TOPIRAMATE- topiramate tablet 
NuCare Pharmaceuticals, Inc.


Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Eye Disorders

Instruct patient taking topiramate tablets should be told to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see Warnings and Precautions ( 5.1), ( 5.2)] .

Oligohidrosis and Hyperthermia

Closely monitor topiramate tablets-treated pateints, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. Counsel patient to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see Warnings and Precautions ( 5.3)] .

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 Warnings and Precautions ( 5.4) and Use in Specific Populations ( 8.1)] .

Suicidal Behavior and Ideation

Counsel patients, their caregivers, and families that AEDs, including topiramate tablets, 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 Warnings and Precautions ( 5.5)] .

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 topiramate tablets to gauge whether it adversely affects their mental performance, motor performance, and/or vision [see Warnings and Precautions ( 5.6)] .

Even when taking topiramate tablets other anticonvulsants, some patients with epilepsy will continue to have unpredictable seizures. Therefore, advise all patients taking topiramate tablets 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 topiramate tablets during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate (oral clefts), which occur early in pregnancy before many women know they are pregnant. There may also be risks to the fetus from chronic metabolic acidosis with use of Topiramateduring pregnancy [see Warnings and Precautions ( 5.7) and Use in Specific Populations ( 8.1), ( 8.9)] . When appropriate, counsel pregnant women and women of childbearing potential about alternative therapeutic options. This is particularly important when topiramate tablets is considered for a condition not usually associated with permanent injury or death.

Advise women of childbearing potential who are not planning a pregnancy to use effective contraception while using topiramate tablets, keeping in mind that there is a potential for decreased contraceptive efficacy when using estrogen-containing birth control with topiramate [see Drug Interactions ( 7.3)] .

Encourage pregnant women using topiramate tablets, to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number, 1-888-233-2334. Information about the North American Drug Pregnancy Registry can be found at [see Use in Specific Populations ( 8.1)] .

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 or vomiting. This hyperammonemia and encephalopathy can develop with topiramate tablets treatment alone or with topiramate tablets treatment with concomitant valproic acid (VPA).

Kidney Stones

Instruct patients, particularly those with predisposing factors, to maintain an adequate fluid intake in order to minimize the risk of kidney stone formatio n [see Warnings and Precautions ( 5.11)].

Instructions for a Missing Dose

Instruct patients that if they miss a single dose of topiramate tablets, 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 topiramate tablets, 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 .

Manufactured by:

Cipla Ltd, Kurkumbh, India

Manufactured for:

Cipla USA, Inc. 9100 S.

Dadeland Blvd., Suite 1500 Miami,

Florida 33156

Revised on: 1/2015

Revised: 2/2021
NuCare Pharmaceuticals, Inc.