Eprontia 25 mg/mL
Topiramate · SOLUTION · Azurity Pharmaceuticals, Inc.
Eprontia is a solution containing topiramate at 25 mg/mL, taken oral. Manufactured by Azurity Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Eprontia
- Generic Name
- Topiramate
- NDC Code (Product)
52652-9001- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Strength
- 25 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA214679
- Drug Class
- Cytochrome P450 3A4 Inducers [MoA]; Cytochrome P450 2C19 Inhibitors [MoA]
- Marketing Start
- 12/06/2021
Recall History
Azurity Pharmaceuticals, Inc.
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE EPRONTIA is 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 ). 1.1 Monotherapy Epilepsy EPRONTIA is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy Epilepsy EPRONTIA is indicated as 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. 1.3 Migraine EPRONTIA is indicated for the preventive treatment of migraine in patients 12 years of age and older.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION EPRONTIA 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 ). 2.1 Dosing in Monotherapy Epilepsy Adults and Pediatric Patients 10 Years of Age and Older The recommended dose for EPRONTIA monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses. The dose should be achieved by titration according to the following schedule (Table 1): Table 1: 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 Pediatric Patients 2 to 9 Years of Age Dosing in patients 2 to 9 years of age is based on weight. During the titration period, the initial dose of EPRONTIA is 25 mg/day nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second…
Contraindications
4 CONTRAINDICATIONS EPRONT IA is contraindicated in patients with a history of hypersensitivity reaction to topiramate, EPRONTIA, or any of the inactive ingredients of EPRONTIA. Anaphylaxis and angioedema have occurred with topiramate [see Warnings and Precautions (5.13)] . History of hypersensitivity reaction to topiramate, EPRONTIA, or any of the inactive ingredients of EPRONTIA ( 4 , 5.13).
Drug Interactions
7 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 EPRONTIA ( 7.7 ). 7.1 Antiepileptic Drugs Concomitant administration of phenytoin or carbamazepine with topiramate resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to topiramate given alone. A dosage adjustment may be needed [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.3 )] . Concomitant administration of valproic acid and topiramate has been associated with hypothermia and hyperammonemia with and without encephalopathy. Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported [see Warnings and Precautions ( 5.12 , 5.14 ), Clinical Pharmacology ( 12.3 )] . 7.2 Other Carbonic Anhydrase Inhibitors Concomitant use of EPRONTIA, 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. Therefore, patients given E…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: Acute Myopia and Secondary Angle Closure Glaucoma Syndrome [see Warnings and Precautions ( 5.1 )] Visual Field Defects [see Warnings and Precautions ( 5.2 )] Oligohidrosis and Hyperthermia [see Warnings and Precautions ( 5.3 )] Metabolic Acidosis [see Warnings and Precautions ( 5.4 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.5 )] Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.6 )] Decrease of Bone Mineral Density [see Warnings and Precautions ( 5.9 )] Negative Effects on Growth (Height and Weight) [see Warnings and Precautions ( 5.10 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [see Warnings and Precautions ( 5.11 )] Serious Skin Reactions [see Warnings and Precautions ( 5.12 )] Anaphylaxis and Angioedema [see Warnings and Precautions ( 5.13 )] Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid [VPA] Use) [see Warnings and Precautions ( 5.14 )] Kidney Stones [see Warnings and Precautions ( 5.15 )] Hypothermia with Concomi…
Frequently Asked Questions
What is Eprontia used for?
Eprontia contains Topiramate. It is a solution taken oral. Consult your doctor for specific uses.
Is Eprontia a controlled substance?
Eprontia is not classified as a controlled substance by the DEA.
What is the generic name for Eprontia?
The generic name for Eprontia is Topiramate. There are 12 other brand versions of Topiramate.
What is the NDC code for Eprontia 25 mg/mL?
The NDC (National Drug Code) for Eprontia 25 mg/mL is 52652-9001, listed by Azurity Pharmaceuticals, Inc..