Cogentin 0.5mg Tablets

Manufacturer MERCK HUMAN HEALTH 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
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 involuntary movements caused by certain medications (drug-induced extrapyramidal symptoms). It works by balancing 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 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 disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the proper disposal method, or look into local drug take-back programs.

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 and dizziness.
  • Be cautious in hot weather or during strenuous exercise, as this medication can decrease sweating and increase the risk of heatstroke.
  • Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness, blurred vision, or drowsiness.
  • To relieve dry mouth, suck on sugarless candy or ice chips, or use artificial saliva products.
  • To prevent constipation, increase fiber intake, drink plenty of fluids, and engage in regular exercise.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 0.5 to 6 mg daily, typically divided into 1 to 4 doses
Dose Range: 0.5 - 6 mg

Condition-Specific Dosing:

Parkinsonism: Initial: 0.5 to 1 mg at bedtime, gradually increased to 1 to 2 mg daily in 1 to 4 doses. Maintenance: 0.5 to 6 mg daily.
Drug-induced Extrapyramidal Disorders: 1 to 4 mg once or twice daily. Initial: 1 to 2 mg once or twice daily. For acute dystonia, 1 to 2 mg IM/IV, then 1 to 2 mg orally twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (contraindicated in children under 3 years)
Child: Not established for routine use; limited data for drug-induced extrapyramidal symptoms in children >3 years: 0.02-0.05 mg/kg/dose once or twice daily, max 4 mg/day.
Adolescent: Similar to adult dosing for drug-induced extrapyramidal symptoms, with caution.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution due to potential accumulation of drug/metabolites.
Severe: No specific adjustment recommended, use with caution due to potential accumulation of drug/metabolites.
Dialysis: Not well studied; use with caution, monitor for adverse effects.

Hepatic Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution due to potential for impaired metabolism.
Severe: No specific adjustment recommended, use with caution due to potential for impaired metabolism.

Pharmacology

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Mechanism of Action

Benztropine is a centrally acting anticholinergic agent that acts by blocking cholinergic receptors in the central nervous system (CNS), thereby helping to restore the balance between cholinergic and dopaminergic activity in the basal ganglia. It also has antihistaminic properties.
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Pharmacokinetics

Absorption:

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

Distribution:

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

Elimination:

HalfLife: 6-10 hours (variable, some sources suggest longer)
Clearance: Not precisely quantified.
ExcretionRoute: Primarily renal (urine), some fecal.
Unchanged: Not precisely quantified.
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Pharmacodynamics

OnsetOfAction: Within 1 hour (oral); within minutes (IM/IV)
PeakEffect: 2-4 hours (oral)
DurationOfAction: 6-10 hours (variable)

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
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
Decreased sweating, heat stroke, and 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 right away.

Other Possible Side Effects

Like all medications, this drug may cause side effects. Many people experience no side effects or only mild 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 disorientation
  • Hallucinations
  • Difficulty urinating or inability to urinate
  • Severe constipation or abdominal pain
  • Blurred vision or eye pain (especially if sudden)
  • Fever or heatstroke symptoms (e.g., hot, dry skin, rapid pulse, confusion)
  • Rash or allergic reaction
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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 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 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 drugs and health issues. Never start, 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 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 complications, including paralytic ileus (a condition where the bowel stops functioning), fever, and heat stroke. In some cases, these conditions have been fatal. Therefore, it is crucial to review all your medications with your doctor and pharmacist to ensure safe use.

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. Similarly, 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:

  • Dilated pupils
  • Hot, dry skin
  • Flushed face
  • Dry mucous membranes
  • Difficulty swallowing
  • Tachycardia
  • Hypertension (early), hypotension (late)
  • Urinary retention
  • Paralytic ileus
  • CNS effects: confusion, disorientation, hallucinations, delirium, agitation, psychosis, seizures, coma, respiratory depression.

What to Do:

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

Drug Interactions

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Major Interactions

  • Other anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, phenothiazines, quinidine, disopyramide) - increased risk of additive anticholinergic effects (e.g., dry mouth, blurred vision, constipation, urinary retention, confusion, hallucinations).
  • Dopamine antagonists (e.g., phenothiazines, butyrophenones, metoclopramide) - Benztropine may antagonize the therapeutic effects of these drugs on psychosis, while these drugs may antagonize the antiparkinsonian effects of benztropine.
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Moderate Interactions

  • CNS depressants (e.g., alcohol, opioids, benzodiazepines) - increased risk of additive CNS depression (e.g., sedation, dizziness).
  • Potassium chloride (oral forms) - increased risk of gastrointestinal lesions due to delayed gastric emptying.

