Galantamine ER 16mg Capsules
It is used to treat dementia in people with Alzheimer's disease.
Drug Class
Cholinesterase Inhibitor
Pharmacologic Class
Acetylcholinesterase Inhibitor; Allosteric Modulator of Nicotinic Acetylcholine Receptors
Pregnancy Category
Category C
FDA Approved
Jun 2001
DEA Schedule
Not Controlled
Overview
What is this medicine?
Galantamine ER is a medication used to treat mild to moderate 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 perform daily activities.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow these guidelines:
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's 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 secure location, out of 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's 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 three consecutive days, contact your doctor before restarting your medication.
To get the most benefit from your medication, follow these guidelines:
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's 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 secure location, out of 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's 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 three consecutive days, contact your doctor before restarting your medication.
Lifestyle & Tips
- Take the capsule once daily in the morning, preferably with food to reduce stomach upset.
- Swallow the capsule whole; do not chew, crush, or open it.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.
- If you stop taking the medication for several days, consult your doctor before restarting, as you may need to restart at a lower dose.
- Stay hydrated, especially if experiencing nausea, vomiting, or diarrhea.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 8 mg once daily for 4 weeks. Maintenance: 16 mg once daily for at least 4 weeks. Max: 24 mg once daily.
Dose Range:
8 - 24 mg
Condition-Specific Dosing:
Mild to Moderate Alzheimer's Disease:
Initial: 8 mg once daily for 4 weeks. If tolerated, increase to 16 mg once daily for at least 4 weeks. If tolerated and further clinical benefit is desired, may increase to 24 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed (CrCl > 50 mL/min)
Moderate:
Maximum dose 16 mg/day (CrCl 9-50 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 dosage adjustment needed (Child-Pugh A)
Moderate:
Maximum dose 16 mg/day (Child-Pugh B)
Severe:
Not recommended (Child-Pugh C)
Confidence:
Medium
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.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90% (oral solution)
Tmax:
Approximately 4.5-5 hours (ER capsules)
FoodEffect:
Food does not affect the AUC or Cmax of galantamine ER capsules, but may delay Tmax by about 1.5 hours. Taking with food may reduce gastrointestinal side effects.
Distribution:
Vd:
Approximately 175 L
ProteinBinding:
Approximately 18%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 7-8 hours (ER capsules)
Clearance:
Approximately 6.2 L/hr
ExcretionRoute:
Renal (primarily 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.
PeakEffect:
Not acutely measurable for cognitive effects; peak plasma concentration reached in 4.5-5 hours.
DurationOfAction:
Extended-release formulation provides once-daily dosing.
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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Abnormal heart rhythms, including:
+ Slow heartbeat
+ Irregular heartbeat
Gastrointestinal bleeding, characterized by:
+ Black, tarry, or bloody stools
+ Vomiting blood or coffee ground-like material
Urinary retention or difficulty passing urine
Seizures
New or worsening trouble controlling body movements
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, such as:
- 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. 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 unusual symptoms, contact your doctor for guidance:
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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Abnormal heart rhythms, including:
+ Slow heartbeat
+ Irregular heartbeat
Gastrointestinal bleeding, characterized by:
+ Black, tarry, or bloody stools
+ Vomiting blood or coffee ground-like material
Urinary retention or difficulty passing urine
Seizures
New or worsening trouble controlling body movements
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, such as:
- 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. 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 unusual symptoms, contact your doctor for guidance:
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
- Slow heart rate, dizziness, or fainting spells (syncope)
- New or worsening chest pain or shortness of breath
- Seizures
- Difficulty urinating or increased urinary incontinence
- Signs of stomach bleeding (e.g., black, tarry stools; vomit that looks like coffee grounds)
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 the medication.
This list is not exhaustive, and it is crucial to discuss all your health concerns with your doctor. To ensure safe treatment, 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 to do so. This will help prevent potential interactions and ensure the medication is suitable for your specific health needs.
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 the medication.
This list is not exhaustive, and it is crucial to discuss all your health concerns with your doctor. To ensure safe treatment, 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 to do so. This will help prevent potential interactions and ensure the medication is suitable for your specific health needs.
