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PENDO-GABAPENTIN is a brand name for Gabapentin, supplied as a capsule. 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.
General: pendo-GABAPENTIN is not considered effective in the treatment of absence seizures and should therefore be used with caution in patients who have mixed seizure disorders that include absence seizures. Discontinuation of Treatment with pendo-GABAPENTIN As with other anticonvulsant agents, abrupt withdrawal is not recommended because of the possibility of increased seizure frequency.
There have been post-marketing reports of adverse events such as anxiety, insomnia, nausea, pain and sweating following abrupt discontinuation of treatment. (See ADVERSE REACTIONS, Post-Market Adverse Drug Reactions). When in the judgement of the clinician there is a need for dose reduction, discontinuation or substitution with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
Concomitant Use With Morphine Patients who require concomitant treatment with morphine may experience increases in pendo- GABAPENTIN concentrations. Patients should be carefully observed for signs and symptoms of CNS depression, such as somnolence, and the dose of pendo-GABAPENTIN or morphine should be reduced appropriately.
(See DRUG INTERACTIONS). Psychomotor Impairment Patients with uncontrolled epilepsy should not drive or handle potentially dangerous machinery. During clinical trials, the most common adverse reactions observed were somnolence, ataxia, fatigue, and nystagmus.
Patients should be advised to refrain from activities requiring mental alertness or physical coordination until they are sure that pendo-GABAPENTIN does not affect them adversely. Carcinogenesis and Mutagenesis Gabapentin produced an increased incidence of acinar cell adenomas and carcinomas in the pancreas of male rats, but not female rats or in mice, in oncogenic studies with doses of 2000 mg/kg which resulted in plasma concentrations 14 times higher than those occurring in humans at a dose of 2400 mg/day.
The relevance of these pancreatic acinar cell tumours in male rats to humans is unknown, particularly since tumours of ductal rather than acinar cell origin are the predominant form of human pancreatic cancer. (See TOXICOLOGY, Carcinogenicity Studies).
Dependence/Tolerance The abuse and dependence potential of gabapentin has not been evaluated in human studies. As with any CNS active drug, however, physicians should carefully evaluate patients for history of pendo-GABAPENTIN Product Monograph Page 5 of 33 drug abuse and follow such patients closely, observing them for signs of abuse or misuse of pendo-GABAPENTIN.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Gabapentin in Canada.
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Serious Dermatological Reactions There have been post-marketing reports of Stevens-Johnson syndrome (SJS) and Erythema multiforme (EM) in patients during treatment with gabapentin. Should signs and symptoms suggest SJS or ER, gabapentin should be discontinued immediately.
(see Post-Marketing Adverse Drug Reactions) Hypersensitivity There have been reports in the post-marketing experience of hypersensitivity including systemic reactions and cases of urticaria and angioedema. (see Post-Marketing Adverse Drug Reactions) Severe, life-threatening, systemic hypersensitivity reactions such as Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in patients taking antiepileptic drugs including gabapentin.
It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately.
Gabapentin should be discontinued if an alternative etiology for the signs or symptoms cannot be established. Prior to initiation of treatment with gabapentin, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity such as fever or lymphadenopathy may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.
Special Populations Pregnant Women:
No evidence of impaired fertility or harm to the fetus due to gabapentin administration was revealed in reproduction studies in mice at doses up to 62 times, and in rats and rabbits at doses up to 31 times the human dose of 2400 mg/day.
There are no adequate and well-controlled studies to establish the safety of gabapentin in pregnant women. Gabapentin should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus.
Nursing Women:
Gabapentin is excreted in human milk. Because the effect on the nursing infant is unknown, caution should be exercised when gabapentin is administered to a nursing mother. Gabapentin should be used in nursing mothers only if the potential benefit to the mother outweighs the potential risks to the fetus.
Pediatrics:
The safety and efficacy in patients under the age of 18 have not been established. pendo-GABAPENTIN Product Monograph Page 6 of 33 Safety Data in 39 patients between the ages of 12 and 18 years included in the double-blind, placebo-controlled trials showed that, at doses of 900 to 1200 mg/day, the incidence of adverse events in this group of patients was similar to that observed in older individuals.
In controlled clinical trials involving patients, 3 to 12 years of age (N=323), psychiatric adverse events such as emotional lability, hostility, hyperkinesia and thought disorder were reported at a higher frequency in patients treated with gabapentin compared to placebo.
Geriatrics:
Systematic studies in geriatric patients have not been conducted. Adverse clinical events reported among 59 patients over the age of 65 years treated with gabapentin did not differ from those reported for younger individuals. The small number of individuals evaluated and the limited duration of exposure limits the strength of any conclusions reached about the influence of age, if any, on the kind and incidence of adverse events associated with the use of gabapentin.
As pendo-GABAPENTIN […]