QUETIAPINE FUMARATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

QUETIAPINE FUMARATE (UNII: 2S3PL1B6UJ) (QUETIAPINE - UNII:BGL0JSY5SI)

Available from:

Ascend Laboratories, LLC

INN (International Name):

QUETIAPINE FUMARATE

Composition:

QUETIAPINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1) ]. Quetiapine is 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, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see Clinical Studies (14.2) ]. Quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studies (14.2) ]. Quetiapine is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2) ]. Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions. Hypersensitivity to quetiapine or to any excipients in the quetiapine formulation. Anaphylactic reactions have been reported in patients treated with quetiapine. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including quetiapine tablets, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.   Risk Summary Neonates exposed to antipsychotic drugs ( including quetiapine tablet) during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations). Overall available data from published epidemiologic studies of pregnant women exposed to quetiapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). There are risks to the mother associated with untreated schizophrenia, bipolar I, or major depressive disorder, and with exposure to antipsychotics, including, quetiapine tablet during pregnancy (see Clinical Considerations) . In animal studies, embryo-fetal toxicity occurred including delays in skeletal ossification at approximately 1 and 2 times the maximum recommended human dose (MRHD) of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD. In addition, fetal weights were decreased in both species. Maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and approximately 1-2 times the MRHD in rabbits. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations   Disease-associated maternal and/or fetal risk   There is a risk to the mother from untreated schizophrenia, or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors. A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Fetal/neonatal adverse reactions   Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including quetiapine tablets, during the third trimester of pregnancy. These symptoms varied in severity. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Data   Human Data   Published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. A retrospective cohort study from a Medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk of major birth defects. Animal Data   When pregnant rats and rabbits were exposed to quetiapine during organogenesis, there was no teratogenic effect in fetuses. Doses were 25, 50 and 200 mg/kg in rats and 25, 50 and 100 mg/kg in rabbits which are approximately 0.3, 0.6 and 2-times (rats) and 0.6, 1 and 2-times (rabbits) the MRHD, for schizophrenia of 800 mg/day based on mg/m2 body surface area. However, there was evidence of embryo-fetal toxicity, including delays in skeletal ossification at approximately 1 and 2 times the MRHD of 800 mg/day in both rats and rabbits and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD. In addition, fetal weights were decreased in both species. Maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and at approximately 1-2 times the MRHD (all doses tested) in rabbits. In a peri/postnatal reproductive study in rats, no drug-related effects were observed when pregnant dams were treated with quetiapine at doses 0.01, 0.1, and 0.2 times the MRHD of 800 mg/day based on mg/m2 body surface area. However, in a preliminary peri/postnatal study, there were increases in fetal and pup death, and decreases in mean litter weight at 3 times the MRHD. Risk Summary Limited data from published literature report the presence of quetiapine in human breast milk at relative infant dose of <1% of the maternal weight-adjusted dosage. There are no consistent adverse events that have been reported in infants exposed to quetiapine through breast milk. There is no information on the effects of quetiapine on milk production. The developmental and health  benefits of breastfeeding should be considered along with the mother’s clinical need for quetiapine tablets and any potential adverse effects on the breastfed child from quetiapine tablets or from the mother’s underlying condition. Infertility   Females   Based on the pharmacologic action of quetiapine (D2 antagonism), treatment with quetiapine tablets may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see Warnings and Precautions (5.15)]. In general, the adverse reactions observed in children and adolescents during the clinical trials were similar to those in the adult population with few exceptions.  Increases in systolic and diastolic blood pressure occurred in children and adolescents and did not occur in adults.  Orthostatic hypotension occurred more frequently in adults (4-7%) compared to children and adolescents (< 1%) [see Warnings and Precautions (5.7) and Adverse Reactions (6.1)]. Schizophrenia The efficacy and safety of quetiapine in the treatment of schizophrenia in adolescents aged 13 to 17 years were demonstrated in one 6-week, double-blind, placebo-controlled trial [see Indications and Usage (1.1), Dosage and Administration (2.2), Adverse Reactions (6.1), and Clinical Studies (14.1)]. Safety and effectiveness of quetiapine in pediatric patients less than 13 years of age with schizophrenia have not been established. Maintenance The safety and effectiveness of quetiapine in the maintenance treatment of bipolar disorder has not been established in pediatric patients less than 18 years of age. The safety and effectiveness of quetiapine in the maintenance treatment of schizophrenia has not been established in any patient population, including pediatric patients. Bipolar Mania The efficacy and safety of quetiapine in the treatment of mania in children and adolescents ages 10 to 17 years with bipolar I disorder was demonstrated in a 3-week, double-blind, placebo-controlled, multicenter trial [see Indications and Usage (1.2), Dosage and Administration (2.3), Adverse Reactions (6.1), and Clinical Studies (14.2)] . Safety and effectiveness of quetiapine in pediatric patients less than 10 years of age with bipolar mania have not been established. Bipolar Depression Safety and effectiveness of Quetiapine in pediatric patients less than 18 years of age with bipolar depression have not been established. A clinical trial with SEROQUEL XR was conducted in children and adolescents (10 to 17 years of age) with bipolar depression, efficacy was not established. Some differences in the pharmacokinetics of quetiapine were noted between children/adolescents (10 to 17 years of age) and adults.  When adjusted for weight, the AUC and Cmax of quetiapine were 41% and 39% lower, respectively, in children and adolescents compared to adults. The pharmacokinetics of the active metabolite, norquetiapine, were similar between children/adolescents and adults after adjusting for weight [see Clinical Pharmacology (12.3)] . Of the approximately 3700 patients in clinical studies with quetiapine, 7% (232) were 65 years of age or over.  In general, there was no indication of any different tolerability of quetiapine in the elderly compared to younger adults. Nevertheless, the presence of factors that might decrease pharmacokinetic clearance, increase the pharmacodynamic response to quetiapine, or cause poorer tolerance or orthostasis, should lead to consideration of a lower starting dose, slower titration, and careful monitoring during the initial dosing period in the elderly.  The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients [see Clinical Pharmacology (12.3) and Dosage and Administration (2.3 )] . Clinical experience with quetiapine in patients with renal impairment is limited [see Clinical Pharmacology (12.3)]. Since quetiapine is extensively metabolized by the liver, higher plasma levels are expected in patients with hepatic impairment.  In this population, a low starting dose of 25 mg/day is recommended and the dose may be increased in increments of 25 mg/day - 50 mg/day [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)] .  Quetiapine is not a controlled substance. Quetiapine has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed.  Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of quetiapine, e.g., development of tolerance, increases in dose, drug-seeking behavior.

