Seroquet 100mg

Tablet
Quetiapine Fumarate
Unimed Unihealth MFG. Ltd

Other Strength:
- Seroquet 25mg
- Seroquet ER 200mg

Alternative:
- Qutap 100mg
- Qmax 100mg
- Renapine 100mg



Seroquet
Presentation
Seroquet 25 tablet: Pale orange, round shaped, film coated tablet; each tablet contains Quetiapine Fumarate INN equivalent to Quetiapine 25mg.
Seroquet 100 tablet: Yellow, barrel shaped, scored, film coated tablet; each tablet contains Quetiapine Fumarate INN equivalent to Quetiapine 100mg.

Indication
Seroquet (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 & administration
Adult: 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 50mg (Day 1), 100mg (Day 2), 200mg (Day 3) and 300mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750mg/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 100mg (Day 1), 200mg (Day 2), 300mg (Day 3) and 400mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800mg/day. The usual effective dose is in the range of 400 to 800mg/day.

Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300mg/day. The daily dose for the first four days of therapy is 50mg (Day 1), 100mg (Day 2), 200mg (Day 3) and 300mg (Day 4). Quetiapine can be titrated to 400mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600mg, however no additional benefit was seen in the 600mg 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 400mg to 800mg a day) as combination therapy with a mood stabilizer.

Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.

Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.

Contra-indications, warnings etc.
Contra-indications: Quetiapine is contra-indicated in patients who are hypersensitive to it.

Precautions: 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. Concomitant Illness: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension. Quetiapine may induce orthostatic hypotension especially during the initial dose-titration period. Seizures: As with other antipsychotics, caution is recommended when treating patients with a history of seizures. Tardive Dyskinesia and Extrapyramidal Symptoms (EPS): If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Quetiapine should be considered. Neuroleptic Malignant Syndrome: This syndrome has been associated with antipsychotic treatment. Quetiapine should be discontinued and appropriate medical treatment given. QT Prolongation: As with other antipsychotics, caution should be exercised when Quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation. Neutropenia: Severe neutropenia (<0.5 x 109/L) has been uncommonly reported in Quetiapine clinical trials. Most cases of severe neutropenia have occurred within the first two months of starting therapy with Quetiapine. Hyperglycemia & diabetes mellitus: Increases in blood glucose and hyperglycaemia, and occasional reports of diabetes, have been observed in clinical trials with Quetiapine.

Use in pregnancy & lactation: The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.

Pediatric use: Quetiapine is not indicated for use in children and adolescents below 18 years of age.
Drug interactions: Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.

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.

Overdose: In clinical trials, survival has been reported in acute overdoses of up to 30grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.

Pharmaceutical precautions
Store in a cool and dry place, protected from light.

Packaging quantities
Seroquet 25 tablet: Carton containing 30 tablets in blister. Seroquet 100 tablet: Carton containing 30 tablets in blister.

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