SERTRALINE oral

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    Last updated: November 2021

     

     
    Prescription under medical supervision

     

    Therapeutic action

    • Antidepressant, selective serotonin re-uptake inhibitor (SSRI)

    Indications

    • Major depression, if fluoxetine or paroxetine poorly tolerated or contra-indicated
    • Severe post-traumatic stress disorder

    Forms and strengths

    • 50 mg and 100 mg tablets

    Dosage

    Major depression

    • Adult: 25 mg once daily for 3 days, then 50 mg once daily. In case of insufficient response after 3 weeks, increase up to 100 mg daily max.

     

    Severe post-traumatic stress disorder

    • Adult: 50 mg once daily

    Duration

    • Major depression: at least 9 months. Discontinue treatment gradually (e.g. half dose once daily for 2 weeks and then on alternate days for 2 weeks). If signs of relapse or withdrawal occur, increase the dose and decrease it more gradually.
    • Severe post-traumatic stress disorder: 2 to 3 months after symptoms resolveDiscontinue treatment gradually (over at least 2 weeks). 

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with severe hepatic impairment. Reduce the dose by half in patients with mild to moderate hepatic impairment.
    • Administer with caution and monitor use in patients with epilepsy, diabetes; history of: gastrointestinal bleeding, bipolar disorders, suicidal ideation, or closed-angle glaucoma.
    • May cause:
      • gastrointestinal disturbances, drowsiness, fatigue, headache, dizziness, seizures, sexual dysfunction, blurred vision, hyponatraemia especially in older patients;
      • mental disorders: anxiety, insomnia, agitation, aggressive behaviour, suicidal ideation;
      • withdrawal symptoms very frequent if discontinued abruptly: dizziness, paraesthesia, nightmares, anxiety, tremors and headaches.
    • Avoid combination with:
      • alcohol (risk of drowsiness); aspirin, NSAIDs and warfarin (risk of bleeding);
      • serotonergic drugs: other SSRI, tricyclic antidepressants, ondansetron, tramadol, etc. (risk of serotonin syndrome).
    • Monitor combination with: risperidone (increased plasma concentration), drugs which lower the seizure threshold (antipsychotics, mefloquine, etc.).
    • Pregnancy and breast-feeding: no contra-indication; re-evaluate whether the treatment is still necessary; if it is continued, maintain sertraline at effective dose. Observe the neonate (risk of agitation, tremors, hypotony, respiratory difficulties, sleeping disorders, etc.) if the mother was under treatment in the 3rd trimester. 

    Remarks

    • It is necessary to wait at least 2 to 3 weeks before assessing the antidepressant effect. This must be explained to the patient.

    Storage

     
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    –  Below 25 °C