A tailored approach to dosing1
EPRONTIA™ 25 mg/mL - Initial dose, titration, and recommended maintenance dose vary by indication and age group
Product labeling, packaging, and imagery are for representation purposes only.
Monotherapy Titration Schedule for Adults and Pediatric Patients
(10 Years and Older)
| Morning Dose | Evening Dose | |
|---|---|---|
| Week 1 | 25 mg | 25 mg |
| Week 2 | 50 mg | 50 mg |
| Week 3 | 75 mg | 75 mg |
| Week 4 | 100 mg | 100 mg |
| Week 5 | 150 mg | 150 mg |
| Week 6 | 200 mg | 200 mg |
Monotherapy Target Total Maintenance Dosing for Patients
(2 to 9 Years of Age)
| Weight (kg) | Total Daily Dose (mg/day)* Minimum Maintenance Dose | Total Daily Dose (mg/day)* Maximum Maintenance Dose |
|---|---|---|
| Up to 11 | 150 | 250 |
| 12-22 | 200 | 300 |
| 23-31 | 200 | 350 |
| 32-38 | 250 | 350 |
| Greater than 38 | 250 | 400 |
*Administered in 2 equally divided doses. The total daily dose should not exceed the maximum maintenance dose for each range of body weight.
- Dosing in patients 2 to 9 years of age is weight-based
- During the titration period, the initial dose of EPRONTIA™ oral solution is 25 mg/day nightly for the first week
- Dosage can be increased by 25 to 50 mg/day each subsequent week as tolerated
- Based on tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week
- Titration to the minimum maintenance dose should be attempted over 5-7 weeks of the total titration period
- Based upon tolerability and clinical response, additional titration up to the maximum maintenance dose can be attempted at 25 to 50 mg/day weekly increments
Adult Dosing (17 Years of Age and Older) in Adjunctive Therapy for Epilepsy
| Seizure Type | Daily Dose* |
|---|---|
| Partial-Onset or Lennox-Gastaut Syndrome | 200-400 mg |
| Primary Generalized Tonic-Clonic | 400 mg |
*Administered in 2 divided doses.
- EPRONTIA™ should be initiated at 25 to 50 mg/day, followed by titration to an effective dose in increments of 25 to 50 mg/day every week
Pediatric Dosing (2-16 Years of Age) in Adjunctive Therapy for the Treatment of Partial-Onset Seizures, Primary Generalized Tonic-Clonic Seizures, and Seizures Associated With Lennox-Gastaut Syndrome
| Weight (kg) |
Minimum Daily Dose† (5 mg/kg/day) |
Maximum Daily Dose† (9 mg/kg/day) |
|---|---|---|
| 11 | 55 | 99 |
| 22 | 110 | 198 |
| 31 | 155 | 279 |
| 38 | 190 | 342 |
| 50 | 250 | 400 |
†Administered in 2 divided doses.
Total daily dose should not exceed 400 mg/day.
- Titration should begin at 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in 2 divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome
Dosing (12 Years of Age and Older) for the Preventive Treatment of Migraine
| Morning Dose | Evening Dose | |
|---|---|---|
| Week 1 | None | 25 mg |
| Week 2 | 25 mg | 25 mg |
| Week 3 | 25 mg | 50 mg |
| Week 4 | 50 mg | 50 mg |
- The recommended daily dose of EPRONTIA™ oral solution as preventive treatment of migraine is 100 mg/day administered in 2 divided doses
- Dose and titration rate should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used
Important Safety Information (cont)
Serious Skin Reactions: Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported. EPRONTIA should be discontinued at the first sign of a rash unless the rash is clearly unrelated to the drug. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. Inform patients about the signs of serious skin reactions.
Please see additional Important Safety Information throughout, and the accompanying full Prescribing Information.
Important Safety Information (cont)
Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid Use): Topiramate treatment can cause hyperammonemia with or without encephalopathy, the risk of which appears to be dose related, and which has been reported more frequently with concomitant use of valproic acid. In patients who develop unexplained lethargy, vomiting or changes in mental status associated with topiramate, hyperammonemic encephalopathy should be considered and an ammonia level should be measured.
Please see additional Important Safety Information throughout, and the accompanying full Prescribing Information.
Important Safety Information (cont)
Kidney Stones: EPRONTIA can cause an increased risk of kidney stones. The concomitant use of topiramate with any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet, may increase the risk of kidney stone formation. Instruct patients to stay well hydrated while taking EPRONTIA.
Hypothermia with Concomitant Valproic Acid Use: Hypothermia has been reported in association with topiramate use with concomitant valproic acid both in conjunction with hyperammonemia and in the absence of hyperammonemia. Consider discontinuation of topiramate or valproate in patients who develop hypothermia. Blood ammonia levels should be assessed during clinical management.
Adverse Reactions: The most common side effects for EPRONTIA include: tingling of the arms and legs, dizziness, not feeling hungry, sleepiness/drowsiness, nausea, slow reactions, a change in the way foods taste, difficulty with memory, diarrhea, pain in the abdomen, weight loss, fever, nervousness, abnormal vision, upper respiratory tract infections, decreased feeling or sensitivity, especially in the skin, speech problems, tiredness.
Please see additional Important Safety Information throughout, and the accompanying full Prescribing Information.