Generic Name: Quetiapine Fumarate 100mg
Manufacturer: Incepta Pharmaceuticals Ltd.
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Indications
Quetiapine is used to treat acute and chronic psychoses, such as schizophrenia, as well as bipolar disorder, which includes: manic episodes therapy meeting DSM-IV criteria for mania associated with bipolar disorder, treatment of depressive episodes associated with bipolar disorder, and maintenance therapy of bipolar I disorder in conjunction with a mood stabilizer to avoid recurrence of manic, depressive, or mixed episodes
Pharmacology
The mechanism of action of Quetiapine, like those of other medications used to treat schizophrenia and acute manic episodes associated with bipolar illness, remains unclear. It has been hypothesized, however, that the effectiveness of this medication in schizophrenia is mediated through a combination of dopamine type 2 (D2) and serotonin type 2 (5HT2) antagonism. Some of the additional effects of Quetiapine may be explained by antagonism at receptors other than dopamine and 5HT 2 with comparable receptor affinities. The inhibition of histamine H1 receptors by quetiapine may explain the somnolence experienced with this medication. The inhibition of adrenergic 1 receptors by quetiapine may explain the orthostatic hypotension reported with this medication.
Dosage & Administration
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 of 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 800mg/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 800mg/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 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, 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 stabilizer 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 totaling 400mg to 800mg a day) as a combination therapy with a mood stabilizer.
Interaction
When Quetiapine is used with medications known to induce electrolyte imbalance or to lengthen the QT interval, extreme caution should be observed. Co-administration of Quetiapine with thioridazine or carbamazepine increased Quetiapine clearance. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, increased Quetiapine clearance.
Contraindications
Quetiapine is not recommended for people who are hypersensitive to it.
Side Effects
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 hemoglobin, and extrapyramidal symptoms are the most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine.
Pregnancy & Lactation
Quetiapine's safety and effectiveness during human pregnancy have not been demonstrated. As a result, quetiapine should be used during pregnancy only if the benefits outweigh the dangers, and the given dose and duration of therapy should be as low and as brief as feasible. It is unknown how much Quetiapine is secreted in human milk. Women who are breast-feeding should avoid doing so while taking Quetiapine.
Precautions & Warnings
Suicide/suicidal ideation or clinical deterioration: Depression is linked to an increased risk of suicidal ideation, self-harm, and suicide (suicide-related events). This danger exists until there is a substantial remission.
Concurrent Illness: Quetiapine should be taken with caution in individuals who have a history of cardiovascular illness, cerebrovascular disease, or other diseases that predispose to hypotension. Quetiapine can cause orthostatic hypotension, especially during the dose-titration phase.
Tardive Dyskinesia and Extrapyramidal Symptoms (EPS): If signs and symptoms of tardive dyskinesia develop, the dose of Quetiapine should be reduced or discontinued.
Neuroleptic Malignant Syndrome (NMS): This syndrome has been linked to antipsychotic medication. Quetiapine should be stopped and proper medical therapy should be administered.
QT Prolongation: As with other antipsychotics, Quetiapine should be used with caution in individuals with cardiovascular illness or a family history of QT prolongation.
Severe neutropenia (0.5x109/L) has been observed infrequently in Quetiapine clinical studies. The majority of instances of severe neutropenia have occurred within the first two months after commencing Quetiapine treatment.
Hyperglycemia and diabetes mellitus: In clinical studies using Quetiapine, increases in blood glucose and hyperglycemia, as well as infrequent reports of diabetes, have been noted.
Storage Conditions
Keep this medication out of children's sight and reach. Do not use this medication after the expiry date printed on the blister pack or carton. The expiration date is the final day of that month. Keep away from light and in a cold, dry location.
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