Galantamine Hydrobromide
Generic: GALANTAMINE HYDROBROMIDE
Basic Information
Manufacturer
Hikma Pharmaceuticals USA Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
d5b0e225-e94d-4324-afb2-b6e51c949dd0
Indications & Usage
1 INDICATIONS AND USAGE Galantamine is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.
Galantamine is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.
( 1 )
Galantamine is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.
( 1 )
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 Subjects 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 Hikma Pharmaceuticals USA Inc.
at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical 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 in galantamine-treated patients from double-blind clinical trials (≥5%) 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 3956 galantamine-treated patients who participated in 8 placebo-controlled clinical studies and 1454 subjects 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 Galantamine (n=3956) % Placebo (n=2546) % Metabolism and Nutrition Disorders Decreased Appetite 7.4 2.1 Psychiatric Disorders Depression 3.6 2.3 Nervous System Disorders Headache 7.1 5.5 Dizziness 7.5 3.4 Tremor 1.6 0.7 Somnolence 1.5 0.8 Syncope 1.4 0.6 Lethargy 1.3 0.4 Cardiac Disorders Bradycardia 1.0 0.3 Gastrointestinal Disorders Nausea 20.7 5.5 Vomiting 10.5 2.3 Diarrhea 7.4 4.9 Abdominal Discomfort 2.1 0.7 Abdominal Pain 3.8 2.0 Dyspepsia 1.5 1.0 Musculoskeletal and Connective Tissue Disorders Muscle Spasms 1.2 0.5 General Disorders and Administration Site Conditions Fatigue 3.5 1.8 Asthenia 2.0 1.5 Malaise 1.1 0.5 Investigations Decreased Weight 4.7 1.5 Injury, Poisoning and Procedural Complications Fall 3.9 3.0 Laceration 1.1 0.5 The 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=3956) 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=1454) who participated in open-label studies.
Adverse reactions listed in Table 1 above were not included below: Metabolism and Nutrition Disorders: Dehydration Nervous System Disorders: Dysgeusia, Hypersomnia, Paresthesia Eye Disorders: Blurred vision Cardiac Disorders: First degree atrioventricular block, Palpitations, Sinus bradycardia, Supraventricular extrasystoles Vascular Disorders: Flushing, Hypotension Gastrointestinal Disorders: Retching Skin and Subcutaneous Tissue Disorders: Hyperhidrosis Musculoskeletal and Connective Tissue Disorders: Muscular weakness Discontinuations Due to Adverse Reactions: In the 8 placebo-controlled studies of adults, 418 (10.6%) galantamine-treated patients (n=3956) and 56 (2.2%) placebo patients (n=2546) discontinued due to an adverse reaction.
Those events with an incidence of ≥0.5% in the galantamine-treated patients included nausea (245, 6.2%), vomiting (129, 3.3%), decreased appetite (60, 1.5%), dizziness (50, 1.3%), diarrhea (31, 0.8%), headache (29, 0.7%), and decreased weight (26, 0.7%).
The only event with an incidence of ≥0.5% in placebo patients was nausea (17, 0.7%).
In the 5 open-label studies, 103 (7.1%) patients (n=1454) discontinued due to an adverse reaction.
Those events with an incidence of ≥0.5% included nausea (43, 3.0%), vomiting (23, 1.6%), decreased appetite (13, 0.9%), headache (12, 0.8%), decreased weight (9, 0.6%), dizziness (8, 0.6%), and diarrhea (7, 0.5%).
6.2 Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of galantamine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency: Immune System Disorders: Hypersensitivity Psychiatric Disorders: Hallucinations Nervous System Disorders: Seizures Ear and Labyrinth Disorders: Tinnitus Cardiac Disorders: Complete atrioventricular block Vascular Disorders: Hypertension Hepatobiliary Disorders: Hepatitis, Increased hepatic enzyme Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome, Acute generalized exanthematous pustulosis, Erythema multiforme
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc.
at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical 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 in galantamine-treated patients from double-blind clinical trials (≥5%) 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 3956 galantamine-treated patients who participated in 8 placebo-controlled clinical studies and 1454 subjects 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 Galantamine (n=3956) % Placebo (n=2546) % Metabolism and Nutrition Disorders Decreased Appetite 7.4 2.1 Psychiatric Disorders Depression 3.6 2.3 Nervous System Disorders Headache 7.1 5.5 Dizziness 7.5 3.4 Tremor 1.6 0.7 Somnolence 1.5 0.8 Syncope 1.4 0.6 Lethargy 1.3 0.4 Cardiac Disorders Bradycardia 1.0 0.3 Gastrointestinal Disorders Nausea 20.7 5.5 Vomiting 10.5 2.3 Diarrhea 7.4 4.9 Abdominal Discomfort 2.1 0.7 Abdominal Pain 3.8 2.0 Dyspepsia 1.5 1.0 Musculoskeletal and Connective Tissue Disorders Muscle Spasms 1.2 0.5 General Disorders and Administration Site Conditions Fatigue 3.5 1.8 Asthenia 2.0 1.5 Malaise 1.1 0.5 Investigations Decreased Weight 4.7 1.5 Injury, Poisoning and Procedural Complications Fall 3.9 3.0 Laceration 1.1 0.5 The 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=3956) 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=1454) who participated in open-label studies.
Adverse reactions listed in Table 1 above were not included below: Metabolism and Nutrition Disorders: Dehydration Nervous System Disorders: Dysgeusia, Hypersomnia, Paresthesia Eye Disorders: Blurred vision Cardiac Disorders: First degree atrioventricular block, Palpitations, Sinus bradycardia, Supraventricular extrasystoles Vascular Disorders: Flushing, Hypotension Gastrointestinal Disorders: Retching Skin and Subcutaneous Tissue Disorders: Hyperhidrosis Musculoskeletal and Connective Tissue Disorders: Muscular weakness Discontinuations Due to Adverse Reactions: In the 8 placebo-controlled studies of adults, 418 (10.6%) galantamine-treated patients (n=3956) and 56 (2.2%) placebo patients (n=2546) discontinued due to an adverse reaction.
Those events with an incidence of ≥0.5% in the galantamine-treated patients included nausea (245, 6.2%), vomiting (129, 3.3%), decreased appetite (60, 1.5%), dizziness (50, 1.3%), diarrhea (31, 0.8%), headache (29, 0.7%), and decreased weight (26, 0.7%).
The only event with an incidence of ≥0.5% in placebo patients was nausea (17, 0.7%).
In the 5 open-label studies, 103 (7.1%) patients (n=1454) discontinued due to an adverse reaction.
Those events with an incidence of ≥0.5% included nausea (43, 3.0%), vomiting (23, 1.6%), decreased appetite (13, 0.9%), headache (12, 0.8%), decreased weight (9, 0.6%), dizziness (8, 0.6%), and diarrhea (7, 0.5%).
6.2 Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of galantamine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency: Immune System Disorders: Hypersensitivity Psychiatric Disorders: Hallucinations Nervous System Disorders: Seizures Ear and Labyrinth Disorders: Tinnitus Cardiac Disorders: Complete atrioventricular block Vascular Disorders: Hypertension Hepatobiliary Disorders: Hepatitis, Increased hepatic enzyme Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome, Acute generalized exanthematous pustulosis, Erythema multiforme