Information about SETOXIN

Composition:
Each film coated tablet contains 20 mg paroxetine.
Indications:
Major Depressive Disorder:
Paroxetine is indicated for the treatment of major depressive disorder.
The effects of paroxetine in hospitalized depressed patients have not been adequately studied.
The efficacy of paroxetine in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial.
Obsessive Compulsive Disorder:
Paroxetine is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD) as defined in the DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
Panic Disorder:
Paroxetine is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.
Social Anxiety Disorder:
Paroxetine is indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in DSM-IV. Social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.
Generalized Anxiety Disorder:
Paroxetine is indicated for the treatment of Generalized Anxiety Disorder (GAD), as defined in DSM-IV.
Post-traumatic Stress Disorder:
Paroxetine is indicated for the treatment of Posttraumatic Stress Disorder (PTSD).
Pregnancy:
Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations.
Dosage and Administration:
Major Depressive Disorder:
Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the effectiveness of paroxetine in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 20-mg dose may benefit from dose increases, in 10-mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least 1 week.
Obsessive Compulsive Disorder:
Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of paroxetine in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10-mg/day increments. Dose changes should occur at intervals of at least 1 week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of paroxetine in the treatment of OCD. The maximum dosage should not exceed 60 mg/day.
Panic Disorder:
PAROXETINE should be administered as a single daily dose with or without food, usually in the morning. The target dose of paroxetine in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10-mg/day increments and at intervals of at least 1 week.
Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of PAXIL. The maximum dosage should not exceed 60 mg/day.
Social Anxiety Disorder:
Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/day. In clinical trials the effectiveness of paroxetine was demonstrated in patients dosed in a range of 20 to 60 mg/day. While the safety of paroxetine has been evaluated in patients with social anxiety disorder at doses up to 60 mg/day, available information does not suggest any additional benefit for doses above 20 mg/day.
Generalized Anxiety Disorder:
Paroxetine should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of paroxetine was demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended starting dosage and the established effective dosage is 20 mg/day. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week.
Post-traumatic Stress Disorder:
Paroxetine should be administered as a single daily dose with or without food, usually in the morning. The recommended starting dosage and the established effective dosage is 20 mg/day. In 1 clinical trial, the effectiveness of paroxetine was demonstrated in patients dosed in a range of 20 to 50 mg/day. However, in a fixed dose study, there was not sufficient evidence to suggest a greater benefit for a dose of 40 mg/day compared to 20 mg/day. Dose changes, if indicated, should occur in 10 mg/day increments and at intervals of at least 1 week.
Storage conditions: 
Do not store above 30°C.
Packaging: 
Carton pack of 10 or 30 film coated tablets.