Quetiapine Fumarate

QUETIAPINE FUMARATE- quetiapine fumarate tablet
RedPharm Drug, Inc.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [SEE WARNINGS AND PRECAUTIONS (5.1)]. Quetiapine tablets are not approved for the treatment of patients with dementia-related psychosis [SEE WARNINGS AND PRECAUTIONS (5.1)].

Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [SEE WARNINGS AND PRECAUTIONS (5.2)].

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [SEE WARNINGS AND PRECAUTIONS (5.2)].

Quetiapine tablets are not approved for use in pediatric patients under ten years of age [SEE USE IN SPECIFIC POPULATIONS (8.4)].

HIGHLIGHTS OF PRESCRIBING INFORMATION


These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS.
Quetiapine tablets, for oral use
Initial U.S. Approval: 1997

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis


Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Quetiapine tablets are not approved for elderly patients with dementia-related psychosis. (5.1)

Suicidal Thoughts and Behaviors


Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants. (5.2)

Monitor for worsening and emergence of suicidal thoughts and behaviors. (5.2)

INDICATIONS AND USAGE

Quetiapine is an atypical antipsychotic indicated for the treatment of:


Schizophrenia ( 1.1)

Bipolar I disorder manic episodes ( 1.2)

Bipolar disorder, depressive episodes ( 1.2)

DOSAGE AND ADMINISTRATION


Quetiapine 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 years), Monotherapy (2.2)

25 mg twice daily

400 to 600 mg/day

600 mg/day

Bipolar Depression-Adults (2.2)

50 mg once daily at bedtime

300 mg/day

300 mg/day


Geriatric Use: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly. ( 2.3, 8.5)

Hepatic Impairment: Lower starting dose (25 mg/day) and slower titration may be needed. ( 2.4, 8.7,12.3)

DOSAGE FORMS AND STRENGTHS

Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg (3)

CONTRAINDICATIONS

Known hypersensitivity to quetiapine or any components in the formulation. (4)

WARNINGS AND PRECAUTIONS


Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse events (e.g. stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs. ( 5.3)

Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring. ( 5.4)

Metabolic Changes: Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. ( 5.5)

o
Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes.
o
Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment.
o
Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended.


Tardive Dyskinesia: Discontinue if clinically appropriate. ( 5.6)

Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease. (5.7)

Increased Blood Pressure in Children and Adolescents: Monitor blood pressure at the beginning of, and periodically during treatment in children and adolescents. ( 5.8)

Leukopenia, Neutropenia and Agranulocytosis: Monitor complete blood count frequently during the first few months of treatment in patients with a pre-existing low white cell count or a history of leukopenia/neutropenia and discontinue quetiapine at the first sign of a decline in WBC in absence of other causative factors. ( 5.9)

Cataracts: Lens changes have been observed in patients during long-term quetiapine treatment. Lens examination is recommended when starting treatment and at 6-month intervals during chronic treatment. ( 5.10)

ADVERSE REACTIONS


Most common adverse reactions (incidences ≥ 5% and twice placebo):
Adults: somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, weight gain, lethargy, ALT increased, dyspepsia. ( 6.1)

Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased. ( 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 quetiapine dose by 5 fold within 7 to 14 days of discontinuation of CYP3A4 inducers. ( 2.6, 7.1, 12.3)

USE IN SPECIFIC POPULATIONS


Pregnancy: Limited human data. Based on animal data, may cause fetal harm. Quetiapine should be used only if the potential benefit justifies the potential risk. ( 8.1)

Nursing Mothers: Discontinue drug or nursing, taking into consideration importance of drug to mother’s health. ( 8.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 8/2016

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS
1 INDICATIONS AND USAGE
1.1 Schizophrenia
1.2 Bipolar Disorder
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Recommended Dosing
2.3 Dose Modifications in Elderly Patients
2.4 Dose Modifications in Hepatically Impaired Patients
2.5 Dose Modifications When Used with CYP3A4 Inhibitors
2.6 Dose Modifications When Used with CYP3A4 Inducers
2.7 Reinitiation of Treatment in Patients Previously Discontinued
2.8 Switching from Antipsychotics
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis
5.2 Suicidal Thoughts and Behaviors in Adolescents and Young Adults
5.3 Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis
5.4 Neuroleptic Malignant Syndrome (NMS)
5.5 Metabolic Changes
5.6 Tardive Dyskinesia
5.7 Hypotension
5.8 Increases in Blood Pressure (Children and Adolescents)
5.9 Leukopenia, Neutropenia and Agranulocytosis
5.10 Cataracts
5.11 QT Prolongation
5.12 Seizures
5.13 Hypothyroidism
5.14 Hyperprolactinemia
5.15 Potential for Cognitive and Motor Impairment
5.16 Body Temperature Regulation
5.17 Dysphagia
5.18 Discontinuation Syndrome
6 ADVERSE REACTIONS
6.1 Clinical Study Experience
6.2 Post Marketing Experience
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on Quetiapine
7.2 Effect of Quetiapine on Other Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
10 OVERDOSAGE
10.1 Human Experience
10.2 Management of Overdosage
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Schizophrenia
14.2 Bipolar Disorder
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

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