Page 4 - P4304.1-V99_PS Magazine - July 24

Quetiapine Film-coated Tablets symptoms (EPS) compared to placebo in patients treated for major exacerbation of diabetes occasionally associated with ketoacidosis or malabsorption should not take this medicine. Quetiapine contains
depressive episodes in bipolar disorder. The use of quetiapine has coma has been reported rarely, including some fatal cases. In some less than 1 mmol sodium (23 mg) per tablet, that is to say essentially
been associated with the development of akathisia, characterised by cases, a prior increase in body weight has been reported which may ‘sodium-free’. Effects on ability to drive and use machines: Given its
a subjectively unpleasant or distressing restlessness and need to be a predisposing factor. Appropriate clinical monitoring is advisable primary central nervous system effects, quetiapine may interfere
50mg & 400mg x 60 move often accompanied by an inability to sit or stand still. This is in accordance with utilised antipsychotic guidelines. Patients treated with activities requiring mental alertness. Therefore, patients should
most likely to occur within the first few weeks of treatment. In with any antipsychotic agent including quetiapine, should be be advised not to drive or operate machinery, until individual
patients who develop these symptoms, increasing the dose may be observed for signs and symptoms of hyperglycaemia (such as susceptibility to this is known.
detrimental. Tardive dyskinesia: If signs and symptoms of tardive polydipsia, polyuria, polyphagia and weakness), and patients with
25mg x 60 dyskinesia appear, dose reduction or discontinuation of quetiapine diabetes mellitus or with risk factors for diabetes mellitus should be Pregnancy & Lactation: Pregnancy: First trimester: The moderate
100mg x 60 should be considered. The symptoms of tardive dyskinesia can worsen monitored regularly for worsening of glucose control. Weight should amount of published data from exposed pregnancies do not suggest
150mg x 60 or even arise after discontinuation of treatment. Somnolence and be monitored regularly. Lipids: Increases in triglycerides, LDL and total an increased risk of malformations due to treatment. However,
200mg x 60 dizziness: Quetiapine treatment has been associated with somnolence cholesterol, and decreases in HDL cholesterol have been observed. based on all available data, a definite conclusion cannot be drawn.
300mg x 60 and related symptoms, such as sedation. In patients with bipolar Lipid changes should be managed as clinically appropriate. QT Therefore, quetiapine should only be used during pregnancy if the
Already available depression, onset is usually within the first 3 days of treatment and Prolongation: In use in accordance with the SmPC, quetiapine was not benefits justify the potential risks. Third trimester: Neonates exposed
in the Accord predominantly of mild to moderate intensity. Patients experiencing associated with a persistent increase in absolute QT intervals. QT to antipsychotics (including quetiapine) during the third trimester of
portfolio somnolence of severe intensity may require more frequent contact for prolongation was reported with quetiapine at the therapeutic doses pregnancy are at risk of adverse reactions including extrapyramidal
a minimum of 2 weeks from onset of somnolence, or until symptoms and in overdose. As with other antipsychotics, caution should be and/or withdrawal symptoms that may vary in severity and duration
improve and treatment discontinuation may need to be considered. exercised when quetiapine is prescribed in patients with following delivery. There have been reports of agitation, hypertonia,
Orthostatic hypotension: Quetiapine treatment has been associated cardiovascular disease or family history of QT prolongation. Also, hypotonia, tremor, somnolence, respiratory distress, or feeding
with orthostatic hypotension and related dizziness which, like caution should be exercised when quetiapine is prescribed either with disorder. Consequently, newborns should be monitored carefully.
