Galantamine ER 8mg 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 2004
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 or stabilize symptoms like memory loss and confusion.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided to you and adhere to the prescribed regimen. Take your medication at the same time every day to establish a routine. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better.
For optimal absorption, take your medication with food, preferably with breakfast. Additionally, drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. When taking your medication, swallow the tablet whole; do not chew, break, or crush it.
Storing and Disposing of Your Medication
To maintain the efficacy and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a 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. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember, with food. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses. If you miss taking your medication for more than three consecutive days, contact your doctor before restarting your medication regimen.
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided to you and adhere to the prescribed regimen. Take your medication at the same time every day to establish a routine. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better.
For optimal absorption, take your medication with food, preferably with breakfast. Additionally, drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. When taking your medication, swallow the tablet whole; do not chew, break, or crush it.
Storing and Disposing of Your Medication
To maintain the efficacy and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a 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. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember, with food. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses. If you miss taking your medication for more than three consecutive days, contact your doctor before restarting your medication regimen.
Lifestyle & Tips
- Take Galantamine ER capsules once daily, preferably with food to reduce stomach upset.
- Swallow the capsule whole; do not crush, chew, or open the capsule.
- Take your medication at the same time each day to help you remember.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not take two doses at once.
- If you stop taking the medication for several days, consult your doctor before restarting, as you may need to restart at a lower dose and titrate up again.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 8 mg once daily. After 4 weeks, increase to 16 mg once daily. After an additional 4 weeks, increase to 24 mg once daily if tolerated and clinically indicated.
Dose Range:
8 - 24 mg
Condition-Specific Dosing:
mild_to_moderate_alzheimers_dementia:
Titrate slowly to target dose of 16-24 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl >90 mL/min)
Moderate:
No adjustment needed (CrCl 9-89 mL/min)
Severe:
Maximum dose 16 mg once daily (CrCl <9 mL/min)
Dialysis:
Not studied, caution advised. Maximum dose 16 mg once daily.
Hepatic Impairment:
Mild:
No adjustment needed (Child-Pugh 5-6)
Moderate:
Maximum dose 16 mg once daily (Child-Pugh 7-9)
Severe:
Contraindicated (Child-Pugh >9)
Pharmacology
Mechanism of Action
Galantamine is a reversible, competitive acetylcholinesterase inhibitor. It is thought to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase. Galantamine also acts as an allosteric potentiator of nicotinic acetylcholine receptors, which may contribute to its therapeutic effects in Alzheimer's disease.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
Approximately 4.5-5 hours (for ER capsules)
FoodEffect:
Food does not affect the extent of absorption (AUC) of galantamine ER, but Tmax may be slightly delayed. Taking with food may reduce gastrointestinal side effects.
Distribution:
Vd:
Approximately 175 L
ProteinBinding:
Approximately 18%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 7-8 hours (for ER capsules)
Clearance:
Approximately 6.2 L/hour
ExcretionRoute:
Renal (major), Fecal (minor)
Unchanged:
Approximately 20-30% (in urine)
Pharmacodynamics
OnsetOfAction:
Gradual (therapeutic effects may take weeks to months to become apparent)
PeakEffect:
Steady-state plasma concentrations are reached within about 7 days of once-daily dosing.
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
+ 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. 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 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. 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 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. 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 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. 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
- Fainting or feeling lightheaded
- Very slow heartbeat
- New or worsening muscle weakness or cramps
- Difficulty breathing
- Seizures
- Signs of gastrointestinal 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 this 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 the following information to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* All your health problems, as they may interact with this medication
Remember, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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, 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 safe treatment, please disclose the following information to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* All your health problems, as they may interact with this medication
Remember, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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, so regular weight checks will be necessary. Be sure to discuss your weight changes with your doctor.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to consult with your doctor. You and your doctor will need to weigh the benefits and risks of this medication to both you and your baby.
While taking this drug, you may experience weight loss, so regular weight checks will be necessary. Be sure to discuss your weight changes with your doctor.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to consult with your doctor. You and your doctor will need to 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)
- Collapse
- Convulsions
- Severe muscle weakness (cholinergic crisis)
- Respiratory depression
What to Do:
In case of overdose, immediately contact a poison control center (1-800-222-1222) or seek emergency medical attention. Atropine may be used as an antidote for cholinergic crisis.
