Galantamine hydrobromide
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]
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Overview
Galantamine hydrobromide is a cholinergic muscarinic agonist that is FDA approved for the treatment of mild to moderate dementia of the Alzheimer's type. Common adverse reactions include dehydration, aggression, upper and lower GI bleeding, hypokalemia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Galantamine hydrobromide is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Galantamine hydrobromide in adult patients.
Non–Guideline-Supported Use
- Alzheimer's disease
- Multi-infarct dementia
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Galantamine hydrobromide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Galantamine hydrobromide in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Galantamine hydrobromide in pediatric patients.
Contraindications
It is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation
Warnings
Anesthesia
- Galantamine, as a cholinesterase inhibitor, is likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia.
Cardiovascular Conditions
- Because of their pharmacological action, cholinesterase inhibitors have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. These actions may be particularly important to patients with supraventricular cardiac conduction disorders or to patients taking other drugs concomitantly that significantly slow heart rate. Postmarketing surveillance of marketed anticholinesterase inhibitors has shown, however, that bradycardia and all types of heart block have been reported in patients both with and without known underlying cardiac conduction abnormalities. Therefore all patients should be considered at risk for adverse effects on cardiac conduction.
- In randomized controlled trials, bradycardia was reported more frequently in galantamine-treated patients than in placebo-treated patients, but was rarely severe and rarely led to treatment discontinuation. The overall frequency of this event was 2 to 3% for galantamine doses up to 24 mg/day compared with <1% for placebo. No increased incidence of heart block was observed at the recommended doses.
- 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 BID 0.4% [3/692]; 8 mg BID 1.3% [7/552]; 12 mg BID 2.2% [6/273]).
Gastrointestinal 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.
Genitourinary
- Although this was not observed in clinical trials with galantamine, cholinomimetics may cause bladder outflow obstruction.
Neurological Conditions
Seizures
- Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. However, seizure activity may also be a manifestation of Alzheimer's disease. In clinical trials, there was no increase in the incidence of convulsions with galantamine, compared to placebo.
Pulmonary Conditions
- Because of its cholinomimetic action, galantamine should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease.
Adverse Reactions
Clinical Trials Experience
Pre-Marketing Clinical Trial Experience
- The specific adverse event data described in this section are based on studies of the immediate release tablet formulation.
Adverse Events Leading to Discontinuation
- In two large scale, placebo-controlled trials of 6 months duration in which patients were titrated weekly from 8 to 16 to 24, and to 32 mg/day, the risk of discontinuation because of an adverse event in the galantamine group exceeded that in the placebo group by about threefold. In contrast, in a 5-month trial with escalation of the dose by 8 mg/day every 4 weeks, the overall risk of discontinuation because of an adverse event was 7%, 7%, and 10% for the placebo, galantamine 16 mg/day, and galantamine 24 mg/day groups, respectively, with gastrointestinal adverse effects the principle reason for discontinuing galantamine. Table 1 shows the most frequent adverse events leading to discontinuation in this study.
This image is provided by the National Library of Medicine.
Adverse Events Reported in Controlled Trials
- The reported adverse events in trials using galantamine reflect experience gained under closely monitored conditions in a highly selected patient population. In actual practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior and the types of patients treated may differ.
- The majority of these adverse events occurred during the dose-escalation period. In those patients who experienced the most frequent adverse event, nausea, the median duration of the nausea was 5 to 7 days.
- Administration of galantamine with food, the use of anti-emetic medication, and ensuring adequate fluid intake may reduce the impact of these events.
- The most frequent adverse events, defined as those occurring at a frequency of at least 5% and at least twice the rate on placebo with the recommended maintenance dose of either 16 or 24 mg/day of galantamine under conditions of every 4 week dose-escalation for each dose increment of 8 mg/day, are shown in Table 2. These events were primarily gastrointestinal and tended to be less frequent with the 16 mg/day recommended initial maintenance dose.
This image is provided by the National Library of Medicine.
- Adverse events occurring with an incidence of at least 2% in placebo-treated patients that was either equal to or greater than with galantamine treatment were constipation, agitation, confusion, anxiety, hallucination, injury, back pain, peripheral edema, asthenia, chest pain, urinary incontinence, upper respiratory tract infection, bronchitis, coughing, hypertension, fall, and purpura.
- There were no important differences in adverse event rates related to dose or sex. There were too few non-Caucasian patients to assess the effects of race on adverse event rates.
- No clinically relevant abnormalities in laboratory values were observed.
