Paroxetine

PAXIL is indicated in adults for the treatment of: Major depressive disorder (MDD) in adults Obsessive compulsive disorder (OCD) in adults Panic disorder (PD) in adults Social anxiety disorder (SAD) in adults Generalized anxiety disorder (GAD) in adults Posttraumatic stress disorder (PTSD) in adults PAXIL is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of: Major depressive disorder (MDD) in adults Obsessive compulsive disorder (OCD) in adults Panic disorder (PD) in adults Social anxiety disorder (SAD) in adults Generalized anxiety disorder (GAD) in adults Posttraumatic stress disorder (PTSD) in adults

The mechanism of action of PAXIL in the treatment of major depressive disorder (MDD), social anxiety disorder (SAD), obsessive compulsive disorder (OCD), panic disorder (PD), generalized anxiety disorder (GAD) and post-traumatic stress disorder (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).

Prior to initiating treatment with PAXIL, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. Administer PAXIL as a once daily dose in the morning, with or without food. Administer the tablets or the oral suspension. Shake oral suspension well before administration ( 2. 2) · Recommended starting and maximum daily dosage for MDD, OCD, PD, and PTSD in the table below. If inadequate response to starting dosage, increase the dosage by 10 mg/day weekly intervals (e.g., if the starting dosage is 20 mg/day increase the dosage the next week to 30 mg/day) to the maximum dosage: Indication Starting Daily Dosage Maximum Daily Dosage 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 is 20 mg once daily.

PAXIL 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. Who receive drugs that can prolong QTc interval and are also CYP450 2D6 substrates With known hypersensitivity to paroxetine or any of the inactive ingredients in PAXIL. Hypersensitivity reactions have included anaphylaxis, angioedema, and Stevens- Johnson syndrome. PAXIL is contraindicated in patients: Taking, or within 14 days of stopping monoamine oxidase inhibitors (MAOIs). Who receive drugs that can prolong QTc interval and are also CYP2D6 substrates.

Boxed 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 for emergence of suicidal thoughts and behaviors. PAXIL is not approved for use in pediatric patients. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS. Serotonin Syndrome:: Monitor all patients taking PAXIL for the emergence of serotonin syndrome. If occurs, immediately discontinue PAXIL and serotonergic agents and initiate supportive measures. Embryofetal Toxicity: For women who intend to become pregnant or who are in their first trimester of pregnancy, PAXIL, should be initiated only after consideration of the other available treatment options.

The following adverse reactions are included in more detail in other sections of the prescribing information: Suicidal thoughts and behaviors Serotonin syndrome Increased risk of bleeding Activation of mania/hypomania Discontinuation syndrome Seizures Angle-closure glaucoma Hyponatremia Sexual Dysfunction Fracture Most common adverse reactions (≥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.

Table 9 presents clinically significant drug interactions with PAXIL. Table 9: Clinically Significant Drug Interactions with PAXIL Monoamine Oxidase Inhibitors Mechanism and Clinical Effect(s) The concomitant use of SSRIs, including PAXIL and monoamine oxidase inhibitors (MAOIs) increases the risk of serotonin syndrome. Prevention or Management PAXIL is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue. CYP2D6 Substrates that Prolong the QTc Interval Mechanism and Clinical Effect(s) PAXIL is a strong CYP2D6 inhibitor. Concomitant use of PAXIL with CYP2D6 substrates that prolong the QTc interval can increase the concentration of those CYP2D6 substrates and may result in a greater increase in the QTc interval and adverse reactions associated with QTc interval prolongation.

Store tablets between 15° and 30°C (59° and 86°F). Store oral suspension at or below 25°C (77°F).