Aricept 23mg Tablets
It is used to treat dementia in people with Alzheimer's disease.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Cognition enhancer
Pharmacologic Class
Acetylcholinesterase inhibitor
Pregnancy Category
C
FDA Approved
Aug 2010
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aricept 23mg is a medicine used to treat severe Alzheimer's disease. It works by increasing a natural substance in the brain called acetylcholine, which is important for memory and thinking. This can help improve memory, awareness, and the ability to perform daily activities in some people with Alzheimer's.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed, even if you start to feel better. Take the medication at bedtime, with or without food. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids.
It's essential to swallow the medication whole, without chewing, breaking, or crushing it.
Storing and Disposing of Your Medication
Store the 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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, skip it and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you miss seven consecutive days of medication, contact your doctor for guidance on how to proceed.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed, even if you start to feel better. Take the medication at bedtime, with or without food. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids.
It's essential to swallow the medication whole, without chewing, breaking, or crushing it.
Storing and Disposing of Your Medication
Store the 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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, skip it and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you miss seven consecutive days of medication, contact your doctor for guidance on how to proceed.
Lifestyle & Tips
- Take the tablet once daily in the evening, just before bedtime, to help reduce side effects like nausea.
- Swallow the tablet whole; do not crush, chew, or split it.
- Maintain regular follow-up appointments with your doctor to monitor your condition and side effects.
- Report any new or worsening symptoms, especially severe nausea, vomiting, diarrhea, or fainting spells.
- Inform all healthcare providers, including dentists, that you are taking donepezil, especially before any surgery or dental procedures, due to potential interactions with anesthesia.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
23 mg orally once daily
Dose Range:
23 - 23 mg
Condition-Specific Dosing:
severeAlzheimersDisease:
Initiate only after patient has been stabilized on donepezil 10 mg/day for at least 3 months. Administer in the evening just prior to bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific recommendations; donepezil is not dialyzable.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Caution advised; monitor for adverse effects. No specific dose adjustment guidelines.
Severe:
Caution advised; monitor for adverse effects. No specific dose adjustment guidelines.
Pharmacology
Mechanism of Action
Donepezil is a reversible inhibitor of acetylcholinesterase (AChE), the enzyme responsible for the hydrolysis of acetylcholine. By inhibiting AChE, donepezil increases the concentration of acetylcholine at cholinergic synapses in the central nervous system. This enhancement of cholinergic function is thought to be responsible for the therapeutic effects in Alzheimer's disease.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
3-4 hours
FoodEffect:
Food does not affect the rate or extent of absorption.
Distribution:
Vd:
12 L/kg
ProteinBinding:
Approximately 96% (primarily to albumin and alpha1-acid glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 70 hours
Clearance:
0.13 L/hr/kg
ExcretionRoute:
Urine (57%), Feces (15%)
Unchanged:
Approximately 17% (urine)
Pharmacodynamics
OnsetOfAction:
Within 3 weeks (clinical effect)
PeakEffect:
Not precisely defined for clinical effect, but steady-state plasma concentrations are reached within 15 days.
DurationOfAction:
Due to long half-life, effects persist for several days after discontinuation.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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
Severe dizziness or fainting
Slow heartbeat
Abnormal heartbeat
Difficulty urinating
Seizures
Severe stomach pain
Heartburn
Vomiting blood or coffee ground-like material
Black, tarry, or bloody stools
New or worsening trouble breathing
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dizziness, fatigue, or weakness
Diarrhea, upset stomach, or vomiting
Sleep disturbances
Muscle cramps
Decreased appetite
Weight loss
Headache
This is not an exhaustive list of all 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.
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 right away:
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
Severe dizziness or fainting
Slow heartbeat
Abnormal heartbeat
Difficulty urinating
Seizures
Severe stomach pain
Heartburn
Vomiting blood or coffee ground-like material
Black, tarry, or bloody stools
New or worsening trouble breathing
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dizziness, fatigue, or weakness
Diarrhea, upset stomach, or vomiting
Sleep disturbances
Muscle cramps
Decreased appetite
Weight loss
Headache
This is not an exhaustive list of all 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.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent nausea, vomiting, or diarrhea
- Black, tarry stools or vomit that looks like coffee grounds (signs of stomach bleeding)
- Slow heartbeat or fainting spells (syncope)
- Dizziness or lightheadedness
- New or worsening muscle cramps or weakness
- Difficulty urinating
- Seizures
- Worsening of asthma or COPD symptoms
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug does not cure Alzheimer's disease, and you should continue to receive regular care from your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, be sure to discuss this with your doctor, as you will need to carefully weigh the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Vomiting
- Salivation (excessive drooling)
- Sweating
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Respiratory depression (slow, shallow breathing)
- Collapse
- Convulsions
- Increased muscle weakness (potentially leading to death if respiratory muscles are involved)
What to Do:
Immediately call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment involves general supportive measures and may include atropine sulfate as an antidote for cholinergic crisis.
