils
Memory problems or loss
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Weakness
Difficulty moving around
Numbness in fingers
Decreased sweating, which can lead to heat stroke and potentially life-threatening high body temperatures, especially in hot weather or during physical activity

If you experience a fever or decreased sweating during activities or in warm temperatures, contact your doctor right away.

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 symptoms that bother you or do not go away, contact your doctor or seek medical help:

Constipation
Upset stomach or vomiting
Dry mouth
Feeling nervous and excitable

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. 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 confusion, disorientation, or hallucinations
  • Difficulty urinating or inability to urinate
  • Severe constipation or abdominal pain
  • Blurred vision or eye pain (especially if sudden)
  • Fast or irregular heartbeat
  • Signs of heatstroke (fever, hot dry skin, confusion, rapid pulse)
  • Uncontrolled muscle movements or worsening of symptoms
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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 symptoms you experienced with the allergy.
If you have been diagnosed with tardive dyskinesia, a severe muscle disorder.
If you have glaucoma.

For Parents or Guardians:

If your child is under 3 years of age, do not administer this medication. It is not recommended for children younger than 3 years.

Additional Considerations:

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help determine if it is safe to take this medication with 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 engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.

Combining this medication with certain other drugs can lead to severe and potentially life-threatening complications, including paralytic ileus (a condition where the bowel becomes blocked), fever, and heat stroke. To minimize this risk, carefully review all your medications with your doctor and pharmacist.

To manage dry mouth, a common side effect, practice good oral hygiene, and consider sucking on hard, sugar-free candy or chewing sugar-free gum. Regular dental check-ups are also recommended.

When administering this medication to children, exercise caution, as they may be more susceptible to certain side effects. Similarly, if you are 65 or older, use this medication with caution, as you may be more prone to experiencing side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor 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
  • Blurred vision
  • Flushed, hot, dry skin
  • Fever
  • Tachycardia
  • Urinary retention
  • Constipation
  • Confusion
  • Disorientation
  • Hallucinations
  • Agitation
  • Seizures
  • Coma
  • Respiratory depression

What to Do:

Call 911 or Poison Control immediately (1-800-222-1222). Seek emergency medical attention. Treatment is supportive and may include physostigmine for severe anticholinergic toxicity.

Drug Interactions

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Major Interactions

  • Other anticholinergics (e.g., tricyclic antidepressants, phenothiazines, antihistamines, disopyramide): Increased risk of anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation, confusion, paralytic ileus).
  • CNS depressants (e.g., alcohol, opioids, benzodiazepines): Enhanced sedation and CNS depression.
  • Dopaminergic agents (e.g., levodopa): May enhance or antagonize effects depending on the specific condition and dose.
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Moderate Interactions

  • Drugs that prolong QT interval: Theoretical risk of additive QT prolongation, though not a primary effect of benztropine.
  • Metoclopramide: Antagonizes the prokinetic effect of metoclopramide.
  • Antacids/Adsorbent antidiarrheals: May reduce absorption of benztropine if given concurrently.

Monitoring

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Baseline Monitoring

Baseline neurological assessment

Rationale: To establish the severity of Parkinsonism or extrapyramidal symptoms before treatment.

Timing: Prior to initiation of therapy

Mental status assessment

Rationale: To assess for pre-existing cognitive impairment, which may worsen with anticholinergics.

Timing: Prior to initiation of therapy

Ophthalmologic exam (intraocular pressure)

Rationale: To rule out narrow-angle glaucoma, a contraindication.

Timing: Prior to initiation of therapy (if risk factors present)

Urinary function assessment

Rationale: To assess for pre-existing urinary retention or prostatic hypertrophy.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in symptoms)

Frequency: Regularly during dose titration and periodically thereafter

Target: Improvement in tremor, rigidity, dystonia

Action Threshold: Lack of improvement or worsening of symptoms may require dose adjustment or alternative therapy.

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

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.

CNS side effects (confusion, hallucinations, memory impairment)

Frequency: Regularly, especially in elderly patients

Target: Absence of new or worsening cognitive impairment

Action Threshold: Onset or worsening of cognitive impairment, confusion, or hallucinations requires immediate evaluation and possible dose reduction/discontinuation.

Vital signs (heart rate, blood pressure)

Frequency: Periodically

Target: Within normal limits

Action Threshold: Significant tachycardia or orthostatic hypotension may require intervention.

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Constipation
  • Urinary retention
  • Dizziness
  • Nausea
  • Nervousness
  • Confusion
  • Hallucinations
  • Memory impairment
  • Tachycardia
  • Heat intolerance
  • Skin rash

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but human data are limited.

Trimester-Specific Risks:

First Trimester: Limited data; theoretical risk of teratogenicity based on animal studies.
Second Trimester: Limited data.
Third Trimester: Limited data; theoretical risk of anticholinergic effects in the neonate if used close to delivery.
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Lactation

It is not known whether benztropine is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants (e.g., anticholinergic effects, CNS depression), 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: Risk L3 (Moderate Concern) - Potential for anticholinergic effects (sedation, dry mouth, constipation, urinary retention) in the infant. Monitor infant for drowsiness, feeding difficulties, and constipation.
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Pediatric Use

Not recommended for children under 3 years of age. Use in older children for drug-induced extrapyramidal disorders should be done with caution and careful monitoring due to increased sensitivity to anticholinergic effects.

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Geriatric Use

Elderly patients are particularly susceptible to the anticholinergic side effects of benztropine, including confusion, hallucinations, memory impairment, constipation, and urinary retention. Use with extreme caution, starting with lower doses and titrating slowly. Avoid if possible in patients with cognitive impairment or dementia.

Clinical Information

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Clinical Pearls

  • Benztropine is particularly effective for tremor and rigidity in Parkinson's disease, but less so for bradykinesia.
  • It is a first-line agent for acute drug-induced dystonic reactions, often given parenterally (IM/IV) for rapid relief.
  • Due to its anticholinergic properties, it should be used with extreme caution or avoided in patients with glaucoma (especially narrow-angle), prostatic hypertrophy, urinary retention, or gastrointestinal obstruction.
  • Patients should be warned about potential for heat intolerance and advised to avoid overheating and stay hydrated.
  • Abrupt discontinuation can lead to withdrawal symptoms or worsening of parkinsonian symptoms; taper dose gradually.
  • Monitor for CNS side effects, especially in the elderly, as confusion and hallucinations can be significant.
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Alternative Therapies

  • Other anticholinergics (e.g., trihexyphenidyl, procyclidine)
  • Amantadine (for Parkinsonism and drug-induced EPS)
  • Beta-blockers (e.g., propranolol for tremor)
  • Dopamine agonists (e.g., pramipexole, ropinirole for Parkinson's)
  • Levodopa/carbidopa (for Parkinson's)
  • For drug-induced EPS: Diphenhydramine (parenteral for acute dystonia), benzodiazepines (e.g., lorazepam for akathisia).
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets
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 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 happened.