Sertraline Sandoz

Sertraline Sandoz Dosage/Direction for Use

sertraline

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Treatment of major depressive episodes: The usual daily dose is 50 mg. If dose increments are required, these should be made in steps of 50 mg at minimum intervals of 1 week. Dose changes should not be performed more than once per week due to elimination half-life of sertraline of 24 hours. The maximum daily dose is 200 mg.
Treatment of obsessive-compulsive disorder (OCD): Initially 50 mg once daily. If dose increments are required, these should be made in steps of 50 mg at minimum intervals of 1 week. Dose changes should not be performed more than once per week due to elimination half-life of sertraline of 24 hours. The maximum daily dose is 200 mg.
Treatment of panic disorder, treatment of post-traumatic stress disorder (PTSD) and treatment of social phobia: Initially 25 mg once daily. Increase the dose to 50 mg once daily after 1 week. If dose increments are required, these should be made in steps of 50 mg at minimum intervals of not less than one week. Dose changes should not be performed more than once per week due to elimination half-life of sertraline of 24 hours. The maximum daily dose is 200 mg.
Children and adolescents under 18 years of age: Sertraline should not be used in the treatment of children and adolescents under the age of 18 years, except for patients with obsessive compulsive disorder (see Precautions).
During long-term therapy the aim is to administer the lowest possible dosage which provides adequate therapeutic efficacy.
Treatment of obsessive-compulsive disorder (OCD) in children and adolescents (6 -17 years of age): Initially 50 mg as a single daily dose (aged 13 - 17).
Initially 25 mg as a single daily dose (aged 6 - 12). The dosage may be increased to 50 mg once daily after one week.
The maximum dose in adolescents under 18 years of age is 200 mg daily. However, lower doses should be considered in patients with low body weight to avoid elevated plasma levels. The diagnosis should be verified by a specialist in child or adolescent psychiatry.
Elderly: As the elimination half-life may be prolonged in elderly patients, it should be advised that the dosage should be as low as possible in the elderly.
Patients with impaired hepatic function: In patients with impaired hepatic function sertraline tablets should be used with caution. Although it is not clear if dosage adjustments are necessary in case of impaired hepatic function, it is recommended that the dose is reduced or the interval between the dosage prolonged. Sertraline should not be used in case of severe hepatic impairment as no clinical data are available.
Patients with impaired renal function: Dose adjustment is not necessary (see Precautions).
Method and duration of administration: Sertraline tablets should be taken as a single daily dose either in the morning or in the evening. Tablets can be taken with or without food, with a sufficient amount of liquid.
The onset of antidepressant effect may occur within 7 days, however, the maximum effect is generally reached after 2-4 weeks of treatment. It is advisable that the patients are informed of this.
The duration of treatment depends upon the nature and severity of the disorder. After remission of the symptoms of depression, patients should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Withdrawal symptoms seen on discontinuation of SSRI: 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 Precautions and Adverse Reactions). 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.
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