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BRANCICO XL is a brand name for Quetiapine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Brancico XL/Quetiapine Zentiva XL 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Different dosing schedules exist for each indication. It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition. Adults For the treatment of schizophrenia and moderate to severe manic episodes in bipolar disorder Brancico XL/Quetiapine Zentiva XL should be administered at least one hour before a meal.
The daily dose at the start of therapy is 300 mg on Day 1 and 600 mg on Day 2. The recommended daily dose is 600 mg, however if clinically justified the dose may be increased to 800 mg daily. The dose should be adjusted within the effective dose range of 400 mg to 800 mg per day, depending on the clinical response and tolerability of the patient.
For maintenance therapy in schizophrenia no dosage adjustment is necessary. For the treatment of major depressive episodes in bipolar disorder Brancico XL/Quetiapine Zentiva XL should be administered at bedtime. 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. 1). Individual patients may benefit from a 600 mg dose. Doses greater than 300 mg should be initiated by physicians experienced in treating bipolar disorder. In individual patients, in the event of tolerance concerns, clinical trials have indicated that dose reduction to a minimum of 200 mg could be considered.
For preventing recurrence in bipolar disorder For preventing recurrence of manic, mixed or depressive episodes in bipolar disorder, patients who have responded to Brancico XL/Quetiapine Zentiva XL for acute treatment of bipolar disorder should continue on Brancico XL/Quetiapine Zentiva XL at the same dose administered at bedtime.
Brancico XL/Quetiapine Zentiva XL dose can be adjusted depending on clinical response and tolerability of the individual patient within the dose range of 300 mg to 800 mg/day. It is important that the lowest effective dose is used for maintenance therapy.
For add-on treatment of major depressive episodes in MDD Brancico XL/Quetiapine Zentiva XL should be administered prior to bedtime. The daily dose at the start of therapy is 50 mg on Day 1 and 2, and 150 mg on Day 3 and 4. 1) and at 50 mg/day in short-term monotherapy trials.
There is an increased risk of adverse events at higher doses. Clinicians should therefore ensure that the lowest effective dose, starting with 50 mg/day, is used for treatment. The need to increase the dose from 150 to 300 mg/day should be based on individual patient evaluation.
The most commonly reported Adverse Drug Reactions (ADRs) with quetiapine (>10%) are somnolence, dizziness, headache, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.
The incidences of ADRs associated with quetiapine therapy, are tabulated below (Table 1) according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group 1995). Table 1 ADRs associated with quetiapine therapy The frequencies of adverse events are ranked according to the following: 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) and not known (cannot be estimated from the available data).
SOC Very Common Common Uncommon:
Rare Very Rare Not known Blood and lymphatic system disorders Decreased haemoglobin22 Leucopenia 1,28, Decreased neutrophil count, Eosinophils Neutropenia1, Thrombocytop enia, Anaemia, platelet count decreased13 Agranulocyt osis26 increased27 Immune system disorders Hypersensitivi ty (including allergic skin reactions) Anaphyl actic reaction 5 Endocrine disorders Hyperprolactina emia15, decreases in total T424, decreases in free T424, decreases in total T324, increases in TSH 24 Decreases in free T324, Hypothyroidis m21 Inappro priate antidiur etic hormon e secretio n Metabolism and nutritional disorders Elevations in serum triglyceride levels 10,30 Elevations in total cholesterol (predominantly LDL cholesterol) 11,30 Decreases in HDL cholesterol 17, 30, Weight gain 8,30 Increased appetite, blood glucose increased to hyperglycaemic levels 6,30 Hyponatraemi a 19, Diabetes Mellitus 1,5 Exacerbation of pre-existing diabetes Metabolic syndrome29 Psychiatric disorders Abnormal dreams and nightmares, Suicidal ideation and suicidal behaviour20 Somnambuli sm and related reactions such as sleep talking and sleep related eating disorder Nervous system disorders Dizziness 4, 16, somnolence 2, 16, headache, Extrapyramidal symptoms1, 21 Dysarthria Seizure 1, Restless legs syndrome, Tardive dyskinesia 1, 5, Syncope 4, 16, Confusional state Cardiac disorders Tachycardia 4, Palpitations 23 QT prolongation 1, 12,18, Bradycardia32 Cardiomyopathy and