Product summary:

Quetiapine tablets, USP 25 mg Peach coloured, film coated, round shape, biconvex tablets, debossed with "262” on one side and plain on other side. Bottles of 100 tablets                                                                   NDC 67877-242-01 Bottles of 1000 tablets                                                                 NDC 67877-242-10 Carton pack of 100 tablets (10 x 10’s blister pack)                      NDC 67877-242-38 Carton pack of 10 tablets (1 x 10’s blister pack)                          NDC 67877-242-33 Quetiapine tablets, USP 50 mg White coloured, film coated, round shape, biconvex tablets, debossed with"337" on one side and plain on other side. Bottles of 100 tablets                                                                   NDC 67877-249-01 Bottles of 1000 tablets                                                                 NDC 67877-249-10 Carton pack of 100 tablets (10 x 10’s blister pack)                      NDC 67877-249-38 Carton pack of 10 tablets (1 x 10’s blister pack)                          NDC 67877-249-33 Quetiapine tablets, USP 100 mg Yellow coloured, film coated, round shape, biconvex tablets, debossed with "261" on one side and plain on other side. Bottles of 100 tablets                                                                   NDC 67877-250-01 Bottles of 1000 tablets                                                                 NDC 67877-250-10 Carton pack of 100 tablets (10 x 10’s blister pack)                      NDC 67877-250-38 Carton pack of 10 tablets (1 x 10's blister pack)                          NDC 67877-250-33 Quetiapine tablets, USP 150 mg Off white to light yellow coloured, film coated, round shape, biconvex tablets, debossed with "353" on one side and plain on other side. Bottles of 100 tablets                                                                   NDC 67877-245- 01 Carton pack of 100 tablets (10 x 10's blister pack)                      NDC 67877-245-38 Carton pack of 10 tablets (1 x 10's blister pack)                          NDC 67877-245-33 Quetiapine tablets, USP 200 mg White coloured, film coated, round shape, biconvex tablets, debossed with "260" on one side and plain on other side. Bottles of 100 tablets                                                                   NDC 67877-246- 01 Bottles of 1000 tablets                                                                 NDC 67877-246-10 Carton pack of 100 tablets (10 x 10's blister pack)                      NDC 67877-246-38 Carton pack of 10 tablets (1 x 10's blister pack)                          NDC 67877-246-33 Quetiapine tablets, USP 300 mg White coloured, film coated, capsule shaped, biconvex tablets, debossed with "259" on one side and plain on other side. Bottles of 60 tablets                                                                     NDC 67877-247- 60 Bottles of 1000 tablets                                                                 NDC 67877-247-10 Carton pack of 100 tablets (10 x 10's blister pack)                      NDC 67877-247-38 Carton pack of 10 tablets (1 x 10's blister pack)                          NDC 67877-247-33 Quetiapine tablets, USP 400 mg Yellow coloured, film coated, capsule shaped, biconvex tablets, debossed with "336" on one side and plain on other side. Bottles of 100 tablets                                                                   NDC 67877-248- 01 Bottles of 1000 tablets                                                                 NDC 67877-248-10 Carton pack of 100 tablets (10 x 10's blister pack)                      NDC 67877-248-38 Carton pack of 10 tablets (1 x 10's blister pack)                          NDC 67877-248-33 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET
Ascend Laboratories, LLC
----------
MEDICATION GUIDE
Quetiapine Tablets, USP
(kwe-TYE-a-peen)
Read this Medication Guide before you start taking quetiapine tablets
and each time you get a refill.
There may be new information. This information does not take the place
of talking to your healthcare
provider about your medical condition or your treatment.
What is the most important information I should know about quetiapine?
Quetiapine may cause serious side effects, including:
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 is not 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:
o all risks and benefits of treatment with antidepressant medicines.
o all treatment choices for depression or other serious mental illness
•
Antidepressant medications 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?
o Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is
started or when the dose is changed.
o Call the healthcare provider right away to report new or sudden
changes in mood, behavior, thoughts,
or f

Summary of Product characteristics

QUETIAPINE FUMARATE - QUETIAPINE FUMARATE TABLET
ASCEND LABORATORIES, LLC
----------
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 IS 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 tablets, USP 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 peri