somnolence has onset usually during the initial dose-titration period. medicines known to increase QT interval, or with concomitant Breast-feeding: Based on very limited data from published reports on
This could increase the occurrence of accidental injury (fall), especially neuroleptics, especially in the elderly, in patients with congenital quetiapine excretion into human breast milk, excretion of quetiapine
in the elderly population. Therefore, patients should be advised to long QT syndrome, congestive heart failure, heart hypertrophy, at therapeutic doses appears to be inconsistent. Due to lack of robust
Product Presentation exercise caution until they are familiar with the potential effects of hypokalaemia or hypomagnesaemia. Cardiomyopathy and data, a decision must be made whether to discontinue breast-feeding
the medication. Quetiapine should be used with caution in patients Myocarditis: Cardiomyopathy and myocarditis have been reported. In or to discontinue Quetiapine therapy taking into account the benefit
Livery Accord Accord with known cardiovascular disease, cerebrovascular disease, or other patients with suspected cardiomyopathy or myocarditis of breast feeding for the child and the benefit of therapy for the
Strength 50mg 400mg conditions predisposing to hypotension. Dose reduction or more discontinuation of quetiapine should be considered. Severe cutaneous woman. Fertility: The effects of quetiapine on human fertility have
gradual titration should be considered if orthostatic hypotension adverse reactions (SCARs): Including Stevens-Johnson syndrome
Pack Size 60 60 occurs, especially in patients with underlying cardiovascular disease. (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalised not been assessed.
Product Format Film-coated Tablet Film-coated Tablet Sleep apnoea syndrome: Sleep apnoea syndrome has been reported in Exanthematous Pustulosis (AGEP), Erythema Multiforme (EM) and Adverse Events include: Adverse events which could be considered
serious: Leucopenia, neutropenia, thrombocytopenia, anaemia,
patients using quetiapine. In patients receiving concomitant central Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Legal Category POM POM nervous system depressants and who have a history of or are at risk which can be life-threatening or fatal have been reported very rarely agranulocytosis, hypersensitivity, anaphylactic reactions,
Pack Dimensions (HxWxD) 46mmx105mmx36mm 61mmx115mmx58mm for sleep apnoea, such as those who are overweight/obese or are with quetiapine treatment. SCARs commonly present with one or hyperprolactinaemia, hypothyroidism, inappropriate antidiuretic
male, quetiapine should be used with caution. Seizures: No data is more of the following symptoms: extensive cutaneous rash which hormone secretion, blood glucose increased to hyperglycaemic
Shelf Life 24 months 24 months available about the incidence of seizures in patients with a history of may be pruritic or associated with pustules, exfoliative dermatitis, levels, diabetes mellitus, suicidal ideation and suicidal behaviour,
PIP Code 126-5446 126-5453 seizure disorder. As with other antipsychotics, caution is fever, lymphadenopathy and possible eosinophilia or neutrophilia. seizure, tardive dyskinesia, syncope, tachycardia, QT prolongation,
recommended when treating patients with a history of seizures. Most of these reactions occurred within 4 weeks after initiation of bradycardia, cardiomyopathy and myocarditis, dyspnoea, stroke,
EAN Code 5055565781715 5055565781470 Neuroleptic malignant syndrome: Neuroleptic malignant syndrome quetiapine therapy, some DRESS reactions occurred within 6 weeks pancreatitis, intestinal obstruction/Ileus, jaundice, hepatitis,
has been associated with antipsychotic treatment, including after initiation of quetiapine therapy. If signs and symptoms angioedema, Severe cutaneous adverse reactions (SCARs), including
quetiapine. Clinical manifestations include hyperthermia, altered suggestive of these severe skin reactions appear, quetiapine should Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN),
Prescribing Information: Quetiapine 50, 400 mg film-coated tablets mental status, muscular rigidity, autonomic instability, and increased be withdrawn immediately and alternative treatment should be drug reaction with eosinophilia and systemic symptoms (DRESS),
Please refer to the Summary of Product Characteristics (SmPC) before prescribing. creatine phosphokinase. In such an event, quetiapine should be considered. Withdrawal: Acute withdrawal symptoms such as erythema multiforme, acute generalised exanthematous pustulosis
discontinued and appropriate medical treatment given. Severe insomnia, nausea, headache, diarrhoea, vomiting, dizziness and (AGEP), cutaneous vasculitis, rhabdomyolysis, urinary retention,
neutropenia and agranulocytosis: Severe neutropenia (neutrophil irritability have been described after abrupt cessation of quetiapine. neuroleptic malignant disorder, hypothermia, ventricular arrhythmia,

Presentation: Each tablet contains 50 or 400 mg of quetiapine 800 mg/day administered twice daily. It is important that the lowest development are not known. Suicide/suicidal thoughts or clinical count <0.5 X 10 /L) has been reported. Most cases of severe Gradual withdrawal over a period of at least one to two weeks is sudden unexplained death, cardiac arrest. Additional adverse events
9
(as quetiapine fumarate). effective dose is used for maintenance therapy. Elderly: Quetiapine worsening: Depression in bipolar disorder is associated with an neutropenia have occurred within a couple of months of starting advisable. Elderly patients with dementia-related psychosis: which could be considered serious in paediatric population: increases
Indications: For treatment of schizophrenia. For treatment of should be used with caution in the elderly, especially during the initial increased risk of suicidal thoughts, self-harm and suicide (suicide- therapy with quetiapine, with no apparent dose relationship, and Quetiapine is not approved for the treatment of dementia-related in blood pressure.
