Galantamine Hbr 8mg Tablets
It is used to treat dementia in people with Alzheimer's disease.
Drug Class
Agents for Alzheimer's Disease
Pharmacologic Class
Acetylcholinesterase Inhibitors; Nicotinic Allosteric Modulators
Pregnancy Category
C
FDA Approved
Feb 2001
DEA Schedule
Not Controlled
Overview
What is this medicine?
Galantamine 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 Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. 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 to feel better.
It is recommended to take your medication with food to help your body absorb it properly. Additionally, drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe and secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are any 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. 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 your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. 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 to feel better.
It is recommended to take your medication with food to help your body absorb it properly. Additionally, drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe and secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are any 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you miss taking your medication for more than three consecutive days, contact your doctor before restarting your medication.
Lifestyle & Tips
- Take with food to reduce stomach upset (nausea, vomiting).
- Take exactly as prescribed; do not stop suddenly without consulting your doctor.
- Stay hydrated, especially if experiencing diarrhea or vomiting.
- Report any new or worsening symptoms, especially severe nausea, vomiting, diarrhea, slow heartbeat, or fainting.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 4 mg twice daily. Titration: Increase to 8 mg twice daily after 4 weeks, then to 12 mg twice daily after an additional 4 weeks, if tolerated. Maintenance: 8-12 mg twice daily.
Dose Range:
8 - 24 mg
Condition-Specific Dosing:
mild_to_moderate_alzheimers:
Initial: 4 mg twice daily. Target maintenance: 16-24 mg/day in divided doses.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 50 mL/min)
Moderate:
Max dose 16 mg/day (CrCl 9-50 mL/min)
Severe:
Not recommended (CrCl < 9 mL/min)
Dialysis:
Not recommended; data insufficient
Hepatic Impairment:
Mild:
No adjustment needed (Child-Pugh A)
Moderate:
Max dose 16 mg/day (Child-Pugh B)
Severe:
Not recommended (Child-Pugh C)
Confidence:
High
Pharmacology
Mechanism of Action
Galantamine is a reversible, competitive acetylcholinesterase inhibitor. It increases the concentration of acetylcholine in the synaptic cleft by inhibiting its breakdown. Additionally, it is an allosteric potentiator of nicotinic acetylcholine receptors, which may enhance cholinergic neurotransmission.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
Approximately 1 hour (immediate-release)
FoodEffect:
Food does not affect AUC or Cmax, but Tmax may be delayed by 1.5 hours. Administer with food to reduce GI side effects.
Distribution:
Vd:
Approximately 175 L
ProteinBinding:
18%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 7 hours
Clearance:
Approximately 6 L/hour
ExcretionRoute:
Renal (major), Fecal (minor)
Unchanged:
Approximately 20-30% (urine)
Pharmacodynamics
OnsetOfAction:
Within hours (cholinesterase inhibition)
PeakEffect:
Weeks to months for clinical benefit (due to titration and disease progression)
DurationOfAction:
Approximately 12 hours (based on twice-daily dosing)
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some individuals 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
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 difficulties, including trouble 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, 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 or seek medical help:
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 individuals 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
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 difficulties, including trouble 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, 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 or seek medical help:
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 (can lead to dehydration)
- Slow heartbeat (bradycardia)
- Fainting spells (syncope)
- New or worsening stomach pain or heartburn
- Difficulty urinating
- Seizures
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 that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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 that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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. Be sure to discuss your weight changes with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify 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. Be sure to discuss your weight changes with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify 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
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Collapse
- Seizures
- Severe muscle weakness
- Respiratory depression
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 cholinergic effects
- Succinylcholine - prolonged neuromuscular blockade
- Anticholinergic agents (e.g., atropine, benztropine) - antagonism of galantamine's effects
Moderate Interactions
- Beta-blockers (e.g., metoprolol, propranolol) - increased risk of bradycardia
- Digoxin - increased risk of bradycardia
- Drugs metabolized by CYP2D6 (e.g., paroxetine, quinidine) - increased galantamine levels
- Drugs metabolized by CYP3A4 (e.g., ketoconazole, erythromycin) - increased galantamine levels
- 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 track disease progression/response to therapy.
Timing: Prior to initiation
Heart rate and blood pressure
Rationale: To assess for bradycardia or hypotension, especially in patients with cardiac conditions.
Timing: Prior to initiation
Weight
Rationale: To monitor for significant weight loss due to GI side effects.
Timing: Prior to initiation
Routine Monitoring
Cognitive function
Frequency: Every 6-12 months or as clinically indicated
Target: Stabilization or slower decline
Action Threshold: Significant decline may warrant re-evaluation of therapy
Heart rate and blood pressure
Frequency: Periodically, especially during dose titration or if symptoms occur
Target: Within normal limits for patient
Action Threshold: Bradycardia (<50 bpm), symptomatic hypotension, or syncope
Gastrointestinal symptoms (nausea, vomiting, diarrhea)
Frequency: Regularly, especially during dose titration
Target: Minimal to absent
Action Threshold: Persistent or severe symptoms requiring dose reduction or discontinuation
Weight
Frequency: Periodically
Target: Stable
Action Threshold: Significant unintentional weight loss
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Anorexia
- Dizziness
- Headache
- Bradycardia
- Syncope
- Falls
- Urinary incontinence
- Muscle cramps
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk, but human data limited.
Second Trimester:
Potential risk, but human data limited.
Third Trimester:
Potential risk, but human data limited.
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 concern (potential for cholinergic effects in infant).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.
Geriatric Use
Galantamine is primarily used in the geriatric population. No specific dose adjustment is required based solely on age, but dose titration should be done carefully due to increased susceptibility to adverse effects (e.g., GI, cardiac) in older adults.
Clinical Information
Clinical Pearls
- Always titrate the dose slowly to minimize gastrointestinal side effects.
- Administer with breakfast and dinner to reduce GI upset.
- Monitor for signs of bradycardia or syncope, especially in patients with pre-existing cardiac conditions.
- Ensure adequate hydration, particularly if GI side effects are prominent.
- Galantamine has a dual mechanism of action (AChE inhibition and nicotinic allosteric modulation), which may offer a unique benefit compared to other AChE inhibitors.
- If therapy is interrupted for several days or longer, re-initiate at the lowest dose and re-titrate.
Alternative Therapies
- Donepezil (Aricept) - another acetylcholinesterase inhibitor
- Rivastigmine (Exelon) - another acetylcholinesterase inhibitor (oral, patch)
- Memantine (Namenda) - NMDA receptor antagonist (often used in moderate to severe AD, or in combination with AChEIs)
Cost & Coverage
Average Cost:
Varies, typically $30-$100 per 30 tablets (8mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.