Sertraline oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of sertraline.
Drugs List
Therapeutic Indications
Uses
Depression - severe
Obsessive-compulsive disorders
Panic disorders with or without agoraphobia
Prevention of relapse or recurrence of depressive illness
Social anxiety disorder
Treatment of post-traumatic stress disorder
Dosage
Sertraline may be started not less than fourteen days after discontinuing treatment with an irreversible monoamine oxidase inhibitor (MAOI) and at least one day after discontinuing treatment with the reversible MAOI moclobemide. At least seven days should elapse after discontinuing sertraline treatment before starting a reversible or irreversible MAOI.
Adults
Dosage during long term therapy should be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response.
Depression and obsessive compulsive disorder (OCD)
Initial dose: 50mg daily.
Titration stage: Patients not responding to 50mg daily may benefit from dose increases. Dose changes, at intervals at not less than one week, should be made in steps of 50mg. The therapeutic effect is usually seen within seven days, although this may take longer in OCD.
Maintenance dose: 50mg to 200mg daily.
Maximum dose: 200mg daily.
To prevent recurrence of major depressive episodes, long term treatment may be appropriate, with the patient being evaluated regularly. Patients in long term treatment for depression should be treated for at least six months to ensure they are free from symptoms.
Panic disorder, social anxiety disorder and post-traumatic stress disorder (PTSD)
Initial dose: 25mg daily, increased to 50mg once daily after one week.
Titration stage: Patients not responding to 50mg daily may benefit from dose increases. Dose changes, at intervals at not less than one week, should be made in steps of 50mg. The therapeutic effect is usually seen within seven days.
Maximum dose: 200mg daily.
Continued treatment in panic disorder should be evaluated regularly, as relapse prevention has not been shown for these disorders.
Elderly
A lower or less frequent dosage is recommended in elderly patients, as elderly may be more at risk of developing hyponatraemia with sertraline and related drugs.
Children
Obsessive compulsive disorder (OCD)
Treatment should only be initiated by specialists.
Children aged 12 to 18 years
Initial dose: 50mg daily. Increase in steps of 50mg over several weeks if necessary.
Maintenance dose: 50mg to 200mg daily.
Maximum dose: 200mg daily.
Children aged 6 to 12 years
Initial dose: 25mg daily. Increase to 50mg daily after one week.
Patients not responding to 50mg daily may benefit from dose increases. Dose changes, at intervals at not less than one week, should be made in steps of 50mg.
The generally lower bodyweight of children compared to adults should be taken into consideration in increasing the dose from 50mg daily in order to avoid excessive dosing.
Major depressive disorder (unlicensed)
Children aged 12 to 18 years
Initial dose: 50mg.
Patients not responding to 50mg daily may benefit from dose increases. Dose changes, at intervals at not less than one week, should be made in steps of 50mg.
Maximum dose: 200mg daily.
