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SERTRALINE is a brand name for Sertraline. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sertraline is indicated for the treatment of: Major depressive episodes. Prevention of recurrence of major depressive episodes. Panic disorder, with or without agoraphobia. Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years. Social anxiety disorder. Post traumatic stress disorder…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Initial treatment Depression and OCD Sertraline treatment should be started at a dose of 50 mg/day. Panic Disorder, PTSD, and Social Anxiety Disorder Therapy should be initiated at 25 mg/day. After one week, the dose should be increased to 50 mg once daily.
This dose regimen has been shown to reduce the frequency of early treatment emergent adverse reactions characteristic of panic disorder. Titration Depression, OCD, Panic Disorder, Social Anxiety Disorder and PTSD Patients not responding to a 50 mg dose may benefit from dose increases.
Dose changes should be made in steps of 50 mg at intervals of at least one week, up to a maximum of 200 mg/day. Changes in dose should not be made more frequently than once per week given the 24-hour elimination half life of sertraline.
The onset of therapeutic effect may be seen within 7 days. However, longer periods are usually necessary to demonstrate therapeutic response, especially in OCD. Maintenance Dose during long-term therapy should be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response.
Depression Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE). In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during current episode.
Patients with depression should be treated for a sufficient period of time of at least 6 months to ensure they are free from symptoms. Panic disorder and OCD Continued treatment in panic disorder and OCD should be evaluated regularly, as relapse prevention has not been shown for these disorders.
4). Hepatic impairment The use of sertraline in patients with hepatic disease should be approached with caution. 4). 4). 4).
Paediatric population Children and adolescents with OCD Age 13-17 years:
Initially 50 mg once daily.
Age 6-12 years:
Initially 25 mg once daily. The dose may be increased to 50 mg once daily after one week. Subsequent doses may be increased in case of less than desired response in 50 mg increments over a period of some weeks, as needed. The maximum dose is 200 mg daily.
Nausea is the most common undesirable effect. In the treatment of social anxiety disorder, sexual dysfunction (ejaculation failure) in men occurred in 14% for sertraline vs 0% in placebo. These undesirable effects are dose dependent and are often transient in nature with continued treatment.
The undesirable effects profile commonly observed in double-blind, placebo- controlled studies in patients with OCD, panic disorder, PTSD and social anxiety disorder was similar to that observed in clinical trials in patients with depression.
Adverse reactions listed in Table 1 were observed from post-marketing experience (frequency not known) and placebo-controlled clinical trials (comprising a total of 2542 patients on sertraline and 2145 on placebo) in depression, OCD, panic disorder, PTSD and social anxiety disorder.
Some adverse drug reactions listed in Table 1 may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy. Tabulated list of adverse reactions Frequency of adverse reactions observed from placebo-controlled clinical trials in depression, OCD, panic disorder, PTSD and social anxiety disorder.
Pooled analysis and post-marketing experience (frequency not known). Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (frequency cannot be estimated from the available data) Table 1.
4). cerebrovascula r spasm (including reversible cerebral vasoconstrictio n syndrome and Call- Fleming syndrome) *§, also reported were signs and symptoms associated with Serotonin Syndrome* or Neuroleptic Malignant Syndrome: In some cases associated with concomitant use of serotonergic medicinal products that included agitation, confusion, diaphoresis, diarrhoea, fever, hypertension, rigidity and tachycardia§.
Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) The development of potentially life-threatening syndromes like serotonin syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) has been reported with SSRIs, including treatment with sertraline.
g. methylene blue), antipsychotics and other dopamine antagonists, and with opiate medicinal products. 3). Switching from Selective Serotonin Reuptake Inhibitors (SSRIs), antidepressants or anti-obsessional medicinal products There is limited controlled experience regarding the optimal timing of switching from SSRIs, antidepressants or anti-obsessional medicinal products to sertraline.
Care and prudent medical judgment should be exercised when switching, particularly from long-acting agents such as fluoxetine. g. tryptophan, fenfluramine and 5- HT agonists Co-administration of sertraline with other medicinal products which enhance the effects of serotonergic neurotransmission such as tryptophan or fenfluramine or 5-HT agonists, or the herbal medicinal product, St John’s Wort (hypericum perforatum), should be undertaken with caution and avoided whenever possible due to the potential for a pharmacodynamic interaction.
QTc Prolongation/Torsade de Pointes (TdP) Cases of QTc prolongation and Torsade de Pointes (TdP) have been reported during post-marketing use of sertraline. The majority of reports occurred in patients with other risk factors for QTc prolongation/TdP.
Effect on QTc prolongation was confirmed in a thorough QTc study in healthy volunteers, with a statistically significant positive exposure-response relationship. 1). Activation of hypomania or mania Manic/hypomanic symptoms have been reported to emerge in a small proportion of patients treated with marketed antidepressant and anti- obsessional medicinal products, including sertraline.
Therefore sertraline should be used with caution in patients with a history of mania/hypomania. Close surveillance by the physician is required. Sertraline should be discontinued in any patient entering a manic phase. Schizophrenia Psychotic symptoms might become aggravated in schizophrenic patients.
1. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome with symptoms such as agitation, tremor and hyperthermia. Sertraline must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI.
5). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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However, the generally lower body weights of children compared to those of adults should be taken into consideration when increasing the dose from 50 mg. Dose changes should not occur at intervals of less than one week. Efficacy is not shown in paediatric major depressive disorder.
4) Method of administration Sertraline should be administered once daily, either in the morning or evening. Sertraline tablet can be administered with or without food The tablet can be divided into equal doses. Withdrawal symptoms seen on discontinuation of sertraline Abrupt discontinuation should be avoided.
8). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
g. Stevens- Johnson syndrome* and epidermal necrolysis*§, angioedema, photosensitivit y§, skin reaction*§ Musculoskel etal and Connective Tissue Back Pain, arthralgia*, myalgia Muscle cramps*, osteoarthriti s, muscular Bone disorder, rhabdomyolysi s*§ Trismus *, Disorders weakness, muscle twitching Renal and Urinary Disorders Nocturia, urinary retention, polyuria, pollakiura, micturition disorder, urinary incontinenc e* Oliguria, urinary hesitation* Reproductiv e System and Breast Disorders** Ejacula- tion failure Erectile dysfunction, menstruatio n irregular* Menorrhagi a, vaginal haemorrhag e, sexual dysfunction, female sexual dysfunction , Atrophic vulvovaginitis, balanoposthitis *§, genital discharge, priapism*, galactorrhoea* , gynaecomastia * Postpart um haemorr hage** General Disorders and Administrati on Site Conditions Fatigue* Chest pain*, malaise*, pyrexia*, asthenia* Oedema […]
Seizures Seizures may occur with sertraline therapy: sertraline should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. Sertraline should be discontinued in any patient who develops seizures.
Suicide/suicidal thoughts/suicide attempts or clinical worsening 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 suicide may increase in the early stages of recovery.
Other psychiatric conditions, for which sertraline 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, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
A meta-analysis of placebo- controlled clinical trials of antidepressant medicinal products in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany medicinal product therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI. Paediatric population Sertraline should not be used in the treatment of children and adolescents under the age of 18 years, except for patients with obsessive compulsive disorder aged 6-17 years old.
Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
If, based on clinical need, a decision to treat is nevertheless taken; the patient should be carefully monitored for appearance of suicidal symptoms. In addition only limited clinical evidence is available concerning, long-term safety data in children and adolescents […]