Galantamine ER 24mg Capsules
It is used to treat dementia in people with Alzheimer's disease.
Drug Class
Agents for Alzheimer's Disease
Pharmacologic Class
Acetylcholinesterase Inhibitor; Nicotinic Allosteric Potentiator
Pregnancy Category
Category C
FDA Approved
Jun 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Galantamine ER is a medicine used to treat mild to moderate Alzheimer's disease. It works by increasing a natural substance in the brain called acetylcholine, which is important for memory and thinking. This can help improve or maintain mental function in some people with Alzheimer's.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
It is recommended to take your medication with food to help your body absorb it properly.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Take your medication with breakfast to help you remember to take it at the same time every day.
Swallow your medication whole, without chewing, breaking, or crushing it.
Storing and Disposing of Your Medication
To ensure your medication remains effective and safe:
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe and secure 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.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember, with food.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for the missed dose.
If you miss taking your medication for more than 3 days in a row, contact your doctor before restarting your medication.
To get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
It is recommended to take your medication with food to help your body absorb it properly.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Take your medication with breakfast to help you remember to take it at the same time every day.
Swallow your medication whole, without chewing, breaking, or crushing it.
Storing and Disposing of Your Medication
To ensure your medication remains effective and safe:
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe and secure 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.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember, with food.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for the missed dose.
If you miss taking your medication for more than 3 days in a row, contact your doctor before restarting your medication.
Lifestyle & Tips
- Take galantamine ER once daily in the morning, preferably with food, to help reduce stomach upset.
- Swallow the capsule whole; do not chew, crush, or open it.
- Ensure adequate hydration, especially if experiencing nausea, vomiting, or diarrhea.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially over-the-counter cold or allergy medicines, as they may interact with galantamine.
- Be aware of potential side effects like dizziness or slow heart rate, which can increase the risk of falls. Use caution when driving or operating machinery until you know how the medication affects you.
- Do not stop taking galantamine suddenly without consulting your doctor, as this may worsen symptoms.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
24 mg once daily (maintenance dose)
Dose Range:
8 - 24 mg
Condition-Specific Dosing:
Alzheimer's Disease (Mild to Moderate):
Initial: 8 mg once daily for 4 weeks. Increase to 16 mg once daily for 4 weeks. Maintenance: 24 mg once daily. Doses should be taken in the morning with food.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required (CrCl 50-89 mL/min)
Moderate:
Maximum dose 16 mg/day (CrCl 9-49 mL/min)
Severe:
Not recommended (CrCl < 9 mL/min)
Dialysis:
Not recommended; Galantamine and its metabolites are not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment required (Child-Pugh A)
Moderate:
Maximum dose 16 mg/day (Child-Pugh B)
Severe:
Not recommended (Child-Pugh C)
Pharmacology
Mechanism of Action
Galantamine is a reversible, competitive acetylcholinesterase inhibitor. It is also an allosteric potentiator of nicotinic acetylcholine receptors (nAChRs), which may enhance the presynaptic release of acetylcholine and modulate postsynaptic nicotinic receptor activity. This dual mechanism is thought to increase the availability of acetylcholine in the synaptic cleft, thereby enhancing cholinergic neurotransmission in the central nervous system.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90% (for immediate release, ER formulation designed for sustained release)
Tmax:
4.5-5 hours (for extended-release capsules)
FoodEffect:
Food does not significantly affect the AUC or Cmax of galantamine ER, but taking it with food may reduce cholinergic side effects.
Distribution:
Vd:
175 L
ProteinBinding:
18%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 10 hours (for extended-release capsules)
Clearance:
Approximately 6.2 L/hr
ExcretionRoute:
Renal (primarily as unchanged drug and metabolites)
Unchanged:
Approximately 20-25% (unchanged drug in urine)
Pharmacodynamics
OnsetOfAction:
Not acutely measurable for cognitive effects; therapeutic effects are gradual over weeks to months.
PeakEffect:
Steady-state plasma concentrations are reached within 7 days of once-daily dosing.
