Galantamine Hydrobromide 24 mg Capsule, Extended Release, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Cholinesterase Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Galantamine helps boost a brain chemical called acetylcholine that Alzheimer's disease gradually depletes. This can help maintain memory and thinking for a period of time, but it d...
- What exactly does galantamine do for Alzheimer's — will it stop the disease from getting worse?
- Nausea and vomiting are the most common side effects, especially when the dose is being increased. The good news is that nausea usually only lasts about 5 to 7 days and tends to ge...
- I heard galantamine can upset your stomach — is there anything I can do about that?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $1.67 | $50.16 / 30 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Galantamine Hydrobromide 24 mg 47335-0837-08 | Sun | 100 capsules | — | AB | FDA listed | — |
| Galantamine Hydrobromide 24 mg 63629-2363-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Galantamine 24 mg 65862-0746-01 | Aurobindo | 100 capsules | — | AB | FDA listed | — |
| Galantamine Hydrobromide 24 mgthis 72162-1448-03 | Bryant | 30 capsules | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72162-1448-03 You're viewing this | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1448-3) | 2023-08-25 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Galantamine hydrobromide is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended starting dosage is 8 mg/day in morning; increase to initial maintenance dose of 16 mg/day after a minimum of 4 weeks. Based on clinical benefit and tolerability, dosage may be increased to 24 mg/day after a minimum of 4 weeks at 16 mg/day. ( 2.1 ) Take with food; ensure adequate fluid intake during treatment ( 2.1 ) Hepatic impairment: should not exceed 16 mg/day for moderate hepatic impairment; do not use in patients with severe hepatic impairment ( 2.2 ) Renal impairment: should not exceed 16 mg/day for creatinine clearance 9 to 59 mL/min; do not use in patients with creatinine clearance less than 9 mL/min.
( 2.3 ) Conversion from galantamine tablets to galantamine hydrobromide extended-release capsules should occur at the same daily dosage with the last dose of galantamine tablets taken in evening and starting galantamine hydrobromide extended-release capsules once daily treatment the next morning. (2.5)
2.1Recommended Dosage and Administration Administer galantamine hydrobromide extended-release capsules once daily in the morning, preferably with food. Ensure adequate fluid intake during treatment. The recommended starting dosage of galantamine hydrobromide extended-release capsules is 8 mg/day.
Increase to the initial maintenance dosage of 16 mg/day after a minimum of 4 weeks. A further increase to 24 mg/day may be attempted after a minimum of 4 weeks at 16 mg/day. Increase dosage based upon assessment of clinical benefit and tolerability of the previous dosage.
The dosage of galantamine hydrobromide extended-release capsules shown to be effective in a controlled clinical trial is 16 to 24 mg/day.
2.2Dosage in Patients with Hepatic Impairment In patients with moderate hepatic impairment (Child-Pugh score of 7 to 9), the dosage should generally not exceed 16 mg/day. The use of galantamine hydrobromide extended-release capsules in patients with severe hepatic impairment (Child-Pugh score of 10 to 15) is not recommended [see Clinical Pharmacology (12.3)].
2.3Dosage in Patients with Renal Impairment In patients with creatinine clearance of 9 to 59 mL/min, the dosage should generally not exceed 16 mg/day. In patients with creatinine clearance less than 9 mL/min, the use of galantamine hydrobromide extended-release capsules is not recommended [see Clinical Pharmacology (12.3)].
2.4Treatment Interruption If therapy has been interrupted for more than three days, the patient should be restarted at the lowest dosage and the dosage escalated to the current dose. The abrupt withdrawal of galantamine hydrobromide extended-release capsules in those patients who had been receiving dosages in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same dosages of that drug.