Monitoring

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Baseline Monitoring

Baseline neurological assessment

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

Timing: Prior to initiation of therapy

Mental status assessment

Rationale: To assess for pre-existing cognitive impairment, which may increase susceptibility to anticholinergic-induced confusion or psychosis.

Timing: Prior to initiation of therapy

Intraocular pressure (IOP)

Rationale: To identify patients with narrow-angle glaucoma, as anticholinergics can precipitate acute attacks.

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

Bowel and bladder function

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

Timing: Prior to initiation of therapy

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Routine Monitoring

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

Frequency: Regularly, especially during dose titration and maintenance

Target: Minimize severity while maintaining therapeutic effect

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

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

Frequency: Regularly, especially in elderly patients or those with cognitive impairment

Target: Maintain baseline cognitive function

Action Threshold: If new or worsening cognitive symptoms, consider dose reduction or discontinuation.

Parkinsonian symptoms or extrapyramidal symptoms

Frequency: Regularly, to assess therapeutic efficacy

Target: Improvement in symptoms without excessive side effects

Action Threshold: If symptoms worsen or do not improve, consider dose adjustment or alternative therapy.

Body temperature

Frequency: Monitor in hot weather or during strenuous exercise

Target: Normal body temperature

Action Threshold: If hyperthermia develops, discontinue drug and implement cooling measures.

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Symptom Monitoring

  • Dry mouth
  • Blurred vision
  • Constipation
  • Urinary retention
  • Dizziness
  • Sedation
  • Nausea
  • Nervousness
  • Confusion
  • Disorientation
  • Hallucinations
  • Memory impairment
  • Tachycardia
  • Heat intolerance
  • Fever

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, but data are limited.
Second Trimester: Potential for fetal harm, but data are limited.
Third Trimester: Potential for fetal harm, but data are limited. May cause anticholinergic effects in the neonate if used close to term.
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Lactation

L3 (Moderate risk). Benztropine is excreted into breast milk. It may decrease milk production due to its anticholinergic effects. Monitor the infant for anticholinergic effects (e.g., sedation, constipation, urinary retention, dry mouth). Use with caution, or consider an alternative.

Infant Risk: Moderate risk of adverse effects (e.g., sedation, constipation, dry mouth, urinary retention) and potential for decreased milk supply.
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Pediatric Use

Contraindicated in children under 3 years of age due to potential for severe adverse reactions. Use with extreme caution in older children, especially for drug-induced extrapyramidal symptoms, as they may be more susceptible to adverse effects.

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Geriatric Use

Elderly patients are particularly susceptible to the anticholinergic side effects of benztropine, especially CNS effects such as confusion, disorientation, hallucinations, and memory impairment. They are also at increased risk for constipation, urinary retention, and heat intolerance. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Benztropine is often used as an adjunctive therapy for Parkinson's disease, particularly for tremor and rigidity, but less effective for bradykinesia.
  • It is highly effective in treating drug-induced extrapyramidal symptoms (EPS), especially acute dystonia, akathisia, and parkinsonism caused by antipsychotics.
  • Due to its anticholinergic properties, it should be used with caution in patients with glaucoma (especially narrow-angle), prostatic hypertrophy, urinary retention, or gastrointestinal obstruction.
  • Patients should be advised to avoid abrupt discontinuation, as this can lead to a worsening of Parkinsonian symptoms or withdrawal symptoms.
  • Monitor for signs of heatstroke, especially in warm environments or during exercise, as benztropine can impair sweating.
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Alternative Therapies

  • Other anticholinergics (e.g., trihexyphenidyl)
  • Amantadine (for Parkinson's and drug-induced EPS)
  • Dopaminergic agents (e.g., levodopa/carbidopa, dopamine agonists for Parkinson's disease)
  • Beta-blockers (e.g., propranolol for tremor)
  • Benzodiazepines (for akathisia or dystonia, short-term)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (0.5mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.