Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)
Aphena Pharma Solutions - Tennessee, LLC
QUETIAPINE FUMARATE
QUETIAPINE 25 mg
ORAL
PRESCRIPTION DRUG
Quetiapine fumarate tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6 week trials in adults. The effectiveness of quetiapine fumarate tablets 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 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
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. 25 mg Tablets : Peach, round, biconvex, film coated tablets. Engraved with 'APO' on one side and “QUE’ over ‘25’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-371-01) Bottles of 1000 (NDC 60429-371-10) 50 mg Tablets : White, round, biconvex, film coated tablets. Engraved with 'APO' on one side and ‘QUE’ over ‘50’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-372-01) Bottles of 1000 (NDC 60429-372-10) 100 mg Tablets : Yellow, round, biconvex film coated tablets. Engraved with 'APO' on one side and ‘QUE’ over ‘100’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-373-01) Bottles of 1000 (NDC 60429-373-10) 200 mg Tablets : White, round, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE’ over ‘200’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-374-01) Bottles of 1000 (NDC 60429-374-10) 300 mg Tablets : White, capsule-shaped, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE300’ on the other side. They are supplied as follows: Bottles of 60 (NDC 60429-375-60) 400 mg Tablets : Yellow, capsule-shaped, biconvex, film coated tablets. Engraved ‘APO’ on one side and ‘QUE 400’ on the other side. They are supplied as follows: Bottles of 100 (NDC 60429-376-01) Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED Aphena Pharma Solutions - Tennessee, LLC ---------- MEDICATION GUIDE Quetiapine Fumarate (kwe-TYE-a-peen FUE-ma-rate) 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 fumarate tablets 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 fumarate tablets can increase the risk of death in elderly people who have memory lost (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: What else do I need to know about antidepressant medicines? 3. High blood sugar (hyperglycemia): High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar can lead to: a. Build up of acid in your blood due to ketones (ketoacidosis) b. Coma c. Death Increases in blood sugar can happen in some people who take quetiapine fumarate tablets. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes) your healthcare provider should check your blood sugar before you start quetiapine fumarate tablets and during therapy. Call you doctor Citiți documentul complet
QUETIAPINE FUMARATE- QUETIAPINE FUMARATE TABLET, FILM COATED APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- 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._ 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), 5/2010 INDICATIONS AND USAGE Quetiapine Fumarate Tablets is an atypical antipsychotic indicated for the: Treatment of schizophrenia (1.1) Adults: Efficacy was established in three 6 week clinical trials in patients with schizophrenia (14.1) Acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex (1.2) Acute treatment of depressive episodes associated with bipolar disorder (1.2) Maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex (1.2) DOSAGE AND ADMINISTRATION Quetiapine fumarate tablets can be taken with or without food. (3) Indication Dosing Instructions Recommended Dose /Dose Range Schizophre nia-Adults (2.1) (3) 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, in intervals of not less than 2 days. (3) 150 to 750 mg/day (3) Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) (3) Day 1: Twice daily dosing totaling 100 mg. (3) Day 2: Twice daily dosin Citiți documentul complet