Duloxetine oral 20mg & 40mg
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing 20mg or 40mg of duloxetine (as hydrochloride).
Drugs List
Therapeutic Indications
Uses
Moderate to severe stress urinary incontinence in women - treatment
Dosage
Adults
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 Doses should be withdrawn over at least 1 to 2 weeks to avoid withdrawl reactions.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.
Contraindications
Children under 18 years
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Glucose-galactose malabsorption syndrome
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
Bipolar disorder
Cardiac impairment
Coagulopathy
Dehydration
Hepatic cirrhosis
History of mania
Hypertension
Pregnancy
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
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
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 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
Akathisia
Altered temperature sensation
Anaphylactic reaction
Angioneurotic oedema
Anorexia
Anorgasmia
Anxiety
Attention disturbances
Behavioural disturbances
Bleeding disorders
Bruising
Bruxism
Chills
Cold sweat
Convulsions
Creatine phosphokinase increased
Decreased appetite
Dehydration
Disorientation
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyskinesia
Eosinophilic pneumonia
Epistaxis
Eructation
Extrapyramidal effects
Flushing
Gait abnormality
Gastro-intestinal disturbances
Gastro-intestinal haemorrhage
Glaucoma
Haematochezia
Halitosis
Hallucinations
Headache
Hepatic disorders
Hyperglycaemia
Hyperprolactinaemia
Hypersensitivity reactions
Hypertension
Hypertensive crisis
Hyponatraemia
Hypothyroidism
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
Jaundice
Laryngitis
Lethargy
Malaise
Menopausal-like symptoms
Muscle disorders
Mydriasis
Myoclonus
Nervousness
Night sweats
Orthostatic hypotension
Pain
Palpitations
Paraesthesia
Peripheral coldness
Photosensitivity
Postpartum haemorrhage
Psychomotor restlessness
Reduced libido
Serotonin syndrome
Sexual dysfunction
Skin reactions
Sleep disturbances
Somnolence
Stevens-Johnson syndrome
Stomatitis
Suicidal tendencies
Supraventricular arrhythmias
Syncope
Tachycardia
Throat tightness
Tinnitus
Tremor
Trismus
Urinary retention
Urinary tract disorders
Utero-vaginal haemorrhage
Vertigo
Visual disturbances
Weakness
Weight changes
Withdrawal symptoms
Yawning
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.
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: https://www.mhra.gov.uk
Last accessed: 10 April 2019
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 April 2019
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: 31 October 2018
Last accessed: 10 April 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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