Tablet, Generic Name: Quetiapine Fumarate 200 mg, Manufacturer: Sanofi Bangladesh LTD.
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Quetiapine is indicated for the treatment of Acute and chronic psychoses, including schizophrenia, Bipolar Disorder including: treatment of manic episodes satisfying DSM-IV criteria for mania associated with bipolar disorder, treatment of depressive episodes associated with bipolar disorder, maintenance treatment of bipolar I disorder, in combination with a mood stabilizer, for the prevention of recurrence of manic, depressive or mixed episodes.
Dosage: Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. 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). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.
Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. 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 dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800 mg/day.
Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The 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). Quetiapine can be titrated to 400 mg on Day 5 and up to 600 mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300 mg and 600 mg, however no additional benefit was seen in the 600 mg group during short term treatment. Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400 mg to 800 mg a day) as combination therapy with a mood stabilizer.
Side effects: The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, 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.
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