Patient/caregiver was educated on precautions to be exercised while taking dothiepin as follows:

  1. Dothiepin carries the risk of causing and/or aggravating cardiac arrhythmias. Dothiepin can also interact with many antibacterial and antifungal antibiotics, antiarrhythmic medications, antidepressants, and antipsychotic medications, resulting in development or aggravation of underlying cardiac arrhythmias, leading to debility and sudden cardiac death. Avoid taking dothiepin along with medications belonging to the above-mentioned groups, to prevent any dangerous arrhythmias from developing. Discuss with your physician regarding your history of cardiac arrhythmias, if any, if you are newly started on dothiepin. If you are newly diagnosed with any cardiac arrhythmias or started on any antiarrhythmic medications, discuss with your physician regarding your safety with continuing on dothiepin, if you have been using the medication for long.
  2. Individuals with complaint of dehydration, secondary to history of diarrhea, vomiting, or poor fluid intake, can suffer electrolyte disturbances and be more prone to develop arrhythmias with dothiepin. Electrolyte disturbances, such as, low potassium and magnesium levels, secondary to diuretic pill intake, can also act as a precipitating factor for cardiac arrhythmias with dothiepin. Observing compliance with recommended hydration measures can help prevent development of arrhythmias in these individuals. Also, observe compliance with any periodical lab draws ordered for electrolyte levels and closely follow for development of signs and symptoms of cardiac arrhythmia, such as, episodes of chest pain, rapid heart rate, palpitations, dizziness, and shortness of breath. Report any such findings to your physician immediately, so that, an alternative plan of care could be considered.
  3. Serotonin is one chemical in the brain, which in permissible amounts, is believed to reduce anxiety and promote happiness and well-being. Very excessive concentrations of serotonin in the brain can lead to serotonin syndrome. Individuals with serotonin syndrome can present with mania, excitement, hallucinations, agitation, insomnia, pounding heartbeat, very rapid heart rate, overactive reflexes, and diarrhea. Dothiepin use, especially along with a few other antidepressants, such as, citalopram, fluoxetine, and sertraline, can significantly increase the serotonin levels in the body, lead to development of serotonin syndrome, and so, is contraindicated. Caution must be exercised even when discontinuing on any of the above mentioned antidepressant medications with potential to increase serotonin levels and starting on dothiepin, by observing a window period of atleast 2 weeks, before the transition to dothiepin is made. Using dothiepin with these medications closely can result in dangerously elevated serotonin in the blood, leading to development of serotonin syndrome.
  4. Dothiepin use can sometimes increase the risk for deterioration and worsening of clinical symptoms of mood disorders. Continue taking dothiepin, as recommended, even if your mood feels better and discontinuing the medication abruptly, without your physician’s recommendation, can result in disruption of chemical balance in the brain, resulting in worsening of mood disorder and severe withdrawal symptoms.  Individuals can present with complaints such as, feeling low, anxiety, panic attacks, trouble sleeping, gross appetite changes, impulsiveness, agitation, aggression, hallucinations, mania, and suicidal thoughts. Report any continuing/deteriorating symptoms of mood disorder immediately to your physician, so that, a dose change or change in plan of care could be considered.