Seroxat/Seroxat CR

Seroxat/Seroxat CR Indications/Uses

paroxetine

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Indications/Uses
Seroxat: Treatment of Major Depressive Episode.
Treatment of Obsessive Compulsive Disorder (OCD).
Treatment of Panic Disorder with or without agoraphobia.
Treatment of Social Anxiety Disorder/Social Phobia.
Treatment of Generalised Anxiety Disorder.
Treatment of Post-traumatic Stress Disorder.
Seroxat CR: Adults: Depression: SEROXAT CR is indicated for symptomatic relief of Major Depressive Disorder.
SEROXAT CR has not been systematically evaluated beyond 12 weeks in controlled clinical trials; however, the effectiveness of immediate-release paroxetine hydrochloride in maintaining a response in depression for at least 6 months has been demonstrated in a placebocontrolled trial (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions). The physician who elects to use SEROXAT CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Panic Disorder: SEROXAT CR is indicated for the symptomatic treatment of panic disorder, with or without agoraphobia.
Panic disorder (DSM-IV) is characterised by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
Social Phobia (Social Anxiety Disorder): SEROXAT CR is indicated for the symptomatic relief of generalized social phobia (social anxiety disorder), a disorder characterized by marked and persistent fear, anxious anticipation, or avoidance of multiple social situations (e.g. interacting with strangers, attending social gatherings, dealing with authority figures) and/or performance situations (e.g. eating, writing, working while being observed, or public speaking). A diagnosis of social phobia/social anxiety disorder should not be made unless the fear, anxious anticipation, or avoidance of social and/or performance situations interferes significantly with the person's normal routine, occupational functioning, social life, or causes marked distress.
Premenstrual Dysphoric Disorder: SEROXAT CR is indicated for the symptomatic treatment of premenstrual dysphoric disorder (PMDD). The efficacy of SEROXAT CR in the treatment of PMDD has been established in 3 placebo-controlled trials (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions).
The essential features of PMDD, according to DSM-IV, include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating, and weight gain. These symptoms occur regularly, in most menstrual cycles, during the luteal phase and remit within a few days following the onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. Typically, the symptoms are comparable in severity (but not duration) to those of a major depressive episode. The presence of the cyclical pattern of symptoms must be confirmed by at least two consecutive months of prospective daily symptom ratings. It is estimated that at least 75% of women report minor or isolated premenstrual changes; however, only 3 to 5% of women experience symptoms that may meet the criteria for PMDD. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant.
Long-Term Use of SEROXAT CR: The effectiveness of SEROXAT CR in long-term use (i.e. more than 12 weeks for depression, panic disorder and social phobia and more than 3 menstrual cycles for premenstrual dysmorphic disorder), has not yet been established in controlled trials for depression, panic disorder, social phobia or premenstrual dysmorphic disorder. Therefore, the physician who elects to use SEROXAT CR for extended periods in these indications should periodically re-evaluate the long-term usefulness of the drug for the individual patient. (see Dosage & Administration).
Geriatrics (> 65 years of age): Evidence from clinical studies indicates that there are differences in the pharmacokinetic profile of paroxetine in the geriatric population relative to younger adults, which may be associated with differences in safety or effectiveness. A brief discussion can be found in the appropriate sections (see Precautions, Pharmacology under Actions and Dosage & Administration).
Pediatrics (<18 years of age): SEROXAT CR is not indicated for use in patients below the age of 18 years (see Precautions).
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in