Benztropine 1mg/ml Inj, 2ml

Manufacturer WEST-WARD Active Ingredient Benztropine Injection(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
Aug 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 (like antipsychotics). It works by helping to restore the balance of natural substances in the brain.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Adhere to the dosage instructions provided by your healthcare team. This medication is administered via injection into a muscle or vein.

For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.

If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications, as they can increase dizziness and drowsiness.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause blurred vision and dizziness.
  • To relieve dry mouth, chew sugarless gum, suck on hard candy, or use saliva substitutes.
  • To prevent constipation, increase fiber in your diet, drink plenty of fluids, and engage in regular exercise.
  • Avoid overheating in hot weather or during exercise, as this medication can decrease sweating and increase the risk of heat stroke.

Dosing & Administration

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Adult Dosing

Standard Dose: For drug-induced extrapyramidal disorders: 1-2 mg IM or IV, then 1-4 mg orally 1-2 times daily. For acute dystonia: 1-2 mg IM or IV, usually provides relief within minutes.
Dose Range: 0.5 - 6 mg

Condition-Specific Dosing:

Parkinsonism: 0.5-6 mg/day orally or parenterally in divided doses, starting with 0.5-1 mg at bedtime, increasing by 0.5 mg increments every 5-6 days as needed.
Drug-induced extrapyramidal disorders (prophylaxis): 1-2 mg orally 2-3 times daily.
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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 reactions: 0.02-0.05 mg/kg/dose IM or IV, up to 1-2 mg/dose. Max 6 mg/day.
Adolescent: Similar to adult dosing for drug-induced extrapyramidal reactions: 1-2 mg IM or IV, then 1-4 mg orally 1-2 times daily.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor for increased anticholinergic effects.
Moderate: Use with caution; consider lower initial doses and slower titration. Monitor closely for anticholinergic side effects.
Severe: Use with caution; consider lower initial doses and slower titration. Monitor closely for anticholinergic side effects. Data limited.
Dialysis: Not well studied. Likely not dialyzable due to high volume of distribution. Use with caution, monitor for adverse effects.

Hepatic Impairment:

Mild: Use with caution; monitor for increased anticholinergic effects.
Moderate: Use with caution; consider lower initial doses and slower titration. Monitor closely for anticholinergic side effects. Data limited.
Severe: Use with caution; consider lower initial doses and slower titration. Monitor closely for anticholinergic side effects. Data limited.

Pharmacology

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Mechanism of Action

Benztropine is a centrally acting anticholinergic agent that selectively blocks muscarinic acetylcholine receptors in the central nervous system (CNS), particularly in the basal ganglia. This action helps to restore the balance between cholinergic and dopaminergic activity, which is disrupted in Parkinson's disease and drug-induced extrapyramidal symptoms. It also possesses antihistaminic properties.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified for IM/IV, assumed to be 100% for IV.
Tmax: IV: Immediate; IM: 15-30 minutes
FoodEffect: Not applicable for injectable formulation.

Distribution:

Vd: Not precisely quantified in humans, but widely distributed.
ProteinBinding: Not extensively studied, but likely binds to plasma proteins.
CnssPenetration: Yes

Elimination:

HalfLife: Variable, reported as 6-24 hours (some sources suggest 12-24 hours).
Clearance: Not precisely quantified.
ExcretionRoute: Renal excretion of metabolites and some unchanged drug.
Unchanged: Small percentage
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Pharmacodynamics

OnsetOfAction: IV: Within minutes; IM: 15-30 minutes
PeakEffect: IV/IM: Within 1-2 hours
DurationOfAction: 6-10 hours (up to 24 hours for some effects)
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Trouble swallowing or speaking
Decreased appetite
Weight loss
Trouble passing urine
Pain when passing urine
Fast heartbeat
Larger pupils
Memory problems or loss
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Weakness
Trouble moving around
Numbness of fingers
Sweating less, heat stroke, and deadly high body temperatures have occurred with this medication. Be cautious in hot weather and during physical activity. If you experience a fever or do not sweat during activities or in warm temperatures, contact your doctor immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have minor ones. If you are bothered by any of the following side effects or if they 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. 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 hallucinations
  • Difficulty urinating or inability to urinate
  • Severe constipation or abdominal pain
  • Rapid or irregular heartbeat
  • Eye pain or blurred vision (especially if sudden)
  • Fever or heat intolerance
  • Skin rash
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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 conditions before starting this medication:

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.
If you have been diagnosed with tardive dyskinesia, a severe muscle disorder.
If you have glaucoma, a condition that affects the eyes.

For Parents or Guardians:

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 medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
+ All prescription and over-the-counter medications you are taking
+ Any natural products or vitamins you are using
+ Your medical history, including any health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with 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 engaging in activities that require your full attention, such as driving, wait until you understand how this medication affects you.

Combining this drug with certain other medications can lead to severe and potentially life-threatening complications, including paralytic ileus (a condition where the bowel stops functioning), 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, suck on sugar-free candy, or chew 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.

