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SONDATE XL 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 : o For the treatment of moderate to severe manic episodes in bipolar disorder o For the treatment of major depressive episodes in bipolar disorder o For the prevention of recurrence of manic or depressed episodes in patients…
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 Quetiapine should be administrated 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 Quetiapine 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 quetiapine for acute treatment of bipolar disorder should continue on quetiapine at the same dose administered at bedtime.
Quetiapine 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:
Quetiapine 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.
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, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10,000, <1/1000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
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 > 3 x 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) As with other antipsychotics with alpha1 adrenergic blocking activity, quetiapine may commonly induce orthostatic hypotension, associated with dizziness, tachycardia and, in some patients, syncope, especially during the initial dose-titration period.
4). (5) Calculation of Frequency for these ADR’s have only been taken from post marketing data with the immediate release formulation of quetiapine. 1 mmol/L) on at least one occasion (7) An increase in the rate of dysphagia with quetiapine vs.
placebo was only observed in the clinical trials in bipolar depression (8) Based on >7% increase in body weight from baseline. Occurs predominantly during the early weeks of treatment in adults (9) The following withdrawal symptoms have been observed most frequently in acute placebo-controlled, monotherapy clinical trials, which evaluated discontinuation symptoms: insomnia, nausea, headache, diarrhoea, vomiting, dizziness, and irritability.
As quetiapine 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. Concomitant administration of cytochrome P450 3A4 inhibitors, such as HIV- protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin and nefazodone, is contraindicated. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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 SONDATE XL at the equivalent total daily dose taken once daily. Individual dosage adjustments may be necessary.
Elderly:
As with other antipsychotics and antidepressants, quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration of quetiapine 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:
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. 2.
Renal impairment:
Dosage adjustment is not necessary in patients with renal impairment.
Hepatic impairment:
Quetiapine is extensively metabolized by the liver. Therefore, quetiapine 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 Quetiapine should be administered once daily, without food.
The tablets should be swallowed whole and not split, chewed or crushed. The prolonged-release tablet keeps its shape during the whole digestion releasing the active ingredient and is eliminated intact in the faeces.
The incidence of these reactions had decreased significantly after 1 week post- discontinuation. 172 mmol/L) (patients <18 years of age) on at least one occasion. 769 mmol/L) has been very commonly observed. 07 mmol/L). (12) See text below […]
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 hyperglycemia) 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). Extrapyramidal symptoms In placebo controlled clinical trials of adult patients quetiapine was associated with an increased incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for major depressive episodes in bipolar disorder and major depressive disorder.
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 […]