Aricept 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
Agents for Alzheimer's Disease
Pharmacologic Class
Cholinesterase Inhibitors
Pregnancy Category
Category C
FDA Approved
Nov 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Donepezil 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. It can help improve memory, awareness, and the ability to function in people with Alzheimer's, but it is not a cure.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Take your medication at bedtime, with or without food. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from 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 by your doctor or pharmacist. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.
Missing a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at once or take extra doses. If you miss seven days of your medication, contact your doctor for guidance on what to do next.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Take your medication at bedtime, with or without food. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from 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 by your doctor or pharmacist. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.
Missing a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at once or take extra doses. If you miss seven days of your medication, contact your doctor for guidance on what to do next.
Lifestyle & Tips
- Take donepezil exactly as prescribed by your doctor, usually once daily at bedtime.
- Taking it at bedtime may help reduce side effects like nausea.
- Do not stop taking donepezil suddenly without consulting your doctor, as this may worsen symptoms.
- Report any new or worsening symptoms to your doctor.
- Maintain a healthy lifestyle, including a balanced diet, regular exercise (as appropriate), and mental stimulation, as these can complement treatment for Alzheimer's disease.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg orally once daily at bedtime for 4-6 weeks, then may increase to 10 mg orally once daily at bedtime.
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
mild_moderate_alzheimers:
Initial 5 mg/day, maintenance 10 mg/day.
severe_alzheimers:
For severe AD, a 23 mg dose is available, but the request is for 10mg tablets. The 10mg dose is also used in severe AD.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment typically required.
Moderate:
No dose adjustment typically required.
Severe:
Use with caution; monitor for adverse effects. No specific dose adjustment guidelines.
Dialysis:
Not significantly dialyzable. Use with caution; monitor for adverse effects.
Hepatic Impairment:
Mild:
No dose adjustment typically required.
Moderate:
Use with caution; monitor for adverse effects. No specific dose adjustment guidelines.
Severe:
Use with caution; 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 in the synaptic cleft, thereby enhancing cholinergic neurotransmission in the central nervous system. This action is thought to compensate for the cholinergic deficit observed 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 alpha-1-acid glycoprotein)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 70 hours
Clearance:
Not available (variable)
ExcretionRoute:
Urine (57%), Feces (15%)
Unchanged:
Approximately 17% (in urine)
Pharmacodynamics
OnsetOfAction:
Clinical effects may take weeks to months to become apparent.
PeakEffect:
Steady-state plasma concentrations are achieved within approximately 15 days.
DurationOfAction:
Due to its long half-life, once-daily dosing maintains therapeutic concentrations.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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
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 breathing difficulties
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 any other unusual symptoms, contact your doctor for guidance:
Dizziness, fatigue, or weakness
Diarrhea, stomach upset, or vomiting
Sleep disturbances
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, 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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
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 breathing difficulties
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 any other unusual symptoms, contact your doctor for guidance:
Dizziness, fatigue, or weakness
Diarrhea, stomach upset, or vomiting
Sleep disturbances
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, 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
- New or worsening stomach pain or heartburn
- Very slow heart rate or fainting spells (syncope)
- Seizures
- Difficulty urinating
- Dark stools or vomiting blood (signs of GI bleeding)
- Worsening of breathing 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, 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.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions. Your doctor and pharmacist will work together to determine the best course of treatment for you.
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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions. Your doctor and pharmacist will work together to determine the best course of treatment for you.
Precautions & Cautions
It is essential to inform all 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 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 (potentially 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. Treatment may involve supportive care and atropine as an 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., phenytoin, carbamazepine, rifampin, dexamethasone, phenobarbital): May decrease donepezil plasma concentrations.
- Beta-blockers (e.g., metoprolol, propranolol): Increased risk of bradycardia and syncope.
- NSAIDs (Nonsteroidal Anti-inflammatory Drugs): Increased risk of gastrointestinal bleeding (due to increased gastric acid secretion from cholinergic stimulation).
Monitoring
Baseline Monitoring
Cognitive function (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 cardiac history)
Rationale: Donepezil can cause bradycardia and syncope due to its cholinergic effects.
Timing: Prior to initiation of therapy, especially in patients with pre-existing cardiac conditions.
Gastrointestinal symptoms
Rationale: To assess for baseline GI issues that may be exacerbated by donepezil.
Timing: Prior to initiation of therapy.
Routine Monitoring
Cognitive function
Frequency: Periodically (e.g., every 6-12 months or as clinically indicated)
Target: Improvement or stabilization of cognitive scores
Action Threshold: Significant decline in cognitive function may warrant re-evaluation of therapy.
Heart rate and blood pressure
Frequency: Regularly, especially during dose titration and in patients with cardiac risk factors
Target: Within normal limits for the patient
Action Threshold: Symptomatic bradycardia (<50 bpm), syncope, or significant hypotension should prompt evaluation and potential dose reduction/discontinuation.
Gastrointestinal symptoms (nausea, vomiting, diarrhea, dyspepsia)
Frequency: Regularly, especially during dose titration
Target: Minimal to no symptoms
Action Threshold: Persistent or severe GI symptoms may require dose reduction or discontinuation.
Weight
Frequency: Periodically
Target: Stable
Action Threshold: Significant unintentional weight loss may indicate underlying issues or drug-related adverse effects.
Symptom Monitoring
- Bradycardia (slow heart rate)
- Syncope (fainting)
- Dizziness
- Nausea
- Vomiting
- Diarrhea
- Dyspepsia (indigestion)
- Anorexia
- Insomnia
- Muscle cramps
- Fatigue
- Agitation
- Urinary incontinence
Special Patient Groups
Pregnancy
Donepezil is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, though human data are limited.
Second Trimester:
Potential for adverse effects on fetal development, though human data are limited.
Third Trimester:
Potential for adverse effects on fetal development, though human data are limited. Cholinergic effects could theoretically affect uterine tone or fetal heart rate.
Lactation
Donepezil is excreted in the milk of rats. 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 L3 (Moderately safe, but caution advised). Potential for cholinergic effects in the infant (e.g., bradycardia, GI upset).
Pediatric Use
The safety and effectiveness of donepezil 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 should be monitored closely.
Clinical Information
Clinical Pearls
- Donepezil should be taken once daily at bedtime to help minimize gastrointestinal side effects such as nausea and vomiting.
- Titrate the dose slowly (e.g., 5 mg for 4-6 weeks before increasing to 10 mg) to improve tolerability.
- Donepezil is not a cure for Alzheimer's disease but may help slow the progression of symptoms and improve cognitive function.
- Patients and caregivers should be educated on common side effects and when to seek medical attention, particularly for syncope or severe GI symptoms.
- Monitor for signs of bradycardia, especially in patients with pre-existing cardiac conditions or those taking other medications that slow heart rate (e.g., beta-blockers).
Alternative Therapies
- Other Cholinesterase Inhibitors: Rivastigmine (Exelon), Galantamine (Razadyne)
- NMDA Receptor Antagonist: Memantine (Namenda) - often used in moderate to severe AD, sometimes in combination with donepezil.
Cost & Coverage
Average Cost:
Check current 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'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, including the amount taken and the time it happened, to ensure you receive the best possible care.