Country: United States
Language: English
Source: NLM (National Library of Medicine)
QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)
Major Pharmaceuticals
QUETIAPINE FUMARATE
QUETIAPINE 25 mg
ORAL
PRESCRIPTION DRUG
Quetiapine fumarate tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6 week trials in adults. The effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see Clinical Studies (14.1)]. Pediatric use information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients. Quetiapine fumarate tablets are indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, [see Clinical Studies (14.2) ]. Quetiapine fum
Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘1’ on other side and they are supplied in unit dose package of 100 (10 x 10). Unit dose package of 100 (10 x 10) NDC 0904-6277-61 Quetiapine fumarate tablets are available as 50 mg, white colored, round, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘2’ on other side and they are supplied in unit dose package of 100 (10 x 10). Unit dose package of 100 (10 x 10) NDC 0904-6278-61 Quetiapine fumarate tablets are available as 100 mg, yellow colored, round, biconvex, film coated tablets debossed with ‘R’ on one side and ‘3’ on other side and they are supplied in unit dose package of 100 (10 x 10). Unit dose package of 100 (10 x 10) NDC 0904-6279-61 Quetiapine fumarate tablets are available as 200 mg, white, round, biconvex, film coated tablets, debossed with ‘R’ on one side and ‘5’ on other side and they are supplied in unit dose package of 100 (10 x 10). Unit dose package of 100 (10 x 10) NDC 0904-6280-61 Quetiapine fumarate tablets are available as 400 mg, yellow colored, capsule shaped, biconvex, film coated tablets, debossed with ‘R' on one side and ‘7’ on other side and they are supplied in unit dose package of 100 (10 x 10). Unit dose package of 100 (10 x 10) NDC 0904-6281-61 Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]
Abbreviated New Drug Application
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED Major Pharmaceuticals ---------- MEDICATION GUIDE QUETIAPINE FUMARATE TABLETS Read this Medication Guide before you start taking quetiapine fumarate tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about quetiapine fumarate tablets? Quetiapine may cause serious side effects, including 1. Risk of death in the elderly with dementia 2. Risk of suicidal thoughts or actions 3. High blood sugar (hyperglycemia) 4. High fat levels in your blood (increased cholesterol and triglycerides) 5. Weight gain These serious side effects are described below: 1.Risk of death in the elderly with dementia: Medicines like quetiapine can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine fumarate tablets are not approved for treating psychosis in the elderly with dementia. 2.Risk of suicidal thoughts or actions: (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions): Talk to your, or your family member’s, healthcare provider about: • all risks and benefits of treatment with antidepressant medicines. • all treatment choices for depression or other serious mental illness. • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic- depressive illness), or suicidal thoughts or actions. • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Read the complete document
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED MAJOR PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE QUETIAPINE FUMARATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUETIAPINE FUMARATE TABLETS. QUETIAPINE FUMARATE TABLETS INITIAL U.S. APPROVAL: 1997 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA RELATED PSYCHOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • RECENT MAJOR CHANGES Warnings and Precautions, Hyperglycemia (5.4), 1/2011 Warnings and Precautions, Hyperlipidemia (5.5), 1/2011 Warnings and Precautions, Weight Gain (5.6), 1/2011 Warnings and Precautions, QT prolongation (5.12), 6/2011 Warnings and Precautions, Hypothyroidism (5.14), 1/2011 Warnings and Precautions, Withdrawal (5.23), 05/2010 INDICATIONS AND USAGE Quetiapine is an atypical antipsychotic indicated for the: Treatment of schizophrenia (1.1) (1) • Acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex (1.2) (1) • Acute treatment of depressive episodes associated with bipolar disorder (1.2) (1) • Maintenance treatment of bipolar disorder as an adjunct to lithium or divalproex (1.2) (1) • DOSAGE AND ADMINISTRATION Quetiapine fumarate tablets can be taken with or without food. (2) INDICATION (2) DOSING INSTRUCTIONS* (2) RECOMMENDED DOSE / DOSE RANGE (2) Schizophrenia-Adults (2.1) (2) Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, 150 to 750 mg/day (2) Antipsychotic drugs are associated with an increased risk of death (5.1) Quetiapine is not approved for elderly patients with Dementia-Related Psychosis (5.1) Increased risk Read the complete document