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PENDO-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: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Carcinogenesis and Mutagenesis See Product Monograph Part II:
TOXICOLOGY – Mutagenicity, Carcinogenicity, 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 pendo-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. 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 hydrobromide 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 hydrobromide and in female patients than in patients receiving placebo.
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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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 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 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. Convulsions have been reported with galantamine hydrobromide (see ADVERSE REACTIONS). Seizure activity may also be a manifestation of Alzheimer’s disease.
The risk/benefit of galantamine hydrobromide treatment for patients with a history of seizure disorder must therefore be carefully evaluated. Galantamine hydrobromide 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 hydrobromide in these patient populations is unknown.
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 hydrobromide should be prescribed with care for patients with a history of asthma or obstructive pulmonary disease.
, erythema multiforme), have been reported in patients receiving galantamine hydrobromide (see ADVERSE REACTIONS, Post-Market Adverse Drug Reactions). Patients or caregivers should be instructed to inform their health care provider of any skin reactions that occur during treatment with pendo-GALANTAMINE ER.
It is recommended that treatment should be discontinued at the first appearance of […]