Aricept ODT 10mg 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
Cholinesterase Inhibitor
Pharmacologic Class
Central Acetylcholinesterase Inhibitor
Pregnancy Category
Category C
FDA Approved
Nov 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aricept ODT is a medication used to treat Alzheimer's disease. It works by increasing a natural substance in the brain called acetylcholine, which is important for memory and thinking. This medicine comes as an orally disintegrating tablet, meaning it dissolves quickly in your mouth without water.
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 feel well. Take the medication at bedtime, with or without food. Unless your doctor advises you to limit fluid intake, drink plenty of non-caffeinated liquids.
Before taking the medication, wash and dry your hands. Do not handle the tablet with wet or damp hands. Place the tablet on your tongue and let it dissolve. Do not swallow the tablet whole. Only remove the medication from the blister pack when you are ready to take it, and take it immediately after opening the pack. Do not store the removed medication 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 bathrooms. 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 have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or 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 feel well. Take the medication at bedtime, with or without food. Unless your doctor advises you to limit fluid intake, drink plenty of non-caffeinated liquids.
Before taking the medication, wash and dry your hands. Do not handle the tablet with wet or damp hands. Place the tablet on your tongue and let it dissolve. Do not swallow the tablet whole. Only remove the medication from the blister pack when you are ready to take it, and take it immediately after opening the pack. Do not store the removed medication 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 bathrooms. 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 have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or 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, usually in the evening just before bedtime, to help reduce side effects like nausea.
- Place the tablet on your tongue and allow it to dissolve completely before swallowing. Do not chew or crush it.
- Maintain a balanced diet and stay hydrated, especially if experiencing gastrointestinal side effects.
- Report any new or worsening symptoms to your doctor, especially dizziness, fainting, or severe stomach upset.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg orally once daily for 4-6 weeks, then may increase to 10 mg orally once daily.
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
mildToModerateAlzheimersDisease:
Initial 5 mg once daily, may increase to 10 mg once daily after 4-6 weeks.
moderateToSevereAlzheimersDisease:
Initial 5 mg once daily, may increase to 10 mg once daily after 4-6 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment generally required.
Moderate:
No dose adjustment generally required.
Severe:
Use with caution; no specific dose adjustment recommendations, but monitor for adverse effects.
Dialysis:
Donepezil is not dialyzable; no specific dose adjustment recommendations.
Hepatic Impairment:
Mild:
No dose adjustment generally required.
Moderate:
No dose adjustment generally required.
Severe:
Use with caution; no specific dose adjustment recommendations, but monitor for adverse effects.
Pharmacology
Mechanism of Action
Donepezil is a reversible inhibitor of acetylcholinesterase, the enzyme responsible for the hydrolysis of acetylcholine. By inhibiting acetylcholinesterase, 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:
Approximately 100%
Tmax:
3-4 hours
FoodEffect:
Food does not affect the rate or extent of absorption.
Distribution:
Vd:
Approximately 12 L/kg
ProteinBinding:
Approximately 96% (primarily to albumin and alpha1-acid glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 70 hours
Clearance:
Approximately 0.13 L/hr/kg
ExcretionRoute:
Urine (57%) and feces (14.5%)
Unchanged:
Approximately 17% (in urine)
Pharmacodynamics
OnsetOfAction:
Gradual, clinical effects typically observed over several weeks.
PeakEffect:
Clinical effects may take several weeks to months to stabilize.
DurationOfAction:
Due to its long half-life, once-daily dosing provides sustained acetylcholinesterase inhibition.