DurationOfAction:
24 hours (due to extended-release formulation)
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent 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 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
Abnormal heart rhythms, including:
+ Slow heartbeat
+ Irregular heartbeat
Gastrointestinal symptoms, such as:
+ Black, tarry, or bloody stools
+ Vomiting blood or coffee ground-like material
Urinary problems, including:
+ Difficulty passing urine
Neurological symptoms, such as:
+ Seizures
+ New or worsening trouble controlling body movements
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, characterized by:
- Red, swollen, blistered, or peeling skin
- Skin irritation (with or without fever)
- Red or irritated eyes
- Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects in some people. While many individuals 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 or headache
Diarrhea, upset stomach, or vomiting
Decreased appetite
Weight loss
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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 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
Abnormal heart rhythms, including:
+ Slow heartbeat
+ Irregular heartbeat
Gastrointestinal symptoms, such as:
+ Black, tarry, or bloody stools
+ Vomiting blood or coffee ground-like material
Urinary problems, including:
+ Difficulty passing urine
Neurological symptoms, such as:
+ Seizures
+ New or worsening trouble controlling body movements
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, characterized by:
- Red, swollen, blistered, or peeling skin
- Skin irritation (with or without fever)
- Red or irritated eyes
- Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects in some people. While many individuals 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 or headache
Diarrhea, upset stomach, or vomiting
Decreased appetite
Weight loss
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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 that leads to dehydration or significant weight loss.
- Slow heart rate (bradycardia) or fainting (syncope).
- New or worsening stomach pain, heartburn, or signs of gastrointestinal bleeding (e.g., black, tarry stools, coffee-ground vomit).
- Difficulty urinating or worsening urinary incontinence.
- New or worsening seizures.
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).
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 allergic reaction you experienced, including any symptoms that occurred.
If you have a history of kidney disease or liver disease, as these conditions may affect how your body processes this medication.
This list is not exhaustive, and it is crucial to discuss all your health concerns with your doctor. To ensure your safety, please disclose all the following information to your doctor and pharmacist:
A complete list of all prescription and over-the-counter medications you are taking, including natural products and vitamins.
Any health problems you are experiencing or have experienced in the past.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so. This will help prevent potential interactions between medications and minimize risks associated with your health conditions.
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 allergic reaction you experienced, including any symptoms that occurred.
If you have a history of kidney disease or liver disease, as these conditions may affect how your body processes this medication.
This list is not exhaustive, and it is crucial to discuss all your health concerns with your doctor. To ensure your safety, please disclose all the following information to your doctor and pharmacist:
A complete list of all prescription and over-the-counter medications you are taking, including natural products and vitamins.
Any health problems you are experiencing or have experienced in the past.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so. This will help prevent potential interactions between medications and minimize risks associated with your health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While taking this drug, you may experience weight loss, and regular weight checks will be necessary to monitor this potential side effect. Be sure to discuss any concerns or questions you have about weight loss with your doctor.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, it is crucial to consult with your doctor. You and your doctor will need to carefully weigh the benefits and risks of taking this medication to ensure the best possible outcome for both you and your baby.
While taking this drug, you may experience weight loss, and regular weight checks will be necessary to monitor this potential side effect. Be sure to discuss any concerns or questions you have about weight loss with your doctor.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, it is crucial to consult with your doctor. You and your doctor will need to carefully weigh the benefits and risks of taking this medication to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Severe vomiting
- Severe diarrhea
- Excessive sweating
- Salivation (drooling)
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Collapse
- Muscle weakness
- Muscle fasciculations (twitching)
- Seizures
- Severe abdominal cramps
- Miosis (pinpoint pupils)
- Respiratory depression
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment involves general supportive measures. Atropine may be used as an antidote for cholinergic crisis.
Drug Interactions
Major Interactions
- Anticholinergic agents (e.g., atropine, scopolamine): May antagonize the effects of galantamine.
- Other cholinesterase inhibitors (e.g., donepezil, rivastigmine): Increased risk of cholinergic side effects (e.g., nausea, vomiting, diarrhea, bradycardia, syncope). Concomitant use is not recommended.