bipolar disorder: treatment of moderate to severe manic episodes in dosing period. The rate of dose titration may need to be slower, and related events). This risk persists until significant remission occurs. As some fatal cases. Possible risk factors for neutropenia include pre- psychosis. An approximately 3-fold increased risk of cerebrovascular Other Very Common adverse events: Decreased haemoglobin,
bipolar disorder; treatment of major depressive episodes in bipolar the daily therapeutic dose lower, than that used in younger subjects, improvement may not occur during the first few weeks or more of existing low white blood cell count (WBC) and history of drug induced adverse events has been seen in the dementia population with some elevations in serum triglyceride levels, elevations in total cholesterol
depending on the clinical response and tolerability of the individual treatment, patients should be closely monitored until such
disorder; prevention of recurrence of manic or depressed episodes neutropenia. However, some cases occurred in patients without pre- atypical antipsychotics. The mechanism for this increased risk is not
existing risk factors. Quetiapine should be discontinued in patients known. An increased risk cannot be excluded for other antipsychotics (predominantly LDL cholesterol), decreases in HDL cholesterol,
in patients with bipolar disorder who previously responded to patient. Efficacy and safety have not been evaluated in patients improvement occurs. It is general clinical experience that the risk of with a neutrophil count <1.0 X 10 /L. Patients should be observed for or other patient populations. Quetiapine should be used with caution weight gain, dizziness, somnolence, headache, extrapyramidal
9
quetiapine treatment. over 65 years with depressive episodes in the framework of bipolar suicide may increase in the early stages of recovery. Physicians should
disorder. Paediatric population: Quetiapine is not recommended for consider the potential risk of suicide-related events after abrupt signs and symptoms of infection and neutrophil counts followed. in patients with risk factors for stroke. It has been reported that symptoms, dry mouth, withdrawal (discontinuation) symptoms.
Dosage and Administration: Different dosing schedules exist for use in children and adolescents below 18 years of age, due to a lack cessation of quetiapine treatment, due to the known risk factors for Neutropenia should be considered in patients presenting with elderly patients with dementia-related psychosis are at an increased Additional very common adverse events in paediatric population:
each indication. It must therefore be ensured that patients receive of data to support use in this age group. Renal impairment: Dosage the disease being treated. Other psychiatric conditions for which infection or fever, particularly in the absence of obvious predisposing risk of death. Elderly patients with Parkinson’s disease (PD)/ elevations in prolactin, increased appetite, vomiting.