Drug Interactions
Contraindicated Interactions
- Drugs that significantly inhibit both CYP2D6 and CYP3A4 in patients with moderate to severe hepatic impairment (e.g., ketoconazole, paroxetine, quinidine, ritonavir) due to increased galantamine exposure.
Major Interactions
- Other cholinesterase inhibitors (e.g., donepezil, rivastigmine): Increased risk of cholinergic side effects (bradycardia, syncope, GI upset).
- Anticholinergic agents (e.g., atropine, benztropine, oxybutynin): Antagonistic effects, reduced efficacy of both drugs.
- Drugs that significantly inhibit CYP2D6 (e.g., paroxetine, quinidine): Increased galantamine exposure.
- Drugs that significantly inhibit CYP3A4 (e.g., ketoconazole, ritonavir): Increased galantamine exposure.
- Neuromuscular blocking agents (e.g., succinylcholine): Exaggerated neuromuscular blockade.
Moderate Interactions
- Beta-blockers (e.g., metoprolol, propranolol): Increased risk of bradycardia and syncope.
- Digoxin: Increased risk of bradycardia.
- NSAIDs: Increased risk of peptic ulcers (theoretical, due to increased gastric acid secretion via cholinergic stimulation).
Minor Interactions
- Not specifically identified as minor, but general caution with drugs affecting heart rate or GI motility.
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.
Timing: Prior to initiation of therapy
Renal function (CrCl)
Rationale: To determine appropriate dosing adjustments in patients with renal impairment.
Timing: Prior to initiation of therapy
Hepatic function (Child-Pugh score)
Rationale: To determine appropriate dosing adjustments or contraindication in patients with hepatic impairment.
Timing: Prior to initiation of therapy
Weight
Rationale: Cholinesterase inhibitors can cause weight loss.
Timing: Prior to initiation of therapy
Routine Monitoring
Cognitive function assessment
Frequency: Every 6-12 months, or as clinically indicated
Target: Stabilization or slower decline in cognitive scores
Action Threshold: Significant decline or lack of benefit may warrant re-evaluation of therapy.
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 interruption, or discontinuation.
Weight
Frequency: Periodically
Target: Stable weight
Action Threshold: Significant unintentional weight loss may require nutritional assessment and intervention.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Anorexia
- Weight loss
- Bradycardia
- Syncope
- Muscle cramps
- Fatigue
- Insomnia
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 based on animal studies at doses higher than human therapeutic doses.
Second Trimester:
Potential for developmental toxicity based on animal studies at doses higher than human therapeutic doses.
Third Trimester:
Potential for developmental toxicity based on animal studies at doses higher than human therapeutic doses. Cholinesterase inhibitors may cause uterine contractions and premature labor.
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:
Risk unknown; potential for cholinergic effects in infant.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Galantamine is not indicated for use in pediatric patients.
Geriatric Use
No specific dose adjustment is required based solely on age. However, geriatric patients may be more susceptible to adverse effects such as bradycardia, syncope, and gastrointestinal disturbances. Dose adjustments are necessary based on renal and hepatic function, which may be impaired in older adults. Monitor closely for adverse events.
Clinical Information
Clinical Pearls
- Galantamine ER should be taken once daily, preferably in the morning with food to minimize gastrointestinal side effects.
- Slow titration is crucial to improve tolerability and reduce the incidence of adverse events.
- Patients should be advised not to crush, chew, or open the extended-release capsules.
- Monitor for signs of bradycardia, syncope, and gastrointestinal distress, especially during dose escalation.
- Galantamine is not a cure for Alzheimer's disease but may help slow the progression of symptoms and improve cognitive function in some patients.
- If therapy is interrupted for several days, re-initiate at the lowest dose and re-titrate to avoid adverse effects.
Alternative Therapies
- Donepezil (Aricept)
- Rivastigmine (Exelon, Exelon Patch)
- Memantine (Namenda)
- Memantine/Donepezil combination (Namzaric)
Cost & Coverage
Average Cost:
Varies widely (e.g., $30-$200+) per 30 capsules
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 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 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 details about the medication taken, the amount, and the time it happened.