- Drugs that significantly inhibit CYP2D6 (e.g., paroxetine, quinidine, fluoxetine): May increase galantamine exposure, requiring dose reduction.
- Drugs that significantly inhibit CYP3A4 (e.g., ketoconazole, ritonavir, erythromycin): May increase galantamine exposure, requiring dose reduction.
- Drugs that prolong the QT interval: Theoretical risk of additive effect, monitor ECG in susceptible patients.
Moderate Interactions
- Beta-blockers (e.g., metoprolol, propranolol): Increased risk of bradycardia and syncope.
- Digoxin: Increased risk of bradycardia and syncope.
- Neuromuscular blocking agents (e.g., succinylcholine): May exaggerate neuromuscular blockade during anesthesia.
- NSAIDs: Increased risk of GI bleeding due to increased gastric acid secretion (cholinergic effect).
Minor Interactions
- Not available
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: Galantamine can cause bradycardia and syncope due to cholinergic effects.
Timing: Prior to initiation of therapy
Weight
Rationale: To monitor for significant weight loss, which can occur due to GI side effects.
Timing: Prior to initiation of therapy
ECG
Rationale: Consider for patients with pre-existing cardiac conduction abnormalities or those at risk for bradycardia.
Timing: Prior to initiation of therapy, if indicated
Routine Monitoring
Cognitive function assessment
Frequency: Every 6-12 months or as clinically indicated
Target: Stabilization or slower decline of cognitive scores
Action Threshold: Significant decline in cognitive function may warrant re-evaluation of treatment or dose adjustment.
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: Symptomatic bradycardia (<50 bpm), syncope, or significant hypotension may require dose reduction or discontinuation.
Gastrointestinal symptoms (nausea, vomiting, diarrhea)
Frequency: Regularly, especially during dose titration
Target: Minimal to no symptoms
Action Threshold: Persistent or severe symptoms may require dose reduction, temporary discontinuation, or symptomatic treatment.
Weight
Frequency: Periodically
Target: Stable weight
Action Threshold: Significant unintentional weight loss may indicate persistent GI side effects or other issues.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Anorexia
- Weight loss
- Bradycardia
- Syncope
- Falls
- Urinary incontinence
- Muscle cramps
- Fatigue
- Insomnia
- Agitation
Special Patient Groups
Pregnancy
Galantamine 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:
Animal studies show developmental toxicity at doses higher than human therapeutic doses. Risk to human fetus is uncertain.
Second Trimester:
Not available
Third Trimester:
Not available
Lactation
Galantamine 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 risk) - Potential for cholinergic effects in the infant (e.g., bradycardia, vomiting, diarrhea).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Galantamine is not indicated for use in children.
Geriatric Use
Galantamine is primarily used in the geriatric population for Alzheimer's disease. While efficacy is established, older patients may be more susceptible to cholinergic side effects (e.g., bradycardia, syncope, GI upset). Dose titration and careful monitoring are crucial.
Clinical Information
Clinical Pearls
- Galantamine ER should be taken once daily in the morning with food to minimize gastrointestinal side effects.
- The extended-release formulation helps improve adherence and reduce peak-to-trough fluctuations compared to immediate-release formulations.
- Titration is crucial to minimize side effects; do not skip titration steps.
- Monitor for signs of bradycardia, syncope, and falls, especially in patients with pre-existing cardiac conditions.
- Inform patients and caregivers that galantamine treats symptoms of Alzheimer's disease but does not cure it or stop its progression.
- If treatment is interrupted for several days, re-initiate at the lowest dose and re-titrate to avoid severe side effects.
- Be mindful of drug interactions, particularly with other cholinergic agents, anticholinergics, and drugs affecting CYP2D6/3A4.
Alternative Therapies
- Donepezil (Aricept)
- Rivastigmine (Exelon, Exelon Patch)
- Memantine (Namenda)
- Memantine/Donepezil combination (Namzaric)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$150 per 30 capsules (24mg)
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 is essential to contact your doctor promptly. 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 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.