clear information on the appropriate dosage for their condition. adjustment is not necessary. Hepatic impairment: Quetiapine is quetiapine is prescribed can also be associated with an increased risk factor(s), and should be managed as clinically appropriate. Patients Parkinsonism: In patients with MDD, an increased risk of death during Other Common adverse events: Decreased neutrophil count,
Adults: For the treatment of schizophrenia: Quetiapine should be extensively metabolised by the liver. Therefore, Quetiapine should of suicide related events. In addition, these conditions may be co- should be advised to immediately report the appearance of signs/ use of quetiapine in patients aged >65 years has been observed. This
administered twice a day. The total daily dose for the first 4 days of be used with caution in patients with known hepatic impairment, morbid with major depressive episodes. The same precautions symptoms consistent with agranulocytosis or infection (e.g., fever association is not present in patients without PD. Caution should be eosinophils increased, decreases in total T4, decreases in free
therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 especially during the initial dosing period. Patients with known observed when treating patients with major depressive episodes weakness, lethargy, or sore throat) at any time during Quetiapine exercised if quetiapine is prescribed to elderly patients with PD. T4, decreases in total T3, increases in TSH, increased appetite,
mg (Day 4). From day 4 onwards, the dose should be titrated to the hepatic impairment should be started with 25 mg/day. The dosage should therefore be observed when treating patients with other therapy. Such patients should have a WBC count and an absolute Dysphagia: Dysphagia has been reported with quetiapine. Quetiapine abnormal dreams and nightmares, dysarthria, palpitations, vision
usual effective dose of 300 to 450 mg/day. Depending on the clinical should be increased daily with increments of 25 - 50 mg/day until an psychiatric disorders. Patients with a history of suicide related events, neutrophil count (ANC) performed promptly, especially in the should be used with caution in patients at risk for aspiration blurred, orthostatic hypotension, constipation, dyspepsia, vomiting,
response and tolerability of the individual patient, the dose may be effective dosage, depending on the clinical response and tolerability or those exhibiting a significant degree of suicidal ideation prior to absence of predisposing factors. Anti-cholinergic (muscarinic) effects: pneumonia. Constipation and intestinal obstruction: Constipation elevations in serum aminotransferase (ALT), elevations in gamma-
adjusted within the range 150 to 750 mg/day. For the treatment of of the individual patient. Method of administration: Quetiapine can be commencement of treatment are known to be at greater risk of Nor-quetiapine, an active metabolite of quetiapine, has moderate to represents a risk factor for intestinal obstruction. Constipation and GT levels, mild asthenia, peripheral oedema, irritability, pyrexia.
moderate to severe manic episodes in bipolar disorder: Quetiapine administered with or without food. Swallow the tablets whole with suicidal thoughts or suicide attempts, and should receive careful strong affinity for several muscarinic receptor subtypes. This intestinal obstruction have been reported with quetiapine, with some Additional common adverse events in paediatric population: rhinitis.
should be administered twice a day. The total daily dose for the first water. monitoring during treatment. Clinical trial analysis of antidepressant contributes to ADRs reflecting anti-cholinergic effects when fatal reports in patients who are at higher risk of intestinal See SmPC for details of other adverse events.
four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day drugs in adult patients with psychiatric disorders showed an increased quetiapine is used at recommended doses, when used concomitantly obstruction, including those that are receiving multiple concomitant
3) and 400 mg (Day 4). Further dosage adjustments up to 800 mg Contraindications: Hypersensitivity to the active substance or to risk of suicidal behaviour with antidepressants compared to placebo with other medications having anti-cholinergic effects, and in the medications that decrease intestinal motility and/or may not report Presentation and Price:
/ day by Day 6 should be in increments of no greater than 200 mg/ any of the excipients of this product. Concomitant administration in patients less than 25 years old. Close supervision of patients and in setting of overdose. Quetiapine should be used with caution in symptoms of constipation. Patients with intestinal obstruction/ileus 50 mg x 60 £6.25, 400 mg x 60 £25.00.
day. The dose may be adjusted depending on clinical response and of cytochrome P450 3A4 inhibitors, such as HIV- protease inhibitors, particular those at high risk should accompany drug therapy patients receiving medications having anti-cholinergic (muscarinic) should be managed with close monitoring and urgent care. Venous Legal Category: POM
tolerability of the individual patient, within the range of 200 to 800 azole-antifungal agents, erythromycin, clarithromycin and especially in early treatment and following dose changes. Patients effects, in patients with a current diagnosis or prior history of urinary thromboembolism (VTE): Cases of VTE have been reported with Further information is available from:
mg/day. The usual effective dose is in the range of 400 to 800 mg/ nefazodone. (and caregivers of patients) should be alerted about the need to retention, clinically significant prostatic hypertrophy, intestinal antipsychotic drugs. Since patients treated with antipsychotics often Accord-UK Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS.
