LUSTRAL

Sertraline should be administered once daily, either in the morning or evening. Sertraline tablet can be administered with or without food Initial treatment Depression and OCD Sertraline treatment should be started at a dose of 50 mg/day.

Panic Disorder, PTSD, and Social Anxiety Disorder 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.

Titration Depression, OCD, Panic Disorder, Social Anxiety Disorder and PTSD 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.

Maintenance Dosage during long-term therapy should be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response. Depression 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.

Panic disorder and OCD Continued treatment in panic disorder and OCD should be evaluated regularly, as relapse prevention has not been shown for these disorders. Paediatric patients Children and adolescents with obsessive compulsive disorder 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.

Nausea is the most common undesirable effect. In the treatment of social anxiety disorder, sexual dysfunction (ejaculation failure) in men occurred in 14% for sertraline vs 0% in placebo. These undesirable effects are dose dependent and are often transient in nature with continued treatment.

The undesirable effects profile commonly observed in double-blind, placebo- controlled studies in patients with OCD, panic disorder, PTSD and social anxiety disorder was similar to that observed in clinical trials in patients with depression.

Table 1 displays adverse reactions observed from post-marketing experience (frequency not known) and placebo-controlled clinical trials (comprising a total of 2542 patients on sertraline and 2145 on placebo) in depression, OCD, panic disorder, PTSD and social anxiety disorder.

Some adverse drug reactions listed in Table 1 may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.

Table 1:

Adverse Reactions Frequency of adverse reactions observed from placebo-controlled clinical trials in depression, OCD, panic disorder, PTSD and social anxiety disorder. Pooled analysis and post-marketing experience. System Organ Class Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Frequency Not Known (Cannot be Estimated From the Available Data) Infections and infestations upper respiratory tract infection, pharyngitis, rhinitis gastroenteritis, otitis media diverticulitis§ Neoplasms benign, malignant and unspecified (including cysts and polyps) neoplasm Blood and lymphatic system disorders lymphadenopathy, thrombocytopenia∗§, leukopenia∗§ Immune system disorders hypersensitivity∗, seasonal allergy∗ anaphylactoid reaction∗ Endocrine hypothyroidism∗ hyperprolactinaemia∗ Table 1: Adverse Reactions Frequency of adverse reactions observed from placebo-controlled clinical trials in depression, OCD, panic disorder, PTSD and social anxiety disorder.

Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) The development of potentially life-threatening syndromes like serotonin syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) has been reported with SSRIs, including treatment with sertraline.

g. methylene blue), antipsychotics and other dopamine antagonists, and with opioids. 3). Switching from Selective Serotonin Reuptake Inhibitors (SSRIs), antidepressants or antiobsessional drugs There is limited controlled experience regarding the optimal timing of switching from SSRIs, antidepressants or antiobsessional drugs to sertraline.

Care and prudent medical judgment should be exercised when switching, particularly from long-acting agents such as fluoxetine. g. tryptophan, fenfluramine and 5-HT agonists Co-administration of sertraline with other drugs which enhance the effects of serotonergic neurotransmission such as amphetamines, tryptophan or fenfluramine or 5-HT agonists, or the herbal medicine, St John’s Wort (hypericum perforatum), should be undertaken with caution and avoided whenever possible due to the potential for a pharmacodynamic interaction.

QTc Prolongation/Torsade de Pointes (TdP) Cases of QTc prolongation and TdP have been reported during post-marketing use of sertraline. The majority of reports occurred in patients with other risk factors for QTc prolongation/TdP. Effect on QTc prolongation was confirmed in a thorough QTc study in healthy volunteers, with a statistically significant positive exposure-response relationship.

1). Activation of hypomania or mania Manic/hypomanic symptoms have been reported to emerge in a small proportion of patients treated with marketed antidepressant and antiobsessional drugs, including sertraline. Therefore sertraline should be used with caution in patients with a history of mania/hypomania.

Close surveillance by the physician is required. Sertraline should be discontinued in any patient entering a manic phase. Schizophrenia Psychotic symptoms might become aggravated in schizophrenic patients. Seizures Seizures may occur with sertraline therapy: sertraline should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored.

Hypersensitivity to the active substance or any of the excipients. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome with symptoms such as agitation, tremor and hyperthermia.

Sertraline must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI. 5). 5).