Contraindications
Children under 6 years
Within 2 weeks of discontinuing MAOIs
Long QT syndrome
Severe hepatic impairment
Torsade de pointes
Uncontrolled epileptic disorder
Precautions and Warnings
Elderly
Electroconvulsive therapy
Family history of long QT syndrome
Patients under 25 years
Predisposition to hyponatraemia
Predisposition to narrow angle glaucoma
Suicidal ideation
Breastfeeding
Cardiac disorder
CYP2C19 poor metaboliser genotype
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of coagulopathy
History of glaucoma
History of hypomania
History of mania
History of torsade de pointes
Lactose intolerance
Narrow angle glaucoma
Pregnancy
Schizophrenia
Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Reduce dose in patients with hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Some formulations contain lactose
Consider monitoring ECG in patients at risk of QT prolongation
Discontinue treatment if patient develops seizures
May cause hyponatraemia
Monitor antidiabetic drug treatment
Monitor for signs of suicide ideation or behaviour
Monitor growth and development in children on prolonged therapy
Monitor patients for signs and symptoms of Neuroleptic Malignant Syndrome
Monitor patients for signs and symptoms of Serotonin Syndrome
Monitor patients with epilepsy while taking this treatment
Monitor serum electrolytes
Consider dose reduction or discontinuation if serotonin syndrome suspected
Do not increase dosage in patients who develop akathisia
Increased risk of fractures in patients over 50 years
May cause growth retardation in children
May exacerbate schizophrenia
May affect results of some laboratory tests
Avoid abrupt withdrawal
Avoid MAOIs for 7 days after discontinuing this drug
To discontinue, reduce dose gradually
Consider discontinuing if symptoms of hyponatraemia occur
Discontinue if patient enters a manic phase
Maintain treatment at the lowest effective dose
Not licensed for all indications in all age groups
Advise patient not to take St John's wort concurrently
Advise patients to avoid aspirin and NSAID use
Advise patient to avoid alcohol during treatment
Advise patient to avoid grapefruit products
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. Such risk persists until significant improvement occurs. As this may not occur at the start of sertraline therapy, 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 sertraline is prescribed can also be associated with an increased risk of suicide related events. Therefore the same precautions observed when treating patients with major depressive disorder should therefore be observed when treating with other psychiatric disorders.
Take care when switching from serotonin selective reuptake inhibitors, antidepressants or anti-obsessional drugs to sertraline.
Pregnancy and Lactation
Pregnancy
Use sertraline with caution during pregnancy.
The manufacturer does not recommend the use of sertraline during pregnancy unless the benefit to the mother outweighs the potential risk to the foetus.
Human data is limited and as such a potential risk cannot be ruled out.
Available reports have associated sertraline with developmental toxicities such as, spontaneous abortions, preterm delivery, respiratory distress, persistent pulmonary hypertension, low birth weight, neonatal serotonin syndrome, neonatal withdrawal and abnormal neurobehaviour beyond the neonatal period. However, the absolute risk appears to be small (Briggs, 2015).
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). After birth, close observation of neonates exposed to SSRIs or SNRIs is recommended especially for signs of PPHN. Sertraline exposure within one month prior to delivery has also been shown to increase the risk of postpartum haemorrhage.
Sertraline has been reported to cause withdrawal symptoms in neonates whose mothers received sertraline during pregnancy, particularly during the third trimester. Monitoring of the neonate for withdrawal symptoms is recommended when SSRIs have been used up to delivery. To prevent neonatal adaptation disorders, dose reduction or even treatment interruption in the days immediately preceding delivery can be discussed with the patient if the clinical course allows. However, to prevent a relapse at this vulnerable stage, pre-pregnancy dosage should be started immediately after delivery.
The following symptoms may occur in the neonate after maternal SSRI/SNRI use in later stages of pregnancy, respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These symptoms may be due to either the serotoninergic effects or discontinuation symptoms. In the majority of instances the complications occur immediately or soon after birth (within 24 hours).
Lactation
Use sertraline with caution during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking sertraline unless the benefit outweighs the risk. Available data regarding sertraline levels in breast milk suggest that small quantities of sertraline are excreted in human breast milk. Due to the low levels excreted, it is thought that the amount ingested by the infant are small and is not usually detected in infant serum levels.
Breastfed infants who are exposed to sertraline during the third trimester of pregnancy may have a reduced risk of poor neonatal adaptation over formula fed infants.