- Other Adverse Events Observed During Clinical Trials
- Galantamine was administered to 3055 patients with Alzheimer's disease. A total of 2357 patients received galantamine in placebo-controlled trials and 761 patients with Alzheimer's disease received galantamine 24 mg/day, the maximum recommended maintenance dose. About 1000 patients received galantamine for at least one year and approximately 200 patients received galantamine for two years.
- To establish the rate of adverse events, data from all patients receiving any dose of galantamine in 8 placebo-controlled trials and 6 open-label extension trials were pooled. The methodology to gather and codify these adverse events was standardized across trials, using WHO terminology. All adverse events occurring in approximately 0.1% are included, except for those already listed elsewhere in labeling, WHO terms too general to be informative, or events unlikely to be drug caused. Events are classified by body system and listed using the following definitions: frequent adverse events - those occurring in at least 1/100 patients; infrequent adverse events - those occurring in 1/100 to 1/1000 patients; rare adverse events - those occuring in fewer than 1/1000 patients. These adverse events are not necessarily related to galantamine treatment and in most cases were observed at a similar frequency in placebo-treated patients in the controlled studies. Additional adverse events observed in other clinical trials are also included below.
Body As a Whole
- General Disorders
- Frequent: chest pain, asthenia, fever, malaise
- Cardiovascular System Disorders
- Postural hypotension, hypotension, dependent edema, cardiac failure, myocardial ischemia or infarction
- Central & Peripheral Nervous System Disorders
- Vertigo, hypertonia, convulsions, involuntary muscle contractions, paresthesia, ataxia, hypokinesia, hyperkinesia, apraxia, aphasia, leg cramps, tinnitus, transient ischemic attack or cerebrovascular accident
Gastrointestinal System Disorders
- Frequent
- Flatulence; Infrequent: gastritis, melena, dysphagia, rectal hemorrhage, dry mouth, saliva increased, diverticulitis, gastroenteritis, hiccup; Rare: esophageal perforation
Heart Rate & Rhythm Disorders
- Infrequent
- AV block, palpitation, atrial arrhythmias including atrial fibrillation and supraventricular tachycardia, QT prolonged, bundle branch block, T-wave inversion, ventricular tachycardia; Rare: severe bradycardia
Metabolic & Nutritional Disorders
- Infrequent
- Hyperglycemia, alkaline phosphatase increased
Platelet, Bleeding & Clotting Disorders
- Infrequent
- Purpura, epistaxis, thrombocytopenia
Psychiatric Disorders
- Infrequent
- Apathy, paroniria, paranoid reaction, libido increased, delirium.
- Rare
- Suicidal ideation, suicide
Urinary System Disorders
- Frequent
- Incontinence
- Infrequent
- Hematuria, micturition frequency, cystitis, urinary retention, nocturia, renal calculi
Postmarketing Experience
- Other adverse events from post-approval controlled and uncontrolled clinical trials and post-marketing experience observed in patients treated with galantamine include:
Body as a Whole
General Disorders
- Dehydration (including rare, severe cases leading to renal insufficiency and renal failure)
Psychiatric Disorders
- Aggression
Gastrointestinal System Disorders
- Upper and lower GI bleeding
Metabolic & Nutritional Disorders
- Hypokalemia
- These adverse events may or may not be causally related to the drug.
Drug Interactions
There is limited information regarding Galantamine hydrobromide Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Galantamine hydrobromide in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Galantamine hydrobromide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Galantamine hydrobromide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Galantamine hydrobromide in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Galantamine hydrobromide in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Galantamine hydrobromide in geriatric settings.
Gender
There is no FDA guidance on the use of Galantamine hydrobromide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Galantamine hydrobromide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Galantamine hydrobromide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Galantamine hydrobromide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Galantamine hydrobromide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Galantamine hydrobromide in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Galantamine hydrobromide Administration in the drug label.
Monitoring
There is limited information regarding Galantamine hydrobromide Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Galantamine hydrobromide and IV administrations.
Overdosage
There is limited information regarding Galantamine hydrobromide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Galantamine hydrobromide Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Galantamine hydrobromide Mechanism of Action in the drug label.
Structure
There is limited information regarding Galantamine hydrobromide Structure in the drug label.
Pharmacodynamics
There is limited information regarding Galantamine hydrobromide Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Galantamine hydrobromide Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Galantamine hydrobromide Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Galantamine hydrobromide Clinical Studies in the drug label.
How Supplied
There is limited information regarding Galantamine hydrobromide How Supplied in the drug label.
Storage
There is limited information regarding Galantamine hydrobromide Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Galantamine hydrobromide Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Galantamine hydrobromide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Galantamine hydrobromide Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Galantamine hydrobromide Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.