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SABRIL is a brand name for Vigabatrin, 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…
Verbatim from this product's HC label. Tap a section to expand.
General Information for Patients:
Patients receiving Sabril should be given the following instructions by the physician: 1. Patients should be warned that Sabril treatment can damage the vision. Sabril can result in a loss of peripheral vision (narrowing of the field of vision) which may lead to permanent impairment of eyesight.
About 1/3 of patients who take Sabril are affected. 2. Symptoms of vision loss from Sabril are unlikely to be recognized by patients or caregivers before vision loss is severe.
Patients should have their eyes examined before Serious Warnings and Precautions:
VISION LOSS A number of ophthalmological abnormalities, including visual field defects, rare cases of bilateral optic disc pallor, subtle peripheral retinal atrophy, optic atrophy, and rare cases of optic neuritis have been reported in patients receiving Sabril (see WARNINGS AND PRECAUTIONS, Ophthalmologic).
Visual field defects have been reported in about 1/3 of patients receiving Sabril, although the actual prevalence may be higher. Based on available data, the usual pattern is a concentric constriction of the visual field of both eyes, which is generally more marked nasally than temporally.
In the central visual field (within 30 degrees of eccentricity), a nasal annular defect is frequently seen. To detect visual field defects, appropriate visual field testing (perimetry) by a standardized static perimetry (such as Humphrey or Octopus) or kinetic perimetry (such as Goldmann) must be performed before treatment initiation and at three month intervals.
Available data suggests that visual field defects may be permanent even after discontinuation of vigabatrin treatment. It is possible that vision loss can worsen despite discontinuation of Sabril therapy. Symptoms of vision loss from Sabril are unlikely to be recognized by patients or caregivers before vision loss is severe.
In patients who have any pre-existing visual field defects, either detected on perimetry or through clinical symptoms, vigabatrin use should be considered only if the benefits outweigh the risks. If visual field defects are exhibited in any patients using Sabril, consideration should be given to the gradual discontinuation of Sabril.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Sabril should only be used when the potential benefits outweigh the risk for developing a visual field defect. If clinically meaningful seizure improvement is not observed within 3 months of therapy initiation in adults, and 4 weeks in infants, Sabril therapy should be discontinued.
Sabril should not be used concomitantly with other retinotoxic drugs. Vigabatrin Product Monograph Page 6 of 44 beginning Sabril treatment and at regular intervals (approximately every 3 months) thereafter. 3. Patients should be advised to tell their doctor immediately of any change in their eyesight such as narrowing of the field of vision, blurred vision or any other visual symptoms, if they start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of them that seem to come out of nowhere.
4. Women of childbearing potential should be advised to inform their doctor if they are pregnant or intend to become pregnant while on Sabril therapy. Sabril is contraindicated in pregnancy and lactation. 5. Mothers should discuss with their doctor whether to take Sabril or breastfeed their baby, they should not do both.
6. Patients should be advised not to drive a car or operate other complex machinery, and refrain from other activities requiring mental alertness or physical coordination until they are familiar with the effects of Sabril on their ability to perform such activities.
Withdrawal of Antiepileptic Drugs (AEDs):
As with other antiepileptic drugs, abrupt discontinuation may lead to rebound seizures. If a patient is to be withdrawn from Sabril treatment, it is recommended that this be done gradually by reducing dose over a 2-4 week period if possible.
In controlled clinical studies in adults with complex partial seizures (CPS) and pediatric patients with IS, Sabril was discontinued by gradual reduction of the daily dose of 1 g/day once a week in adults, and of 25-50 mg/kg/day every 3-4 days in infants.
Somnolence and Fatigue:
Sabril causes somnolence and fatigue. Patients should be advised not to drive a car or operate other complex machinery, and refrain from other activities requiring mental alertness or physical coordination until they are familiar with the effects of Sabril on their ability to perform such activities.
Pooled data from two Sabril controlled trials demonstrated that 24% (54/222) of Sabril patients experienced somnolence compared to 10% (14/135) of placebo patients. In those same studies, 28% of Sabril patients experienced fatigue compared to 15% (20/135) of placebo patients.
Almost 1% of Sabril patients discontinued from clinical trials for somnolence and almost 1% discontinued for fatigue.
Edema:
Sabril causes edema. Pooled data from controlled trials demonstrated increased risk among Sabril patients compared to placebo patients for peripheral edema (Sabril 2%, placebo 1%), and edema (Sabril 1%, placebo 0%). In these studies, one Sabril and no placebo patients discontinued for an edema related AE.
There was no apparent association between edema and cardiovascular adverse events such as hypertension or congestive heart failure. Dependence/Tolerance The abuse and dependence potential of Sabril has not been evaluated in human studies.
It is not possible to predict the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. , incrementation of dose, drug-seeking behaviour). Sabril did not produce adverse Vigabatrin Product Monograph Page 7 of 44 events or overt behaviours associated with abuse when administered to humans or animals.
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