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 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 this medication to 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 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 this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Vomiting
- Diarrhea
- Excessive sweating
- Salivation (drooling)
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Collapse
- Seizures
- Muscle weakness
- Severe muscle cramps
- Respiratory depression (slow, shallow breathing)
What to Do:
Call 911 or Poison Control immediately (1-800-222-1222). Treatment is supportive and may include atropine for severe cholinergic symptoms.
Drug Interactions
Major Interactions
- Other cholinesterase inhibitors (e.g., donepezil, rivastigmine): Increased risk of cholinergic side effects.
- Succinylcholine: Enhanced neuromuscular blockade.
Moderate Interactions
- Anticholinergic agents (e.g., atropine, scopolamine, tricyclic antidepressants, antipsychotics): Antagonistic effects, reduced efficacy of both drugs.
- Beta-blockers (e.g., metoprolol, carvedilol): Increased risk of bradycardia and syncope.
- Digoxin: Increased risk of bradycardia and AV block.
- Drugs metabolized by CYP2D6 (e.g., paroxetine, quinidine, fluoxetine): May increase galantamine levels.
- Drugs metabolized by CYP3A4 (e.g., ketoconazole, ritonavir, erythromycin): May increase galantamine levels.
Minor Interactions
- NSAIDs: Increased risk of GI bleeding (theoretical, due to increased gastric acid secretion).
Monitoring
Baseline Monitoring
Cognitive function (e.g., MMSE, ADAS-Cog)
Rationale: To establish baseline and monitor therapeutic response.
Timing: Prior to initiation
Heart rate and rhythm (ECG if clinically indicated)
Rationale: To assess for pre-existing bradycardia or conduction abnormalities, as galantamine can cause bradycardia and syncope.
Timing: Prior to initiation
Weight
Rationale: To monitor for significant weight loss, a potential side effect.
Timing: Prior to initiation
Gastrointestinal symptoms
Rationale: To assess for pre-existing GI conditions that may be exacerbated (e.g., peptic ulcer disease).
Timing: Prior to initiation
Routine Monitoring
Cognitive function
Frequency: Every 3-6 months or as clinically indicated
Target: Improvement or stabilization of cognitive scores
Action Threshold: Significant decline may indicate need for re-evaluation 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 requires immediate evaluation and potential dose reduction/discontinuation.
Gastrointestinal symptoms (nausea, vomiting, diarrhea)
Frequency: Regularly, especially during dose titration
Target: Tolerable levels
Action Threshold: Severe or persistent symptoms may require dose reduction or discontinuation.
Weight
Frequency: Periodically
Target: Stable
Action Threshold: Significant unexplained weight loss.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Anorexia
- Weight loss
- Bradycardia (slow heart rate)
- Syncope (fainting)
- Chest pain
- Shortness of breath
- Seizures
- Urinary incontinence
Special Patient Groups
Pregnancy
Galantamine is classified as 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 observed in animal studies at doses higher than human therapeutic doses.
Second Trimester:
Similar risks as first trimester; no specific human data.
Third Trimester:
Similar risks as first trimester; no specific human data.
Lactation
It is not known whether 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 (e.g., bradycardia, GI upset) in the infant.
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. No specific dose adjustment is required based solely on age, but dose titration should be done carefully, and patients should be monitored for adverse effects, especially cardiovascular and gastrointestinal.
Clinical Information
Clinical Pearls
- Always start with the lowest dose (8 mg ER) and titrate slowly to minimize gastrointestinal side effects.
- Take with food to improve tolerability.
- Ensure adequate hydration, especially during initial titration or if GI side effects occur.
- Monitor heart rate and blood pressure, particularly in patients with pre-existing cardiac conditions or those on concomitant medications that affect heart rate.
- Galantamine ER capsules should be swallowed whole and not crushed or chewed.
- If treatment is interrupted for several days, re-initiate at the lowest dose and re-titrate.
- Inform patients that this medication helps manage symptoms but does not cure Alzheimer's disease.
Alternative Therapies
- Donepezil (Aricept)
- Rivastigmine (Exelon, Exelon Patch)
- Memantine (Namenda)
- Memantine/Donepezil combination (Namzaric)
Cost & Coverage
Average Cost:
Varies, typically $100-$300 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.