Galantamine Hydrobromide Tablets

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Galantamine hydrobromide tablets are a drug that plays an important role in the treatment of neurological diseases, especially in the treatment of Alzheimer's disease (AD), showing significant therapeutic effects. It has a dual effect. On the one hand, as a reversible and competitive acetylcholinesterase inhibitor, it can inhibit the breakdown of acetylcholine, increase the concentration of acetylcholine in synaptic cleft, and enhance cholinergic neurotransmission; On the other hand, conformational modulation of nicotinic acetylcholine receptors enhances their sensitivity to acetylcholine and further amplifies signal transduction. Used for the treatment of mild to moderate Alzheimer's disease. Multiple randomized double-blind placebo-controlled trials have confirmed that it can effectively improve patients' cognitive function, enhance daily living abilities, and alleviate behavioral symptoms. For other types of dementia with cognitive impairment such as vascular dementia and Lewy body dementia, although they are not formal indications, some studies have shown certain therapeutic effects, but caution should be exercised when using them. This product is for laboratory use only.

Additional information of chemical compound:

Galantamine Hydrobromide +. COA

Certificate of Analysis
Compound name	Galantamine Hydrobromide
CAS No.	1953-04-4
Grade	Pharmaceutical grade
Quantity	Customized
Packaging standard	Customized
Manufacturer	Shaanxi BLOOM TECH Co., Ltd
Lot No.	20250109001
MFG	Jan 12th 2025
EXP	Jan 8th 2029
Structure
TEST STANDARD	GB/T24768-2009 Industry. Stnndard
Item	Enterprise standard	Analysis result
Appearance	White or almost white powder	Conformed
Water content	≤4.5%	0.30%
Loss on drying	≤1.0%	0.15%
Heavy Metals	Pb≤0.5ppm	N.D.
	As≤0.5ppm	N.D.
	Hg≤0.5ppm	N.D.
	Cd≤0.5ppm	N.D.
Purity (HPLC)	≥99.0%	99.5%
Single impurity	<0.8%	0.48%
Residue on ignition	<0.20%	0.064%
Total microbial count	≤750cfu/g	80
E. Coli	≤2MPN/g	N.D.
Salmonella	N.D.	N.D.
Ethanol (by GC)	≤5000ppm	400ppm
Storage	Store in a sealed, dark and dry place at-20 degrees

Galantamine hydrobromide tablets are a selective and reversible acetylcholinesterase inhibitor that increases synaptic acetylcholine concentration by inhibiting acetylcholinesterase activity and regulates nicotinic acetylcholine receptors to enhance neural signal transmission. Its indications include cognitive decline caused by Alzheimer's disease, dementia related memory impairment, and organic brain lesions. The specific application scenarios are as follows:

Core indication: Alzheimer's disease (AD)

 

1. Disease characteristics and treatment needs
Alzheimer's disease is characterized by progressive cognitive decline, and its pathological mechanisms involve decreased levels of acetylcholine, deposition of beta amyloid protein, and neuronal damage. Improving symptoms through a dual mechanism:
Acetylcholinesterase inhibition: reduces acetylcholine breakdown and enhances cholinergic neurotransmission;
Receptor regulation: conformational enhancement of nicotinic acetylcholine receptor sensitivity to acetylcholine, further amplifying signal transduction.
Clinical studies have shown that it can significantly improve cognitive domain functions such as directional memory, associative learning, and image recall in patients, and enhance daily living abilities (such as dressing and eating) and behavioral symptoms (such as anxiety and depression).

 

2. Clinical evidence and medication plan
Dose effect: The initial dose is usually 4 mg twice daily, gradually titrated to 16-24 mg/day (sustained-release formulations can be taken in the morning as a single dose) to reduce gastrointestinal side effects such as nausea and vomiting.
Duration of therapeutic effect: Cognitive score significantly improves within 12-24 weeks, and the effect can last for more than 6 months. Long term treatment requires regular assessment of weight, liver function, and electrocardiogram (QT interval).
Target audience: Patients with mild to moderate Alzheimer's disease, especially those with mixed dementia complicated with vascular lesions, may benefit, but a history of severe stroke or recent intracranial hemorrhage must be ruled out.

Extended indication: Dementia related memory impairment

 

1. Vascular dementia (VaD)
Vascular dementia is caused by cerebrovascular disease, and cholinergic system damage is similar to Alzheimer's disease. Although not officially approved for VaD, some studies suggest that it may improve cognitive function in mixed dementia patients with concomitant vascular disease, requiring strict assessment of stroke risk and bleeding tendency.
2. Lewy body dementia (DLB) and Parkinson's disease dementia (PDD)
DLB and PDD are characterized by deposition of Lewy bodies, often accompanied by visual hallucinations, Parkinson's syndrome, and cognitive fluctuations. It may alleviate hallucinations and cognitive symptoms by regulating the cholinergic glutamatergic balance, but caution should be exercised as it may exacerbate extrapyramidal reactions such as tremors and muscle rigidity, and should be used with caution under the guidance of a neurologist.

 

3. Benign memory impairment
There is controversy over the efficacy of Galantamine Hydrobromamide Tablets for non dementia memory impairment, such as age-related memory loss and mild cognitive impairment. Some studies have shown that it can improve cognitive domains such as directional memory and associative learning, but the long-term benefits are not yet clear. Currently, it is only recommended for patients with obvious functional impairment and excluding other organic diseases.

