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Seroxat: Major Depressive Episode: The recommended dose is 20 mg daily. In general, improvement in patients starts after one week but may only become evident from the second week of therapy.
As with all antidepressant drugs, dosage should be reviewed and adjusted if necessary within three to four weeks of initiation of therapy and thereafter as judged clinically appropriate. In some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 50 mg a day in 10 mg steps according to the patient's response.
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Obsessive Compulsive Disorder: The recommended dose is 40 mg daily. Patients should start on 20 mg/day and the dose may be increased gradually in 10 mg increments to the recommended dose. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg/day.
Patients with OCD should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months or even longer (see Pharmacology: Pharmacodynamics under Actions).
Panic Disorder: The recommended dose is 40 mg daily. Patients should be started on 10 mg/day and the dose gradually increased in 10 mg steps according to the patient's response up to the recommended dose. A low initial starting dose is therefore recommended to minimize the potential worsening of panic symptomatology, which is generally recognised to occur early in the treatment of this disorder. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg/day.
Patients with panic disorder should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months or even longer (see Pharmacology: Pharmacodynamics under Actions).
Social Anxiety Disorder/Social Phobia: The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg/day. Long-term use should be regularly evaluated (see Pharmacology: Pharmacodynamics under Actions).
Generalised Anxiety Disorder: The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg/day. Long-term use should be regularly evaluated (see Pharmacology: Pharmacodynamics under Actions).
Post-traumatic Stress Disorder: The recommended dose is 20 mg daily. If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg/day. Long-term use should be regularly evaluated (see Pharmacology: Pharmacodynamics under Actions).
General Information: Withdrawal symptoms seen on discontinuation of SEROXAT Tablets: Abrupt discontinuation should generally be avoided (see Precautions and Adverse Reactions). The taper phase regimen used in clinical trials involved decreasing the daily dose by 10 mg at weekly intervals. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Special patient populations: Older people: Increased plasma concentrations of paroxetine occur in elderly subjects, but the range of concentrations overlaps with that observed in younger subjects. Dosing should commence at the adult starting dose. Increasing the dose might be useful in some patients, but the maximum dose should not exceed 40 mg daily.
Children and adolescents (7-17 years): Paroxetine should not be used for the treatment of children and adolescents as controlled clinical trials have found paroxetine to be associated with increased risk for suicidal behaviour and hostility. In addition, in these trials efficacy has not been adequately demonstrated (see Precautions and Adverse Reactions).
Children aged below 7 years: The use of paroxetine has not been studied in children less than 7 years. Paroxetine should not be used, as long as safety and efficacy in this age group have not been established.
Renal/hepatic impairment: Increased plasma concentrations of paroxetine occur in patients with severe renal impairment (creatinine clearance <30 ml/min) or in those with hepatic impairment. Therefore, dosage should be restricted to the lower end of the dosage range.
Method of administration: It is recommended that paroxetine is administered once daily in the morning with food.
The tablet should be swallowed rather than chewed.
Seroxat CR: General: SEROXAT CR is not indicated for use in children under 18 years of age (see Precautions).
SEROXAT CR should be administered as a single daily dose, usually in the morning, with or without food. Patients should be cautioned that SEROXAT CR tablet should not be chewed or crushed, and should be swallowed whole.
Discontinuation of Treatment with SEROXAT CR: Symptoms associated with the discontinuation of immediate-release paroxetine and SEROXAT CR have been reported in clinical trials and post marketing. Patients should be monitored for these and other symptoms when discontinuing treatment, regardless of the indication for which SEROXAT CR is being prescribed (see Precautions and Adverse Reactions).
A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient's clinical response (see Adverse Reactions).
Adults: Depression: Usual Initial Dosage: The recommended initial dose is 25 mg/day. Patients were dosed in a range of 25 mg to 62.5 mg/day in the clinical trials demonstrating the effectiveness of SEROXAT CR in the treatment of depression. As with all drugs effective in the treatment of depression, the full effect may be delayed. Some patients not responding to a 25-mg dose may benefit from dose increases, in 12.5-mg/day increments, up to a maximum of 62.5 mg/day. Dose changes should occur at intervals of at least 1 week.
