Indicated for:

Monotherapy Epilepsy:

• Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 

Adjunctive Therapy Epilepsy:

• Adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. 

Migraine:

• Preventive treatment of migraine in patients 12 years of age and older.

Antiepileptic drugs (AEDs), including TOPAMAX increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

In patients with renal impairment (creatinine clearance less than 70 mL/min/1.73 m²), one-half of the usual adult dose of TOPAMAX is recommended.

A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving TOPAMAX.

In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults.

Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving topiramate.

Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with TOPAMAX use.

TOPAMAX can cause hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis).

Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended.

TOPAMAX can cause cognitive/neuropsychiatric adverse reactions. The most frequent of these can be classified into three general categories: 1) Cognitive-related dysfunction (e.g., confusion, psychomotor slowing, difficulty with concentration/attention, difficulty with memory, speech or language problems, particularly word-finding difficulties); 2) Psychiatric/behavioral disturbances (e.g., depression or mood problems); and 3) Somnolence or fatigue.

Topiramate treatment can cause hyperammonemia with or without encephalopathy. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid.

Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported in patients receiving topiramate.

TOPAMAX increases the risk of kidney stones.

Hypothermia, defined as a drop in body core temperature to <35°C (95°F), has been reported in association with topiramate use with concomitant valproic acid both in conjunction with hyperammonemia and in the absence of hyperammonemia.

TOPAMAX is associated with an increased risk for bleeding.

In patients with or without a history of seizures or epilepsy, antiepileptic drugs, including TOPAMAX, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency.

An increase in systemic exposure of lithium following TOPAMAX doses of up to 600 mg/day can occur.

Some patients may experience a large increase in amitriptyline concentration in the presence of TOPAMAX and any adjustments in amitriptyline dose should be made according to the patient’s clinical response and not on the basis of plasma levels.

Concomitant administration of valproic acid and TOPAMAX has been associated with hypothermia and hyperammonemia with and without encephalopathy.

Concomitant use of topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation.

Topiramate Cmax and AUC increased when HCTZ was added to TOPAMAX.

A decrease in the exposure of pioglitazone and its active metabolites were noted with the concurrent use of pioglitazone and TOPAMAX in a clinical trial.

Concomitant administration of phenytoin or carbamazepine with TOPAMAX resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to TOPAMAX given alone.

Concomitant administration of TOPAMAX  and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of topiramate to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, TOPAMAX should be used with extreme caution if used in combination with alcohol and other CNS depressants.

Treatment with topiramate for up to 1 year was associated with reductions in Z SCORES for length, weight, and head circumference.

The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking combination oral contraceptive products with TOPAMAX.

TOPAMAX can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts).

Limited data on 5 breastfeeding infants exposed to topiramate showed infant plasma topiramate levels equal to 10-20% of the maternal plasma level.

GoToSource

• Use in patients under the age of 2 years. GoToSource

• Obesity, bipolar disorder, eating disorders including bulimia nervosa, alcohol dependence, adjunctive treatment for schizophrenia, post-traumatic stress disorder and unipolar depression. GoToSource

• Tourette syndrome. GoToSource

• Cocaine dependence. GoToSource

• West syndrome. GoToSource

• Adjunctive treatment for obsessive-compulsive disorder. GoToSource

• Smoking cessation. GoToSource

• Weight loss. GoToSource

• Neuropathic pain. GoToSource

• Resistant major depressive disorder. GoToSource

• Idiopathic intracranial hypertension. GoToSource

Increased risk for atherosclerosis (hardening and narrowing of the arteries). GoToSource

Hypohidrosis (decreased sweating) and hyperthermia (elevated body temperature). GoToSource

Ocular syndrome with acute myopia, sudden vision loss and secondary angle closure glaucoma. GoToSource

Hyperchloremic (too much chloride in the blood) and metabolic acidosis (build up of acid in the body). GoToSource

Fetal harm including increased risk for cleft lip and/or cleft palate (oral clefts). GoToSource

Kidney stones. GoToSource

Bone disease (osteopenia, osteoporosis, osteomalacia) and hypothyroidism (underactive thyroid). GoToSource

Increased risk of suicidal thoughts and behavior. GoToSource

Depression. GoToSource

Mania. GoToSource

Severe intractable epistaxis (nosebleed). GoToSource

Lawsuits filed for birth defects.