国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
PAROXETINE HYDROCHLORIDE (UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H)
Apotex Corp
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
PAROXETINE 12.5 mg
ORAL
PRESCRIPTION DRUG
Paroxetine HCL CR is indicated in adults for the treatment of: - Major depressive disorder (MDD) - Panic disorder (PD) - Social anxiety disorder (SAD) - Premenstrual dysphoric disorder (PMDD) Paroxetine HCL CR is contraindicated in patients: - Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7)]. - Paroxetine HCL CR should not be used in patients receiving medications that can prolong QT interval and are also metabolized by CYP450 2D6,such as thioridazine or pimozide [see Drug Interactions (7),Warnings and Precautions (5.3)]. - With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or to any of the inactive ingredients in Paroxetine HCL CR [see Adverse Reactions (6.1, 6.2)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidep
Paroxetine HCL CR extended‑release tablets, USP are available as: 12.5 mg yellow, round tablets, one face is plain and the other face is engraved with “12.5”. Bottles of 30 NDC 60505-1316-3 25 mg pink, round tablets, one face is plain and the other face is engraved with “25”. Bottles of 30 NDC 60505-1317-3 37.5 mg blue, round tablets, one face is plain and the other face is engraved with “37.5”. Bottles of 30 NDC 60505-1318-3 Store at or below 25°C (77°F); [see USP].
New Drug Application
PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE Apotex Corp ---------- MEDICATION GUIDE Paroxetine HCL CR (PA-rox-eh-tine HY-dro-chlo-ride) extended-release tablets,USP What is the most important information I should know about Paroxetine HCL CR? Paroxetine HCL CR can cause serious side effects, including: • Increased risk of suicidal thoughts or actions. Antidepressant medicines may increase suicidal thoughts and actions in some children and young adults within the first few months of treatment or when the dose is changed. Paroxetine HCL CR is not for use in people younger than 18 years of age. How can I watch for and try to prevent suicidal thoughts and actions? • Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. • Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: • attempts to commit suicide • acting aggressive or violent • new or worse depression • feeling agitated, restless, angry, or irritable • an increase in activity and talking more than what is normal for you • acting on dangerous impulses • thoughts about suicide or dying • new or worse anxiety or panic attacks • trouble sleeping • other unusual changes 阅读完整的文件
PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE APOTEX CORP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PAROXETINE HCL CR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PAROXETINE HCL CR. PAROXETINE HCL CR (PAROXETINE) EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1992 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN PEDIATRIC AND YOUNG ADULT PATIENTS TAKING ANTIDEPRESSANTS. CLOSELY MONITOR ALL ANTIDEPRESSANT-TREATED PATIENTS FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS. PAROXETINE HCL CR IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (5.1, 8.4) RECENT MAJOR CHANGES Warnings and Precautions (5.2 ,5.4, 5.5) 08/2023 INDICATIONS AND USAGE Paroxetine HCL CR is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (1): Major Depressive Disorder (MDD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Premenstrual Dysphoric Disorder (PMDD) DOSAGE AND ADMINISTRATION Swallow tablet whole; do not chew or crush. (2.1) Recommended starting and maximum daily dosage: (2.2, 2.3) Indication Starting Dose Maximum Dose MDD 25 mg/day 62.5 mg/day PD 12.5 mg/day 75 mg/day SAD 12.5 mg/day 37.5 mg/day PMDD 12.5 mg/day 25 mg/day For PMDD, dose continuously or intermittently (luteal phase only). (2.3) If inadequate response to starting dosage, titrate in 12.5 mg per day increments once weekly. (2.2, 2.3) Elderly patients, patients with severe renal impairment or severe hepatic impairment: Starting dose is 12.5 mg per day. Do not exceed 50 mg per day for treatment of MDD and PD and 37.5 mg per day for treatment of SAD. (2.5) When discontinuing Paroxetine HCL CR, reduce dose gradually. (2.7) DOSAGE FORMS AND STRENGTHS Extended-release tablets:12.5 阅读完整的文件