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Gabapentin is approved by Health Canada as an antiepileptic agent and it is also widely used off-label in the treatment of pain and in the management of several psychiatric conditions, including alcohol withdrawal and cocaine dependence.1-4 The exact mechanism by which this central nervous system active agent exerts its antiseizure activity has Gabapentin works by dampening the pain signals sent through the body’s nervous system. • Gabapentin can also be used in the treatment of seizure disorders. How should this medication be used? • Gabapentin comes as a capsule in the following strengths: 100 mg, 300 mg, and 400 mg. Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of gabapentin in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. Health Canada's review concluded that there is evidence supporting a risk of serious breathing problems when gabapentin is used. Health Canada recommended updates to the product information for gabapentin to warn about this risk. We would like to show you a description here but the site won’t allow us. Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of NEURONTIN in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. Information on drugs and health products authorized by Health Canada. Click on a resource to visit a page with more information. You may be taken away from this page to a different Government of Canada website. Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of gabapentin in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. We would like to show you a description here but the site won’t allow us. Information on drug and health products authorized by Health Canada. Health Canada continues to monitor safety information involving gabapentin, as it does for all health products on the Canadian market, to identify and assess potential harms. Gabapentin is an anti-epileptic agent, which is also used off-label in Canada to treat peripheral neuropathic pain and a number of other indications. Gabapentin has the potential to be used inappropriately, and anecdotal reports of its misuse have been increasing. While reviewing safety information given by the manufacturer for this change, Health Canada found cases of respiratory depression in patients treated with gabapentin alone. OTTAWA – Health Canada is advising Canadians about the increased risk of opioid overdose and serious side effects when taking gabapentin (e.g., Neurontin) or pregabalin (e.g., Lyrica) with an opioid. Gabapentin is authorized to treat epilepsy and pregabalin is authorized to treat nerve pain. A comparative, two-way, single-dose, bioavailability study was performed under fed conditions on TEVA-GABAPENTIN (gabapentin) 100 mg capsules and Neurontin® 100 mg capsules by Parke-Davis division of Warner-Lambert Canada. Safety Reviews Each health product authorized for sale in Canada has terms of approval and labeling that reflects Health Canada's understanding of the benefits and harms of the product at the time of approval. Once on the Canadian market, Health Canada continues to monitor safety of health products to identify and assess potential harms. High-dose gabapentin is associated with a twofold increase in adverse efects, including somnolence, tremors, ataxia and nystagmus. Note: GABA = γ-aminobutyric acid, OR = odds ratio. Summary safety review — gabapentin — assessing the potential risk of serious breathing problems. Ottawa: Health Canada; 2016. List of Approved drugs containing Gabapentin listed with Health Canada in the Drug Product Database (DPD) PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Adults TEVA-GABAPENTIN (gabapentin) is indicated as adjunctive therapy for the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
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