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SANDOZ QUETIAPINE XRT is a brand name for Quetiapine, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Schizophrenia Sandoz Quetiapine XRT (quetiapine fumarate extended-release) is indicated for: Management of the manifestations of schizophrenia. Bipolar Disorder Sandoz Quetiapine XRT is indicated as monotherapy for the: Acute management of manic episodes associated with bipolar disorder. Acute management of…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment – Dosing Considerations in Special Populations. 2 Recommended Dose and Dosage Adjustment Schizophrenia Usual Dose: The titration rate, based on the clinical trials (see 14 CLINICAL TRIALS) is shown in the table below.
Day 1 Day 2 After Day 2 Once daily dosing 300 mg 600 mg Up to 800 mg The dose should be adjusted within the effective dose range of 400 mg to 800 mg per day, Sandoz Quetiapine XRT Page 6 of 87 depending on the clinical response and tolerability of the patient.
In a controlled clinical trial, the treatment effect size of 600 mg and 800 mg doses of quetiapine fumarate extended release was greater than that of the 400 mg dose (see 14 CLINICAL TRIALS). In schizophrenia, the safety of doses above 800 mg/day has not been evaluated.
The need for continuing existing EPS medications should be re -evaluated periodically as quetiapine fumarate extended release has not been associated with treatment-emergent EPS across the clinical dose range.
Bipolar Disorder Bipolar Mania Usual Dose:
The titration rate, based on the clinical trial (see 14 CLINICAL TRIALS) is shown in the table below. Day 1 Day 2 After Day 2 Once daily dosing 300 mg 600 mg Up to 800 mg 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.
In bipolar mania, the safety of doses above 800 mg/day has not been evaluated.
Bipolar Depression Usual Dose:
The titration rate, based on the clinical trials (see 14 CLINICAL TRIALS) is shown in the table below. Day 1 Day 2 Day 3 Day 4 and thereafter Once daily dosing 50 mg 100 mg 200 mg 300 mg The usual target dose is 300 mg/day. The dose may be further increased depending on the response and tolerability of the patient.
The maximum dose is 600 mg/day. In quetiapine immediate-release formulation clinical trials antidepressant efficacy was demonstrated with quetiapine immediate-release formulation at both 300 mg/day and 600 mg/day, however no additional benefit was seen in the 600 mg group during short-term treatment.
In bipolar depression, the safety of doses of quetiapine above 600 mg/day has not been evaluated. Major Depressive Disorder Sandoz Quetiapine XRT is indicated for the symptomatic relief of major depressive disorder Sandoz Quetiapine XRT Page 7 of 87 (MDD) when currently available approved antidepressant drugs have failed either due to lack of efficacy and/or lack of tolerability.
, 14 CLINICAL TRIALS). In MDD, the safety of doses above 300 mg/day has not been evaluated. , antipsychotics), may be dose-related (see 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS). The Sandoz Quetiapine XRT dose should thus be periodically reassessed to achieve and maintain the lowest effective dose.
Furthermore, as the long-term safety of quetiapine fumarate extended release in MDD has not been systematically evaluated, the physician who elects to use Sandoz Quetiapine XRT in the treatment of MDD should use Sandoz Quetiapine XRT for the shortest time that is clinically indicated.
When long-term treatment is believed to be indicated, the physician must periodically re-evaluate the long-term usefulness of the drug for the individual patient keeping in mind the long-term risks. Switching patients from Sandoz Quetiapine tablets to Sandoz Quetiapine XRT tablets For more convenient dosing, patients who are currently being treated with divided doses of Sandoz Quetiapine (quetiapine immediate release formulation) may be switched to Sandoz Quetiapine XRT at the equivalent total daily dose taken once daily.
Individual dosage adjustments may be necessary. Switching patients from other antidepressants For many antidepressants a gradual taper is recommended prior to complete discontinuation of Sandoz Quetiapine XRT Page 8 of 87 the drug (physicians should refer to the approved Product Monograph of the specific antidepressant).
There are no systematically collected data to address switching patients from other antidepressants to quetiapine fumarate extended release. Generally there should be no need for a wash-out period between stopping an antidepressant and starting Sandoz Quetiapine XRT.
The physician may elect to initiate Sandoz Quetiapine XRT treatment while tapering the antidepressant, however patients may experience additive side effects during the overlap period. Switching patients from other antipsychotics There are no systematically collected data to specifically address switching patients from other antipsychotics to quetiapine fumarate extended release, or concerning concomitant administration with other antipsychotics.
). Sandoz Quetiapine XRT should only be prescribed in patients with MDD by clinicians who are aware of the importance and are experienced in the early detection and management of the above -mentioned safety issues associated with this class.
Long-term safety of quetiapine fumarate extended release in MDD has not been systematically evaluated. Thus, the physician who elects to use Sandoz Quetiapine XRT in the treatment of MDD should use Sandoz Quetiapine XRT for the shortest time that is clinically indicated.