2.5Switching to Galantamine Hydrobromide Extended-release Capsules from Galantamine Tablets Patients currently being treated with galantamine tablets can convert to galantamine hydrobromide extended-release capsules by taking their last dose of galantamine tablets in the evening and starting galantamine hydrobromide extended-release capsules once daily treatment the next morning. Converting from galantamine tablets to galantamine hydrobromide extended-release capsules should occur at the same total daily dosage.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Galantamine hydrobromide extended-release capsules are available in the following strengths: 8 mg (Size 2 white opaque/white opaque capsules imprinted '835' with black ink on cap and body filled with white color capsule shaped uncoated tablet plain on both sides) 16 mg (Size 2 pink opaque/pink opaque capsules imprinted '836' with black ink on cap and body filled with pink color capsule shaped uncoated tablet plain on both sides) 24 mg (Size 2 caramel opaque/caramel opaque capsules imprinted '837' with black ink on cap and body filled with caramel color capsule shaped uncoated tablet plain on both sides) Extended-release capsules: 8 mg, 16 mg, 24 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Galantamine hydrobromide extended-release capsules are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. Known hypersensitivity to galantamine hydrobromide or any excipients ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serious skin reactions: discontinue at first appearance of skin rash ( 5.1 ) All patients should be considered at risk for adverse effects on cardiac conduction, including bradycardia and AV block, due to vagotonic effects on sinoatrial and atrioventricular nodes ( 5.3 ) Active or occult gastrointestinal bleeding: monitor, especially those with an increased risk for developing ulcers ( 5.4 ) Cholinomimetics may cause bladder outflow obstruction ( 5.5 ) Monitor for respiratory adverse events in patients with a history of severe asthma or obstructive pulmonary disease ( 5.7 )
5.1Serious Skin Reactions Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine hydrobromide extended-release capsules. Inform patients and caregivers that the use of galantamine should be discontinued at the first appearance of a skin rash, unless the rash is clearly not drug-related. If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed and alternative therapy should be considered.
5.2Anesthesia Galantamine, as a cholinesterase inhibitor, is likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia.
5.3Cardiovascular Conditions Because of their pharmacological action, cholinesterase inhibitors have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients both with and without known underlying cardiac conduction abnormalities [see Adverse Reactions (6.1, 6.2)] . Therefore, all patients should be considered at risk for adverse effects on cardiac conduction.
Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope (placebo 0.7% [2/286]; 4 mg twice daily 0.4% [3/692]; 8 mg twice daily 1.3% [7/552]; 12 mg twice daily 2.2% [6/273]).
5.4Gastrointestinal Conditions Through their primary action, cholinomimetics may be expected to increase gastric acid secretion due to increased cholinergic activity. Therefore, patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with an increased risk for developing ulcers, e.g., those with a history of ulcer disease or patients using concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.
Galantamine, as a predictable consequence of its pharmacological properties, has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. During therapy with galantamine, the patient’s weight should be monitored.
5.5Genitourinary Conditions Although this was not observed in clinical trials with galantamine, cholinomimetics may cause bladder outflow obstruction.
5.6Neurological Conditions Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions [see Adverse Reactions (6.2)]. Seizure activity may also be a manifestation of Alzheimer’s disease. Patients with Alzheimer’s disease should be monitored closely for seizures while taking galantamine hydrobromide extended-release capsules.
An increase in cholinergic tone may worsen symptoms related to extrapyramidal disorders [see Adverse Reactions (6.2)].
5.7Pulmonary Conditions Because of its cholinomimetic action, galantamine hydrobromide extended-release capsules should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Respiratory function should be monitored closely for the occurrence of respiratory adverse effects.
5.8Deaths in Patients with Mild Cognitive Impairment (MCI) In two randomized placebo-controlled trials of 2 years duration in…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Serious adverse reactions are discussed in more detail in the following sections of the labeling: Serious Skin Reactions [see Warnings and Precautions ( 5.1 )] Cardiovascular Conditions [see Warnings and Precautions ( 5.3 )] Gastrointestinal Conditions [see Warnings and Precautions ( 5.4 )] Genitourinary Conditions [see Warnings and Precautions ( 5.5 )] Neurological Conditions [see Warnings and Precautions ( 5.6 )] Pulmonary Conditions [see Warnings and Precautions ( 5.7 )] Deaths in Patients with Mild Cognitive Impairment (MCI) [see Warnings and Precautions ( 5.8 )] The most common adverse reactions (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥5%) in galantamine-treated patients from double-blind clinical trials were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. The most common adverse reactions associated with discontinuation (≥1%) in galantamine-treated patients from double-blind clinical trials were nausea (6.2%), vomiting (3.3%), decreased appetite (1.5%), and dizziness (1.3%).
The safety of the extended-release capsule and immediate-release tablet formulations of galantamine was evaluated in 3,956 galantamine-treated patients who participated in 8 placebo-controlled clinical studies and 1,454 patients in 5 open-label clinical studies with mild to moderate dementia of the Alzheimer’s type. In clinical studies, the safety profile of once-daily treatment with extended-release galantamine was similar in frequency and nature to that seen with tablets. The information presented in this section was derived from pooled double-blind studies and from pooled open-label data.
Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials Table 1 lists the adverse reactions reported in ≥1% of galantamine-treated patients in 8 placebo-controlled, double-blind clinical trials. Table 1. Adverse Reactions Reported by ≥1% of Galantamine-Treated Patients in Pooled Placebo-Controlled, Double-Blind Clinical Trials System/Organ Class Adverse Reaction G alantamine (n=3,956) % Placebo (n=2,546) % Metabolism and Nutrition Disorders Decreased appetite 7.4
2.1Psychiatric Disorders Depression 3.6
2.3Nervous System Disorders Headache 7.1
5.5Dizziness 7.5
3.4Tremor 1.6
0.7Somnolence 1.5
0.8Syncope 1.4
0.6Lethargy 1.3
0.4Cardiac Disorders Bradycardia 1.0
0.3Gastrointestinal Disorders Nausea 20.7
5.5Vomiting 10.5
2.3Diarrhea 7.4
4.9Abdominal discomfort 2.1
0.7Abdominal pain 3.8
2.0Dyspepsia 1.5
1.0Musculoskeletal and Connective Tissue Disorders Muscle spasms 1.2
0.5General Disorders and Administration Site Conditions Fatigue 3.5
1.8Asthenia 2.0
1.5Malaise 1.1
0.5Investigations Decreased weight 4.7
1.5Injury, Poisoning and Procedural Complications Fall 3.9
3.0Laceration 1.1
0.5The majority of these adverse reactions occurred during the dose-escalation period. In those patients who experienced the most frequent adverse reaction, nausea, the median duration of the nausea was 5 to 7 days. Other Adverse Reactions Observed in Clinical Trials of Galantamine The following adverse reactions occurred in <1% of all galantamine-treated patients (N=3,956) in the above double-blind, placebo-controlled clinical trial data sets.
In addition, the following also includes all adverse reactions reported at any frequency rate in patients (N=1,454) who participated in open-label studies. Adverse reactions listed in Table 1 above were not included below: Metabolis…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Potential to interfere with the activity of anticholinergic medications ( 7.1 ) Synergistic effect expected when given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents, or cholinergic agonists ( 7.2 )
7.1Use with Anticholinergics Galantamine has the potential to interfere with the activity of anticholinergic medications [see Clinical Pharmacology ( 12.3 )] .
7.2Use with Cholinomimetics and Other Cholinesterase Inhibitors A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol [see Clinical Pharmacology ( 12.3 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data may cause fetal harm. ( 8.1 )
8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of galantamine hydrobromide extended-release capsules in pregnant women. In studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data In rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses, which were associated with maternal toxicity. The no-effect dose for embryo-fetal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the maximum recommended human dose (MRHD) of 24 mg/day on a body surface area (mg/m 2 ) basis.
When galantamine (oral doses of 4, 12, 28, or 40 mg/kg/day) was administered to pregnant rabbits throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest dose which was associated with maternal toxicity. The no-effect dose for embryo-fetal developmental toxicity in rabbits (28 mg/kg/day) is approximately 20 times the MRHD on a mg/m 2 basis. In a study in which pregnant rats were orally dosed with galantamine (2, 8, or 16 mg/kg/day) from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at birth and during the lactation period at the two highest doses.
The no-effect dose for pre- and postnatal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the MRHD on a mg/m 2 basis.
8.2Lactation Risk Summary There are no data on the presence of galantamine in human milk, the effects on the breastfed infant, or the effects of galantamine hydrobromide extended-release capsules on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for galantamine hydrobromide extended-release capsules and any potential adverse effects on the breastfed infant from galantamine hydrobromide extended-release capsules or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6,519 patients have investigated galantamine hydrobromide extended-release capsules in the treatment of mild to moderate dementia of the Alzheimer’s type [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] . The mean age of patients enrolled in these clinical studies was 75 years; 78% of these patients were between 65 and 84 years of age, and 10% of patients were 85 years of age or older.
8.6Hepatic Impairment In patients with moderate hepatic impairment, a dosage adjustment is recommended. The use of galantamine hydrobromide extended-release capsules in patients with severe hepatic impairment is not recommended [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )] .
8.7Renal Impairment In patients with a creatinine clearance of 9 to 59 mL/min, a dosage adjustment is recommended. The use of galantamine hydrobromide extended-release capsules in patients with creatinine clearance less than 9 mL/min is not recommended [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )] .
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of galantamine hydrobromide extended-release capsules in pregnant women. In studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data In rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses, which were associated with maternal toxicity. The no-effect dose for embryo-fetal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the maximum recommended human dose (MRHD) of 24 mg/day on a body surface area (mg/m 2 ) basis.