Drug Interactions
Major Interactions
- Anticholinergic agents (e.g., atropine, scopolamine, benztropine): Donepezil may antagonize the effects of anticholinergic agents.
- Succinylcholine, other neuromuscular blocking agents: Donepezil may exaggerate neuromuscular blockade.
Moderate Interactions
- Beta-blockers (e.g., metoprolol, carvedilol): Increased risk of bradycardia and syncope.
- NSAIDs (e.g., ibuprofen, naproxen): Increased risk of gastrointestinal bleeding (theoretical, due to increased gastric acid secretion via cholinergic stimulation).
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir): May increase donepezil plasma concentrations.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May increase donepezil plasma concentrations.
- CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, phenobarbital): May decrease donepezil plasma concentrations.
- CYP2D6 inducers (e.g., rifampin): May decrease donepezil plasma concentrations.
Monitoring
Baseline Monitoring
Baseline cognitive function assessment (e.g., MMSE, ADAS-Cog)
Rationale: To establish a baseline for evaluating treatment efficacy.
Timing: Prior to initiation of therapy
Heart rate and rhythm (ECG if clinically indicated)
Rationale: Donepezil can cause bradycardia and syncope.
Timing: Prior to initiation of therapy
Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, ulcer history)
Rationale: To assess risk of GI adverse effects.
Timing: Prior to initiation of therapy
Routine Monitoring
Cognitive function assessment
Frequency: Every 6-12 months or as clinically indicated
Target: Stabilization or improvement in cognitive scores
Action Threshold: Significant decline may warrant re-evaluation of treatment.
Heart rate and blood pressure
Frequency: Periodically, especially during dose escalation or if symptoms of bradycardia/syncope occur
Target: Normal limits for the patient
Action Threshold: Symptomatic bradycardia or hypotension may require dose reduction or discontinuation.
Gastrointestinal symptoms
Frequency: Regularly, especially during initial therapy and dose escalation
Target: Absence or manageable level of symptoms
Action Threshold: Persistent or severe nausea, vomiting, diarrhea, or signs of GI bleeding may require dose adjustment or discontinuation.
Weight
Frequency: Periodically
Target: Stable weight
Action Threshold: Significant unexplained weight loss may indicate underlying issues or severe GI side effects.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Anorexia
- Weight loss
- Bradycardia (slow heart rate)
- Syncope (fainting)
- Dizziness
- Insomnia
- Muscle cramps
- Fatigue
- Urinary incontinence
- Seizures (rare)
Special Patient Groups
Pregnancy
Donepezil is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk, but human data are limited.
Second Trimester:
Potential risk, but human data are limited.
Third Trimester:
Potential risk, but human data are limited.
Lactation
It is not known whether donepezil is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from donepezil, 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:
Not available
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Donepezil is not indicated for use in pediatric populations.
Geriatric Use
No specific dose adjustment is required based on age. However, elderly patients may be more susceptible to cholinergic side effects (e.g., bradycardia, syncope, GI upset). The 23 mg dose is specifically for patients with severe Alzheimer's disease who have been stabilized on 10 mg for at least 3 months.
Clinical Information
Clinical Pearls
- The 23 mg dose of donepezil is specifically indicated for patients with severe Alzheimer's disease who have been on donepezil 10 mg/day for at least 3 months and are tolerating it well. It is not for initial therapy.
- Administer donepezil in the evening just prior to bedtime to help mitigate common side effects like nausea and vomiting.
- Patients and caregivers should be educated on the potential for cholinergic side effects, including GI upset, bradycardia, and syncope.
- Monitor for signs of GI bleeding, especially in patients with a history of ulcers or those concurrently taking NSAIDs.
- Donepezil has a long half-life, so steady-state concentrations are reached slowly, and effects persist for several days after discontinuation.
- Caution should be exercised in patients with sick sinus syndrome, supraventricular conduction abnormalities, or a history of syncope, as donepezil can cause bradycardia.
Alternative Therapies
- Rivastigmine (Exelon, Exelon Patch) - another acetylcholinesterase inhibitor
- Galantamine (Razadyne) - another acetylcholinesterase inhibitor
- Memantine (Namenda) - an NMDA receptor antagonist (often used for moderate to severe AD, sometimes in combination with donepezil)
Cost & Coverage
Average Cost:
$400 - $600 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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.