Quetiapine Fumarate Extended-release | Quetiapine Fumarate Tablet, Extended Release while Breastfeeding

It is recommended to breastfeed exclusively for six months and then while introducing to other food sources extend it to twelve months. In this duration most mothers will need help of some sort of medication, It could be for short term like could and flue or it could be something chronic like Arthritis or Diabetes and here comes the question of safety of medication in use. In this post we will figure out what is Quetiapine Fumarate Extended-release | Quetiapine Fumarate Tablet, Extended Release and whether its safe to use Quetiapine Fumarate Extended-release | Quetiapine Fumarate Tablet, Extended Release while nursing or not.

1 INDICATIONS & USAGE Quetiapine Fumarate Extended-release Tablets USP is an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder, manic or mixed episodes (1.2) Bipolar disorder, depressive episodes (1.2) Major depressive disorder, adjunctive therapy with antidepressants (1.3) 1.1 Schizophrenia Quetiapine Fumarate Extended-release Tablets USP is indicated for the treatment of schizophrenia. The efficacy of Quetiapine Fumarate Extended-release Tablets USP in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with quetiapine fumarate tablets [see Clinical Studies (14.1)]. 1.2 Bipolar Disorder Quetiapine Fumarate Extended-release Tablets USP is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of Quetiapine Fumarate Extended-release Tablets USP in manic or mixed episodes of bipolar I disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar I disorder. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar I disorder as well as one 3-week monotherapy trial in children and adolescents (10 – 17 years) with manic episodes associated with bipolar I disorder treated with quetiapine fumarate tablets [see Clinical Studies (14.2)]. Quetiapine Fumarate Extended-release Tablets USP is indicated for the acute treatment of depressive episodes associated with bipolar disorder. The efficacy of Quetiapine Fumarate Extended-release Tablets USP was established in one 8-week trial in adults with bipolar I or II disorder and supported by two 8-week trials in adults with bipolar I or II disorder treated with quetiapine fumarate tablets [see Clinical Studies (14.2)]. Quetiapine Fumarate Extended-release Tablets USP is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was extrapolated from two maintenance trials in adults with bipolar I disorder treated with quetiapine fumarate tablets. The effectiveness of monotherapy for the maintenance treatment of bipolar I disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2)]. 1.3 Adjunctive Treatment of Major Depressive Disorder (MDD) Quetiapine Fumarate Extended-release Tablets USP is indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of Quetiapine Fumarate Extended-release Tablets USP as adjunctive therapy to antidepressants in MDD was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant treatment [see Clinical Studies (14.3)]. 1.4 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder 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.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Quetiapine Fumarate Extended-release Tablets was excreted into human milk. Because of the potential for serious adverse reactions in nursing infants from Quetiapine Fumarate Extended-release Tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother's health. In published case reports, the level of quetiapine in breast milk ranged from undetectable to 170 µg/L. The estimated infant dose ranged from 0.09% to 0.43% of the weight-adjusted maternal dose. Based on a limited number (N=8) of mother/infant pairs, calculated infant daily doses range from less than 0.01 mg/kg (at a maternal daily dose up to 100 mg quetiapine) to 0.1 mg/kg (at a maternal daily dose of 400 mg).