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GLN-TOPIRAMATE is a brand name for Topiramate, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
, Endocrine and Metabolism, Metabolic Acidosis). The highest topiramate overdose reported was calculated to be between 96 and 110 g and resulted in coma lasting 20 to 24 hours followed by full recovery after three to four days. In the event of overdose, Topiramate should be discontinued and general supportive treatment given until clinical toxicity has been diminished or resolved.
Hemodialysis has been shown to be an effective means of removing topiramate from the body. The patient should be well hydrated. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
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Dosage Forms, Strengths, Composition and Packaging Table 3:
Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients oral Tablet 25 mg, 100 mg, 200 mg Hydroxypropyl methyl cellulose, iron oxide red (100 mg & 200 mg), iron oxide yellow (100 mg & 200 mg), lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol 400, polysorbate 80, sodium starch glycolate and titanium dioxide.
Description GLN-TOPIRAMATE Film Coated Tablets GLN-TOPIRAMATE (topiramate) is available as embossed, coated, round tablets in the following strengths and colours: • 25 mg tablet: White to off-white, round, biconvex, film-coated tablet with “ ” on one side and “25" on the other side.
• 100 mg tablet: Yellow, round, biconvex, film-coated tablet with “ ” on one side and “100” on the other side. • 200 mg tablet: Salmon coloured, round, biconvex, film-coated tablet with “ ” on one side and “200” on the other side. PrGLN-TOPIRAMATE (Topiramate Tablets) Page 9 of 73 Protected B / Protégé B Composition GLN-TOPIRAMATE tablets contain 25 mg, 100 mg or 200 mg of topiramate as the active medicinal ingredient.
In addition, GLN-TOPIRAMATE contains the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate.
The tablet coatings contain the following non-medicinal ingredients:
White (25mg): hydroxypropyl methyl cellulose, polyethylene glycol 400, polysorbate 80 and titanium dioxide. Yellow (100 mg): hydroxypropyl methyl cellulose, iron oxide red, iron oxide yellow, polyethylene glycol 400, polysorbate 80, and titanium dioxide.
Salmon (200mg): hydroxypropyl methyl cellulose, iron oxide red, iron oxide yellow, polyethylene glycol 400, polysorbate 80, and titanium dioxide. Packaging GLN-TOPIRAMATE is available in HDPE bottles of 100 tablets. 7. Warnings and Precautions General Antiepileptic drugs (AEDs), including GLN-TOPIRAMATE, should be withdrawn gradually to minimize the potential for seizures or increased seizure frequency.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Topiramate in Canada.
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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.
In clinical trials in adult patients with epilepsy, dosages were decreased by 50-100 mg/day at weekly intervals. 2 Recommended Dose and Dosage Adjustment, Epilepsy, Drug Discontinuation). In patients without a history of seizures or epilepsy, GLN-TOPIRAMATE should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency.
2 Recommended Dose and Dosage Adjustment, Migraine Prophylaxis, Drug Discontinuation). 2 Recommended Dose and Dosage Adjustment, Migraine Prophylaxis, Drug Discontinuation). Carcinogenesis and Genotoxicity See 16 Non-Clinical Toxicology for discussion on animal data.
Driving and Operating Machinery GLN-TOPIRAMATE acts on the central nervous system and may produce drowsiness, dizziness, or other related symptoms. It may also cause visual disturbances and/or blurred vision. These adverse events could potentially be dangerous in patients driving a vehicle or PrGLN-TOPIRAMATE (Topiramate Tablets) Page 10 of 73 Protected B / Protégé B operating machinery.
Accordingly, patients should be advised not to drive or operate complex machinery or engage in other hazardous activities until they have gained sufficient experience on GLN-TOPIRAMATE to gauge whether or not it affects their mental and/or motor performance adversely (See Patient Medication Information).
Endocrine and Metabolism Hyperammonemia and Encephalopathy Topiramate alone or in concomitant treatment with valproic acid (VPA) or other antiepileptic medications can cause hyperammonemia with or without encephalopathy. Although hyperammonemia may be asymptomatic, clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy or vomiting.
Hypothermia can also be a manifestation of hyperammonemia. In patients using concomitant topiramate and valproate this adverse event can occur after starting topiramate treatment or after increasing the daily dose of topiramate. 4 Drug-Drug Interactions).
If hyperammonemia is suspected serum ammonia levels should be monitored (see Monitoring Hyperammonemia and Encephalopathy, below). If elevated serum ammonia concentrations persist, consider discontinuing topiramate and/or VPA. The symptoms and signs of hyperammonemic encephalopathy may abate with discontinuation of either drug.
Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy. Although not studied, topiramate treatment or an interaction of concomitant topiramate and valproic acid treatment may […]