Donepezil 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
Cholinesterase Inhibitor
Pharmacologic Class
Acetylcholinesterase Inhibitor
Pregnancy 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 (acetylcholine) that 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're feeling 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 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 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 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 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 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 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 extra doses. If you miss seven consecutive days of medication, contact your doctor for guidance on how to proceed.
Lifestyle & Tips
- Take this medication exactly as prescribed by your doctor, usually once daily at bedtime.
- For the ODT (Orally Disintegrating Tablet) form: Do not crush, chew, or split the tablet. Place the tablet on your tongue, allow it to dissolve completely, and then swallow with or without water.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double your dose.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products, as interactions can occur.
- Report any new or worsening symptoms to your doctor promptly.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg orally once daily at bedtime for at least 4-6 weeks, then may increase to 10 mg orally once daily at bedtime.
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
mildToModerateAlzheimers:
5 mg orally once daily at bedtime, increasing to 10 mg after 4-6 weeks if tolerated.
moderateToSevereAlzheimers:
10 mg orally once daily at bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment generally required.
Moderate:
No dosage adjustment generally required.
Severe:
Use with caution; monitor for adverse effects. No specific dose adjustment guidelines.
Dialysis:
Donepezil is not dialyzable. No specific dose adjustment guidelines, but monitor closely.
Hepatic Impairment:
Mild:
No dosage adjustment generally 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. 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:
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:
Renal (urine) and Fecal (bile)
Unchanged:
Approximately 17% (urine), 14% (feces)
Pharmacodynamics
OnsetOfAction:
Clinical effects typically observed after several weeks of consistent dosing.
PeakEffect:
Peak clinical benefit may take several months of treatment.
DurationOfAction:
Due to its long half-life, once-daily dosing provides sustained acetylcholinesterase inhibition.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
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 if they bother you or persist, contact your doctor:
Dizziness, fatigue, or weakness
Diarrhea, upset stomach, 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, 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, this medication can cause severe and potentially life-threatening side effects. If you experience 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
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 if they bother you or persist, contact your doctor:
Dizziness, fatigue, or weakness
Diarrhea, upset stomach, 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, 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 nausea, vomiting, or diarrhea
- Black, tarry stools or vomit that looks like coffee grounds (signs of GI bleeding)
- Severe dizziness or fainting (syncope)
- Very slow heartbeat
- New or worsening stomach pain
- Difficulty breathing or worsening asthma/COPD symptoms
- 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 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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or worsen certain health problems.
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 assess potential interactions and ensure safe use.
All your health problems, as this medication may affect certain conditions or be affected by them.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or worsen certain health problems.
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 assess potential interactions and ensure safe use.
All your health problems, as this medication may affect certain conditions or be affected by them.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 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 heartbeat)
- 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 your local emergency number. For poison control, call 1-800-222-1222. Atropine is typically used as an antidote for cholinergic crisis.
Drug Interactions
Major Interactions
- Anticholinergic agents (e.g., atropine, scopolamine, tricyclic antidepressants, antipsychotics): May antagonize the effects of donepezil.
- Succinylcholine, other neuromuscular blocking agents: Donepezil may exaggerate neuromuscular blockade.
Moderate Interactions
- NSAIDs (e.g., ibuprofen, naproxen): Increased risk of gastrointestinal bleeding and peptic ulcers.
- Beta-blockers (e.g., metoprolol, propranolol): Increased risk of bradycardia and syncope.
- Other cholinesterase inhibitors (e.g., rivastigmine, galantamine): Increased risk of cholinergic adverse effects.
- 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.
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 blood pressure
Rationale: Donepezil can cause bradycardia and syncope due to its cholinergic effects.
Timing: Prior to initiation of therapy.
Gastrointestinal symptoms assessment
Rationale: To assess for pre-existing GI conditions (e.g., ulcer disease) that may be exacerbated.
Timing: Prior to initiation of therapy.
Routine Monitoring
Cognitive function assessment
Frequency: Every 6-12 months, or as clinically indicated.
Target: Improvement or stabilization of cognitive decline.
Action Threshold: Significant decline may warrant re-evaluation of treatment plan.
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 may require dose reduction or discontinuation.
Gastrointestinal symptoms (nausea, vomiting, diarrhea, dyspepsia)
Frequency: Regularly, especially during dose titration.
Target: Absence or mild, tolerable symptoms.
Action Threshold: Severe or persistent 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
- Bradycardia
- Syncope
- Dizziness
- Nausea
- Vomiting
- Diarrhea
- Dyspepsia
- Anorexia
- Weight loss
- Insomnia
- Muscle cramps
- Fatigue
- Urinary incontinence
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 for developmental toxicity based on animal studies at high doses.
Second Trimester:
Limited human data, animal studies show some risk.
Third Trimester:
Limited human data, animal studies show some risk.
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, but potential for cholinergic effects in 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, but elderly patients may be more susceptible to cholinergic side effects (e.g., bradycardia, syncope, GI upset).
Clinical Information
Clinical Pearls
- Donepezil ODT is beneficial for patients who have difficulty swallowing conventional tablets.
- Administer donepezil at bedtime to help mitigate common side effects like nausea and dizziness, which may occur more frequently during initial therapy.
- Titrate the dose slowly (e.g., 5 mg for 4-6 weeks before increasing to 10 mg) to improve tolerability and reduce the incidence of adverse effects.
- Monitor for signs of cholinergic crisis, especially if other cholinergic medications are co-administered.
- Patients should be advised to report any signs of gastrointestinal bleeding, such as black or tarry stools, especially if they are also taking NSAIDs.
Alternative Therapies
- Rivastigmine (Exelon, Exelon Patch) - another acetylcholinesterase inhibitor
- Galantamine (Razadyne) - another acetylcholinesterase inhibitor
- Memantine (Namenda) - an NMDA receptor antagonist, often used in combination with donepezil for moderate to severe Alzheimer's.
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 5mg ODT)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. If you have any questions or concerns about your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.