Lexostad 50

Rx

Indications

• Major depressive episodes. Prevention of recurrence of major depressive episodes.
• Panic disorder, with or without agoraphobia.
• Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6 – 17 years.
• Social anxiety disorder.
• Post traumatic stress disorder (PTSD).

Dosage

Initial treatment

• Depression and OCD:
  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.

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

• Depression:
  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.
• Elderly patients:
  Elderly should be dosed carefully, as elderly may be more at risk for hyponatraemia.
• Patients with hepatic impairment:
  The use of sertraline in patients with hepatic disease should be approached with caution. A lower or less frequent dose should be used in patients with hepatic impairment. Sertraline should not be used in cases of severe hepatic impairment.
• Patients with renal impairment:
  No dosage adjustment.

Paediatric population

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. 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.
• No data is available for children under 6 years of age.

Withdrawal symptoms seen on discontinuation of sertraline

• 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. 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 rate.

Usage

• Lexostad 50 is administered orally, either in the morning or evening and can be administered with or without food.

• Hypersensitivity to the active substance or to any of the excipients.
• Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs). Sertraline must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI. Sertraline must be discontinued for at least 7 days before starting treatment with an irreversible MAOI.
• Pimozide.

Very common

• Insomnia, dizziness, somnolence, headache, diarrhoea, nausea, dry mouth, ejaculation failure, fatigue.

Common

• Pharyngitis, decreased appetite, increased appetite, depression, depersonalisation, nightmare, anxiety, agitation, nervousness, libido decreased, bruxism, paraesthesia, tremor, hypertonia, dysgeusia, disturbance in attention, visual disturbance, tinnitus, palpitations, hot flush, yawning, abdominal pain, vomiting, constipation, dyspepsia, flatulence, rash, hyperhidrosis, arthralgia, myalgia, erectile dysfunction, chest pain, malaise.

• Serotonin syndrome (SS) or neuroleptic malignant syndrome (NMS): The development of potentially life-threatening syndromes has been reported with SSRIs. The risk of SS or NMS with SSRIs is increased with concomitant use of other serotonergic drugs, with drugs which impair metabolism of serotonin, antipsychotics and other dopamine antagonists, and with opiate drugs.
• Switching from selective serotonin reuptake inhibitors (SSRIs), antidepressants or anti-obsessional drugs: Care and prudent medical judgment should be exercised when switching, particularly from long-acting agents such as fluoxetine.
• Other serotonergic drugs e.g. tryptophan, fenfluramine and 5-HT agonists: Co-administration of sertraline with other drugs which enhance the effects of serotonergic neurotransmission such as 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.
• QTc prolongation/Torsade de pointes (TdP): Cases of QTc prolongation and torsade de pointes (TdP) have been reported. The majority of reports occurred in patients with other risk factors for QTc prolongation/TdP.
• Activation of hypomania or mania: Manic/hypomanic symptoms have been reported. Sertraline should be used with caution in patients with a history of mania/hypomania. Sertraline should be discontinued in any patient entering a manic phase.
• Schizophrenia: Psychotic symptoms might become aggravated in schizophrenic patients.
• Seizures: Sertraline should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. Sertraline should be discontinued in any patient who develops seizures.
• Suicide/suicidal thoughts/suicide attempts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
• Paediatric population: 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 aged 6 – 17 years old.
• Abnormal bleeding/Haemorrhage: There have been reports of bleeding abnormalities with SSRIs including cutaneous bleeding (ecchymoses and purpura) and other haemorrhagic events such as gastrointestinal or gynaecological bleeding, including fatal haemorrhages. Caution is advised in patients taking SSRIs, particularly in concomitant use with drugs known to affect platelet function as well as in patients with a history of bleeding disorders.
• Hyponatraemia: Hyponatraemia may occur as a result of treatment with SSRIs or SNRIs including sertraline. In many cases, hyponatraemia appears to be the result of a syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases of serum sodium levels lower than 110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatraemia with SSRIs and SNRIs. Also patients taking diuretics or who are otherwise volume-depleted may be at greater risk.
• Withdrawal symptoms seen on discontinuation of sertraline treatment: Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt. It is therefore advised that sertraline should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient’s needs.
• Akathisia/psychomotor restlessness: The use of sertraline has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.
• Hepatic impairment: Sertraline is extensively metabolised by the liver. The use of sertraline in patients with hepatic disease must be approached with caution. If sertraline is administered to patients with hepatic impairment, a lower or less frequent dose should be considered. Sertraline should not be used in patients with severe hepatic impairment.
• Renal impairment: Sertraline dosing does not have to be adjusted based on the degree of renal impairment.
• Use in elderly: The pattern and incidence of adverse reactions in the elderly was similar to that in younger patients.
• Diabetes: Treatment with an SSRI may alter glycaemic control.
• Electroconvulsive therapy: There are no clinical studies establishing the risks or benefits of the combined use of ECT and sertraline.
• Grapefruit juice: The administration of sertraline with grapefruit juice is not recommended.
• Interference with urine screening tests: False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking sertraline.
• Angle-Closure glaucoma: SSRIs including sertraline may have an effect on pupil size resulting in mydriasis. Sertraline should therefore be used with caution in patients with angle-closure glaucoma or history of glaucoma.
• Sertraline is not recommended in pregnancy, unless the clinical condition of the woman is such that the benefit of the treatment is expected to outweigh the potential risk.
• Use in nursing mothers is not recommended unless, in the judgment of the physician, the benefit outweighs the risk.
• Sertraline has no effect on psychomotor performance. However, as psychotropic drugs may impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery, the patient should be cautioned accordingly.