When lengthier treatment is indicated, the physician must periodically re -evaluate the long-term usefulness of the drug for the individual patient keeping in mind the long-term risks (see 14 CLINICAL TRIALS). 1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of quetiapine fumarate extended release in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
1 Special Populations). 2 Geriatrics Geriatrics (> 65 years of age): Sandoz Quetiapine XRT is not indicated in elderly patients with dementia. 1 Special Populations. 2 CONTRAINDICATIONS Sandoz Quetiapine XRT is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Increased mortality in Elderly Patients with Dementia Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.
6-fold increase in death rate in the drug-related patients. , pneumonia) in nature ( see 7 WARNINGS AND PRECAUTIONS, Geriatrics - Use in Geriatric Patients with Dementia). 2 Recommended Dose and Dosage Adjustment – Dosing Considerations in Special Populations.
Sandoz Quetiapine XRT is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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While there is no evidence that the efficacy of Sandoz Quetiapine XRT is superior to other antidepressants, it provides a treatment option for patients who have failed on previous antidepressant treatments. Clinicians must take into account the safety concerns associated with antipsychotic drugs, a class of drugs to which quetiapine fumarate extended release belongs.
Safety concerns of this class include: weight gain; hyperlipidemia; hyperglycemia; Tardive Dyskinesia; and Neuroleptic Malignant Syndrome (see 7 WARNINGS AND PRECAUTIONS). Sandoz Quetiapine XRT should only be prescribed in patients with MDD by clinicians who are aware of the importance and are experienced in the early detection and management of the above-mentioned safety issues associated with this class.
Usual Dose:
The titration rate, based on the clinical trials (see 14 CLINICAL TRIALS) is shown in the table below. Day 1 Day 2 Day 3 Once daily dosing 50 mg 50 mg 150 mg The usual target dose is 150 mg. Some patients may respond to doses as low as 50 mg/day and where clinically indicated dose may be increased to 300 mg/day after Day 4.
In clinical trials, doses between 50 - 300 mg/day were shown to be efficacious, however, the incidence of certain adverse events increased with dose (see 8 ADVERSE REACTIONS, 14 CLINICAL TRIALS). In MDD, the safety of doses above 300 mg/day has not been evaluated.
, antipsychotics), may be dose-related (see 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS). The Sandoz Quetiapine XRT dose should thus be periodically reassessed to achieve and maintain the lowest effective dose. Furthermore, as the long-term safety of quetiapine fumarate extended release in MDD has not been systematically evaluated, the physician who elects to use Sandoz Quetiapine XRT in the treatment of MDD should use Sandoz Quetiapine XRT for the shortest time that is clinically indicated.
When long-term treatment is believed to be indicated, the physician must periodically re-evaluate the long-term usefulness of the drug for the individual patient keeping in mind the long-term risks. Switching patients from Sandoz Quetiapine tablets to Sandoz Quetiapine XRT tablets For more convenient dosing, patients who are currently being treated with divided doses of Sandoz Quetiapine (quetiapine immediate release formulation) may be switched to Sandoz Quetiapine XRT at the equivalent total daily dose taken once daily.
Individual dosage adjustments may be necessary. Switching patients from other antidepressants For many antidepressants a gradual taper is recommended prior to complete discontinuation of Sandoz Quetiapine XRT Page 8 of 87 the drug (physicians should refer to the approved Product Monograph of the specific antidepressant).
There are no systematically collected data to address switching patients from other antidepressants to quetiapine fumarate extended release. Generally there should be no need for a wash-out period between stopping an antidepressant and starting Sandoz Quetiapine XRT.
The physician may elect to initiate Sandoz Quetiapine XRT treatment while tapering the antidepressant, however patients may experience additive side effects during the overlap period. Switching patients from other antipsychotics There are no systematically collected data to specifically address switching patients from other […]
While immediate discontinuation of the prev ious antipsychotic treatment may be acceptable for some patients, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.
When switching patients from depot antipsychotics, if medically appropriate, initiate Sandoz Quetiapine XRT therapy in place of next scheduled injection. The need for continuing existing EPS medication should be re -evaluated periodically.
The following cross-titration schedule has been used in clinical trials with schizophrenia: Day 1 Day 2 Day 3 quetiapine fumarate extended release 300 mg 600 mg Up to 800 mg % Reduction of ongoing antipsychotic treatment 75% 50% 25% Dosing Considerations in Special Populations Pediatric Use Health Canada has not authorized an indication for pediatric use, as safety and efficacy of quetiapine fumarate extended release in children under the age of 18 years have not been established (See 7 WARNINGS AND PRECAUTIONS, Special Populations) Geriatric Use As with other antipsychotics, Sandoz Quetiapine XRT should be used with caution in the elderly, especially during the initial dosing period.
The rate of dose titration of Sandoz Quetiapine XR T may need to be slower, and the daily therapeutic target dose lower, than that used in younger patients. In clinical trials, 68 patients, 65 years of age or over, were treated with quetiapine fumarate extended release (see 7 WARNINGS AND PRECAUTIONS, Special Populations).
