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QUETIAPINE DAWA is a brand name for Quetiapine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Quetiapine is indicated for: • treatment of schizophrenia. • treatment of bipolar disorder: • For the treatment of moderate to severe manic episodes in bipolar disorder • For the treatment of major depressive episodes in bipolar disorder • For the prevention of recurrence of manic or depressed episodes in patients…
Verbatim from this product's MHRA label. Tap a section to expand.
1. 5). 4 Special warnings and precautions for use As quetiapine has several indications, the safety profile should be considered with respect to the individual patient’s diagnosis and the dose being administered. Paediatric population Quetiapine is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group.
8), certain adverse events occurred at a higher frequency in children and adolescents compared to adults (increased appetite, elevations in serum prolactin, vomiting, rhinitis and syncope), or may have different implications for children and adolescents (extrapyramidal symptoms and irritability) and one was identified that has not been previously seen in adult studies (increases in blood pressure).
Changes in thyroid function tests have also been observed in children and adolescents. Furthermore, the long-term safety implications of treatment with quetiapine on growth and maturation have not been studied beyond 26 weeks. Long-term implications for cognitive and behavioural development are not known.
8). Suicide/suicidal thoughts or clinical worsening Depression in bipolar disorder 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.
In addition, physicians should consider the potential risk of suicide- related events after abrupt cessation of quetiapine treatment, due to the known risk factors for the disease being treated. Other psychiatric conditions for which quetiapine 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 episodes. The same precautions observed when treating patients with major depressive episodes 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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A meta-analysis of placebo controlled clinical trials of antidepressant drugs 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 drug 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.
0% vs. 0%, respectively). A population-based retrospective study of quetiapine for the treatment of patients with major depressive disorder showed an increased risk of self-harm and suicide in patients aged 25 to 64 years without a history of self-harm during use of quetiapine with other antidepressants.
Metabolic risk Given the observed risk for worsening of their metabolic profile, including changes in weight, blood glucose (see hyperglycaemia) and lipids, which was seen in clinical studies, patients' metabolic parameters should be assessed at the time of treatment initiation and changes in these parameters should be regularly controlled for during the course of treatment.
8). 1). The use of quetiapine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment.
In patients who develop these symptoms, increasing the dose may be detrimental. Tardive dyskinesia If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of quetiapine should be considered. 8). 8). In clinical trials for treatment of patients with bipolar depression, onset was […]