Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Upjohn UK Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
Sertraline is indicated for the treatment of:
Major depressive episodes. Prevention of recurrence of major depressive episodes.
Panic disorder, with or without agoraphobia.
Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years.
Social anxiety disorder.
Post traumatic stress disorder (PTSD).
Sertraline treatment should be started at a dose of 50 mg/day.
Therapy should be initiated at 25 mg/day. After one week, the dose should be increased to 50 mg once daily. This dosage regimen has been shown to reduce the frequency of early treatment emergent side effects characteristic of panic disorder.
Patients not responding to a 50 mg dose may benefit from dose increases. Dose changes should be made in steps of 50 mg at intervals of at least one week, up to a maximum of 200 mg/day. Changes in dose should not be made more frequently than once per week given the 24-hour elimination half life of sertraline.
The onset of therapeutic effect may be seen within 7 days. However, longer periods are usually necessary to demonstrate therapeutic response, especially in OCD.
Dosage during long-term therapy should be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response.
Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE). In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during current episode. Patients with depression should be treated for a sufficient period of time of at least 6 months to ensure they are free from symptoms.
Continued treatment in panic disorder and OCD should be evaluated regularly, as relapse prevention has not been shown for these disorders.
Elderly should be dosed carefully, as elderly may be more at risk for hyponatraemia (see section 4.4).
The use of sertraline in patients with hepatic disease should be approached with caution. A lower or less frequent dose should be used in patients with hepatic impairment (see section 4.4). Sertraline should not be used in cases of severe hepatic impairment as no clinical data are available (see section 4.4).
No dosage adjustment is necessary in patients with renal impairment (see section 4.4).
Age 13-17 years: Initially 50 mg once daily.
Age 6-12 years: Initially 25 mg once daily. The dosage may be increased to 50 mg once daily after one week.
Subsequent doses may be increased in case of less than desired response in 50 mg increments over a period of some weeks, as needed. The maximum dosage is 200 mg daily. However, the generally lower body weights of children compared to those of adults should be taken into consideration when increasing the dose from 50 mg. Dose changes should not occur at intervals of less than one week.
Efficacy is not shown in paediatric major depressive disorder.
No data is available for children under 6 years of age (see also section 4.4).
Sertraline should be administered once daily, either in the morning or evening.
Sertraline tablet can be administered with or without food.
Abrupt discontinuation should be avoided. When stopping treatment with sertraline the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8). 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.
Sertraline has a margin of safety dependent on patient population and/or concomitant medication. Deaths have been reported involving overdoses of sertraline, alone or in combination with other drugs and/or alcohol. Therefore, any overdosage should be medically treated aggressively.
Symptoms of overdose include serotonin-mediated side effects such as somnolence, gastrointestinal disturbances (e.g nausea and vomiting), tachycardia, tremor, agitation and dizziness. Coma has been reported although less frequently.
QTc prolongation/Torsade de Pointes has been reported following sertraline overdose; therefore, ECG-monitoring is recommended in all ingestions of sertraline overdoses (see sections 4.4, 4.5 and 5.1).
There are no specific antidotes to sertraline. It is recommended to establish and maintain an airway and, if necessary, ensure adequate oxygenation and ventilation. Activated charcoal, which may be used with a cathartic, may be as, or more effective than lavage, and should be considered in treating overdose. Induction of emesis is not recommended. Cardiac (e.g. ECG) and vital sign monitoring is also recommended, along with general symptomatic and supportive measures. Due to the large volume of distribution of sertraline, forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit.
5 years.
Do not store above 30°C.
Tablets are packed in Aluminium/PVC blisters of 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200, 294, 300, or 500 tablets.
Tablets are packed in Aluminium/PVC blister strips containing 30x1.
Not all pack sizes may be marketed.
No special requirements.
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