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Sertindole oral

Updated 2 Feb 2023 | Antipsychotics


Oral formulations of sertindole

Drugs List

  • SERDOLECT 12mg tablets
  • SERDOLECT 16mg tablets
  • SERDOLECT 20mg tablets
  • SERDOLECT 4mg tablets
  • sertindole 12mg tablets
  • sertindole 16mg tablets
  • sertindole 20mg tablets
  • sertindole 4mg tablets
  • Therapeutic Indications


    Schizophrenia - resistant to other treatment



    Patients should start treatment with 4 mg once a day.

    The dose should be increased by increments of 4 mg after 4 to 5 days until the optimal daily maintenance dose, within the range 12 to 20 mg, is reached.
    A starting dose of 8 mg or rapid dose escalation carries an increased risk of postural hypotension.

    Dependent on individual patient response, the dose may be increased to 20 mg once a day. Only in exceptional cases should the maximum dose of 24 mg be considered, however doses above 20 mg once a day have not been demonstrated to consistently improve efficacy.
    Risk of QT prolongation is increased at the higher end of the dose range.


    Slower titration and lower maintenance doses may be appropriate in elderly patients.

    Initiate treatment only after a thorough cardiovascular examination.

    Patients with Hepatic Impairment

    Patients with mild to moderate hepatic impairment require slower titration and a lower maintenance dose.

    Additional Dosage Information

    Re-titration of sertindole in patients for whom treatment has been previously discontinued
    When restarting sertindole treatment in patients who have had an interval of less than one week without sertindole, re-titration is not required and their maintenance dose can be reinstated.
    Patients who have a not received sertindole in over a week should follow the recommended titration schedule. An ECG should be taken prior to re-titration.

    Switching from other anti-psychotics
    Treatment with sertindole can be initiated according to the recommended titration schedule concurrently with cessation of other anti-psychotics.
    For patients treated with depot anti-psychotics, sertindole should be initiated in place of the next depot injection.


    Children under 18 years
    Bradycardia with pulse rate at rest < 50 beats per minute
    Cardiac arrhythmias
    Cardiac hypertrophy
    Congestive cardiac failure
    History of severe cardiac disorder
    Long QT syndrome
    QTc interval greater than 450 milliseconds in males
    QTc interval greater than 470 milliseconds in female adults
    Severe hepatic impairment
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Patients over 65 years
    Cardiovascular disorder
    Cerebrovascular disorder
    CYP2D6 poor metaboliser genotype
    Diabetes mellitus
    Electrolyte imbalance
    Glucose-galactose malabsorption syndrome
    History of seizures
    History of torsade de pointes
    Lactose intolerance
    Mild hepatic impairment
    Parkinson's disease

    Correct electrolyte disorders before treatment
    Reduce dose in patients with hepatic impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Concurrent benzodiazepine may be given for sedation
    Contains lactose
    Perform ECG before treatment
    Consider monitoring ECG in patients at risk of QT prolongation
    Diabetic control may need adjustment
    Monitor blood pressure during titration and early maintenance treatment
    Monitor ECG
    Monitor ECG prior to and after increasing dose
    Monitor serum electrolytes
    Perform ECG if arrhythmic symptoms develop
    Risk of cerebrovascular events
    Consider discontinuation if signs of tardive dyskinesia occur
    Increased risk for venous thromboembolism - take preventive measures
    May cause postural hypotension
    Potential for withdrawal symptoms
    Use low starting dose to avoid postural effects
    Avoid abrupt withdrawal
    Discontinue if patient develops neuroleptic malignant syndrome
    Discontinue treatment if QTc exceeds 500msec

    Sertindole is only for use in patients who are enrolled in clinical studies and who are intolerant to at least one other anti-psychotic agent as sertindole prolongs the QT interval to a greater extent than some other anti-psychotics.

    ECG monitoring should be conducted prior to and during treatment, as well as before and after any dose increases. Monitor ECG at baseline, upon reaching steady state after approximately 3 weeks or when reaching 16 mg, and again after 3 months of treatment. During maintenance therapy an ECG is required every 3 months.

    ECG monitoring is ideally conducted in the morning, and the Bazett or Fridericia formulae for calculating the QTc interval are preferred.

    A 3-fold increase in the risk of cerebrovascular events has been observed in patients treated with some atypical anti-psychotic drugs.

    Postural hypotension may occur during initiation and dose titration. There is a higher risk of postural hypotension with high initial doses and a rapid increase in dose.

    Anti-psychotic drugs may inhibit the effects of dopamine agonists, thus caution should be used in patients with Parkinson's disease

    Hyperglycaemia or pre-existing diabetes has been reported in rare cases during treatment with sertindole. Appropriate clinical monitoring is suggested in diabetic patients and patients with risk factors for diabetes mellitus.

    Pregnancy and Lactation


    Sertindole is contraindicated in pregnancy.

    Safety in human pregnancy has not been established. Sertindole was not teratogenic in animal reproduction studies. A peri/postnatal study in rats showed a decrease in offspring fertility at a dose within the therapeutic range for humans.

    Neonates exposed to sertindole during the third trimester are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms. These adverse reactions may include agitation, hypertonia, tremor, somnolence, respiratory distress or feeding disruptions. Therefore, newborns should be monitored carefully.

    Schaefer (2007) suggests that the use of sertindole is not an indication for the termination of pregnancy. A pregnant patient who is stable with the use of sertindole should keep receiving the drug as changing to an alternative drug may worsen her health. Dose reduction during the days leading up to birth should be considered to prevent neonatal adaptation disorders. Dose should then be adjusted to pre-pregnancy levels immediately after delivery.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Sertindole is contraindicated in breastfeeding.

    Studies in nursing mothers have not been performed, however it is expected that sertindole will be excreted in breast milk. If treatment is necessary, the manufacturer recommends that breastfeeding should be discontinued.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Decreased ejaculate volume
    Deep vein thrombosis (DVT)
    Dry mouth
    Ejaculation disorders
    Erectile dysfunction
    Exacerbation of diabetes
    Extrapyramidal effects
    Failure of ejaculation
    Movement disturbances
    Nasal congestion
    Neuroleptic malignant syndrome
    Peripheral oedema
    Postural hypotension
    Prolongation of QT interval
    Pulmonary embolism
    Reflex tachycardia
    Tardive dyskinesia
    Torsades de pointes
    Weight gain
    White blood cells in the urine

    Withdrawal Symptoms and Signs

    Acute withdrawal symptoms including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. Therefore gradual withdrawal is advisable.


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: October 2016

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [Accessed on 05 September 2016].

    Summary of Product Characteristics: Serdolect 4 mg tablets. Lundbeck. Revised April 2016.

    Summary of Product Characteristics: Serdolect 12 mg tablets. Lundbeck. Revised April 2016.

    Summary of Product Characteristics: Serdolect 16 mg tablets. Lundbeck. Revised April 2016.

    Summary of Product Characteristics: Serdolect 20 mg tablets. Lundbeck. Revised April 2016.

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