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PMS-GALANTAMINE is a brand name for Galantamine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .....................................................................3 CONTRAINDICATIONS ..........................................................................................4 WARNINGS AND PRECAUTIONS ........................................................................4 ADVERSE REACTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions, the adverse drug reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. A total of 2287 patients with mild to moderate Alzheimer’s disease were treated with galantamine in Phase III controlled clinical studies using either a 1-week or 4-week dose- escalation period, and 761 patients received galantamine 24 mg/day, the maximum recommended maintenance dose.
The number of patients who completed the studies was 1686 (72%). The mean duration of treatment for all galantamine groups was 130 days (range 1-214 days). Adverse Events Leading to Discontinuation Overall, 19% (441/2287) of patients treated with galantamine discontinued from Phase III controlled clinical trials due to adverse events compared to 8% (98/1159) in the placebo group.
For patients treated with galantamine, the rate of discontinuation due to adverse events was 14% for males and 22% for females. In the 4-week dose-escalation fixed-dose study (GAL-USA-10), 8% (55/692) of patients treated with galantamine withdrew due to adverse events compared to 7% (20/286) in the placebo group.
During the dose-escalation phase of this study the incidence of discontinuations due to adverse events was 4% for placebo, 5% for galantamine 16 mg/day and 6% for galantamine 24 mg/day. During the maintenance phase, 4% of patients who received placebo, 3% of patients who received galantamine 16 mg/day and 4% of patients who received galantamine 24 mg/day withdrew from this study due to adverse events.
1 shows the most frequent adverse events leading to discontinuation for study GAL USA-l0, in which the recommended 4-week dose-escalation schedule was used. 2. These events were primarily gastrointestinal and tended to occur at a lower rate with 16 mg/day, the initial recommended maintenance dose.
Administration of galantamine with food, the use of anti-emetic medication and ensuring adequate fluid intake may reduce the impact of these events. 2: Most frequent adverse events in a randomized placebo-controlled clinical trial with a 4-week dose increment during dose-escalation and maintenance phases (GAL-USA-l0) week 1-12† week 13-21 Adverse Events Placebo n=286 % 16 mg/day n=279 % 24 mg/day n=273 % Placebo n=259 % 16 mg/day n=243 % 24 mg/day n=241 % Nausea 5 11 13 <1 4 6 Vomiting <1 5 6 <1 2 6 Diarrhea 5 9 4 2 5 2 Anorexia 2 5 5 1 2 5 †Dose escalation occurred with 4 weeks per dose increment.
pms-GALANTAMINE 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 the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph.
WARNINGS AND PRECAUTIONS Carcinogenesis and Mutagenesis See Product Monograph Part II TOXICOLOGY- Carcinogenicity, Mutagenicity for discussion on animal data. Cardiovascular Because of their pharmacological action, cholinesterase inhibitors have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and heart block.
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 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=l39) 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Galantamine in Canada.
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The majority of these adverse events occurred during the dose-escalation period. Nausea and vomiting, the most frequent adverse events, occurred more frequently at higher doses, lasted 5-7 days in most cases, and the majority of patients had one episode.
The incidence of weight loss in this study was, during dose escalation (Weeks 1-12): placebo, 1%; 16 mg/day, 3%; 24 mg/day, 2%; and during the maintenance phase (Weeks 13-21): placebo, <1%; 16 mg/day, 3%; 24 mg/day, 3%. Dose-escalation should be cautious and maintenance dosing should remain flexible and be adjusted according to individual needs.
Adverse Events Reported in Controlled Trials The reported adverse events in galantamine trials 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 behaviour and the types of patients treated may differ.
3 lists the most common adverse events (adverse events occurring with an incidence of 2% with galantamine treatment and in which the incidence was greater than with placebo treatment) for four placebo-controlled trials for patients treated with 16 or 24 mg/day of galantamine.
3 were derived from trials using a 1-week or the recommended 4-week dose-escalation period. 3: Adverse events reported in at least 2% of patients with Alzheimer’s disease administered galantamine and at a frequency greater than with placebo (combined 1- and 4- week dose-escalation data) Body System / Adverse Events Placebo (n=801) % Galantamine † (n=1040) % Body as a whole - general disorders Fatigue 3 5 Syncope 1 2 Central & peripheral nervous system disorders Dizziness 6 9 Headache 5 8 Tremor 2 3 Gastrointestinal system disorders Nausea 9 24 Vomiting 4 13 Diarrhea 7 9 Abdominal pain 4 5 Dyspepsia 2 5 Heart rate and rhythm disorders Bradycardia 1 2 Metabolic and nutritional disorders Weight decrease 2 7 Psychiatric disorders Anorexia 3 9 Depression 5 7 Insomnia 4 5 Somnolence 3 4 Red blood cell disorders Anemia 2 3 Respiratory system disorders Rhinitis 3 4 Urinary system disorders Urinary tract infection 7 8 Hematuria 2 3 †Adverse events in patients treated with 16 or 24 mg/day of galantamine in three placebo-controlled trials with a 1-week dose-escalation period and a 26-week fixed-dose galantamine treatment, and one placebo-controlled trial with the recommended 4-week dose-escalation period and a 21-week fixed-dose […]
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 1-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. Page 5 of 53 Metabolism 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.
g. 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 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 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.
Neurologic Seizures:
In placebo-controlled trials with galantamine, cases of seizure were reported; there was no increase in incidence compared with placebo. Although cholinomimetics are believed to have some potential to cause seizures, seizure activity may also be a manifestation of Alzheimer’s disease.
The risk/benefit of galantamine treatment for patients with a history of seizure disorder must therefore be carefully evaluated. 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.
Page 6 of 53 Peri-Operative Considerations Anesthesia:
Galantamine, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. Respiratory Like other cholinomimetic drugs, galantamine should be prescribed with care for patients with a history of asthma or obstructive pulmonary disease.
Special Populations Hepatic Impairment:
There is limited information on the pharmacokinetics of galantamine in hepatically impaired patients (see ACTION AND CLINICAL PHARMACOLOGY). It is therefore recommended that dose escalation with galantamine in Alzheimer’s disease patients with hepatic impairment be undertaken with caution and under conditions of close […]