Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Paroxetine is indicated in adults for the treatment of: - Major depressive disorder (MDD) - Obsessive compulsive disorder (OCD) - Panic disorder (PD) - Social anxiety disorder (SAD) - Generalized anxiety disorder (GAD) - Posttraumatic stress disorder (PTSD) Paroxetine 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)]. - Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions (5.3) and Drug Interactions (7)]. - T aking pimozide because of risk of QT prolongation[see Warnings and Precautions (5.3), Drug Interactions (7)]. - With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine tablets, USP[see Adverse Reactions (6.1), (6.2)] . Pregnancy Category D [see Warnings and Precautions (5.4)]
Paroxetine 30 mg tablets, USP are modified capsule shape, film-coated tablets. and white to off-white Debossed with "673" on one side and "O" on the other. NDC: 71335-9650-1: 30 Tablets in a BOTTLE NDC: 71335-9650-2: 60 Tablets in a BOTTLE NDC: 71335-9650-3: 90 Tablets in a BOTTLE NDC: 71335-9650-4: 180 Tablets in a BOTTLE Store at: 20-25°C (68-77°F). [See USP Controlled Room Temperature]. Dispense with Medication Guide available at: https://www.oxford-rx.com/med-guides Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Abbreviated New Drug Application
Bryant Ranch Prepack ---------- MEDICATION GUIDE MEDICATION GUIDE Paroxetine tablets, USP (par ox' e teen) Dispense with Medication Guide available at: https://www.oxford-rx.com/med-guides What is the most important information I should know about paroxetine? Paroxetine can cause serious side effects, including: • Increased risk of suicidal thoughts or actions. Paroxetine and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Paroxetine is not for use in children. º Depression or other mental illnesses are the most important causes of suicidal thoughts and actions. How can I watch for and try to prevent 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 in behavior or mood What is paroxetine? Paroxetine is a prescription medicine used in adults to treat: • A certain type of Læs hele dokumentet
PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED BRYANT RANCH PREPACK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PAROXETINE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PAROXETINE TABLETS, USP. PAROXETINE TABLETS, USP, 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 TABLETS, USP IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (5.1, 8.4) RECENT MAJOR CHANGES Warnings and Precautions, Sexual Dysfunction (5.13) 9/2021 INDICATIONS AND USAGE Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (1): Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD) DOSAGE AND ADMINISTRATION Recommended starting and maximum daily dosage for MDD, OCD, PD, and PTSD: (2.2) INDICATION STARTING DAILY DOSE MAXIMUM DAILY DOSE MDD 20 mg 50 mg OCD 20 mg 60 mg PD 10 mg 60 mg PTSD 20 mg 50 mg Recommended starting dosage for SAD and GAD is 20 mg daily. (2.3) Elderly patients, patients with severe renal impairment or severe hepatic impairment: Starting dosage is 10 mg daily. Maximum dosage is 40 mg daily. (2.4) When discontinuing paroxetine, reduce dosage gradually. (2.6, 5.7) DOSAGE FORMS AND STRENGTHS Tablets: 10 mg, scored; 20 mg, scored; 30 mg; and 40 mg tablets. (3) CONTRAINDICATIONS Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOI. (4, 5.3, 7) Concomitant use of pimozide or thioridazine. (4, 5.3, 7) Known hypersensitivity to paroxetine or to any o Læs hele dokumentet