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Dosulepin oral


Oral formulations of dosulepin hydrochloride

Drugs List

  • dosulepin 25mg capsules
  • dosulepin 75mg tablets
  • PROTHIADEN 25mg capsules
  • PROTHIADEN 75mg tablets
  • Therapeutic Indications


    Depressive illness with anxiety



    Initially 75 mg daily in divided doses or as a single dose at night, increasing to 150 mg daily. Up to 225 mg daily has been used in certain circumstances.

    Suggested regimens
    25 or 50 mg three times daily or, alternatively, 75 or 15 mg as a single dose at night. Should the regimen of 150 mg as a single night time dose be adopted, it is much better to give a smaller dose for the first few days.


    Initially 50 to 75 mg daily. As with any antidepressant, the initial dose should be increased with caution under close supervision. Half the normal adult dose may be sufficient to produce satisfactory clinical response.


    Children under 18 years
    Within 2 weeks of discontinuing MAOIs
    Within 2 weeks of discontinuing selegiline
    Atrioventricular block
    Cardiac arrhythmias
    Long QT syndrome
    Recent myocardial infarction
    Severe hepatic impairment
    Torsade de pointes

    Precautions and Warnings

    Electroconvulsive therapy
    Family history of long QT syndrome
    Suicidal ideation
    Bipolar disorder
    Cardiovascular disorder
    Electrolyte imbalance
    Epileptic disorder
    Hepatic impairment
    History of mania
    History of torsade de pointes
    Narrow angle glaucoma
    Prostate disorder
    Thyroid dysfunction
    Urinary retention

    Anaesthetist should be made aware patient is taking this medication
    Correct electrolyte disorders before treatment
    Patients at risk of suicide should be closely supervised
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be initiated and supervised by a specialist
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor for depressive disorders/suicidal ideation-consider discontinuation
    Monitor patients at risk of glaucoma for increases in intraocular pressure
    Monitor serum electrolytes
    Treatment of depression - monitor initially; may take 2-4 weeks to respond
    Advise patient to report any new or worsening depression/suicidal ideation
    Advise patients/carers to seek medical advice if suicidal intent develops
    Consider hyponatraemia in all patients with drowsiness/confusion/seizures
    Increased risk of fractures in patients over 50 years
    Potential for withdrawal symptoms
    Do not withdraw this drug suddenly
    Dosage reduction should be done gradually over about 4 weeks
    Reduce dose in elderly
    Advise patient not to take St John's wort concurrently
    Advise patient that the effects of alcohol may be potentiated

    Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. Furthermore, there is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm

    Patients receiving SSRIs or TCAs, mainly those aged 50 years or older - a review of epidemiological studies shows an increased risk of bone fractures in these patients. The mechanism leading to this increased risk is unclear.

    Pregnancy and Lactation


    Use dosulepin with caution in pregnancy.

    If the mother is using dosulepin before becoming pregnant, treatment should be continued. Evidence suggests that not treating depression during a pregnancy can cause serious harm to the foetus (Schaefer, 2007).
    Serum levels of dosulepin can fluctuate during pregnancy meaning that the effective dose the mother receives maybe ineffective at treating symptoms. Serum levels should be monitored and dose adjusted accordingly. Observation of the mother for psychiatric and complications of pregnancy is recommended.

    At the time of writing there is insufficient information on the potential effects on the developing foetus. Withdrawal effects have been seen in neonates and it is recommended that they be observed for symptoms for at least two days after birth. Consideration should be given to dose reduction or an interruption in treatment immediately preceding 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 ( ).


    Use dosulepin with caution in breastfeeding.

    Dosulepin is broken down into three active metabolites which are present in breast milk. At the time of writing the is not enough information to assess the effect/s of these metabolites on a nursing infant.

    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

    Abnormal liver function tests
    Behavioural disturbances
    Blood sugar changes
    Blurred vision
    Bone marrow depression
    Cardiac arrhythmias
    Cholestatic jaundice
    Difficulty in micturition
    Disturbances in accommodation
    Dry mouth
    ECG changes
    Hypersensitivity reactions
    Inappropriate secretion of antidiuretic hormone
    Increased appetite
    Increased intra-ocular pressure
    Increased risk of fractures
    Involuntary movement disorders
    Paranoid delusions
    Postural hypotension
    Severe hypotension
    Sexual dysfunction
    Taste disturbances
    Testicular swelling
    Weight gain


    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: January 2015

    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 6 January 2015.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Dosulepin capsules 25mg. Teva UK Ltd. Revised November 2013.
    Summary of Product Characteristics: Dosulepin tablets BP 75mg. Teva UK Ltd. Revised November 2013.

    Summary of Product Characteristics: Prothiaden capsules 25mg. Teofarma. Revised July 2010.
    Summary of Product Characteristics: Prothiaden tablets 75mg. Teofarma. Revised July 2010.

    MHRA 4th February 2008
    Last accessed 6 January 2015

    MHRA Drug Safety Update May 2010
    Last accessed: 6 January 2015

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Dosulepin Last revised: 7 September 2013
    Last accessed: 6 January 2015

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