Aricept ODT 5mg 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
Anti-Alzheimer's agent
Pharmacologic Class
Acetylcholinesterase inhibitor
Pregnancy Category
C
FDA Approved
Jul 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Donepezil is a medication used to treat Alzheimer's disease. It works by increasing the levels of 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 take this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed, even if you're feeling well. Take it at bedtime, with or without food, and drink plenty of non-caffeinated liquids unless your doctor advises you to limit your fluid intake.
Before taking the medication, wash and dry your hands. Place the tablet on your tongue and let it dissolve; do not swallow it whole. Only remove the tablet from the blister pack when you're ready to take it, and take it immediately after opening the pack. Do not store the removed tablet for later use. After the tablet has dissolved, drink a glass of water.
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're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to 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 take this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed, even if you're feeling well. Take it at bedtime, with or without food, and drink plenty of non-caffeinated liquids unless your doctor advises you to limit your fluid intake.
Before taking the medication, wash and dry your hands. Place the tablet on your tongue and let it dissolve; do not swallow it whole. Only remove the tablet from the blister pack when you're ready to take it, and take it immediately after opening the pack. Do not store the removed tablet for later use. After the tablet has dissolved, drink a glass of water.
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're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to 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 Aricept ODT exactly as prescribed by your doctor, usually once daily at bedtime.
- Place the tablet on your tongue, allow it to dissolve, and then swallow with or without water.
- Do not crush, chew, or split the tablet.
- Do not stop taking this medication suddenly without consulting your doctor, as it may worsen symptoms.
- Report any new or worsening side effects to your doctor, especially severe nausea, vomiting, diarrhea, dizziness, fainting, or signs of stomach bleeding (e.g., black or tarry stools).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg orally once daily at bedtime
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
Alzheimer's Disease (mild to moderate):
Initial: 5 mg orally once daily at bedtime. After 4-6 weeks, may increase to 10 mg orally once daily at bedtime if tolerated and clinically indicated. Max: 10 mg/day.
Alzheimer's Disease (moderate to severe):
Initial: 5 mg orally once daily at bedtime. After 4-6 weeks, may increase to 10 mg orally once daily at bedtime. After 3 months at 10 mg/day, may increase to 23 mg orally once daily if clinically indicated (for conventional tablets, ODT is only 5mg/10mg). Max for ODT: 10 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
No dose adjustment required, but use with caution due to limited data.
Dialysis:
No specific recommendations; donepezil is not dialyzable.
Hepatic Impairment:
Mild:
No dose adjustment required.
Moderate:
Use with caution; monitor for adverse effects. No specific dose adjustment guidelines.
Severe:
Use with extreme caution; consider lower starting dose and slower titration, or avoidance. 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, which is thought to compensate for the cholinergic deficit 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:
96% (primarily to albumin and alpha1-acid glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 70 hours
Clearance:
0.13 L/hr/kg
ExcretionRoute:
Urine (57%) and feces (14%)
Unchanged:
Approximately 17% (urine)
Pharmacodynamics
OnsetOfAction:
Gradual; therapeutic effects typically observed after several weeks of consistent dosing.
PeakEffect:
Steady-state plasma concentrations are achieved within approximately 15 days.
DurationOfAction:
Long; allows for once-daily dosing.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help 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
Heartburn
Severe stomach pain
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 experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness, fatigue, or weakness
Diarrhea, upset stomach, or vomiting
Trouble sleeping
Muscle cramps
Decreased appetite
Weight loss
Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help 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
Heartburn
Severe stomach pain
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 experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness, fatigue, or weakness
Diarrhea, upset stomach, or vomiting
Trouble sleeping
Muscle cramps
Decreased appetite
Weight loss
Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent nausea, vomiting, or diarrhea
- Black, tarry, or bloody stools (signs of gastrointestinal bleeding)
- Severe dizziness or fainting (syncope)
- Slow heart rate (bradycardia)
- New or worsening muscle cramps or weakness
- Difficulty urinating
- Seizures
- Worsening of respiratory problems (e.g., asthma, COPD)
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, any of 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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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, any of 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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. While this drug can help manage symptoms, it is not a cure for 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
- Sweating
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Respiratory depression
- Collapse
- Convulsions
- Increased muscle weakness (may be fatal if respiratory muscles are involved)
What to Do:
In case of overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Atropine sulfate may be used as an antidote for cholinergic crisis.
Drug Interactions
Major Interactions
- Anticholinergic agents (e.g., atropine, scopolamine, benztropine): May antagonize the effects of donepezil.
