Duloxetine oral 30mg, 60mg, 90mg and 120mg
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing 30mg, 60mg, 90mg or 120mg of duloxetine (as hydrochloride).
Drugs List
Therapeutic Indications
Uses
Depression - severe
Diabetic peripheral neuropathic pain: treatment
Treatment of generalised anxiety disorder (GAD)
Dosage
Adults
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
Contraindications
Children under 18 years
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Hepatic impairment
Hereditary fructose intolerance
Renal impairment - creatinine clearance below 30 ml/minute
Uncontrolled hypertension
Precautions and Warnings
Elderly
Predisposition to hyponatraemia
Predisposition to narrow angle glaucoma
Suicidal ideation
Tobacco smoking
Bipolar disorder
Cardiac impairment
Coagulopathy
Dehydration
Glucose-galactose malabsorption syndrome
Hepatic cirrhosis
History of mania
Hypertension
Pregnancy
Psychiatric disorder
Raised intra-ocular pressure
Seizures
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
Pregnancy
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.
Lactation
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
Aggression
Agitation
Anaphylactic reaction
Angioneurotic oedema
Anxiety
Apathy
Attention disturbances
Blurred vision
Bruxism
Cold sweat
Convulsions
Creatine phosphokinase increased
Cutaneous vasculitis
Decreased appetite
Dehydration
Dermatitis
Disorientation
Dizziness
Dry mouth
Dysgeusia
Ejaculation disorders
Elevated serum potassium
Epistaxis
Erectile dysfunction
Extrapyramidal effects
Falls
Feeling abnormal
Gait abnormality
Gastro-enteritis
Gastro-intestinal symptoms
Glaucoma
Haemorrhage
Hallucinations
Headache
Hepatic failure
Hepatitis
Hot flushes
Hyperglycaemia
Hyperprolactinaemia
Hypersensitivity reactions
Hypertension
Hypertensive crisis
Hyponatraemia
Hypothyroidism
Inappropriate secretion of antidiuretic hormone
Increase in plasma cholesterol
Increase in serum ALT/AST
Increased risk of fractures
Insomnia
Interference with temperature regulation
Jaundice
Laryngitis
Lethargy
Malaise
Mania
Menopausal-like symptoms
Menstrual disturbances
Movement disturbances
Muscle spasm
Mydriasis
Myoclonus
Nausea
Night sweats
Orthostatic hypotension
Pain
Palpitations
Paraesthesia
Peripheral coldness
Photosensitivity
Postpartum haemorrhage
Pruritus
Psychomotor restlessness
Rash
Restless legs
Sensory disturbances
Serotonin syndrome
Sexual dysfunction
Sleep disturbances
Somnolence
Stevens-Johnson syndrome
Stomatitis
Suicidal tendencies
Supraventricular arrhythmias
Sweating
Syncope
Tachycardia
Thirst
Throat tightness
Tinnitus
Tremor
Trismus
Urinary abnormalities
Urticaria
Utero-vaginal haemorrhage
Vertigo
Visual disturbances
Vivid dreams
Weight changes
Yawning
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.
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
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: https://www.mhra.gov.uk
Last accessed: 05 April 2019
NICE Evidence Services Available at: www.nice.org.uk Last accessed:26 October 2021
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Duloxetine. Last revised: 15 February 2021
Last accessed: 25 October 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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