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AURO-RUFINAMIDE is a brand name for Rufinamide, 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…
Verbatim from this product's HC label. Tap a section to expand.
• Patients with Familial Short QT syndrome, family history of short QT syndrome, presence, or history of short QT interval (see WARNINGS AND PRECAUTIONS, QT Shortening). • Patients who are hypersensitive to rufinamide, triazole derivatives or any of the excipients (see WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION).
For a complete listing, see Dosage Forms, Composition and Packaging section.
WARNINGS AND PRECAUTIONS Carcinogenesis and Mutagenesis See PART II:
SCIENTIFIC INFORMATION, TOXICOLOGY. Cardiovascular QT Shortening Formal cardiac ECG studies demonstrated shortening of the QT interval (mean = 20 msec, for doses ≥ 2400 mg twice daily) with rufinamide treatment. In a placebo-controlled study of the QT interval in 117 healthy subjects, a higher percentage of rufinamide-treated subjects (46% at 2400 mg, 46% at 3200 mg, and 65% at 4800 mg) had a QT shortening of greater than 20 msec at Tmax compared to placebo (5 – 10%).
In this placebo-controlled study, a moderate rise in heart rate was induced by rufinamide in only the four subjects who received the maximum dose of 7200 mg/day. Reductions of the QT interval below 300 msec were not observed. In the study in patients 1 to <4 years of age, 12 of 25 rufinamide-treated patients (dose range: 40 to 51 mg/kg/day) had clinically notable increases in heart rate either at various points during the study or at the end of the trial.
There were no clinically significant changes in blood pressure in these patients during the study. Reductions of the QT interval below 300 msec were not observed (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Pediatrics).
The degree of QT shortening induced by rufinamide is without any known clinical risk. Familial Short QT syndrome is associated with an increased risk of sudden death and ventricular arrhythmias, particularly ventricular fibrillation.
Such events in this syndrome are believed to occur primarily when the corrected QT interval falls below 300 msec. Nonclinical data also indicate that QT shortening is associated with ventricular fibrillation. Patients with Familial Short QT syndrome, family history of short QT syndrome, and presence, or history of short QT interval should not be treated with Auro-Rufinamide (see CONTRAINDICATIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
, digoxin, mexiletine, phenytoin, magnesium sulfate). Auro-Rufinamide Product Monograph Page 5 of 40 Dependence/Tolerance The abuse and dependence potential of rufinamide has not been evaluated in humans. Studies in Cynomolgus monkeys have shown no potential for physical or psychological dependence.
Endocrine and Metabolism Auro-Rufinamide contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Neurologic Withdrawal of AEDs As with all antiepileptic drugs, Auro-Rufinamide should be withdrawn gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus.
If abrupt discontinuation of the drug is medically necessary, the transition to another AED should be made under close medical supervision. In clinical trials, rufinamide discontinuation was achieved by reducing the dose by approximately 25% every two days.
Status Epilepticus Cases of status epilepticus have been reported during various controlled clinical trials of rufinamide. In the controlled Lennox Gastaut syndrome (LGS) trial, 3 of 74 (4%) rufinamide- treated patients experienced status epilepticus compared to none of the 64 placebo-treated patients.
In all controlled trials that included patients with different epilepsies, 11 of 1240 (1%) rufinamide-treated patients experienced status epilepticus compared to none of the 635 placebo- treated patients. In these trials, nearly 20% of the patients that had status epilepticus discontinued from study.
In cases where the patient develops new seizure type(s) and/or experiences an increased frequency of status epilepticus, the risk-benefit ratio of continued rufinamide therapy should be reassessed. Status epilepticus has been reported post-market (see ADVERSE REACTIONS).
Dizziness and Ataxia In the controlled LGS trial, 2 of 74 (3%) rufinamide-treated patients experienced dizziness compared to none of the 64 placebo-treated patients. Four rufinamide-treated patients (5%) experienced ataxia compared to none of the placebo-treated patients (see ADVERSE REACTIONS).
In all other controlled trials that included patients with different epilepsies, dizziness was experienced in 190 of 1166 (16%) rufinamide-treated patients compared to 60 of 571 (11%) placebo-treated patients. Thirty-nine rufinamide-treated patients (3%) experienced ataxia compared to 3 (1%) of the placebo-treated patients.
Auro-Rufinamide Product Monograph Page 6 of 40 Patients should be advised about the potential for somnolence or dizziness and advised not to drive or operate machinery until they have gained sufficient experience on Auro-Rufinamide to gauge whether it affects their mental and/or motor performance.
Somnolence and Fatigue In the controlled LGS trial 18 rufinamide-treated patients (24%) experienced somnolence compared to 8 (13%) of the placebo-treated patients. Seven rufinamide-treated patients (10%) experienced fatigue compared to 5 (8%) of the placebo-treated patients.
In all other controlled trials that included patients with different epilepsies, somnolence was experienced by 128 (11%) of rufinamide-treated patients compared to 50 (9%) of the placebo- treated patients. Fatigue was experienced by 162 (14%) of the rufinamide-treated patients compared to 52 (9%) of the placebo-treated patients.
Ophthalmological Effects In the controlled LGS trial, rufinamide treatment was associated with vision-related adverse events such as diplopia, dry eye, eye infection, eye irritation, eye […]