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Duloxetine oral 30mg, 60mg, 90mg and 120mg


Oral formulations containing 30mg, 60mg, 90mg or 120mg of duloxetine (as hydrochloride).

Drugs List

  • CYMBALTA 30mg gastro-resistant capsules
  • CYMBALTA 60mg gastro-resistant capsules
  • DEPALTA 30mg gastro-resistant capsules
  • DEPALTA 60mg gastro-resistant capsules
  • DUCILTIA 30mg gastro-resistant capsules
  • DUCILTIA 60mg gastro-resistant capsules
  • duloxetine 120mg gastro-resistant capsules
  • duloxetine 30mg gastro-resistant capsules
  • duloxetine 60mg gastro-resistant capsules
  • duloxetine 90mg gastro-resistant capsules
  • Therapeutic Indications


    Depression - severe
    Diabetic peripheral neuropathic pain: treatment
    Treatment of generalised anxiety disorder (GAD)



    Major Depressive Disorder
    60mg once daily.
    Maximum dose 120mg per day.
    There is no clinical evidence to suggest patients not responding to the initial dose will benefit from dose up-titrations.

    Therapeutic response is usually seen after 2 to 4 weeks of treatment. After consolidation of the response, it is recommended to continue treatment for several months in order to avoid relapse. Patients with a history of repeated episodes of major depression may benefit from further treatment of 60 to 120mg per day.

    Generalised Anxiety Disorder
    Initial dose: 30mg once daily.
    Increased if necessary to a maintenance dose: 60mg once daily.
    Maximum dose 120mg per day.

    Co-morbid major depressive disorders
    60mg once daily.
    Maximum dose 120mg per day. Dose escalation should be based upon clinical response and tolerability.

    After consolidation of the response, it is recommended to continue treatment for several months in order to avoid relapse.

    Diabetic Peripheral Neuropathic Pain
    60mg once daily.
    Maximum dose 120mg per day administered in evenly divided doses.

    Evaluate treatment response after 2 months and assess the therapeutic benefit regularly, at least every 3 months. In patients with inadequate initial response, additional response after this time is unlikely.

    Patients with Renal Impairment

    The Renal Drug Handbook suggests the following doses for use of duloxetine in renal impairment;

    At a GFR of 30 to 50ml/minute: Dose as in normal renal function.

    At a GFR of 10 to 30ml/minute: Start at a low dose and increase according to response.

    At a GFR of below 10ml/minute: Start at a very low dose and increase according to response


    Children under 18 years
    Within 2 weeks of discontinuing MAOIs
    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
    Tobacco smoking
    Bipolar disorder
    Cardiac impairment
    Glucose-galactose malabsorption syndrome
    Hepatic cirrhosis
    History of mania
    Psychiatric disorder
    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
    Not all available brands are licensed for all indications
    Preparation contains 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
    When used with SSRIs, risk of Serotonin syndrome
    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)
    Advise patient/carers to report signs of suicide ideation or behaviour

    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 (2021) 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

    Abdominal pain
    Anaphylactic reaction
    Angioneurotic oedema
    Attention disturbances
    Blurred vision
    Cold sweat
    Creatine phosphokinase increased
    Cutaneous vasculitis
    Decreased appetite
    Dry mouth
    Ejaculation disorders
    Elevated serum potassium
    Erectile dysfunction
    Extrapyramidal effects
    Feeling abnormal
    Gait abnormality
    Gastro-intestinal symptoms
    Hepatic failure
    Hot flushes
    Hypersensitivity reactions
    Hypertensive crisis
    Inappropriate secretion of antidiuretic hormone
    Increase in plasma cholesterol
    Increase in serum ALT/AST
    Increased risk of fractures
    Interference with temperature regulation
    Menopausal-like symptoms
    Menstrual disturbances
    Movement disturbances
    Muscle spasm
    Night sweats
    Orthostatic hypotension
    Peripheral coldness
    Postpartum haemorrhage
    Psychomotor restlessness
    Restless legs
    Sensory disturbances
    Serotonin syndrome
    Sexual dysfunction
    Sleep disturbances
    Stevens-Johnson syndrome
    Suicidal tendencies
    Supraventricular arrhythmias
    Throat tightness
    Urinary abnormalities
    Utero-vaginal haemorrhage
    Visual disturbances
    Vivid dreams
    Weight changes

    Withdrawal Symptoms and Signs

    Withdrawal Symptoms
    Most common withdrawal symptoms include, dizziness, sensory disturbances, sleep disturbances, fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo.

    Gradual withdrawal over a period of at least one to two weeks is required to reduce the risk of withdrawal reactions. If intolerable symptoms occur following a decrease in dose or discontinuation of the treatment, resuming the previously prescribed dose may be considered.


    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.

    Summary of Product Characteristics: Cymbalta 30mg gastro-resistant capsules, hard. Eli Lilly and Company Ltd. Revised July 2019.

    Summary of Product Characteristics: Cymbalta 60mg gastro-resistant capsules, hard. Eli Lilly and Company Ltd. Revised July 2019.

    Summary of Product Characteristics: Depalta 30mg gastro-resistant capsules, hard. Torrent Pharma Ltd. Revised June 2017.

    Summary of Product Characteristics: Depalta 60mg gastro-resistant capsules, hard. Torrent Pharma Ltd. Revised June 2017.

    Summary of Product Characteristics: Duloxetine 30mg and 60mg gastro-resistant capsules, hard. Accord UK Ltd. Revised February 2021.

    Summary of Product Characteristics: Duloxetine 30mg and 60mg gastro-resistant capsules, hard. Dr Reddy's Laboratories Ltd. Revised December 2018.

    Summary of Product Characteristics: Duloxetine 90mg hard gastro-resistant capsules. Neuraxpharm UK Ltd. Revised June 2021.
    Summary of Product Characteristics: Duloxetine 120mg hard gastro-resistant capsules. Neuraxpharm UK Ltd. Revised June 2021.

    Summary of Product Characteristics: Dutor 30mg and 60mg gastro-resistant capsules, hard. Torrent Pharma UK Ltd. Revised June 2017.

    MHRA Drug Safety Update September 2007
    Available at:
    Last accessed: 05 April 2019

    NICE Evidence Services Available at: Last accessed:26 October 2021

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Duloxetine. Last revised: 15 February 2021
    Last accessed: 25 October 2021

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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