باروكسيديب 37.5 مجم 30 قرص

12.1 Mechanism of Action The mechanism of action of paroxetine tablets in the treatment of MDD, SAD, OCD, PD, GAD, and PTSD is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT).

Paroxetine tablets are 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 tablets are 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)

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 tablets, reduce dosage gradually. ( 2.6 , 5.7 ) 2.1 Administration Information Administer paroxetine tablets as a single daily dose in the morning, with or without food. 2.2 Recommended Dosage for MDD, OCD, PD, and PTSD The recommended starting dosages and maximum dosages of paroxetine tablets in patients with MDD, OCD, PD, and PTSD are presented in Table 1. In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability. Table 1: Recommended Daily Dosage of Paroxetine Tablets in Patients with MDD, OCD, PD, and PTSD Indication Starting Dose Maximum Dose MDD 20 mg 50 mg OCD 20 mg 60 mg PD 10 mg 60 mg PTSD 20 mg 50 mg 2.3 Recommended Dosage for SAD and GAD SAD The starting and recommended dosage in patients with SAD is 20 mg daily. In clinical trials the effectiveness of paroxetine tablets was demonstrated in patients dosed in a range of 20 mg to 60 mg daily. While the safety of paroxetine tablets has been evaluated in patients with SAD at doses up to 60 mg daily, available information does not suggest any additional benefit for doses above 20 mg daily [see Clinical Studies ( 14.4 )]. GAD The starting and recommended dosage in patients with GAD is 20 mg daily. In clinical trials the effectiveness of paroxetine tablets in GAD was demonstrated in patients dosed in a range of 20 mg to 50 mg daily. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg daily [see Clinical Studies ( 14.5 )] . In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability. 2.4 Screen for Bipolar Disorder Prior to Starting Paroxetine Tablets Prior to initiating treatment with paroxetine tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see ( 5.6 )]. 2....

The following are included in more detail in other sections of the prescribing information: Hypersensitivity reactions to paroxetine [see ( 4 )] Suicidal Thoughts and Behaviors [see ( 5.1 )] Serotonin Syndrome [see ( 5.2 )] Embryofetal Toxicity [see ( 5.4 )] Increased Risk of Bleeding [see ( 5.5 )] Activation of Mania/Hypomania [see ( 5.6 )] Discontinuation Syndrome [see ( 5.7 )] Seizures [see ( 5.8 )] Angle-closure Glaucoma [see ( 5.9 )] Hyponatremia [see ( 5.10 )] Bone Fracture [see ( 5.12 )] Sexual Dysfunction [see ( 5.13 )] Most common (≥5% and at least twice placebo) are abnormal ejaculation, asthenia, constipation, decreased appetite, diarrhea, dizziness, dry mouth, female genital disorder, impotence, infection, insomnia, libido decreased, male genital disorder, nausea, nervousness, somnolence, sweating, tremor, yawn. ( 6 ) To report SUSPECTED , contact Solco Healthcare US, LLC. at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data for paroxetine tablets are from: 6-week clinical trials in MDD patients who received paroxetine tablets 20 mg to 50 mg once daily 12-week clinical trials in OCD patients who received paroxetine tablets 20 mg to 60 mg once daily 10- to 12-week clinical trials in PD patients who received paroxetine tablets 10 mg to 60 mg once daily 12-week clinical trials in SAD patients who received paroxetine tablets 20 mg to 50 mg once daily 8-week clinical trials in GAD patients who received paroxetine tablets 10 mg to 50 mg once daily 12-week clinical trials in PTSD patients who received paroxetine tablets 20 mg to 50 mg once daily Leading to Discontinuation Twenty percent (1,199/6,145) of patients treated with paroxetine tablets in clinical trials in MDD and 16.1% (84/522), 11.8% (64/542), 9.4% (44/469), 10.7% (79/735), and 11.7% (79/676) of patients treated with paroxetine tablets in clinical trials in SAD, OCD, PD, GAD, and PTSD, respectively, discontinued treatment due to an adverse reaction. The most common (≥1%) associated with discontinuation (i.e....

Paroxetine tablets are 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 ( 5.2 ), ( 7 )]. Taking thioridazine because of risk of QT prolongation [see ( 5.3 ), ( 7 )] Taking pimozide because of risk of QT prolongation [see ( 5.3 ), ( 7 )]. With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine tablets [see ( 6.1 ), ( 6.2 )] . 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 of the inactive ingredients in paroxetine tablets. ( 4 )