Galantamine Hbr 4mg Tablets

Manufacturer CITRON PHARMA Active Ingredient Galantamine Tablets(ga LAN ta meen) Pronunciation ga LAN ta meen
It is used to treat dementia in people with Alzheimer's disease.
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Drug Class
Cognition Enhancer
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Pharmacologic Class
Acetylcholinesterase Inhibitor; Nicotinic Allosteric Potentiator
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Pregnancy Category
Category C
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FDA Approved
Sep 2001
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DEA Schedule
Not Controlled

Overview

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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 in some people with Alzheimer's.
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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 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.
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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.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 4 mg twice daily for 4 weeks. Titrate: Increase to 8 mg twice daily for at least 4 weeks. Max: 12 mg twice daily.
Dose Range: 4 - 12 mg

Condition-Specific Dosing:

Alzheimer's Disease (Mild to Moderate): Initial: 4 mg twice daily for 4 weeks. Titrate: Increase to 8 mg twice daily for at least 4 weeks. Max: 12 mg twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed (CrCl > 50 mL/min)
Moderate: Max dose 16 mg/day (CrCl 9-49 mL/min)
Severe: Not recommended (CrCl < 9 mL/min)
Dialysis: Not recommended

Hepatic Impairment:

Mild: No dosage adjustment needed (Child-Pugh A)
Moderate: Max dose 16 mg/day (Child-Pugh B)
Severe: Not recommended (Child-Pugh C)

Pharmacology

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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 acts as an allosteric potentiator of nicotinic acetylcholine receptors, which may enhance the release of acetylcholine and other neurotransmitters.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90%
Tmax: Approximately 1 hour (tablets)
FoodEffect: Food does not significantly affect AUC or Cmax, but Tmax may be delayed by 1.5 hours. Can be taken with or without food.

Distribution:

Vd: Approximately 175 L
ProteinBinding: Approximately 18%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 7 hours
Clearance: Approximately 6.6 L/hour
ExcretionRoute: Renal (major), Fecal (minor)
Unchanged: Approximately 20-25% (renal)
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Pharmacodynamics

OnsetOfAction: Within hours (pharmacological effect), clinical benefit seen over weeks to months with titration.
PeakEffect: Clinical peak effect typically observed after several weeks of stable dosing.
DurationOfAction: Due to reversible inhibition, effects persist as long as drug levels are maintained (twice daily dosing).

Safety & Warnings

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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 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.
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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
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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 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.
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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 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.
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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

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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.
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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

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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

Heart rate and rhythm (ECG if clinically indicated)

Rationale: Galantamine can cause bradycardia and AV block.

Timing: Prior to initiation

Weight

Rationale: Cholinergic agents can cause anorexia and weight loss.

Timing: Prior to initiation

Renal function (CrCl)

Rationale: To guide initial dosing and dose adjustments.

Timing: Prior to initiation

Hepatic function (Child-Pugh score)

Rationale: To guide initial dosing and dose adjustments.

Timing: Prior to initiation

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Routine Monitoring

Cognitive function assessment

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.

Heart rate and blood pressure

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.

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, taking with food, or discontinuation.

Weight

Frequency: Periodically

Target: Stable weight

Action Threshold: Significant weight loss may require nutritional assessment or re-evaluation of treatment.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Anorexia
  • Dizziness
  • Headache
  • Bradycardia
  • Syncope
  • Fatigue
  • Insomnia
  • Muscle cramps

Special Patient Groups

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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:

First Trimester: Potential for adverse effects, but human data limited.
Second Trimester: Potential for adverse effects, but human data limited.
Third Trimester: Potential for adverse effects, but human data limited.
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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.

Infant Risk: Risk L3 (Moderate Concern)
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.

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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

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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.
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Alternative Therapies

  • Donepezil (Aricept)
  • Rivastigmine (Exelon)
  • Memantine (Namenda)
  • Memantine/Donepezil combination (Namzaric)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$100+ per 30 tablets (4mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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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 this 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, including the amount taken and the time it happened, to ensure you receive the best possible care.