Galantamine Hbr 4mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions precisely. 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.
It's 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 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're unsure about the best way to dispose of your medication, consult 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 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.
Lifestyle & Tips
- Take with food to reduce stomach upset.
- Take exactly as prescribed; do not stop abruptly without consulting your doctor.
- Report any new or worsening symptoms, especially severe nausea, vomiting, diarrhea, dizziness, or fainting spells.
- Maintain regular follow-up appointments with your doctor to monitor effectiveness and side effects.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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 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 advice:
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 about side effects, 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 spells or severe dizziness
- Slow heartbeat
- Chest pain
- Difficulty breathing
- Seizures
- New or worsening stomach pain or ulcers (especially if history of ulcers)
- Difficulty urinating
Before Using This Medicine
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 provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems, including any medical conditions or diseases
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 any potential interactions or adverse effects.
Precautions & Cautions
While taking this drug, you may experience weight loss, and regular weight checks will be necessary to monitor this potential 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 notify your doctor. Your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Severe nausea
- Vomiting
- Salivation
- Sweating
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Collapse
- Convulsions
- Severe muscle weakness
- Respiratory depression
What to Do:
Immediately call 911 or Poison Control (1-800-222-1222). Treatment is supportive and may include atropine for severe bradycardia or other cholinergic symptoms.
Drug Interactions
Major Interactions
- Other cholinesterase inhibitors (e.g., donepezil, rivastigmine): Increased risk of cholinergic side effects (bradycardia, syncope, seizures).
- Succinylcholine: Prolonged neuromuscular blockade.
- Other cholinomimetics (e.g., bethanechol, pilocarpine): Increased risk of cholinergic side effects.
Moderate Interactions
- Beta-blockers (especially those that slow heart rate): Increased risk of bradycardia and syncope.
- Digoxin: Increased risk of bradycardia and AV block.
- Drugs metabolized by CYP2D6 (e.g., paroxetine, quinidine) or CYP3A4 (e.g., ketoconazole, erythromycin): May increase galantamine levels.
- Anticholinergics (e.g., atropine, scopolamine): Antagonistic effects, reduced efficacy of both drugs.
Monitoring
Baseline Monitoring
Rationale: To establish baseline cognitive status and track disease progression/response to treatment.
Timing: Prior to initiation
Rationale: Galantamine can cause bradycardia and AV block.
Timing: Prior to initiation
Rationale: Cholinergic agents can cause anorexia and weight loss.
Timing: Prior to initiation
Rationale: To guide initial dosing and dose adjustments.
Timing: Prior to initiation
Rationale: To guide initial dosing and dose adjustments.
Timing: Prior to initiation
Routine Monitoring
Frequency: Every 6-12 months or as clinically indicated
Target: Stabilization or improvement in cognitive scores
Action Threshold: Significant decline or lack of benefit may warrant re-evaluation of treatment.
Frequency: Periodically, especially during dose titration or if symptoms of bradycardia/syncope occur
Target: Normal sinus rhythm, HR > 60 bpm
Action Threshold: Symptomatic bradycardia, syncope, or significant hypotension may require dose reduction or discontinuation.
Frequency: Regularly, especially during dose titration
Target: Minimal to no symptoms
Action Threshold: Persistent or severe symptoms may require dose reduction, taking with food, or discontinuation.
Frequency: Periodically
Target: Stable weight
Action Threshold: Significant weight loss may require nutritional assessment or re-evaluation of treatment.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Anorexia
- Dizziness
- Headache
- Bradycardia
- Syncope
- Fatigue
- Insomnia
- Muscle cramps
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. No adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
Lactation
It is not known whether galantamine is excreted in human milk. Due to 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.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.
Geriatric Use
No specific dose adjustment is required based solely on age. However, elderly patients may be more susceptible to cholinergic side effects (e.g., bradycardia, syncope, GI upset) and should be monitored closely. Dose adjustments are based on renal and hepatic function, which may be impaired in the elderly.
Clinical Information
Clinical Pearls
- Always start with the lowest dose (4 mg BID) and titrate slowly to minimize gastrointestinal side effects.
- Taking galantamine with food can help reduce nausea and vomiting.
- If treatment is interrupted for several days or more, re-initiate at the lowest dose and re-titrate.
- Monitor for signs of bradycardia or syncope, especially in patients with pre-existing cardiac conditions.
- Galantamine is not a cure for Alzheimer's disease but may help slow the progression of symptoms in some patients.
Alternative Therapies
- Donepezil (Aricept)
- Rivastigmine (Exelon)
- Memantine (Namenda)
- Memantine/Donepezil combination (Namzaric)