Side Effects
Abnormal bleeding
Abnormal thinking
Abnormal vision
Aggression
Agitation
Alopecia
Altered liver function tests
Amnesia
Anaphylactoid reaction
Angioedema
Anorexia
Anxiety
Apathy
Arthralgia
Attention disturbances
Blood disorders
Blood glucose disturbances
Bruxism
Cardiac disorders
Chest pain
Chills
Choreo-athetoid movements
Convulsions
Depression
Dermatitis
Disturbances of appetite
Dizziness
Dysgeusia
Dyskinesia
Dysphonia
Endocrine disturbances
Epidermal necrolysis
Eye disorder
Fatigue
Flushing
Gait abnormality
Galactorrhoea
Gastrointestinal disorder
Gynaecomastia
Hallucinations
Headache
Hepatic failure
Hepatobiliary disorders
Hypercholesterolaemia
Hyperhidrosis
Hyperkinesia
Hyperprolactinaemia
Hypersensitivity reactions
Hypertonia
Hypoaesthesia
Hyponatraemia
Hypothyroidism
Impaired platelet function
Inappropriate secretion of antidiuretic hormone
Increased risk of fractures
Infections
Insomnia
Involuntary movement disorders
Leucopenia
Lymphadenopathy
Menstrual disturbances
Micturition disorders
Mood changes
Muscle contraction
Muscle cramps
Muscle weakness
Nervousness
Neuroleptic malignant syndrome
Nightmares
Oedema
Osteoarthritis
Pancreatitis
Paraesthesia
Paranoia
Peripheral ischaemia
Photosensitivity
Possible alteration of laboratory tests
Pruritus
Psychiatric disorders
Psychomotor restlessness
Psychotic reactions
Purpura
Pyrexia
Rash
Sensory disturbances
Serotonin syndrome
Severe cutaneous skin eruptions
Sexual dysfunction
Skin disorder
Somnolence
Stevens-Johnson syndrome
Suicidal tendencies
Thrombocytopenia
Tinnitus
Tremor
Urinary incontinence
Urticaria
Vascular disorders
Visual disturbances
Weight changes
Effects on Laboratory Tests
False-positive urine immunoassay screening tests for benzodiazepines have been observed in patients treated with sertraline. The reason is the lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of sertraline therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish sertraline from benzodiazepines.
Withdrawal Symptoms and Signs
Some or all of the withdrawal symptoms associated with sertraline are: dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache. These symptoms are generally mild and resolve within 2 weeks but some patients may experience more intense symptoms which may be prolonged (2 to 3 months). It is therefore advised that sertraline is withdrawn gradually over a period of at least one to two weeks in order to reduce the occurrence of withdrawal reactions. If intolerable symptoms occur during dose reduction or discontinuation, consider resuming at the previous, higher dose before continuing discontinuation more gradually.
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: October 2021
Reference Sources
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: Contulen 50mg film coated tablets. HFA Healthcare Products Ltd. Revised March 2022.
Summary of Product Characteristics: Contulen 100mg film coated tablets. HFA Healthcare Products Ltd. Revised March 2022.
Summary of Product Characteristics: Lustral 50mg film coated tablets. Upjohn UK Ltd. Revised March 2021.
Summary of Product Characteristics: Lustral 100mg film coated tablets. Upjohn UK Ltd. Revised March 2021.
Summary of Product Characteristics: Sertraline 25mg tablets. Zentiva. Revised January 2021.
Summary of Product Characteristics: Sertraline 50mg tablets. Generics UK Ltd. Revised July 2021.
Summary of Product Characteristics: Sertraline 100mg tablets. Generics UK Ltd. Revised July 2021.
Summary of Product Characteristics: Sertraline 50mg film coated tablets. Teva UK Ltd. Revised May 2021.
Summary of Product Characteristics: Sertraline 100mg film coated tablets. Teva UK Ltd. Revised May 2021.
Summary of Product Characteristics: Sertraline 50mg film coated tablets. Dr Reddy's Laboratories (UK) Ltd. Revised September 2021.
Summary of Product Characteristics: Sertraline 100mg film coated tablets. Dr Reddy's Laboratories (UK) Ltd. Revised September 2021.
Summary of Product Characteristics: Sertraline 150mg film-coated tablets. Martindale Pharmaceuticals Ltd. Revised February 2022.
Summary of Product Characteristics: Sertraline 200mg film-coated tablets. Martindale Pharmaceuticals Ltd. Revised February 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 October 2021
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Sertraline Last revised: 15 February 2021
Last accessed: 07 October 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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