When galantamine (oral doses of 4, 12, 28, or 40 mg/kg/day) was administered to pregnant rabbits throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest dose which was associated with maternal toxicity. The no-effect dose for embryo-fetal developmental toxicity in rabbits (28 mg/kg/day) is approximately 20 times the MRHD on a mg/m 2 basis. In a study in which pregnant rats were orally dosed with galantamine (2, 8, or 16 mg/kg/day) from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at birth and during the lactation period at the two highest doses.
The no-effect dose for pre- and postnatal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the MRHD on a mg/m 2 basis.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6,519 patients have investigated galantamine hydrobromide extended-release capsules in the treatment of mild to moderate dementia of the Alzheimer’s type [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14 )] . The mean age of patients enrolled in these clinical studies was 75 years; 78% of these patients were between 65 and 84 years of age, and 10% of patients were 85 years of age or older.
🆘 Overdosage ▾
10 OVERDOSAGE Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center to determine the latest recommendations for the management of an overdose of any drug. As in any case of overdose, general supportive measures should be utilized. Signs and symptoms of significant overdosing of galantamine are predicted to be similar to those of overdosing of other cholinomimetics.
These effects generally involve the central nervous system, the parasympathetic nervous system, and the neuromuscular junction. In addition to muscle weakness or fasciculations, some or all of the following signs of cholinergic crisis may develop: severe nausea, vomiting, gastrointestinal cramping, salivation, lacrimation, urination, defecation, sweating, bradycardia, hypotension, respiratory depression, collapse and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved.
Tertiary anticholinergics such as atropine may be used as an antidote for galantamine hydrobromide overdosage. Intravenous atropine sulfate titrated to effect is recommended at an initial dose of 0.5 mg to 1.0 mg i.v. with subsequent doses based upon clinical response. Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when coadministered with quaternary anticholinergics.
It is not known whether galantamine and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration). Dose-related signs of toxicity in animals included hypoactivity, tremors, clonic convulsions, salivation, lacrimation, chromodacryorrhea, mucoid feces, and dyspnea. In one postmarketing report, one patient who had been taking 4 mg of galantamine daily for a week inadvertently ingested eight 4 mg tablets (32 mg total) on a single day.
Subsequently, she developed bradycardia, QT prolongation, ventricular tachycardia and torsades de pointes accompanied by a brief loss of consciousness for which she required hospital treatment. Two additional cases of accidental ingestion of 32 mg (nausea, vomiting, and dry mouth; nausea, vomiting, and substernal chest pain) and one of 40 mg (vomiting), resulted in brief hospitalizations for observation with full recovery. One patient, who was prescribed 24 mg/day and had a history of hallucinations over the previous two years, mistakenly received 24 mg twice daily for 34 days and developed hallucinations requiring hospitalization.
Another patient, who was prescribed 16 mg/day of oral solution, inadvertently ingested 160 mg (40 mL) and experienced sweating, vomiting, bradycardia, and near-syncope one hour later, which necessitated hospital treatment. His symptoms resolved within 24 hours.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Although the etiology of cognitive impairment in Alzheimer's disease (AD) is not fully understood, it has been reported that acetylcholine-producing neurons degenerate in the brains of patients with Alzheimer's disease. The degree of this cholinergic loss has been correlated with degree of cognitive impairment and density of amyloid plaques (a neuropathological hallmark of Alzheimer's disease). Galantamine, a tertiary alkaloid, is a competitive and reversible inhibitor of acetylcholinesterase.
While the precise mechanism of galantamine's action is unknown, it is postulated 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 cholinesterase. If this mechanism is correct, galantamine’s effect may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact.
There is no evidence that galantamine alters the course of the underlying dementing process.
12.2Pharmacokinetics The pharmacokinetics of galantamine are linear over a dose range of 8 to 32 mg/day. Absorption and Distribution Galantamine is absorbed with time to peak concentration of about 1 hour. The absolute bioavailability of galantamine is about 90%.
Food did not affect the AUC of galantamine, but C max was decreased by 25% and T max was delayed by 1.5 hours, when galantamine was administered with food. The mean volume of distribution of galantamine is 175 L. The plasma protein binding of galantamine is 18% at therapeutically relevant concentrations.
In whole blood, galantamine is mainly distributed to blood cells (52.7%). The blood to plasma concentration ratio of galantamine is 1.2. Metabolism and Elimination Galantamine is metabolized by hepatic cytochrome P450 enzymes, glucuronidated, and excreted unchanged in the urine.
