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GALANTAMINE ER is a brand name for Galantamine, supplied as a capsule (extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: GALANTAMINE ER (galantamine extended release capsules) is indicated for the symptomatic treatment of patients with mild to moderate dementia of the Alzheimer’s type. Galantamine has not been studied in controlled clinical trials for longer than 6 months. GALANTAMINE ER should only be prescribed by (or following…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics, Patients with Mild Cognitive Impairment (MCI)). GALANTAMINE ER should only be prescribed by (or following consultation with) clinicians who are experienced in the diagnosis and management of Alzheimer’s disease. 1 Dosing Considerations • Concomitant Treatment: In patients treated with potent CYP2D6 or CYP3A4 inhibitors, dose reductions can be considered (see 9 DRUG INTERACTIONS).
4 Geriatrics), and patients with hepatic and/or renal impairment (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, Renal). • Missed Dose: The missed dose should be taken at the next scheduled dose. Doses should not be doubled.
5 Missed Dose). 2 Recommended Dose and Dosage Adjustment The dosage of galantamine (as galantamine immediate release formulation) shown to be effective in controlled clinical trials is 16-32 mg/day. As the dose of 32 mg/day is less well tolerated than lower doses and does not provide increased effectiveness, the recommended dose range is 16-24 mg/day.
The dose of 24 mg/day did not provide a statistically significant greater clinical benefit than 16 mg/day. It is possible, however, that a daily dose of 24 mg of galantamine might provide additional benefit for some patients. The recommended starting dose is 8 mg once daily for 4 weeks.
The dose should be increased to the initial maintenance dose of 16 mg once daily after 4 weeks. If this initial maintenance dose is well tolerated, a further increase to 24 mg once daily may be considered only after a minimum of 4 weeks at 16 mg once daily.
The abrupt withdrawal of galantamine in those patients who had been receiving doses in the effective range was not associated with an increased frequency of adverse events in comparison with those continuing to receive the same doses of that drug.
The beneficial effects of galantamine are lost, however, when the drug is discontinued. 1 Pediatrics). 4 Geriatrics). 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Impairment). It is therefore recommended that dose escalation with GALANTAMINE ER in Alzheimer’s disease patients with hepatic impairment be undertaken with caution and under conditions of close monitoring for adverse effects.
Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment. In patients with moderately impaired hepatic function (Child-Pugh score of 7–9), based on pharmacokinetic modelling, dosing with GALANTAMINE ER extended release capsules should begin with 8 mg every other day in the morning, preferably with food, for at least 1 week.
). These actions may be particularly important to patients with “sick sinus syndrome” or other supraventricular cardiac conduction disorders, or to patients taking other drugs concomitantly which significantly slow heart rate. In clinical trials, patients with serious cardiovascular disease were excluded.
Caution should be exercised in treating patients with active coronary artery disease or congestive heart failure. It is recommended that GALANTAMINE ER not be used in patients with cardiac conduction abnormalities (except for right bundle branch block) including “sick sinus syndrome” and those with unexplained syncopal episodes.
In randomized controlled trials, bradycardia was reported at 2-3% for galantamine doses up to 24 mg/day compared with <1% for placebo, but was rarely severe and rarely led to treatment discontinuation. No increased incidence of heart block was observed at the recommended doses.
2% [6/273]). A 6-week cardiovascular safety clinical trial (GAL-USA-16; n=139) was performed to investigate the effect of galantamine at doses up to 32 mg/day. This dosing regimen was: 8 mg/day in Week 1, 16 mg/day in Week 2, 24 mg/day in Weeks 3 and 4, and 32 mg/day in Weeks 5 and 6.
Heart block/pauses greater than two seconds were more common in galantamine-treated patients than in placebo-treated patients. It should be noted that a forced one-week dose escalation was used in this study, which is not recommended.
Whether these cardiac effects are attenuated by slower titration rates is not known. Particular caution is warranted during titration where the majority of pauses occurred in the above study. GALANTAMINE ER (Galantamine Extended-Release Capsules) Page 10 of 64 Driving and Operating Machinery GALANTAMINE ER may cause adverse reactions (such as dizziness and somnolence), which could affect the ability to drive or use machines, especially during the first weeks after initiation of treatment (see 8 ADVERSE REACTIONS).
, Neurologic 07/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS ...................................................................................................................... 1 Pediatrics .......................................................................................................................
2 Geriatrics ....................................................................................................................... 4 2 CONTRAINDICATIONS .........................................................................................................
4 4 DOSAGE AND ADMINISTRATION ......................................................................................... 1 Dosing Considerations ..................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................. 4 Administration .............................................................................................................. 5 Missed Dose ..................................................................................................................
6 5 OVERDOSAGE ..................................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................................... 8 7 WARNINGS AND PRECAUTIONS ..........................................................................................
GALANTAMINE ER is contraindicated in patients with known hypersensitivity to galantamine hydrobromide, other tertiary alkaloid derivatives or to any excipients used in the formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Then the dosage should be increased to 8 mg once daily for at least 4 weeks. In these patients, daily doses should not exceed a total of 16 mg once daily. Since no data are available on the use of galantamine in patients with severe hepatic impairment (Child-Pugh GALANTAMINE ER (Galantamine Extended-Release Capsules) Page 6 of 64 score of 10-15), GALANTAMINE ER is not recommended for this population (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
3 Pharmacokinetics, Special Populations and Conditions, Renal Impairment). It is therefore recommended that dose escalation with GALANTAMINE ER in Alzheimer’s disease patients with renal impairment (creatinine clearance of 9 to 60 mL/min) be undertaken with caution and under conditions of close monitoring for adverse effects.
