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Oral formulations containing 20mg or 40mg of duloxetine (as hydrochloride).

Drugs List

  • duloxetine 20mg gastro-resistant capsules
  • duloxetine 40mg gastro-resistant capsules
  • YENTREVE 20mg gastro-resistant capsules
  • YENTREVE 40mg gastro-resistant capsules
  • Therapeutic Indications


    Moderate to severe stress urinary incontinence in women - treatment



    40mg twice daily.

    After 2 to 4 weeks of treatment, patients should be re-assessed to determine the benefit and tolerability of therapy.

    Some patients may benefit from starting therapy at 20mg twice daily for two weeks before the dose is increased to 40mg twice daily. Dose escalation may decrease, though not eliminate, the risk of nausea and dizziness.

    Patients with Renal Impairment

    No dosage adjustment is necessary in patients with creatinine clearance above 30ml/minute.

    Contraindicated by manufacturer in renal impairment where creatinine clearance is below 30ml/minute.

    The Renal Drug Handbook suggests the following dosage guidelines for the use of duloxetine in renal impairment:
    Glomerular filtration rate 30 to 50ml/minute: Dose as in normal renal function; start with a low dose.
    Glomerular filtration rate 10 to 29ml/minute: Start at low dose and increase according to response.
    Glomerular filtration rate less than 10ml/minute: Start at very low dose and increase according to response.

    Additional Dosage Information

    The combination of duloxetine therapy with pelvic floor muscle training (PFMT) may be more effective than either treatment alone.

    Discontinuing duloxetine
    Gradual withdrawal required. Doses should be withdrawn over at least 1 to 2 weeks to avoid withdrawl reactions. If intolerable symptoms occur following a decrease or discontinuation of the dose, resuming the previously prescribed dose may be considered, followed by a more gradual withdrawl. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.


    Children under 18 years
    Within 2 weeks of discontinuing MAOIs
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Hereditary fructose intolerance
    Renal impairment - creatinine clearance below 30 ml/minute
    Uncontrolled hypertension

    Precautions and Warnings

    Predisposition to hyponatraemia
    Predisposition to narrow angle glaucoma
    Suicidal ideation
    Bipolar disorder
    Cardiac impairment
    Hepatic cirrhosis
    History of mania
    Raised intra-ocular pressure

    Patients at risk of suicide should be closely supervised
    Advise ability to drive/operate machinery may be affected by side effects
    Some formulations contain sucrose
    Monitor blood pressure and heart rate in hypertensive patients
    Monitor patients for adverse reactions including restlessness & agitation
    Monitor patients for signs and symptoms of Serotonin Syndrome
    Reassess need for continued treatment at regular intervals
    Refer women considering pregnancy for specialist advice and monitoring
    Advise patient to report any new or worsening depression/suicidal ideation
    Do not increase dosage in patients who develop akathisia
    Potential for withdrawal symptoms
    Reduce dose if hypertension cannot be controlled
    Avoid abrupt withdrawal
    Advise patient to seek advice at first indications of pregnancy
    Consider discontinuing treatment in cases of marked hypertension
    Dose adjustment required if patient starts/stops smoking during therapy
    Advise patient not to take St John's wort concurrently
    Advise that effects are potentiated by CNS depressants (including alcohol)

    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.

    Other psychiatric conditions for which duloxetine is prescribed can also be associated with an increased risk of suicide related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

    Patients with a history of suicide related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment.

    Patients, (and caregivers of patients) should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour, and to seek medical advice immediately if these symptoms present.

    Duloxetine has been associated with an increase in blood pressure, and clinically significant hypertension in some patients. Duloxetine should be used with caution in patients whose conditions could be compromised by an increased heart rate or by an increase in blood pressure.

    Liver injury including severe elevations of liver enzymes, hepatitis and jaundice have been reported with duloxetine. Duloxetine should be used with caution in patients treated with other medicinal products associated with hepatic injury.

    Pregnancy and Lactation


    Use duloxetine with caution during pregnancy.

    The manufacturers suggest only using duloxetine in pregnancy if the potential benefit outweighs the potential risk to foetus. Animal studies have shown reproductive toxicity effects. Human data is limited and as such a potential risk cannot be ruled out.

    In the later stages of pregnancy, epidemiological data suggest that the use of SSRIs may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Duloxetine use near term may result in discontinuation symptoms, including hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures. Studies have shown duloxetine use within the month prior to birth may increase the risk of postpartum haemorrhage.


    Duloxetine is contraindicated in breastfeeding.

    Duloxetine is excreted in human breast milk in small quantities. The manufacturer recommends not breastfeeding whilst taking duloxetine.

    Lactmed suggests using an alternate drug that has been better studied. However if duloxetine is required by the mother, it is not a reason to discontinue breastfeeding. In this instance the infant should be monitored for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants.

    Side Effects

    Altered temperature sensation
    Anaphylactic reaction
    Angioneurotic oedema
    Attention disturbances
    Behavioural disturbances
    Bleeding disorders
    Cold sweat
    Creatine phosphokinase increased
    Decreased appetite
    Dry mouth
    Eosinophilic pneumonia
    Extrapyramidal effects
    Gait abnormality
    Gastro-intestinal disturbances
    Gastro-intestinal haemorrhage
    Hepatic disorders
    Hypersensitivity reactions
    Hypertensive crisis
    Inappropriate secretion of antidiuretic hormone
    Increase in plasma cholesterol
    Increased blood pressure
    Increased risk of fractures
    Increased sweating
    Increased thirst
    Increases in hepatic enzymes
    Interstitial lung disease
    Menopausal-like symptoms
    Muscle disorders
    Night sweats
    Orthostatic hypotension
    Peripheral coldness
    Postpartum haemorrhage
    Psychomotor restlessness
    Reduced libido
    Serotonin syndrome
    Sexual dysfunction
    Skin reactions
    Sleep disturbances
    Stevens-Johnson syndrome
    Suicidal tendencies
    Supraventricular arrhythmias
    Throat tightness
    Urinary retention
    Urinary tract disorders
    Utero-vaginal haemorrhage
    Visual disturbances
    Weight changes
    Withdrawal symptoms


    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: April 2019

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

    Summary of Product Characteristics: Yentreve 20mg and 40mg hard gastro-resistant capsules. Eli Lilly and Company Ltd. Revised July 2019.
    Summary of Product Characteristics: Dutor 20mg and 40mg Gastro resistant Capsules, hard. Torrent Pharma UK. Revised June 2017.

    Summary of Product Characteristics: Duloxetine 20mg Gastro resistant Capsules, hard. Actavis UK Ltd. Revised March 2015.
    Summary of Product Characteristics: Duloxetine 40mg Gastro resistant Capsules, hard. Actavis UK Ltd. Revised March 2015.

    Summary of Product Characteristics: Duloxetine 20mg Gastro resistant Capsules, hard. Teva UK Ltd. Revised August 2016.
    Summary of Product Characteristics: Duloxetine 40mg Gastro resistant Capsules, hard. Teva UK Ltd. Revised August 2016.

    Summary of Product Characteristics: Duloxetine 20mg Gastro resistant Capsules, hard. Wockhardt UK Ltd. Revised February 2019.
    Summary of Product Characteristics: Duloxetine 40mg Gastro resistant Capsules, hard. Wockhardt UK Ltd. Revised February 2019.

    MHRA Drug Safety Update December 2014
    Available at:
    Last accessed: 10 April 2019

    NICE Evidence Services Available at: Last accessed: 10 April 2019

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Duloxetine. Last revised: 31 October 2018
    Last accessed: 10 April 2019

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