In vitro studies indicate that cytochrome CYP2D6 and CYP3A4 were the major cytochrome P450 isoenzymes involved in the metabolism of galantamine, and inhibitors of both pathways increase oral bioavailability of galantamine modestly. O-demethylation, mediated by CYP2D6 was greater in extensive metabolizers of CYP2D6 than in poor metabolizers. In plasma from both poor and extensive metabolizers, however, unchanged galantamine and its glucuronide accounted for most of the sample radioactivity.
In studies of oral 3 H-galantamine, unchanged galantamine and its glucuronide, accounted for most plasma radioactivity in poor and extensive CYP2D6 metabolizers. Up to 8 hours post-dose, unchanged galantamine accounted for 39 to 77% of the total radioactivity in the plasma, and galantamine glucuronide for 14 to 24%. By 7 days, 93 to 99% of the radioactivity had been recovered, with about 95% in urine and about 5% in the feces.
Total urinary recovery of unchanged galantamine accounted for, on average, 32% of the dose and that of galantamine glucuronide for another 12% on average. After i.v. or oral administration, about 20% of the dose was excreted as unchanged galantamine in the urine in 24 hours, representing a renal clearance of about 65 mL/min, about 20 to 25% of the total plasma clearance of about 300 mL/min. Galantamine has a terminal half-life of about 7 hours.
Galantamine hydrobromide extended-release capsules 24 mg administered once daily under fasting conditions are bioequivalent to galantamine tablets 12 mg twice daily with respect to AUC 24h and C min . The C max and T max of the extended-release capsules were lower and occurred later, respectively, compared with the immediate-release tablets, with C max about 25% lower and median T max occurring about 4.5 to 5 hours after dosing. Dose-proportionality is observed for galantamine hydrobromide extended-release capsules over the dose range of 8 to 24 mg daily and steady state is achieved within a week.
There was no effect of age on the pharmacokinetics of galantamine hydrobromide extended-re…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Although the etiology of cognitive impairment in Alzheimer's disease (AD) is not fully understood, it has been reported that acetylcholine-producing neurons degenerate in the brains of patients with Alzheimer's disease. The degree of this cholinergic loss has been correlated with degree of cognitive impairment and density of amyloid plaques (a neuropathological hallmark of Alzheimer's disease). Galantamine, a tertiary alkaloid, is a competitive and reversible inhibitor of acetylcholinesterase.
While the precise mechanism of galantamine's action is unknown, it is postulated 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 cholinesterase. If this mechanism is correct, galantamine’s effect may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact.
There is no evidence that galantamine alters the course of the underlying dementing process.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Galantamine hydrobromide extended-release capsules are supplied as follows: 24 mg (Size 2 caramel opaque/caramel opaque capsules imprinted ‘837’ with black ink on cap and body filled with caramel color capsule shaped uncoated tablet plain on both sides). Bottles of 30 with child-resistant cap.....NDC 72162-1448-3 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense with a child resistant closure in a well-closed container.
Keep out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
11 DESCRIPTION Galantamine hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4a S ,6 R ,8a S )- 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6 H -benzofuro [3a,3,2- ef ][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C 17 H 21 NO 3 •HBr and a molecular weight of 368.27.
Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is: Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Inactive ingredients include pregelatinized maize starch, hypromellose, hydroxy propyl cellulose, colloidal silicon dioxide, magnesium stearate.
The 16 mg capsule also contains ferric oxide (red). The 24 mg capsule also contains FD & C Yellow 6 Lake (15 to 18%). The capsule shells contain gelatin, and sodium lauryl sulfate.
The capsule shells also contain one or more of the following: titanium dioxide, iron oxide red, iron oxide yellow. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Serious Skin Reactions Advise patients and caregivers to discontinue galantamine hydrobromide extended-release capsules and seek immediate medical attention at the first appearance of skin rash [see Warnings and Precautions ( 5.1 )] . General Dosing Guidance Instruct caregivers about the recommended dosage and administration of galantamine hydrobromide extended-release capsules. Galantamine hydrobromide extended-release capsules should be administered once daily in the morning, preferably with food.
Dose escalation (dose increases) should follow a minimum of four weeks at prior dose. If therapy has been interrupted for more than three days, the patient should be restarted with the lowest dose and then re-titrated to an appropriate dosage [see Dosage and Administration ( 2 )] . Advise patients and caregivers to ensure adequate fluid intake during treatment [see Dosage and Administration ( 2 )] .
Advise patients and caregivers that the most frequent adverse events associated with use of the drug can be minimized by following the recommended dosage and administration. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Limited Survey No.
1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India Revised: 10/2023