Benztropine 0.5mg 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
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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
Mar 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 stiffness caused by certain medications (drug-induced extrapyramidal symptoms). It works by helping to restore the balance of natural substances 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 quality 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 activities requiring mental alertness or coordination (e.g., driving, operating machinery) until you know how this medication affects you, as it can cause dizziness or blurred vision.
  • Avoid alcohol and other CNS depressants, as they can increase drowsiness.
  • Stay hydrated to help with dry mouth, a common side effect. Sugar-free candy or gum may also help.
  • To prevent constipation, increase fiber intake and drink plenty of fluids.
  • Be cautious in hot weather or during exercise, as this medication can decrease sweating and increase the risk of heatstroke. Avoid overheating.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.5 to 6 mg daily, administered orally in single or divided doses.
Dose Range: 0.5 - 6 mg

Condition-Specific Dosing:

parkinsonism: 1 to 2 mg daily, usually at bedtime. May be increased by 0.5 mg increments every 5-6 days to a maximum of 6 mg/day.
drugInducedExtrapyramidalDisorders: 1 to 4 mg once or twice daily. Initial dose 0.5 to 1 mg, increasing as needed.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (Contraindicated in children under 3 years)
Child: Not established (Contraindicated in children under 3 years; use with caution in older children, generally not recommended for routine use)
Adolescent: Not established (Use with caution, generally not recommended for routine use)
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Dose Adjustments

Renal Impairment:

Mild: Adjustment not specifically defined; use with caution.
Moderate: Adjustment not specifically defined; use with caution, monitor for increased anticholinergic effects.
Severe: Adjustment not specifically defined; use with caution, monitor for increased anticholinergic effects.
Dialysis: Considerations: Not dialyzable. Use with caution, monitor for adverse effects.

Hepatic Impairment:

Mild: Adjustment not specifically defined; use with caution.
Moderate: Adjustment not specifically defined; use with caution, monitor for increased anticholinergic effects.
Severe: Adjustment not specifically defined; use with caution, monitor for increased anticholinergic effects.

Pharmacology

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Mechanism of Action

Benztropine is a centrally acting anticholinergic agent that also possesses antihistamine properties. It acts by blocking cholinergic receptors in the central nervous system, thereby helping to restore the balance between cholinergic and dopaminergic activity in the basal ganglia, which is disrupted in Parkinson's disease and drug-induced extrapyramidal symptoms. It also has a weak antihistamine effect.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified, but well absorbed orally.
Tmax: 6 to 8 hours (oral)
FoodEffect: Food may delay absorption but does not significantly affect total absorption.

Distribution:

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

Elimination:

HalfLife: 12 to 24 hours (highly variable, some sources suggest up to 36 hours)
Clearance: Not precisely quantified.
ExcretionRoute: Urine and feces.
Unchanged: Not precisely quantified.
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Pharmacodynamics

OnsetOfAction: Within 1 hour (oral)
PeakEffect: 6 to 8 hours
DurationOfAction: 24 hours

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 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
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
Trouble swallowing or speaking
Decreased appetite
Weight loss
Difficulty passing urine
Pain when passing urine
Rapid heartbeat
Enlarged pupils
Memory problems or loss
Severe constipation or stomach pain, which may indicate a serious 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 immediately.

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, 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 confusion or disorientation
  • Hallucinations (seeing or hearing things that are not there)
  • Difficulty urinating or inability to urinate
  • Severe constipation or abdominal pain
  • Rapid or irregular heartbeat
  • Fever or signs of heatstroke (e.g., hot, dry skin; lack of sweating)
  • Eye pain or sudden vision changes (especially if you have glaucoma)
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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 symptoms you experienced.
If you have been diagnosed with tardive dyskinesia, a severe muscle condition.
* If you have glaucoma.

For Children:
If your child is under 3 years of age, do not administer this medication. It is not approved for use in 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. They will help determine if it is safe to take this medication with your other medications and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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 conditions, including paralytic ileus (a type of bowel blockage), fever, and heat stroke. To minimize this risk, review all your medications with your doctor and pharmacist to ensure safe interactions.

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 at a higher risk for certain side effects.

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

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:

  • Dilated pupils
  • Blurred vision
  • Flushed, hot, dry skin
  • Dry mucous membranes
  • Difficulty swallowing
  • Fever
  • Nausea
  • Vomiting
  • Tachycardia
  • Hypertension (early), hypotension (late)
  • Urinary retention
  • Paralytic ileus
  • CNS stimulation (e.g., restlessness, excitement, agitation, confusion, delirium, hallucinations, seizures)
  • CNS depression (e.g., drowsiness, stupor, coma, respiratory depression) in severe cases

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. Physostigmine may be used as an antidote for severe anticholinergic toxicity.