Application in special clinical scenarios

 

1. perioperative management
Possible enhancement of the effect of neuromuscular blockers (such as succinylcholine) requires preoperative evaluation of the patient's medication history. If continued use is necessary, short acting blockers should be chosen and neuromuscular conduction function should be monitored.
2. Control of Psychobehavioral Symptoms (BPSD)
Alzheimer's disease patients often experience agitation, aggressive behavior, and hallucinations. It is possible to alleviate some symptoms by regulating the cholinergic glutamatergic balance, but reversible causes such as infection and metabolic disorders need to be prioritized. For severe BPSD, it is necessary to combine atypical antipsychotic drugs (such as quetiapine) for treatment.

 

3. Combination therapy strategy
Combination therapy with memantine: memantine (NMDA receptor antagonist) complements its mechanism of action, and combination therapy may further delay cognitive decline, but caution should be exercised regarding the risk of worsening psychiatric symptoms.
Avoid co administration with anticholinergic drugs: anticholinergic drugs (such as pheniramine and tolterodine) may antagonize the efficacy of the product, and the necessity of medication should be strictly evaluated.

Galantamine hydrobromide tablets are the core drug for the treatment of Alzheimer's disease, and their dual mechanism of action, clear clinical efficacy, and relatively controllable safety make them one of the first choices for patients with mild to moderate conditions. Meanwhile, its exploratory application in special types of dementia such as vascular dementia, Lewy body dementia, and benign memory impairment provides more possibilities for the treatment of cognitive impairment.

Galantamine Hydrobromamide Tablets are a selective and reversible acetylcholinesterase inhibitor that improves cognitive function in Alzheimer's disease (AD) patients through a dual action mechanism, and has been extended to the treatment of other neurodegenerative diseases and memory disorders.

Acetylcholinesterase inhibition: enhances acetylcholine concentration

Selective inhibition of acetylcholinesterase (AChE)

It is a second-generation AChE inhibitor that competitively binds to the active site of AChE, inhibiting the hydrolysis of acetylcholine (ACh) and increasing the concentration of ACh in synaptic cleft. Its selectivity is reflected in its much stronger inhibitory effect on AChE than butyrylcholinesterase (BuChE), with an IC50 value of 0.35 μ M and a selectivity factor of 53. This selectivity avoids the peripheral cholinergic side effects (such as gastrointestinal spasms and excessive saliva secretion) that may be caused by non-specific inhibition of BuChE.

Dynamic balance adjustment

In Alzheimer's disease patients, the degeneration of cholinergic neurons in the basal forebrain leads to a decrease in ACh synthesis, which is partially compensated for by inhibiting AChE activity and prolonging the residence time of ACh in the synaptic cleft. Pharmacokinetic studies have shown that its oral bioavailability is 88.5%, the blood-brain barrier penetration rate is high (brain concentration is three times that of plasma), the terminal half-life is about 7-8 hours, and it supports a 2-4 time daily dosing regimen.

Nicotinic acetylcholine receptor (nAChR) allosteric regulation: enhancing receptor sensitivity

 

Conformational enhancement of ligand action

Not only AChE inhibitors, but also nAChR conformational enhancer ligands (APL). It changes the receptor conformation by binding to nAChR conformational sites (such as α 4 β 2, α 3 β 4 subtypes), enhancing the binding affinity of ACh to the receptor and the probability of channel opening. This dual mechanism (inhibiting AChE+conformational regulation of nAChR) significantly improves the efficiency of cholinergic signaling, far surpassing single mechanism drugs such as donepezil.

Improvement of synaptic plasticity

Animal experiments have shown that it can promote the acquisition of passive avoidance behavior in mice and improve memory consolidation disorders induced by scopolamine. In the APP23 transgenic mouse model, intraperitoneal injection at doses of 1.25-2.5 mg/kg significantly alleviated cognitive impairment, and its mechanism was associated with enhanced long-term potentiation (LTP) of the hippocampus, suggesting a long-term regulatory effect on synaptic plasticity.

Question 1: What are the main uses of Galantamine Hydrobromide Tablets?
Galantamine Hydrobromide Tablets (hydrobromic acid galantamine tablets) are mainly used to treat Alzheimer's disease, improving the cognitive functions of patients with mild to moderate dementia, including memory, attention, and language ability. At the same time, it also has an auxiliary effect in improving memory disorders caused by brain organic lesions (such as brain trauma, sequelae of encephalitis).
Question 2: What are the common dosing instructions for this medication?
It is generally recommended to start with a dose of 4mg, twice daily, taken with meals to minimize gastrointestinal discomfort. After 4 weeks, the dose can be adjusted to 8mg, twice daily based on the patient's tolerance. Doctors may further adjust the dosage depending on the patient's condition and liver/kidney function. Elderly patients or those with impaired liver or kidney function should be cautious when adjusting the dosage.
Question 3: What should be noted when using Galantamine Hydrobromide Tablets?
 Contraindications: Patients allergic to the drug components, those with severe asthma or pulmonary dysfunction, patients with angina pectoris or bradycardia, and those with mechanical intestinal obstruction should avoid using this medication.
 Drug interactions: Avoid using in combination with erythromycin (may reduce efficacy); when used in combination with cimetidine or ketoconazole, blood drug concentration monitoring is required (may increase the risk of adverse reactions).
 Adverse reactions: Commonly include nausea, vomiting, diarrhea, dizziness, insomnia, etc. These symptoms usually subside with the prolongation of medication duration; if severe allergic reactions (such as rash, breathing difficulties) occur, stop the medication immediately and seek medical attention.

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