Donepezil 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
Acetylcholinesterase Inhibitor
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 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 function in 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 feel well. Take the medication at bedtime, with or without food. It's essential to 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 thoroughly. Do not touch 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're ready to take it, and take it immediately after opening the pack. Do not store the removed medication for future 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 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 dosing 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 feel well. Take the medication at bedtime, with or without food. It's essential to 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 thoroughly. Do not touch 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're ready to take it, and take it immediately after opening the pack. Do not store the removed medication for future 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 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 dosing 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 exactly as prescribed, usually once daily at bedtime.
- Place the orally disintegrating tablet on the tongue and allow it to dissolve completely before swallowing with or without water.
- Do not crush, chew, or break the tablet.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any new or worsening side effects, especially severe nausea, vomiting, diarrhea, dizziness, fainting, or slow heartbeat.
- Maintain regular follow-up appointments with your doctor to monitor your condition and treatment effectiveness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg orally once daily
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
initial_dose:
5 mg orally once daily for 4-6 weeks, then may increase to 10 mg once daily if tolerated and clinically indicated.
severe_alzheimers:
Some patients with severe Alzheimer's disease may be titrated to 23 mg once daily (not available in ODT formulation).
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; no specific dose adjustment recommendations, but monitor for adverse effects.
Dialysis:
Donepezil is not dialyzable. No specific recommendations, monitor for adverse effects.
Hepatic Impairment:
Mild:
No dose adjustment typically required.
Moderate:
Use with caution; no specific dose adjustment recommendations, but monitor for adverse effects.
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 in the synaptic cleft, thereby enhancing cholinergic neurotransmission in the central nervous system. This action 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:
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 1-3 weeks (clinical effect)
PeakEffect:
Steady-state plasma concentrations are achieved within 15 days.
DurationOfAction:
Due to its long half-life, effects persist for several days after discontinuation.
Confidence:
Medium
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 notice 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. 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 any other symptoms that bother you or do not go away, contact your doctor:
Dizziness, tiredness, 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, 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 notice 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. 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 any other symptoms that bother you or do not go away, contact your doctor:
Dizziness, tiredness, 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, 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 stools or vomit that looks like coffee grounds (signs of stomach bleeding)
- Severe dizziness or fainting (syncope)
- Slow or irregular heartbeat
- New or worsening seizures
- Difficulty urinating
- Muscle weakness or cramps that are severe
- Unexplained weight loss
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) medications, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances.
* 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 current medications and health conditions. Do not initiate, discontinue, or modify 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, 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) medications, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances.
* 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 current medications and health conditions. Do not initiate, discontinue, or modify 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. 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 breast-feeding, 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 (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. Treatment involves general supportive measures and may include atropine as an antidote for cholinergic crisis.
Drug Interactions
Major Interactions
- Anticholinergic agents (e.g., atropine, scopolamine, tricyclic antidepressants, antipsychotics, antihistamines): May antagonize the effects of donepezil.
- Other cholinesterase inhibitors (e.g., rivastigmine, galantamine): Increased risk of cholinergic adverse effects.
Moderate Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, fluoxetine, quinidine): 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.
- Beta-blockers (especially those that slow heart rate): Increased risk of bradycardia and syncope.
- Neuromuscular blocking agents (e.g., succinylcholine): May exaggerate neuromuscular blockade.
Monitoring
Baseline Monitoring
Cognitive function (e.g., MMSE, ADAS-Cog)
Rationale: To establish baseline and assess treatment efficacy.
Timing: Prior to initiation
Heart rate and rhythm (ECG if clinically indicated)
Rationale: Donepezil can cause bradycardia and QT prolongation.
Timing: Prior to initiation, especially in patients with cardiac conduction abnormalities.
Weight
Rationale: To monitor for significant weight loss, a potential adverse effect.
Timing: Prior to initiation
Routine Monitoring
Cognitive function
Frequency: Every 6-12 months or as clinically indicated
Target: Improvement or stabilization of cognitive scores
Action Threshold: Significant decline or lack of benefit may warrant re-evaluation of treatment.
Heart rate
Frequency: Periodically, especially during dose titration or if symptoms of bradycardia occur
Target: Normal sinus rhythm, HR > 60 bpm
Action Threshold: Symptomatic bradycardia, syncope, or significant ECG changes (e.g., new-onset heart block).
Gastrointestinal symptoms (nausea, vomiting, diarrhea)
Frequency: Regularly, especially during dose titration
Target: Absence or mild, tolerable symptoms
Action Threshold: Severe or persistent symptoms requiring dose reduction or discontinuation.
Weight
Frequency: Periodically
Target: Stable weight
Action Threshold: Significant unintentional weight loss.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Anorexia
- Dizziness
- Headache
- Insomnia
- Fatigue
- Muscle cramps
- Syncope
- Bradycardia
- 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:
Limited human data; animal studies show some developmental toxicity at high doses.
Second Trimester:
Limited human data.
Third Trimester:
Limited human data.
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:
L3 (Moderate concern): Potential for cholinergic effects in the infant (e.g., bradycardia, GI upset).
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. No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to cholinergic adverse effects (e.g., bradycardia, syncope, GI upset), and careful monitoring is warranted.
Clinical Information
Clinical Pearls
- Administer donepezil ODT at bedtime to minimize the impact of potential side effects like nausea and dizziness, which are more common during initial therapy.
- The ODT formulation is beneficial for patients who have difficulty swallowing tablets.
- Gradual dose titration (starting at 5mg for 4-6 weeks before increasing to 10mg) is crucial to improve tolerability and reduce gastrointestinal side effects.
- Monitor for signs of bradycardia and syncope, especially in patients with pre-existing cardiac conditions or those taking other heart rate-lowering medications.
- Donepezil does not cure Alzheimer's disease but can help manage symptoms and slow the progression of cognitive decline in some patients.
- Regular assessment of cognitive function and adverse effects is essential to determine continued benefit and tolerability.
Alternative Therapies
- Rivastigmine (Exelon, Exelon Patch)
- Galantamine (Razadyne)
- Memantine (Namenda)
- Memantine/Donepezil combination (Namzaric)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 10mg ODT)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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 overdose, including the medication taken, the amount, and the time it occurred.