EXXUA (GEPIRONE)
EXXUA (GEPIRONE) is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: EXXUA; Generic name: GEPIRONE; Manufacturer: Aytu Therapeutics, LLC.
| Brand name | EXXUA |
|---|---|
| Generic name | GEPIRONE |
| Manufacturer | Aytu Therapeutics, LLC |
| Used for | 1 INDICATIONS AND USAGE EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults. EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ). |
| Dosage | 2 DOSAGE AND ADMINISTRATION Correct electrolyte abnormalities and perform electrocardiogram (ECG) prior to initiating treatment with EXXUA. Do not initiate EXXUA if QTc is > 450 msec ( 2.1 ). Perform ECGs during dosage titration and periodically during treatment ( 2.1 ). The recommended starting dose is 18.2 mg administered orally once daily with food at approximately the same time each day ( 2.2 , 2.3 ). Depending on clinical response and tolerability, the dosage may be increased to 36.3 mg onc |
| Warnings | BOXED WARNING WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1 ) ] . EXXUA is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescr |
| Active ingredient(s) | GEPIRONE HYDROCHLORIDE |
| Route | ORAL |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0c78edd8-6acb-433c-9d34-2527da8d64e1 |