Given the limited experience with quetiapine fumarate extended release in the elderly, and the higher incidence of concomitant illness and concomitant medication in this population, Sandoz Quetiapine XRT should be used with caution.
The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly subjects when compared to younger patients. , 50 mg/day) of Sandoz Quetiapine XRT. The dose can be increased in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerance of the individual patient.
Sandoz Quetiapine XRT Page 9 of 87 In elderly patients with MDD, initial dosing should begin at 50 mg on Days 1-3, the dose can be increased to 100 mg on Day 4, and 150 mg on Day 8 (see 14 CLINICAL TRIALS). Hepatic Impairment Quetiapine is extensively metabolized by the liver (see 10 CLINCIAL PHARMACOLOGY, Special Populations and Conditions).
Therefore, Sandoz Quetiapine XRT should be used with caution in patients with mild hepatic impairment, especially during the initial dosing period. , 50 mg/day) of Sandoz Quetiapine XRT. The dose should be increased daily in increments of 50 mg/day to an effective dose, depending on the clinical response and tolerance in the individual patient.
No pharmacokinetic data are available for quetiapine in patients with moderate to severe hepatic impairment. 3 Pharmacokinetics - Special Populations and Conditions). Renal Impairment As clinical experience is lacking, caution is advised (see 7 WARNINGS AND PRECAUTIONS, Renal).
4 Administration Sandoz Quetiapine XRT is for oral use only. Sandoz Quetiapine XRT tablets should be swallowed whole and not split, chewed or crushed. Sandoz Quetiapine XRT should be administered once daily, generally in the evening.
Sandoz Quetiapine XRT can be administered with […]
2 Recommended Dose and Dosage Adjustment Schizophrenia Usual Dose: The titration rate, based on the clinical trials (see 14 CLINICAL TRIALS) is shown in the table below. Day 1 Day 2 After Day 2 Once daily dosing 300 mg 600 mg Up to 800 mg The dose should be adjusted within the effective dose range of 400 mg to 800 mg per day, Sandoz Quetiapine XRT Page 6 of 87 depending on the clinical response and tolerability of the patient.
In a controlled clinical trial, the treatment effect size of 600 mg and 800 mg doses of quetiapine fumarate extended release was greater than that of the 400 mg dose (see 14 CLINICAL TRIALS). In schizophrenia, the safety of doses above 800 mg/day has not been evaluated.
The need for continuing existing EPS medications should be re -evaluated periodically as quetiapine fumarate extended release has not been associated with treatment-emergent EPS across the clinical dose range.
Bipolar Disorder Bipolar Mania Usual Dose:
The titration rate, based on the clinical trial (see 14 CLINICAL TRIALS) is shown in the table below. Day 1 Day 2 After Day 2 Once daily dosing 300 mg 600 mg Up to 800 mg 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.
In bipolar mania, the safety of doses above 800 mg/day has not been evaluated.
Bipolar Depression Usual Dose:
The titration rate, based on the clinical trials (see 14 CLINICAL TRIALS) is shown in the table below. Day 1 Day 2 Day 3 Day 4 and thereafter Once daily dosing 50 mg 100 mg 200 mg 300 mg The usual target dose is 300 mg/day. The dose may be further increased depending on the response and tolerability of the patient.
The maximum dose is 600 mg/day. In quetiapine immediate-release formulation clinical trials antidepressant efficacy was demonstrated with quetiapine immediate-release formulation at both 300 mg/day and 600 mg/day, however no additional benefit was seen in the 600 mg group during short-term treatment.
In bipolar depression, the safety of doses of quetiapine above 600 mg/day has not been evaluated. Major Depressive Disorder Sandoz Quetiapine XRT is indicated for the symptomatic relief of major depressive disorder Sandoz Quetiapine XRT Page 7 of 87 (MDD) when currently available approved antidepressant drugs have failed either due to lack of efficacy and/or lack of tolerability.
While there is no evidence that the efficacy of Sandoz Quetiapine XRT is superior to other antidepressants, it provides a treatment option for patients who have failed on previous antidepressant treatments. Clinicians must take into account the safety concerns associated with antipsychotic drugs, a class of drugs to which quetiapine fumarate extended release belongs.
Safety concerns of this class include: weight gain; hyperlipidemia; hyperglycemia; Tardive Dyskinesia; and Neuroleptic Malignant Syndrome (see 7 WARNINGS AND PRECAUTIONS). Sandoz Quetiapine XRT should only be prescribed in patients with MDD by clinicians who are aware of the importance and are experienced in the early detection and management of the above-mentioned safety issues associated with this class.
Usual Dose:
The titration rate, based on the clinical trials (see 14 CLINICAL TRIALS) is shown in the table below. Day 1 Day 2 Day 3 Once daily dosing 50 mg 50 mg 150 mg The usual target dose is 150 mg. Some patients may respond to doses as low as 50 […]