- Other cholinesterase inhibitors (e.g., rivastigmine, galantamine): Concomitant use is not recommended due to increased risk of cholinergic side effects.
Moderate Interactions
- Succinylcholine, other neuromuscular blocking agents: Donepezil may exaggerate neuromuscular blockade.
- Beta-blockers (e.g., metoprolol, carvedilol): Increased risk of bradycardia and syncope.
- NSAIDs (e.g., ibuprofen, naproxen): Increased risk of gastrointestinal bleeding, especially in patients with a history of ulcers.
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, fluoxetine): May increase donepezil plasma concentrations.
- CYP2D6 inhibitors (e.g., quinidine, paroxetine, fluoxetine): May increase donepezil plasma concentrations.
Minor Interactions
- CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital): May decrease donepezil plasma concentrations.
- CYP2D6 inducers (e.g., rifampin): May decrease donepezil plasma concentrations.
Monitoring
Baseline Monitoring
Cognitive function assessment (e.g., MMSE, ADAS-Cog)
Rationale: To establish baseline cognitive status and track disease progression/response to treatment.
Timing: Prior to initiation of therapy.
Heart rate and rhythm (ECG if clinically indicated)
Rationale: Donepezil can cause bradycardia and QT prolongation, especially in patients with pre-existing cardiac conditions.
Timing: Prior to initiation, particularly in patients with cardiac risk factors.
Weight
Rationale: To monitor for significant weight loss, which can occur with GI side effects.
Timing: Prior to initiation.
Routine Monitoring
Cognitive function assessment
Frequency: Every 6-12 months, or as clinically indicated.
Target: Improvement or stabilization of cognitive scores.
Action Threshold: Significant decline may warrant re-evaluation of treatment.
Heart rate and blood pressure
Frequency: Periodically, especially during dose titration or if symptoms of bradycardia/syncope occur.
Target: Within normal limits for the patient.
Action Threshold: Bradycardia (<50 bpm), symptomatic hypotension, or syncope.
Gastrointestinal symptoms (nausea, vomiting, diarrhea, dyspepsia)
Frequency: Regularly, especially during dose titration.
Target: Minimal to no symptoms.
Action Threshold: Persistent or severe symptoms may require dose reduction or discontinuation.
Weight
Frequency: Periodically.
Target: Stable.
Action Threshold: Significant unintentional weight loss.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Bradycardia (slow heart rate)
- Syncope (fainting)
- Muscle cramps
- Insomnia
- Anorexia
- Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground emesis)
Special Patient Groups
Pregnancy
Donepezil is classified as 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 for adverse effects on fetal development, though human data are limited.
Second Trimester:
Limited data; potential risks remain.
Third Trimester:
Limited data; potential risks remain.
Lactation
It is not known whether donepezil is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, 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 unknown; potential for cholinergic effects in the infant.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Donepezil is not indicated for use in children.
Geriatric Use
Donepezil is primarily used in the geriatric population for Alzheimer's disease. No specific dose adjustment is required based solely on age. However, geriatric patients may be more susceptible to cholinergic side effects (e.g., bradycardia, syncope, GI upset) and should be monitored closely.
Clinical Information
Clinical Pearls
- Aricept ODT (Orally Disintegrating Tablet) is beneficial for patients who have difficulty swallowing conventional tablets.
- Administer at bedtime to potentially mitigate gastrointestinal side effects like nausea and vomiting, as the patient will be asleep during the peak plasma concentration.
- Therapeutic effects are gradual and may take several weeks to months to become apparent. Patients and caregivers should be counseled on realistic expectations.
- Donepezil does not cure Alzheimer's disease but may help slow the progression of symptoms.
- Monitor for signs of cholinergic crisis, especially during dose escalation or if other cholinergic agents are co-administered.
- Caution should be exercised in patients with a history of asthma, COPD, or other obstructive pulmonary diseases, as cholinesterase inhibitors can increase bronchial secretions and bronchoconstriction.
Alternative Therapies
- Rivastigmine (Exelon, Exelon Patch) - another acetylcholinesterase inhibitor
- Galantamine (Razadyne) - another acetylcholinesterase inhibitor
- Memantine (Namenda) - an NMDA receptor antagonist (often used in moderate to severe AD, sometimes in combination with donepezil)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 for generic 30 tablets per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Generic donepezil is typically covered as a Tier 1 or Tier 2 medication by most insurance plans. Brand-name Aricept ODT may be Tier 3 or higher.
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 your 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.