It is a well known fact that breastfeeding is best source of nutrition for infants. Breast milk provides minerals, vitamins and antibodies in most acceptable format when they need it. Nutrition taken by mother passes to breast-milk and same thing applies to medicines taken by mothers. Not all drugs cause problem for baby but some do. Lets analyze if Quetiapine Fumarate | Remedyrepack Inc. is safe for baby while breastfed.
What is Quetiapine Fumarate | Remedyrepack Inc. used for?
Quetiapine fumarate tablet 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) 1.1 Schizophrenia Quetiapine fumarate tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate tablets 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 fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see Clinical Studies (14.1)] 1.2 Bipolar Disorder Quetiapine fumarate tablet 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 fumarate tablet 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 fumarate tablet 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 fumarate tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials. [ see Clinical Studies (14.2)] . 1.3 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.
What are the risk associated with Quetiapine Fumarate | Remedyrepack Inc. usage while breastfeeding? What precautions shall I take while using it in breastfeeding?
Quetiapine is the only one ingredient used in manufacturing of Quetiapine Fumarate | Remedyrepack Inc., Which makes it easier to analyze its effect in breastfeeding. As per our analysis of Quetiapine it is safe to use Quetiapine Fumarate | Remedyrepack Inc. while lactating. We suggest you to check further details below about Quetiapine usage in 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, 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).
Quetiapine Fumarate | Remedyrepack Inc. 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 | Remedyrepack Inc. 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. Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.
What should I do if already breastfed my kid after using Quetiapine Fumarate | Remedyrepack Inc.?
Quetiapine Fumarate | Remedyrepack Inc. is safe in breastfeeding and should not create any health problem for your baby but in case you feel any health issue associated with Quetiapine Fumarate | Remedyrepack Inc. you should contact your doctor or health care provider. Be it pregnancy or lactation you shall keep your doctor informed.
I am nursing mother and my doctor has suggested me to use Quetiapine Fumarate | Remedyrepack Inc., is it safe?
Definitely, Quetiapine Fumarate | Remedyrepack Inc. is safe in lactation for baby. No wonder your doctor has recommended it.
If I am using Quetiapine Fumarate | Remedyrepack Inc., will my baby need extra monitoring?
No extra baby monitoring required while mother is using Quetiapine Fumarate | Remedyrepack Inc.
Who can I talk to if I have questions about usage of Quetiapine Fumarate | Remedyrepack Inc. in breastfeeding?
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday
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
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week