For patients with renal impairment (creatinine clearance of 9 to 60 mL/min), dose escalation should proceed cautiously and the maintenance dose should generally not exceed 16 mg once daily. Since no data are available on the use of galantamine in patients with a creatinine clearance less than 9 mL/min, GALANTAMINE ER is not recommended for this population (see 7 WARNINGS AND PRECAUTIONS, Renal).
In a population of cognitively-impaired individuals, safe use of this and all other medications may require supervision. 4 Administration GALANTAMINE ER should be administered once daily in the morning, preferably with food. Patients and caregivers should be advised to ensure adequate fluid intake during treatment.
5 Missed Dose The missed dose should be taken at the next scheduled dose. Doses should not be doubled. If therapy has been interrupted for several days or longer, the patient should be restarted at the lowest dose and the dose escalated to the current dose.
Endocrine and Metabolism Weight Monitoring Cholinesterase inhibitors as well as Alzheimer’s disease can be associated with significant weight loss. In controlled clinical trials, the use of galantamine was associated with weight loss.
Weight decrease occurred early during treatment and was related to dose. Weight loss of ≥ 7% occurred more frequently in patients treated with galantamine and in female patients than in patients receiving placebo. Where weight loss may be of clinical concern, body weight should be monitored.
Gastrointestinal Through their primary action, cholinesterase inhibitors may be expected to increase gastric acid secretion due to increased cholinergic activity. , those with a history of ulcer disease or patients using concurrent nonsteroidal anti-inflammatory drugs (NSAIDs).
In controlled clinical studies with galantamine, patients with symptomatic peptic ulceration were excluded. Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding (see 8 ADVERSE REACTIONS).
Galantamine, as a predictable consequence of its pharmacological properties, has been shown to produce nausea, vomiting and diarrhea, anorexia and weight loss. These effects appeared more frequently at higher doses (see 8 ADVERSE REACTIONS), with nausea and vomiting being more prevalent in women and patients with lower body weight and correspondingly higher plasma drug concentrations.
Females are more sensitive to the cholinergic adverse effects associated with cholinesterase inhibitors and in general are more likely to experience nausea and vomiting than are males. In most cases, these effects were of mild to moderate intensity and transient and have resolved during continued galantamine treatment or upon treatment discontinuation.
Genitourinary Although not observed in clinical trials of galantamine, cholinomimetics may cause bladder outflow obstruction. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Impairment). 2 Recommended Dose and Dosage Adjustment, Hepatic Impairment).
Since no data are available on the use of galantamine in patients with severe hepatic impairment (Child-Pugh score of 10-15), GALANTAMINE ER is not recommended for this population. Neurologic Galantamine has not been studied in patients with moderately severe or severe Alzheimer’s disease, non-Alzheimer dementias or individuals with Parkinsonian features.
The efficacy and safety of galantamine in these patient populations is unknown. Seizures In placebo-controlled trials with galantamine, cases of seizure were reported; there was no increase in incidence compared with placebo. Convulsions have been reported with galantamine (see 8 ADVERSE REACTIONS).
Seizure activity may also be a manifestation of Alzheimer’s disease. The risk/benefit of GALANTAMINE ER treatment for patients with a history of seizure disorder must therefore be carefully evaluated. Tremor and Other Extrapyramidal Symptoms Like other cholinomimetics, there have been post-marketing reports of extrapyramidal disorders related to an increase in cholinergic tone that may also worsen symptoms of pre- existing […]
1 Special Populations ..................................................................................................... 1 Pregnant Women .....................................................................................................
2 Breast-feeding .......................................................................................................... 3 Pediatrics..................................................................................................................
4 Geriatrics .................................................................................................................. 12 8 ADVERSE REACTIONS ........................................................................................................
1 Adverse Reaction Overview ........................................................................................ 2 Clinical Trial Adverse Reactions ..................................................................................
3 Less Common Clinical Trial Adverse Reactions ........................................................... 5 Post-Market Adverse Reactions.................................................................................. 21 9 DRUG INTERACTIONS ........................................................................................................
2 Drug Interactions Overview ........................................................................................ 4 Drug-Drug Interactions ...............................................................................................
5 Drug-Food Interactions ............................................................................................... 6 Drug-Herb Interactions ...............................................................................................
7 Drug-Laboratory Test Interactions.............................................................................. 24 10 CLINICAL PHARMACOLOGY .............................................................................................
1 Mechanism of Action ................................................................................................ 2 Pharmacodynamics ...................................................................................................
3 Pharmacokinetics ...................................................................................................... 25 11 STORAGE, STABILITY AND DISPOSAL ...............................................................................
28 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................. 28 PART II: SCIENTIFIC INFORMATION ......................................................................................
29 13 PHARMACEUTICAL INFORMATION .................................................................................. 29 14 CLINICAL TRIALS ..............................................................................................................
1 Trial Design and Study Demographics ...................................................................... 2 Study Results .............................................................................................................
3 Comparative Bioavailability Studies ......................................................................... 38 15 MICROBIOLOGY ..............................................................................................................
40 16 NON-CLINICAL TOXICOLOGY ........................................................................................... 40 17 SUPPORTING PRODUCT MONOGRAPHS ..........................................................................
56 PATIENT MEDICATION INFORMATION […]