Olanzapine | Teva Pharmaceuticals Usa Inc Breastfeeding

Most health expert recommend six month of exclusive breastfeeding but statics suggest that numbers are not good, almost 95% mothers start breastfeeding but this number drops to 40% in first three month and further it drops to 15% till fifth month. Sometime its due to need of medication usage. Because of these statics its important to provide good information on safety of drugs in breastfeeding so that it can be improved when possible. In this FAQ sheet we will discuss about exposure to Olanzapine | Teva Pharmaceuticals Usa Inc while breastfeeding. We will also discuss about common side effects and warnings associated with Olanzapine | Teva Pharmaceuticals Usa Inc.

What is Olanzapine | Teva Pharmaceuticals Usa Inc used for?


Olanzapine is 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 6week 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 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. 1.1 Schizophrenia Oral olanzapine is 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 Oral olanzapine is 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 Oral olanzapine is 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 and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder Oral olanzapine and fluoxetine in combination is indicated for the treatment of depressive episodes associated with bipolar I disorder, based on clinical studies. When using olanzapine and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax. Olanzapine monotheraphy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.

What are the risk associated with Olanzapine | Teva Pharmaceuticals Usa Inc usage while breastfeeding? What precautions shall I take while using it in breastfeeding?

Olanzapine | Teva Pharmaceuticals Usa Inc safe for breastfeeding
Active ingredient in Olanzapine | Teva Pharmaceuticals Usa Inc is Olanzapine and based on our analysis of Olanzapine it appears that using Olanzapine | Teva Pharmaceuticals Usa Inc is safe in breastfeeding. Below is analysis of Olanzapine while 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 | Teva Pharmaceuticals Usa Inc 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 | Teva Pharmaceuticals Usa Inc 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.


Olanzapine | Teva Pharmaceuticals Usa Inc and breastfeeding

What should I do if already breastfed my kid after using Olanzapine | Teva Pharmaceuticals Usa Inc?

Olanzapine | Teva Pharmaceuticals Usa 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 Olanzapine | Teva Pharmaceuticals Usa Inc you should contact your doctor or health care provider. Be it pregnancy or lactation you shall keep your doctor informed.


My health care provider has asked me to use Olanzapine | Teva Pharmaceuticals Usa Inc, what to do?

Usage of Olanzapine | Teva Pharmaceuticals Usa Inc is safe for nursing mothers and baby, No worries.


If I am using Olanzapine | Teva Pharmaceuticals Usa Inc, will my baby need extra monitoring?

No


Who can I talk to if I have questions about usage of Olanzapine | Teva Pharmaceuticals Usa Inc 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