myocarditis Eye Disorders Vision blurred Vascular Orthostatic Venous Stroke33 disorders hypotension 4, 16 thromboemb olism1 Respiratory, thoracic and mediastinal disorder Dyspnoea 23 Rhinitis Gastrointesti nal disorders Dry mouth Constipation, dyspepsia, vomiting25 Dysphagia7 Pancreatitis1, Intestinal obstruction/Il eus Hepato- biliary disorders Elevations in serum alanine aminotransferas e (ALT)3 Elevations in gamma-GT levels3 Elevations in serum aspartate aminotransfera se (AST) 3 Jaundice5, Hepatitis Skin and subcutaneous tissue disorders Angioed ema5, Stevens- Johnson syndrom e5 Toxic Epidermal Necrolysis, Erythema Multiforme Drug reaction with eosinophilia and systemic symptoms (DRESS), Cutaneous vasculitis Musculoskele tal and connective tissue disorders Rhabdo myolysi s Renal and urinary disorders Urinary retention Pregnancy, puerperium and perinatal conditions Drug withdrawal syndrome neonatal31 Reproductive system and breast disorders Sexual dysfunction Priapism, galactorrhoea , breast swelling, menstrual disorder General disorders and administratio n site conditions Withdrawal (discontinuation ) symptoms 1, 9 Mild asthenia, peripheral oedema, irritability, pyrexia Neuroleptic malignant syndrome 1, hypothermia Investigation s Elevations in blood creatine phosphokina se14 1.
As Brancico XL/Quetiapine Zentiva XL has several indications, the safety profile should be considered with respect to the individual patient’s diagnosis and the dose being administered. 1). 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 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.
1. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Switching from quetiapine immediate-release tablets For more convenient dosing, patients who are currently being treated with divided doses of immediate release quetiapine tablets may be switched to Brancico XL/Quetiapine Zentiva XL at the equivalent total daily dose taken once daily.
Individual dosage adjustments may be necessary. Special populations Elderly As with other antipsychotics and antidepressants, Brancico XL/Quetiapine Zentiva XL should be used with caution in the elderly, especially during the initial dosing period.
The rate of dose titration of Brancico XL/Quetiapine Zentiva XL may need to be slower, and the daily therapeutic dose lower, than that used in younger patients. The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients.
Elderly patients should be started on 50 mg/day. The dose can be increased in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerability of the individual patient. In elderly patients with major depressive episodes in MDD, dosing should begin with 50 mg/day on Days 1- 3, increasing to 100 mg/day on Day 4 and 150 mg/day on Day 8.
The lowest effective dose, starting from 50 mg/day should be used. Based on individual patient evaluation, if dose increase to 300 mg/day is required this should not be prior to Day 22 of treatment. Efficacy and safety has not been evaluated in patients over 65 years with depressive episodes in the framework of bipolar disorder.
Paediatric Population Brancico XL/Quetiapine Zentiva XL 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. 2. Renal impairment Dosage adjustment is not necessary in patients with renal impairment.
Hepatic impairment Quetiapine is extensively metabolised by the liver. Therefore, Brancico XL/Quetiapine Zentiva XL should be used with caution in patients with known hepatic impairment, especially during the initial dosing period. Patients with hepatic impairment should be started on 50 mg/day.
The dose can be increased in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerability of the individual patient. Method of administration Brancico XL/Quetiapine Zentiva XL should be administered once daily, without food.
The tablets should be swallowed whole and not split, chewed or crushed.
4. 2. Somnolence may occur, usually during the first two weeks of treatment and generally resolves with the continued administration of quetiapine. 3. Asymptomatic elevations (shift from normal to > 3x ULN at any time) in serum transaminase (ALT, AST) or gamma-GT-levels have been observed in some patients administered quetiapine.
These elevations were usually reversible on continued quetiapine treatment. 4. 4).
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 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). 3% (1/75) for placebo. 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, patient’s 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). Somnolence and dizziness Quetiapine treatment has been associated with somnolence and related symptoms, such as sedation (see […]