Quetiapine Fumarate Tablet, Film Coated, Extended Release Breastfeeding

Do you know that important immune protective proteins are present in breast milk? Breast milk also contains required vitamins, minerals, saturated and un saturated fats. These things are extremely important for development of healthy brain. If you are taking any medicine for short term or for the chronic reason then that passes in breast milk as well, that is why you should always check the drug with your health care provider. Here at DrLact we try to analyze drugs based on available researches and in this sheet we will present our analysis for Quetiapine Fumarate Tablet, Film Coated, Extended Release.

What is Quetiapine Fumarate Tablet, Film Coated, Extended Release used for?


Quetiapine extended-release tablets are 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 extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets 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 to 17 years) treated with quetiapine tablets [see Clinical Studies (14.1)]. 1.2 Bipolar Disorder Quetiapine extended-release tablets are 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 extended-release tablets 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 to 17 years) with manic episodes associated with bipolar I disorder treated with quetiapine tablets [see Clinical Studies (14.2)]. Quetiapine extended-release tablets are indicated for the acute treatment of depressive episodes associated with bipolar disorder. The efficacy of quetiapine extended-release tablets 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 tablets [see Clinical Studies (14.2)]. Quetiapine extended-release tablets are 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 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 extended-release tablets are indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of quetiapine extended-release tablets 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.

Is Quetiapine Fumarate Tablet, Film Coated, Extended Release safe to use while breastfeeding? Can it interfere with growth and development of my kid?

Quetiapine Fumarate Tablet, Film Coated, Extended Release safe for breastfeeding
Active ingredient in Quetiapine Fumarate Tablet, Film Coated, Extended Release is Quetiapine and based on our analysis of Quetiapine it appears that using Quetiapine Fumarate Tablet, Film Coated, Extended Release is safe in breastfeeding. Below is analysis of Quetiapine while breastfeeding.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Quetiapine was excreted into human milk. Because of the potential for serious adverse reactions in nursing infants from quetiapine 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 mcg/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).

Quetiapine Fumarate Tablet, Film Coated, Extended Release Breastfeeding Analsys


Quetiapine while Breastfeeding

Safe

CAS Number: 111974-72-2

It is excreted into breast milk in clinically significant amount. Clinical or development problems in infants whose mothers were treated have not been observed, whether at the short or long term.Very low plasma-levels in these infants were found. Galactorrhea may occur with or without an increased of Prolactin.


Quetiapine Fumarate Tablet, Film Coated, Extended Release Breastfeeding Analsys - 2


Quetiapine while Breastfeeding

CAS Number: 111974-69-7

Maternal quetiapine doses of up to 400 mg daily produce low levels in milk. Limited long-term follow-up of infants exposed to quetiapine indicates that infants generally developed normally. Systematic reviews of second-generation antipsychotics concluded that quetiapine seemed to be the first- or second-choice agent during breastfeeding.[1][2] Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.


Quetiapine Fumarate Tablet, Film Coated, Extended Release and breastfeeding

I already used Quetiapine Fumarate Tablet, Film Coated, Extended Release and meanwhile I breastfed my baby should I be concerned?

As usage of Quetiapine Fumarate Tablet, Film Coated, Extended Release is mostly safe while breastfeeding hence there should not be any concern. In case of any change in behavior or health of your baby you should inform your health care provider about usage of Quetiapine Fumarate Tablet, Film Coated, Extended Release else no further action is required.


My health care provider has asked me to use Quetiapine Fumarate Tablet, Film Coated, Extended Release, what to do?

Usage of Quetiapine Fumarate Tablet, Film Coated, Extended Release is safe for nursing mothers and baby, No worries.


If I am using Quetiapine Fumarate Tablet, Film Coated, Extended Release, will my baby need extra monitoring?

No


Who can I talk to if I have questions about usage of Quetiapine Fumarate Tablet, Film Coated, Extended Release in breastfeeding?

US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

UK
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700

Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week