Olanzapine Tablet Breastfeeding

Breast milk is superior in nutrition, It provides resistance against infections and allergies, It is naturally sterile. Despite all the advantages of breastfeeding some mothers choose to pause the breastfeeding in fear of harmful effects of medicines passing in breast milk. Are you wondering about breastfeeding and using Olanzapine Tablet ? Know what is Olanzapine Tablet and how it can affect your breast milk and whether Olanzapine Tablet is safe for your kid or not.

What is Olanzapine Tablet used for?


Olanzapine tablets are an atypical antipsychotic indicated: As oral formulation for the: Treatment of schizophrenia. ( 1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6-­ week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1) Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3­- week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2) Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3) Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2) Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine tablets and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. ( 1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. ( 1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax. 1.1 Schizophrenia Olanzapine tablets are indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. In adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial [see Clinical Studies ( 14.1)] . When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see Warnings and Precautions ( 5.5)]. 1.2 Bipolar I Disorder (Manic or Mixed Episodes) Monotherapy — Olanzapine tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Efficacy was established in three clinical trials in adult patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one monotherapy maintenance trial. In adolescent patients with manic or mixed episodes associated with bipolar I disorder (ages 13 to 17), efficacy was established in one 3-week trial [see Clinical Studies ( 14.2)]. When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see Warnings and Precautions ( 5.5)]. Adjunctive Therapy to Lithium or Valproate — Olanzapine Tablets are indicated for the treatment of manic or mixed episodes associated with bipolar I disorder as an adjunct to lithium or valproate. Efficacy was established in two 6-week clinical trials in adults. The effectiveness of adjunctive therapy for longer-term use has not been systematically evaluated in controlled 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, pediatric 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 should be part of a total treatment program that often includes psychological, educational and social interventions. 1.5 Olanzapine tablets and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder Olanzapine tablets and fluoxetine in combination is indicated for the treatment of depressive episodes associated with bipolar I disorder, based on clinical studies. When using olanzapine tablets and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax. Olanzapine tablets monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder. 1.6 Olanzapine tablets and Fluoxetine in Combination: Treatment Resistant Depression Oral olanzapine and fluoxetine in combination is indicated for the treatment of treatment resistant depression (major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode), based on clinical studies in adult patients. When using olanzapine and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax. Olanzapine monotherapy is not indicated for the treatment of treatment resistant depression.

Is Olanzapine Tablet usage safe while breastfeeding? If a lactating mother is using it can there be any effect on growth or development of infant?

Olanzapine Tablet safe for breastfeeding
Olanzapine is the only one ingredient used in manufacturing of Olanzapine Tablet, Which makes it easier to analyze its effect in breastfeeding. As per our analysis of Olanzapine it is safe to use Olanzapine Tablet while lactating. We suggest you to check further details below about Olanzapine usage in breastfeeding.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers In a study in lactating, healthy women, olanzapine was excreted in breast milk. Mean infant dose at steady state was estimated to be 1.8% of the maternal olanzapine dose. It is recommended that women receiving olanzapine should not breast-feed.

Olanzapine Tablet Breastfeeding Analsys


Olanzapine while Breastfeeding

Safe

CAS Number: 132539-06-1

It is excreted in breast milk in clinically non-significant amount without problems observed in infants whose mothers were receiving this treatment, whether on psychomotor development, speech improvement and weight gaining.Drug plasma levels in these infants were undetectable or very low. In the neonatal period, isolated cases of sedation and / or withdrawal symptoms have been reported, possibly by accumulative mechanism during pregnancy or added effect from another drug. Some experts think that Olanzapine would be the one of choice during lactation among second-generation antipsychotic drugs (Uguz 2016). May induce increased plasma levels of Prolactin but less frequently and lower than other antipsychotic drugs.


Olanzapine Tablet Breastfeeding Analsys - 2


Olanzapine while Breastfeeding

CAS Number: 132539-06-1

Maternal doses of olanzapine up to 20 mg daily produce low levels in milk and undetectable levels in the serum of breastfed infants. In most cases, short-term side effects have not been reported, but sedation has occurred. Limited long-term follow-up of infants exposed to olanzapine indicates that infants generally developed normally. Systematic reviews of second-generation antipsychotics concluded that olanzapine seemed to be a first-line agent during breastfeeding.[1][2] Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.


Is Olanzapine Tablet safe while breastfeeding

What if I already have used Olanzapine Tablet?

As usage of Olanzapine Tablet 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 Olanzapine Tablet else no further action is required.


I am nursing mother and my doctor has suggested me to use Olanzapine Tablet, is it safe?

Definitely, Olanzapine Tablet is safe in lactation for baby. No wonder your doctor has recommended it.


If I am using Olanzapine Tablet, will my baby need extra monitoring?

No extra baby monitoring required while mother is using Olanzapine Tablet


Who can I talk to if I have questions about usage of Olanzapine Tablet 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