Drug Interactions

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Major Interactions

  • Phenothiazines (additive anticholinergic effects, increased risk of tardive dyskinesia)
  • Butyrophenones (additive anticholinergic effects, increased risk of tardive dyskinesia)
  • Tricyclic antidepressants (additive anticholinergic effects, increased risk of paralytic ileus, hyperpyrexia)
  • Monoamine Oxidase Inhibitors (MAOIs) (additive anticholinergic effects)
  • Other anticholinergics (e.g., atropine, scopolamine, antihistamines with anticholinergic properties) (additive anticholinergic effects, increased risk of CNS depression, confusion, delirium)
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Moderate Interactions

  • CNS depressants (e.g., alcohol, sedatives, hypnotics, opioids) (additive CNS depression)
  • Metoclopramide (antagonism of prokinetic effect)
  • Digoxin (may increase digoxin levels due to decreased GI motility)
  • Antacids (may decrease absorption of benztropine if given concurrently)
  • Potassium chloride (wax-matrix formulations) (increased risk of GI lesions due to delayed transit)

Monitoring

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Baseline Monitoring

Baseline neurological assessment

Rationale: To establish the severity of Parkinsonism or drug-induced extrapyramidal symptoms before initiating therapy.

Timing: Prior to initiation of therapy.

Mental status assessment

Rationale: To identify baseline cognitive function, as benztropine can cause confusion or hallucinations.

Timing: Prior to initiation of therapy.

Intraocular pressure (IOP)

Rationale: In patients with glaucoma, as anticholinergics can increase IOP.

Timing: Prior to initiation of therapy in patients with glaucoma or at risk.

Urinary output/history of urinary retention

Rationale: Anticholinergics can exacerbate urinary retention.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy of symptom control (e.g., tremor, rigidity, dystonia)

Frequency: Regularly during dose titration and periodically thereafter.

Target: Reduction in target symptoms.

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

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

Frequency: Regularly, especially during dose titration.

Target: Minimization of side effects.

Action Threshold: Severe or intolerable side effects may require dose reduction or discontinuation.

Mental status (e.g., confusion, disorientation, hallucinations)

Frequency: Regularly, especially in elderly patients.

Target: Maintenance of baseline cognitive function.

Action Threshold: New onset or worsening of cognitive impairment requires immediate evaluation and possible dose adjustment/discontinuation.

Body temperature

Frequency: Periodically, especially in hot weather or during exercise.

Target: Normal body temperature.

Action Threshold: Hyperthermia may indicate impaired sweating due to anticholinergic effects.

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Constipation
  • Urinary retention or hesitancy
  • Dizziness
  • Nausea
  • Nervousness
  • Confusion
  • Disorientation
  • Hallucinations
  • Memory impairment
  • Tachycardia
  • Hyperthermia (especially in hot weather)

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 is limited.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though human data is limited and conflicting.
Second Trimester: Risk of anticholinergic effects on the fetus.
Third Trimester: Risk of anticholinergic effects on the fetus and neonate (e.g., urinary retention, paralytic ileus, respiratory depression) if used close to delivery.
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Lactation

Benztropine is excreted into breast milk. Due to potential for anticholinergic effects in the infant (e.g., sedation, constipation, urinary retention) and potential for decreased milk supply, use is generally not recommended during breastfeeding. If use is necessary, monitor the infant closely for adverse effects.

Infant Risk: Moderate to High (L4 - Possibly Hazardous)
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Pediatric Use

Contraindicated in children under 3 years of age due to potential for severe adverse reactions, including hyperthermia and CNS effects. Use with extreme caution and only if clearly indicated in older children, as safety and efficacy are not well-established. Children are more susceptible to anticholinergic side effects.

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Geriatric Use

Elderly patients are particularly susceptible to the anticholinergic side effects of benztropine, including confusion, hallucinations, urinary retention, constipation, and impaired thermoregulation. It is listed on the Beers Criteria as a medication to avoid in older adults due to its high anticholinergic burden and risk of adverse cognitive effects. Use with extreme caution, starting with the lowest effective dose and titrating slowly, or consider alternative therapies.

Clinical Information

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Clinical Pearls

  • Benztropine is particularly effective for drug-induced extrapyramidal symptoms (EPS), especially dystonia and akathisia, but less effective for tardive dyskinesia.
  • Administering the dose at bedtime can help mitigate daytime drowsiness and manage nocturnal symptoms of Parkinsonism.
  • Patients should be advised to report any signs of confusion, hallucinations, or difficulty urinating immediately.
  • Due to its long half-life, once-daily dosing is often sufficient, but divided doses may be used to manage side effects or optimize symptom control.
  • Tapering the dose gradually is recommended if discontinuing therapy to avoid rebound extrapyramidal symptoms.
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Alternative Therapies

  • Trihexyphenidyl (another anticholinergic for Parkinsonism/EPS)
  • Diphenhydramine (antihistamine with anticholinergic properties, sometimes used for acute dystonia)
  • Amantadine (for Parkinsonism and drug-induced EPS)
  • Propranolol (for akathisia)
  • Beta-blockers (for tremor)
  • Dopaminergic agents (e.g., levodopa/carbidopa, dopamine agonists for Parkinson's disease)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (0.5mg)
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.