Safety & Warnings
Side Effects
Serious 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 immediately or seek emergency 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
Severe dizziness or fainting
Abnormally slow heartbeat
Irregular heartbeat
Difficulty urinating
Seizures
Heartburn
Severe stomach pain
Vomiting blood or coffee ground-like material
Black, tarry, or bloody stools
New or worsening breathing difficulties
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 if they bother you or persist, contact your doctor:
Dizziness, fatigue, or weakness
Diarrhea, stomach upset, or vomiting
Sleep disturbances
Muscle cramps
Decreased appetite
Weight loss
Headache
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 immediately or seek emergency 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
Severe dizziness or fainting
Abnormally slow heartbeat
Irregular heartbeat
Difficulty urinating
Seizures
Heartburn
Severe stomach pain
Vomiting blood or coffee ground-like material
Black, tarry, or bloody stools
New or worsening breathing difficulties
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 if they bother you or persist, contact your doctor:
Dizziness, fatigue, or weakness
Diarrhea, stomach upset, or vomiting
Sleep disturbances
Muscle cramps
Decreased appetite
Weight loss
Headache
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 nausea, vomiting, or diarrhea
- Black or tarry stools (signs of GI bleeding)
- New or worsening stomach pain
- Slow or irregular heartbeat
- Dizziness or fainting spells (syncope)
- Difficulty urinating
- Seizures
- Unusual weakness or muscle cramps
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergy, be sure to describe the symptoms you experienced.
This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must 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 any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergy, be sure to describe the symptoms you experienced.
This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must 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 for 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 (potentially leading to death if respiratory muscles are involved)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Atropine is a commonly used antidote for cholinergic crisis.
Drug Interactions
Major Interactions
- Anticholinergic agents (e.g., atropine, scopolamine): May antagonize the effects of donepezil.
- Succinylcholine, other neuromuscular blocking agents: May prolong neuromuscular blockade.
Moderate Interactions
- 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., rifampin, phenytoin, carbamazepine, phenobarbital): May decrease donepezil plasma concentrations.
- Beta-blockers (e.g., metoprolol, carvedilol): Increased risk of bradycardia and syncope.
- NSAIDs (e.g., ibuprofen, naproxen): Increased risk of gastrointestinal bleeding (due to increased gastric acid secretion).
Monitoring
Baseline Monitoring
Cognitive function assessment (e.g., MMSE, ADAS-Cog)
Rationale: To establish baseline cognitive status and track disease progression/response to therapy.
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, especially in patients with pre-existing cardiac conditions.
Routine Monitoring
Cognitive function assessment
Frequency: Every 6-12 months or as clinically indicated
Target: Not applicable (monitoring for stability or slowing of decline)
Action Threshold: Significant decline may warrant re-evaluation of therapy.
Heart rate and blood pressure
Frequency: Periodically, especially during dose titration or if symptoms of bradycardia/syncope occur
Target: Normal physiological range
Action Threshold: Symptomatic bradycardia (<50 bpm), syncope, or significant hypotension may require dose reduction or discontinuation.
Gastrointestinal symptoms (nausea, vomiting, diarrhea)
Frequency: Regularly, especially during initiation and dose titration
Target: Absence of severe symptoms
Action Threshold: Persistent or severe symptoms may require dose reduction 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
- Dizziness
- Headache
- Insomnia
- Fatigue
- Muscle cramps
- Syncope
- Bradycardia (slow heart rate)
- 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 to fetus, but human data are limited.
Second Trimester:
Potential risk to fetus, but human data are limited.
Third Trimester:
Potential risk to fetus, 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:
Unknown, but potential for serious adverse effects (e.g., 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
No specific dose adjustment is required based solely on age. However, elderly patients may be more susceptible to cholinergic side effects (e.g., bradycardia, syncope, GI upset), and careful monitoring is warranted.
Clinical Information
Clinical Pearls
- Aricept ODT is particularly useful for patients who have difficulty swallowing tablets.
- Administering donepezil at bedtime may help mitigate common gastrointestinal side effects like nausea and vomiting.
- Patients and caregivers should be educated on the potential for dizziness and syncope, especially when initiating therapy or increasing dose.
- Donepezil does not cure Alzheimer's disease but may help slow the progression of symptoms.
- Regular reassessment of cognitive function and tolerability is crucial to determine continued benefit.
Alternative Therapies
- Rivastigmine (Exelon, Exelon Patch) - another cholinesterase inhibitor
- Galantamine (Razadyne) - another cholinesterase inhibitor
- Memantine (Namenda) - NMDA receptor antagonist (often used in moderate to severe AD, sometimes in combination with donepezil)
Cost & Coverage
Average Cost:
Varies, typically $10-$50 for generic 10mg, higher for brand per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic, Tier 3 or higher for brand
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.