day. For the treatment of major depressive episodes in bipolar disorder: Warnings and Precautions: As quetiapine has several indications, monitor for any clinical worsening, suicidal behaviour or thoughts obstruction or related conditions, increased intraocular pressure or present with acquired risk factors for VTE, all possible risk factors for
Quetiapine should be administered once daily at bedtime. The total the safety profile should be considered with respect to the individual and unusual changes in behaviour and to seek medical advice narrow angle glaucoma. Interactions: Concomitant use of quetiapine VTE should be identified before and during treatment with quetiapine Marketing Authorisation Numbers:
daily dose for the first four days of therapy is 50 mg (Day 1), 100 patient’s diagnosis and the dose being administered. Paediatric immediately if these symptoms present. A study of quetiapine for the with a strong hepatic enzyme inducer such as carbamazepine or and preventive measures undertaken. Pancreatitis: Pancreatitis has PL 20075/1463, 1464.
mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). The recommended population: Quetiapine is not recommended for use in children and treatment of patients with major depressive disorder showed an phenytoin substantially decreases quetiapine plasma concentrations, been reported. While not all cases were confounded by risk factors, Date of PI Preparation: December 2023
daily dose is 300 mg. Individual patients may benefit from a 600 mg adolescents below 18 years of age, due to a lack of data to support use increased risk of self-harm and suicide in patients aged 25 to 64 years which could affect the efficacy of Quetiapine therapy. In patients many patients had factors which are known to be associated with
dose. Doses greater than 300 mg should be initiated by physicians in this age group. Clinical trials with quetiapine have shown that in without a history of self-harm during use of quetiapine with other receiving a hepatic enzyme inducer, initiation of quetiapine treatment pancreatitis such as increased triglycerides, gallstones, and alcohol Document Number: UK-05641
experienced in treating bipolar disorder. In individual patients, in addition to the known safety profile identified in adults certain antidepressants. Metabolic risk: Given the observed risk for worsening should only occur if the physician considers that the benefits of consumption. Additional information: Quetiapine use in combination
the event of tolerance concerns, dose reduction to a minimum of 200 adverse events occurred at a higher frequency in children and of their metabolic profile, including changes in weight, blood glucose quetiapine outweigh the risks of removing the hepatic enzyme with divalproex or lithium in acute moderate to severe manic Adverse events should be reported.
mg could be considered. For preventing recurrence in bipolar disorder: adolescents, and one was identified that has not been previously seen (hyperglycaemia) and lipids, patients’ metabolic parameters should inducer. It is important that any change in the inducer is gradual, and episodes is limited; however, combination therapy was well tolerated. Reporting forms and information can be found at
For preventing of recurrence of manic, mixed or depressive episodes in adult studies (increases in blood pressure). Changes in thyroid be assessed at the time of treatment initiation and changes in these if required, replaced with a non-inducer (e.g. sodium valproate). Misuse and abuse: Cases of misuse and abuse have been reported. www.mhra.gov.uk/yellowcard
in bipolar disorder, patients who have responded to quetiapine for function tests have also been observed in children and adolescents. parameters should be regularly controlled for during the course of Weight: Weight gain has been reported in patients who have been Caution may be needed when prescribing quetiapine to patients with Adverse events should also be reported to
acute treatment of bipolar disorder should continue therapy at the Furthermore, the long-term safety implications of treatment with treatment. Worsening in these parameters should be managed as treated with quetiapine, and should be monitored and managed as a history of alcohol or drug abuse. Excipients: Quetiapine contain Accord-UK LTD on 01271 385257 or
same dose. The dose may be adjusted depending on clinical response quetiapine on growth and maturation have not been studied beyond clinically appropriate. Extrapyramidal symptoms: In adult patients clinically appropriate as in accordance with utilised antipsychotic lactose. Patients with rare hereditary problems of galactose email medinfo@accord-healthcare.com
and tolerability of the individual patient, within the range of 300 to 26 weeks. Long-term implications for cognitive and behavioural quetiapine is associated with an increased incidence of extrapyramidal guidelines. Hyperglycaemia: Hyperglycaemia and/or development or intolerance, the total lactase deficiency, or glucose-galactose

UK-Gen-Quet-01406 | Date of Preparation: April 2024 UK-Gen-Quet-01406 | Date of Preparation: April 2024
4 PS Magazine | MDS Terms Information Buy direct online at PSUK.co.uk

05/06/2024 16:21:25
P4304.1-V99_PS Magazine - July 24.indd 4 05/06/2024 16:21:25
P4304.1-V99_PS Magazine - July 24.indd 4