Quetiapine fumarate is the generic equivalent of the brand-name drug QUETIAPINE FUMARATE. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Quetiapine fumarate through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder manic episodes (1.2) Bipolar disorder, depressive episodes (1.2) 1.1 Schizophrenia Quetiapine tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1) ] . 1.2 Bipolar Disorder Quetiapine tablets are indicated for the…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.2) ] Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome…
Drug Interactions
7 DRUG INTERACTIONS Concomitant use of strong CYP3A4 inhibitors: Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) ( 2.5 , 7.1, 12.3 ) Concomitant use of strong CYP3A4 inducers: Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7 to 14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. John’s wort) ( 2.6 , 7.1, 12.3 ) Discontinuation of strong CYP3A4 inducers: Reduce…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Quetiapine tablets can be taken with or without food ( 2.1 ) Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia - Adults (2.2) 25 mg twice daily 150 to 750 mg/day 750 mg/day Schizophrenia - Adolescents (13 to 17 years) (2.2) 25 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania - Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania - Children and Adolescents (10 to 17 ye…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking quetiapine. Increased Mortality in Elderly Patients with Dementia-Related Psychosis Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. Quetiapine is not approved for elderly patients with dementia-related psychosis [see Warning…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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