Topiramate 50 mg Immediate Release Tablets — Generic For Topamax — Cipla

These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS.

TOPIRAMATE tablets, for oral use

Initial U.S. Approval: 1996

Indications And Usage

Topiramate tablets are indicated for:

Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2)

Preventive treatment of migraine in patients 12 years of age and older (1.3)

Dosage And Administration

Topiramate tablets initial dose, titration, and recommended maintenance dose varies by indication and age group. See Full Prescribing Information for recommended dosage, and dosing considerations in patients with renal impairment, geriatric patients, and patients undergoing hemodialysis (2.1, 2.2, 2.3, 2.4, 2.5, 2.6)

Dosage Forms And Strengths

Tablets: 25 mg, 50 mg, 100 mg, and 200 mg (3)

Contraindications

None (4).

Warnings And Precautions

• Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue topiramate tablets as soon as possible (5.1)
• Visual field defects: consider discontinuation of topiramate tablets (5.2)
• Oligohidrosis and hyperthermia: monitor decreased sweating and increased body temperature, especially in pediatric patients (5.3)
• Metabolic acidosis: baseline and periodic measurement of serum bicarbonate is recommended; consider dose reduction or discontinuation of topiramate tablets if clinically appropriate (5.4)
• Suicidal behavior and ideation: antiepileptic drugs increase the risk of suicidal behavior or ideation (5.5)
• Cognitive/neuropsychiatric

• Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue topiramate tablets as soon as possible (5.1)
• Visual field defects: consider discontinuation of topiramate tablets (5.2)
• Oligohidrosis and hyperthermia: monitor decreased sweating and increased body temperature, especially in pediatric patients (5.3)
• Metabolic acidosis: baseline and periodic measurement of serum bicarbonate is recommended; consider dose reduction or discontinuation of topiramate tablets if clinically appropriate (5.4)
• Suicidal behavior and ideation: antiepileptic drugs increase the risk of suicidal behavior or ideation (5.5)
• Cognitive/neuropsychiatric

Acute myopia and secondary angle closure glaucoma: can lead to permanent visual loss; discontinue topiramate tablets as soon as possible (5.1)

Visual field defects: consider discontinuation of topiramate tablets (5.2)

Oligohidrosis and hyperthermia: monitor decreased sweating and increased body temperature, especially in pediatric patients (5.3)

Metabolic acidosis: baseline and periodic measurement of serum bicarbonate is recommended; consider dose reduction or discontinuation of topiramate tablets if clinically appropriate (5.4)

Suicidal behavior and ideation: antiepileptic drugs increase the risk of suicidal behavior or ideation (5.5)

Cognitive/neuropsychiatric adverse reactions: use caution when operating machinery including cars; depression and mood problems may occur (5.6)

Fetal Toxicity: use during pregnancy can cause major congenital malformations, including but not limited to cleft lip and/or palate, and being small for gestational age (5.7)

Withdrawal of AEDs: withdraw topiramate tablets gradually (5.8)

Decrease in Bone Mineral Density: has been shown to decrease bone mineral density and bone mineral content in pediatric patients (5.9)

Negative effects on growth (height and weight): may slow height increase and weight gain; carefully monitor children receiving prolonged therapy (5.10)

Serious skin reactions: If SJS or TEN is suspected, discontinue topiramate tablets (5.11)

Hyperammonemia/encephalopathy: measure ammonia if encephalopathic symptoms occur (5.12)

Kidney stones: avoid use with other carbonic anhydrase inhibitors, drugs causing metabolic acidosis, or in patients on a ketogenic diet (5.13)

Hypothermia has been reported with and without hyperammonemia during topiramate treatment with concomitant valproic acid use (5.14)

Adverse Reactions

Epilepsy: Most common (>10% more frequent than placebo or low-dose topiramate tablets) adverse reactions in adult and pediatric patients were: paresthesia, anorexia, weight loss, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision and fever (6.1)

Migraine: Most common (≥5% more frequent than placebo) adverse reactions in adult and pediatric patients were: paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain and upper respiratory tract infection (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd, at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Contraceptives: decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg/day (7.4)

Monitor lithium levels if lithium is used with high-dose topiramate tablets (7.7)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 4/2025