Topamax Patient Counseling Information

Eye Disorders: Instruct patients taking TOPAMAX to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see Acute Myopia and Secondary Angle Closure Glaucoma Syndrome and Visual Field Defects under Precautions].
Oligohidrosis and Hyperthermia: Closely monitor TOPAMAX-treated patients, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. Counsel patients to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see Oligohidrosis and Hyperthermia under Precautions].
Metabolic Acidosis: Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [see Metabolic Acidosis under Precautions and Pregnancy under Use in Pregnancy & Lactation].
Suicidal Behavior and Ideation: Counsel patients, their caregivers, and families that AEDs, including TOPAMAX, may increase the risk of suicidal thoughts and behavior, and advise of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, or behavior or thoughts about self-harm. Instruct patients to immediately report behaviors of concern to their healthcare providers [see Suicidal Behavior and Ideation under Precautions].
Interference with Cognitive and Motor Performance: Warn patients about the potential for somnolence, dizziness, confusion, difficulty concentrating, or visual effects, and advise patients not to drive or operate machinery until they have gained sufficient experience on TOPAMAX to gauge whether it adversely affects their mental performance, motor performance, and/or vision [see Cognitive/Neuropsychiatric Adverse Reactions under Precautions].
Even when taking TOPAMAX or other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures. Therefore, advise all patients taking TOPAMAX for epilepsy to exercise appropriate caution when engaging in any activities where loss of consciousness could result in serious danger to themselves or those around them (including swimming, driving a car, climbing in high places, etc.). Some patients with refractory epilepsy will need to avoid such activities altogether. Discuss the appropriate level of caution with patients, before patients with epilepsy engage in such activities.
Fetal Toxicity: Inform pregnant women and women of childbearing potential that use of TOPAMAX during pregnancy can cause fetal harm. TOPAMAX increases the risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), which occur early in pregnancy before many women know they are pregnant. Also inform patients that infants exposed to topiramate monotherapy in utero may be SGA [see Pregnancy under Use in Pregnancy & Lactation]. There may also be risks to the fetus from chronic metabolic acidosis with use of TOPAMAX during pregnancy [see Fetal Toxicity under Precautions and Pregnancy under Use in Pregnancy & Lactation]. When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options.
Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using TOPAMAX, keeping in mind that there is a potential for decreased contraceptive efficacy when using estrogen-containing or progestin-only contraceptives with topiramate [see Contraceptives under Interactions].
Decrease in Bone Mineral Density: Inform the patient or caregiver that long-term treatment with TOPAMAX can decrease bone formation and increase bone resorption in children [see Decrease in Bone Mineral Density under Precautions].
Negative Effects on Growth (Height and Weight): Discuss with the patient or caregiver that long-term TOPAMAX treatment may attenuate growth as reflected by slower height increase and weight gain in pediatric patients [see Negative Effects on Growth (Height and Weight) under Precautions].
Serious Skin Reactions: Inform patients about the signs of serious skin reactions. Instruct patients to immediately inform their healthcare provider at the first appearance of skin rash [see Serious Skin Reactions under Precautions].
Hyperammonemia and Encephalopathy: Warn patients about the possible development of 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 and/or vomiting. This hyperammonemia and encephalopathy can develop with TOPAMAX treatment alone or with TOPAMAX treatment with concomitant valproic acid (VPA).
Instruct patients to contact their physician if they develop unexplained lethargy, vomiting, or changes in mental status [see Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid Use) under Precautions].
Kidney Stones: Instruct patients, particularly those with predisposing factors, to maintain an adequate fluid intake in order to minimize the risk of kidney stone formation [see Kidney Stones under Precautions].
Instructions for a Missing Dose: Instruct patients that if they miss a single dose of TOPAMAX, it should be taken as soon as possible. However, if a patient is within 6 hours of taking the next scheduled dose, tell the patient to wait until then to take the usual dose of TOPAMAX, and to skip the missed dose. Tell patients that they should not take a double dose in the event of a missed dose. Advise patients to contact their healthcare provider if they have missed more than one dose.