Maintenance Therapy: There is no body of evidence available to answer the question of how long the patient treated with SEROXAT CR should remain on it for the symptoms of panic and depression. It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Whether the dose of an antidepressant needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.
Systematic evaluation of the efficacy of immediate-release paroxetine hydrochloride has shown that efficacy is maintained for at least 6 months with doses that averaged about 30 mg, which corresponds to a 37.5-mg dose of SEROXAT CR, based on relative bioavailability considerations.
Panic Disorder: Usual Initial Dosage: Patients should be started on 12.5 mg/day. Dose changes should occur in 12.5-mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 12.5 to 75 mg/day in the clinical trials demonstrating the effectiveness of SEROXAT CR. The maximum dosage should not exceed 75 mg/day.
Maintenance Therapy: Panic disorder is a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Social Phobia (Social Anxiety Disorder): Usual Initial Dosage: The recommended initial dose is 12.5 mg/day. Patients were dosed in a range of 12.5 mg to 37.5 mg/day in the clinical trial demonstrating the effectiveness of SEROXAT CR in the treatment of social anxiety disorder. Some patients not responding to a 12.5 mg dose may benefit from dose increases, , in increments of 12.5 mg/day, up to a maximum of 37.5 mg/day. Dose changes should occur at intervals of at least 1 week.
Maintenance Therapy: There is no body of evidence available to answer the question of how long the patient treated with SEROXAT CR should remain on it. Although the efficacy of SEROXAT CR beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognised as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Premenstrual Dysphoric Disorder: Usual Initial Dosage: In clinical trials, both 12.5 mg/day and 25 mg/day were shown to be effective with continuous dosing, or intermittent luteal phase dosing.
The recommended dose is 12.5 mg/day limited to the luteal phase of the menstrual cycle, starting 14 days prior to the expected onset of menses, and terminating on the first day of menses. Some patients not responding to a 12.5 mg dose may benefit from a dose increase to 25 mg/day. Dose changes should occur at intervals of at least 1 week.
Continuous dosing of SEROXAT CR, administered daily throughout the menstrual cycle may be considered if efficacy with luteal phase dosing is sub-optimal. Dose changes should occur at intervals of at least 1 week.
Maintenance/Continuation Therapy: The effectiveness of SEROXAT CR in long-term use, that is, for more than 3 menstrual cycles has not been evaluated in controlled trials. Therefore, 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.
Special Populations: Treatment of Pregnant Women: Epidemiological studies of pregnancy outcomes following maternal exposure to antidepressants in the first trimester have reported an increase in the risk of congenital malformations, particularly cardiovascular (e.g. ventricular and atrial septal defects), associated with the use of paroxetine. If a patient becomes pregnant while taking SEROXAT CR, she should be informed of the current estimate of risk to the fetus (see Precautions) and consideration should be given to switching to other treatment options. Treatment with SEROXAT CR should only be continued for an individual patient, if the potential benefits outweigh the potential risks. For women who intend to become pregnant, or are in their first trimester of pregnancy, initiation of paroxetine should be considered only after other treatment options have been evaluated (see Precautions).
Post-marketing reports indicate that some neonates exposed to SEROXAT CR, SSRIs, or other newer antidepressants late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. (see Precautions) When treating pregnant women with SEROXAT CR during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering SEROXAT CR in the third trimester.
Dosage for Elderly (> 65 years) or Debilitated: Administration of SEROXAT CR to the elderly is associated with increased plasma levels and prolongation of the elimination half life relative to younger adults (see Pharmacology under Actions). The recommended initial dose of SEROXAT CR is 12.5 mg/day for elderly patients and debilitated patients. Increases may be made if indicated. Dosage should not exceed 50 mg/day.
Pediatrics: SEROXAT CR is not indicated for use in children under 18 years of age (see Indications and Precautions).
Renal/Hepatic Impairment: SEROXAT CR should be used with caution in patients with renal or hepatic impairment. The recommended initial dose is 12.5 mg/day in patients with clinically significant renal or hepatic impairment. A maximum dose of 50 mg/day should not be exceeded (see Precautions and Pharmacology under Actions).
