Quetiapine Fumarate (Page 12 of 15)

16 HOW SUPPLIED/STORAGE AND HANDLING

Quetiapine tablets USP, 25 mg (as quetiapine) are pink colored, round, biconvex, film-coated tablets, debossed “LU” on one side and “Y15” on the other side, which are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-327-01

Quetiapine tablets USP, 50 mg (as quetiapine) are white, round, biconvex, film-coated tablets, debossed “LU” on one side and “Y16” on the other side, which are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-338-01

Quetiapine tablets USP, 100 mg (as quetiapine) are yellow colored, round, biconvex, film-coated tablets, debossed “LU” on one side and “Y17” on the other side, which are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-349-01

Quetiapine tablets USP, 200 mg (as quetiapine) are white, round, biconvex, film-coated tablets, debossed “LU” on one side and “Y18” on the other side, which are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-360-01

Quetiapine tablets USP, 300 mg (as quetiapine) are white, capsule shape, biconvex, film-coated tablets, debossed “LU” on one side and “Y19” on the other side, which are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-371-01

Quetiapine tablets USP, 400 mg (as quetiapine) are yellow colored, capsule shape, biconvex, film-coated tablets, debossed “LU” on one side and “Y20” on the other side, which are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-382-01

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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 Warnings and Precautions (5.1)].

Suicidal Thoughts and Behaviors
Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions (5.2)].

Neuroleptic Malignant Syndrome (NMS)
Patients should be advised to report to their physician any signs or symptoms that may be related to NMS. These may include muscle stiffness and high fever [see Warnings and Precautions (5.4)].

Hyperglycemia and Diabetes Mellitus
Patients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus. Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those that develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment [see Warnings and Precautions (5.5)].

Hyperlipidemia
Patients should be advised that elevations in total cholesterol, LDL-cholesterol and triglycerides and decreases in HDL-cholesterol may occur. Patients should have their lipid profile monitored at the beginning of and periodically during treatment [see Warnings and Precautions (5.5)].

Weight Gain
Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly [see Warnings and Precautions (5.5)].

Orthostatic Hypotension
Patients should be advised of the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing, which may lead to falls), especially during the period of initial dose titration, and also at times of re-initiating treatment or increases in dose [see Warnings and Precautions (5.7)].

Increased Blood Pressure in Children and Adolescents
Children and adolescent patients should have their blood pressure measured at the beginning of, and periodically during, treatment [see Warnings and Precautions (5.9)].

Leukopenia/Neutropenia
Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should be advised that they should have their CBC monitored while taking quetiapine. Patients should be advised to talk to their doctor as soon as possible if they have a fever, flu-like symptoms, sore throat, or any other infection as this could be a result of a very low WBC, which may require quetiapine to be stopped and/or treatment to be given [see Warnings and Precautions (5.10)].

Interference with Cognitive and Motor Performance
Patients should be advised of the risk of somnolence or sedation (which may lead to falls), especially during the period of initial dose titration. Patients should be cautioned about performing any activity requiring mental alertness, such as operating a motor vehicle (including automobiles) or operating machinery, until they are reasonably certain quetiapine therapy does not affect them adversely [see Warnings and Precautions (5.16)].

Heat Exposure and Dehydration
Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.17)].

Concomitant Medication
As with other medications, patients should be advised to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs [see Drug Interactions (7.1)].

Pregnancy
Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with quetiapine. Advise patients that quetiapine may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to quetiapine during pregnancy [see Use in Specific Populations (8.1)].

Infertility
Advise females of reproductive potential that quetiapine may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Use in Specific Populations (8.3)].

Need for Comprehensive Treatment Program
Quetiapine is indicated as an integral part of a total treatment program for adolescents with schizophrenia and pediatric bipolar disorder that may include other measures (psychological, educational, and social). Effectiveness and safety of quetiapine have not been established in pediatric patients less than 13 years of age for schizophrenia or less than 10 years of age for bipolar mania. Appropriate educational placement is essential and psychosocial intervention is often helpful. The decision to prescribe atypical antipsychotic medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms [see Indications and Usage (1.3)].

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from BluePoint Laboratories as follows:
(25 mg / 100 UD) NDC 60687-327-01 packaged from NDC 68001-185
(50 mg / 100 UD) NDC 60687-338-01 packaged from NDC 68001-180
(100 mg / 100 UD) NDC 60687-349-01 packaged from NDC 68001-184
(200 mg / 100 UD) NDC 60687-360-01 packaged from NDC 68001-182
(300 mg / 100 UD) NDC 60687-371-01 packaged from NDC 68001-183
(400 mg / 100 UD) NDC 60687-382-01 packaged from NDC 68001-181

Distributed by:
American Health Packaging
Columbus, OH 43217

8432701/0822

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