Epimate-50 Special Precautions

Patient should observe adequate hydration during treatment of topiramate to reduce the risk of nephrolithiasis. Proper hydration prior to and during activities (e.g., exposure to warm temperatures and exercise) may reduce risk of heat-related adverse events. Topiramate should be gradually withdrawn to minimize the potential for seizure or increased seizure frequency in patients with or without a history of epilepsy/seizure. Daily dosage can be decreased in weekly interval by 50-100 mg in adults with epilepsy and by 25-50 mg in adults receiving topiramate at doses up to 100 mg/day for migraine prophylaxis. Gradual withdrawal in children is also recommended over 2-8 weeks period. In cases where rapid withdrawal is medically required, monitoring is recommended.
Mood Disturbances/Depression: During treatment with topiramate, mood disturbances and/or depression may occur.
Suicidal Ideation/Suicide: Although the mechanism of this risk is unknown, increased risk of suicidal thoughts or behavior in patients taking topiramate were observed. Patients and caregivers should seek immediate medical advice if signs and symptoms occur.
Nephrolithiasis: Topiramate may increase the risk for renal stone formation in some patients with predisposing risk factors to nephrolithiasis, with family history of nephrolithiasis and patients with hypercalciuria. Risk factors (e.g., renal colic, renal pain or flank pain) cannot reliably predict stone formation.
Acute Myopia and Secondary Angle-Closure Glaucoma: There have been rare reports of acute myopia with secondary angle-closure glaucoma in adults and children receiving topiramate. Symptoms include decreased visual acuity and ocular pain which generally appear within one month of starting treatment; hyperaemia and raised intra-ocular pressure may be present with or without mydriasis. Choroidal effusions resulting in anterior displacement of lens and iris have been reported. Appropriate measures to reduce intra-ocular pressure should be taken, and discontinuation of topiramate as rapidly as possible to reverse the symptoms. Elevated intra-ocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.
Metabolic Acidosis: Metabolic acidosis has been associated with topiramate treatment. Generally, the decreases in serum bicarbonate are mild to moderate and occur as soon after starting topiramate. Clinical signs such as hyperventilation may develop. Baseline and periodic serum bicarbonate levels should be monitored during topiramate treatment. If metabolic acidosis develops or persists, it may be necessary to reduce the dose or discontinue topiramate although, in some cases, correcting the acidosis with alkali therapy may be appropriate.
Hepatic Impairment: Topiramate should be administered with caution in patients with hepatic impairment as the clearance of topiramate may be decreased.
Effects on the Ability to Drive and Use Machines: Topiramate acts on the central nervous system and may cause dizziness, drowsiness and other related symptoms. It may also cause visual disturbances and/or blurred vision. These adverse events may potentially be dangerous in patients driving a vehicle or operating machinery.