PAROXETINE oral

Prescription under medical supervision

Therapeutic action

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

Indications

– Major depression
– Generalised anxiety
– Severe post-traumatic stress disorders (PTSD)

Forms and strengths

– 20 mg scored tablet

Dosage

–  Depression
Adult: 20 mg once daily at bedtime. In case of insufficient response after 4 weeks, increase up to 40 mg daily max.

– Generalised anxiety, PTSD
Adult: 10 to 20 mg once daily at bedtime

Duration

– Depression: at least 9 months. The treatment should be discontinued gradually (10 mg daily for 2 weeks then, 10 mg on alternate days for 2 weeks). If signs of relapse or withdrawal occur, increase the dose.
– Generalised anxiety, PTSD: 2 to 3 months after symptoms resolve. The treatment should be discontinued gradually (over at least 2 weeks).  

Contra-indications, adverse effects, precautions

– Administer with caution and monitor use in patients with epilepsy, diabetes, hepatic or renal impairment (max. 20 mg daily); 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 elderly patients;
• mental disorders: anxiety, insomnia, agitation, aggressive behaviour, suicidal ideation;
• frequent withdrawal symptoms if discontinued abruptly: dizziness, paraesthesia, nightmares, anxiety, tremors and headaches.
– Avoid combination with:
• alcohol (risk of drowsiness); aspirin and NSAIDs (risk of bleeding);
• serotonergic drugs: other selective serotonin re-uptake inhibitors, tricyclic antidepressants (amitriptyline, clomipramine, imipramine), ondansetron, tramadol, etc. (risk of serotonin syndrome).
– Monitor combination with: risperidone (increased plasma concentration), drugs which lower the seizure threshold (antipsychotics, mefloquine, etc.).
– Pregnancy: re-evaluate whether the treatment is still necessary; if it is continued, avoid paroxetine and use sertraline.
– Breast-feeding: no contra-indication

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: below 25 °C -  -