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
  • Nausea
  • Vomiting
  • Tachycardia
  • Hypertension (initially), followed by hypotension
  • Urinary retention
  • Paralytic ileus
  • CNS effects: confusion, disorientation, hallucinations, delirium, agitation, seizures, coma, respiratory depression.

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive, potentially including physostigmine for severe anticholinergic toxicity.

Drug Interactions

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Major Interactions

  • Other anticholinergic drugs (e.g., tricyclic antidepressants, phenothiazines, antihistamines, quinidine, disopyramide): Increased risk of severe anticholinergic effects (e.g., paralytic ileus, urinary retention, heat stroke, CNS depression/excitement).
  • Metoclopramide: Benztropine may antagonize the prokinetic effects of metoclopramide.
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Moderate Interactions

  • Alcohol and other CNS depressants: Additive sedative effects.
  • Levodopa: Benztropine may delay gastric emptying, potentially affecting levodopa absorption.
  • Drugs that cause QT prolongation: Theoretical risk of additive QT prolongation, though not a primary effect of benztropine.

Monitoring

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Baseline Monitoring

Mental status and cognitive function

Rationale: To establish baseline for potential anticholinergic CNS effects (confusion, hallucinations).

Timing: Prior to initiation of therapy.

Vital signs (heart rate, blood pressure)

Rationale: To assess for potential cardiovascular effects (tachycardia, orthostatic hypotension).

Timing: Prior to initiation of therapy.

Bowel and bladder function

Rationale: To assess for baseline constipation or urinary retention, which can be exacerbated by anticholinergic effects.

Timing: Prior to initiation of therapy.

Intraocular pressure (in patients with glaucoma)

Rationale: Anticholinergics can precipitate acute angle-closure glaucoma.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Extrapyramidal symptoms (EPS) control

Frequency: Daily to weekly, then as needed based on clinical response.

Target: Resolution or significant reduction of symptoms.

Action Threshold: If symptoms persist or worsen, consider dose adjustment or alternative therapy.

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

Frequency: Daily to weekly, then as needed.

Target: Minimal to tolerable side effects.

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

Mental status and cognitive function

Frequency: Periodically, especially in elderly patients.

Target: Stable cognitive function.

Action Threshold: New onset or worsening confusion/hallucinations requires immediate assessment and dose adjustment/discontinuation.

Bowel and bladder function

Frequency: Regularly.

Target: Normal bowel movements and urinary output.

Action Threshold: Severe constipation or urinary retention requires intervention.

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Constipation
  • Urinary retention
  • Dizziness
  • Lightheadedness
  • Nausea
  • Nervousness
  • Confusion
  • Hallucinations
  • Tachycardia
  • Difficulty swallowing
  • Heat intolerance

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: Limited data, theoretical risk of developmental abnormalities due to anticholinergic effects.
Second Trimester: Limited data, monitor for maternal anticholinergic side effects.
Third Trimester: Limited data, theoretical risk of anticholinergic effects in the neonate if used close to delivery.
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Lactation

L3 (Moderately Safe). Benztropine is excreted into breast milk. Anticholinergic effects may reduce milk production. Monitor infant for anticholinergic effects (e.g., drowsiness, constipation, urinary retention, dry mouth). Use with caution, especially in preterm or jaundiced infants.

Infant Risk: Low to moderate risk of anticholinergic effects; potential for decreased milk supply.
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Pediatric Use

Not recommended for children under 3 years of age due to lack of safety and efficacy data. Use with caution in older children, especially for drug-induced extrapyramidal reactions. Children may be more sensitive to anticholinergic side effects.

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Geriatric Use

Elderly patients are more susceptible to anticholinergic side effects, including confusion, hallucinations, memory impairment, constipation, urinary retention, and heat intolerance. Start with lower doses and titrate slowly. Avoid use in elderly patients with cognitive impairment or dementia due to increased risk of delirium.

Clinical Information

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Clinical Pearls

  • Benztropine injection is particularly useful for rapid relief of acute dystonic reactions caused by antipsychotics or other dopamine receptor blocking agents.
  • It can be used prophylactically to prevent drug-induced extrapyramidal symptoms when initiating or increasing doses of antipsychotics.
  • Patients should be advised not to stop benztropine abruptly, especially if used for Parkinson's disease, as this can lead to a worsening of symptoms or cholinergic rebound.
  • Monitor for signs of heat stroke, especially in hot weather or during strenuous activity, as benztropine can impair sweating.
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Alternative Therapies

  • Other anticholinergic agents (e.g., trihexyphenidyl)
  • Amantadine (for Parkinson's and drug-induced EPS)
  • Dopamine agonists (e.g., pramipexole, ropinirole for Parkinson's)
  • Beta-blockers (e.g., propranolol for tremor)
  • Benzodiazepines (e.g., lorazepam for acute dystonia)
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Cost & Coverage

Average Cost: Varies, typically $10-$50 per 2ml vial (1mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.