Quetiapine Abbreviated Prescribing Information

Abbreviated Prescribing Information: Quetiapine Rosemont 20mg/ml Oral Suspension Consult Summary of Product Characteristics before prescribing. Presentation: An off-white oral suspension, each 1ml containing 20mg Quetiapine. Therapeutic Indications: Quetiapine oral suspension is indicated for the treatment of Schizophrenia; bipolar disorder; moderate to severe manic episodes in bipolar disorder; major depressive episodes in bipolar disorder; and for the prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment. Posology and Method of Administration: Quetiapine Oral Suspension can be administered with or without food. For the treatment of schizophrenia, Quetiapine Oral Suspension should be administered twice a day. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4) and from Day 4 onwards, the dose should be titrated to the usual effective dose of 300 to 450 mg/day. Depending on the clinical response and tolerability of the individual patient, the dose may be adjusted within the range 150 to 750 mg/day. For the treatment of manic episodes associated with bipolar disorder, Quetiapine Oral Suspension should be administered twice a day. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. The usual effective dose is in the range of 400 to 800 mg/day. Quetiapine Oral Suspension should be administered once daily at bedtime for the treatment of major depressive episodes in bipolar disorder. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). The recommended daily dose is 300 mg. For preventing recurrence of manic, mixed or depressive episodes in bipolar disorder, the dose may be adjusted depending on clinical response and tolerability of the individual patient, within the range of 300 to 800 mg/day administered twice daily. It is important that the lowest effective dose is used for maintenance therapy. Quetiapine should be used with caution in the elderly and in patients with known hepatic impairment, especially during the initial dosing period. Dose adjustment is not necessary in patients with renal impairment. Paediatric population: Quetiapine Oral Suspension is not recommended for use in children and adolescents below 18 years of age. Contra-indications: Hypersensitivity to the active substance or any of the excipients. Concomitant administration of cytochrome P450 3A4 inhibitors. Special Warnings and Precautions for use: Caution should be exercised with the following: Suicidal thoughts or clinical worsening, patients with major depressive episodes in bipolar disorder, decline in metabolic profile, extrapyramidal symptoms, tardive dyskinesia, somnolence, dizziness including sedation, orthostatic hypotension, sleep apnoea syndrome, seizures, neuroleptic malignant syndrome, severe neutropenia and agranulocytosis, anticholinergic effects, weight gain, hyperglycaemia, lipid changes, QT prolongation, withdrawal symptoms, dysphagia, constipation, intestinal obstruction, venous thromboembolism, pancreatitis, and in concomitant use with strong hepatic enzyme inducers. Cardiomyopathy and myocarditis have been reported in clinical trials and post-marketing experiences, suggesting that discontinuation of quetiapine should be considered in patients with suspected conditions. Severe cutaneous adverse reactions (SCARS), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis (AGEP), erythema multiforme, and drug reactions with eosinophilia and systemic symptoms (DRESS), are rarely reported with quetiapine treatment.These reactions typically involve extensive rash, exfoliative dermatitis, fever, lymphadenopathy, and possible eosinophilia or neutrophilia. If severe symptoms appear, quetiapine should be withdrawn immediately. Concomitant administration of quetiapine and other serotonergic agents, such as MAO inhibitors, selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic antidepressants may result in serotonin syndrome, a potentially life-threatening condition. If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, and a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms. Quetiapine is not approved for patients with dementia-related psychosis and caution should be exercised with elderly patients with Parkinson’s disease. Physicians should be cautious in prescribing high doses to adults with low body weight (50Kg) and patients with a history of alcohol or drug abuse. Excipient warnings: Contains methyl and propyl parahydroxybenzoate, propylene glycol (E1520) and sodium. Any warning from the MC, CHM CSM or MHRA: No. Black Triangle notice: Not applicable. Legal Category: Prescription only medicine. A list of common and serious adverse reactions are Decreased haemoglobin, elevated serum triglyceride and total cholesterol (predominantly LDL cholesterol) levels, decreased HDL cholesterol, weight gain, dizziness, somnolence, headache, extrapyramidal symptoms, dry mouth, and withdrawal symptoms, Leucopenia decreased neutrophil count, agranulocytosis, eosinophils increased, hyper-prolactinaemia, decreases in total T4, free T4, total T3, and increased TSH, Increased appetite, blood glucose increased to hyperglycaemic levels, abnormal dreams and nightmares, suicidal ideation, suicidal behaviour, seizure, tardive dyskinesia, dysarthria, tachycardia, palpitations, platelet count decreased, anaemia, hypersensitivity, jaundice, hepatitis, pancreatitis, venous thromboembolism, anaphylactic reaction, SJS, cardiomyopathy and myocarditis, vision blurred, orthostatic hypotension, dyspnoea, constipation, dyspepsia, vomiting, elevated serum alanine aminotransferase and gamma-GT levels., AGEP, TEN, DRESS, cutaneous vasculitis, neuroleptic malignant syndrome, rhabdomyolyisis, mild asthenia, peripheral oedema, irritability, and pyrexia (Refer to SmPC for other reported events). Pack Size and NHS Price: 150ml – £208.95. Marketing Authorisation Number: PL 00427/0240. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, United Kingdom (UK). Date of Preparation: 19 Nov 2024.