Galantamine Hydrobromide

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Galantamine Oral Solution:
• Recommended starting dosage is 4 mg (1 mL) twice daily; increase dose to initial maintenance dosage of 8 mg (2 mL) twice daily after a minimum of 4 weeks. Based on clinical benefit and tolerability, dosage may be increased to 12 mg (3 mL) twice daily after a minimum of 4 weeks at 8 mg (2 mL) twice daily. ( 2.2 )
• Take with meals; ensure adequate fluid intake during treatment. ( 2.2 )
• Hepatic Impairment:
• should not exceed 16 mg (4 mL)/day for moderate hepatic impairment;
• do not use in patients with severe hepatic impairment. ( 2.3 )
• Renal Impairment:
• should not exceed 16 mg (4 mL)/day for creatinine clearance 9 mL to 59 mL/min;
• do not use in patients with creatinine clearance less than 9 mL/min. ( 2.4 ) 2.2 Galantamine Oral Solution The dosage of galantamine tablets shown to be effective in controlled clinical trials is 16 mg to 32 mg/day given as twice daily dosing. As the dosage of 32 mg/day is less well tolerated than lower dosages and does not provide increased effectiveness, the recommended dosage range is 16 mg to 24 mg/day given twice daily. The dosage of 24 mg/day did not provide a statistically significant greater clinical benefit than 16 mg/day. It is possible, however, that a daily dosage of 24 mg of galantamine might provide additional benefit for some patients. The recommended starting dosage of galantamine oral solution is 4 mg (1 mL) twice a day (8 mg (2 mL)/day). The dosage should be increased to the initial maintenance dosage of 8 mg (2 mL) twice a day (16 mg (4 mL)/day) after a minimum of 4 weeks. A further increase to 12 mg (3 mL) twice a day (24 mg (6 mL)/day) should be attempted after a minimum of 4 weeks at 8 mg (2 mL) twice a day (16 mg (4 mL)/day). Dosage increases should be based upon assessment of clinical benefit and tolerability of the previous dose. Galantamine oral solution should be administered twice a day, preferably with morning and evening meals. Patients and caregivers should be advised to ensure adequate fluid intake during treatment. 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 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. The beneficial effects of galantamine are lost, however, when the drug is discontinued. 2.3 Dosage 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 (4 mL)/day. The use of galantamine in patients with severe hepatic impairment (Child-Pugh score of 10 to 15) is not recommended [see Clinical Pharmacology (12.3) ]. 2.4 Dosage in Patients with Renal Impairment In patients with creatinine clearance of 9 mL to 59 mL/min, the dosage should generally not exceed 16 mg (4 mL)/day. In patients with creatinine clearance less than 9 mL/min, the use of galantamine is not recommended [see Clinical Pharmacology (12.3) ] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6519 patients have investigated galantamine 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Serious Skin Reactions:
• Advise patients and caregivers to discontinue galantamine 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.
• Galantamine oral solution should be administered twice per day, preferably with the morning and evening meals.
• 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.
• Oral Solution Instruction Sheet:
• Instruct caregivers in the correct procedure for administering galantamine oral solution.
• In addition, inform them of the existence of an Instruction Sheet (included with the product) describing how the solution is to be administered.
• Urge caregivers to read this sheet prior to administering galantamine oral solution, and to direct questions about the administration of the solution to either their physician or pharmacist.
• Distributed by: Hikma Pharmaceuticals USA Inc.
• Berkeley Heights, NJ 07922 C50000575/03 Revised October 2023

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Galantamine Oral Solution USP, 4 mg/mL is a clear, colorless to pale yellow solution supplied in 100 mL bottles with a calibrated (in milliliters) syringe.
• The minimum calibrated volume is 0.5 mL, while the maximum calibrated volume is 5 mL.
• Oral Solution – 4 mg/mL ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied Galantamine Oral Solution, USP 4 mg/mL oral solution is supplied in a 100 mL bottle as a clear, colorless to pale yellow solution with a calibrated (in milliliters) syringe.
• The minimum calibrated volume is 0.5 mL, while the maximum calibrated volume is 5 mL.
• NDC 0054-0137-49: Bottle of 100 mL
• 16.2 Storage and Handling Galantamine Oral Solution, USP should be stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] DO NOT FREEZE.
• Keep this and all drugs out of the reach of children.

Quoted from the official label, section “How Supplied”.

What is in it

• Galantamine Oral Solution, USP contains galantamine hydrobromide, USP, 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 an empirical formula of C 17 H 21 NO 3
• HBr and a molecular weight of 368.27. Galantamine hydrobromide, USP is a white to off-white powder and is sparingly soluble in water. The structural formula is:
• Galantamine Oral Solution, USP contains 4 mg (as 5.13 mg galantamine hydrobromide, USP) per mL. The inactive ingredients are methylparaben, propylparaben, purified water and saccharin sodium. Galantamine may contain hydrochloric acid and/or sodium hydroxide to adjust pH. Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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