Bupropion Hydrochloride Tablet, Film Coated, Extended Release while Breastfeeding

Q: If I am using Bupropion Hydrochloride Tablet, Film Coated, Extended Release , will my baby need extra monitoring?

Not much monitoring required while using Bupropion Hydrochloride Tablet, Film Coated, Extended Release

Bupropion Hydrochloride Tablet, Film Coated, Extended Release 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 Bupropion Hydrochloride Tablet, Film Coated, Extended Release while breastfeeding. We will also discuss about common side effects and warnings associated with Bupropion Hydrochloride Tablet, Film Coated, Extended Release.

What is Bupropion Hydrochloride Tablet, Film Coated, Extended Release used for?

Bupropion hydrochloride extended-release tablets, USP (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of bupropion hydrochloride extended-release tablets, USP (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets, USP (SR) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Can I continue breastfeeding if I am using Bupropion Hydrochloride Tablet, Film Coated, Extended Release? How long does it stays in breast milk?

Bupropion Hydrochloride Tablet, Film Coated, Extended Release low risk for breastfeeding

Bupropion hydrochloride is the one and only active ingredient present in Bupropion Hydrochloride Tablet, Film Coated, Extended Release. Bupropion hydrochloride in itself is a low risk drug for lactation so it is easy to understand that Bupropion Hydrochloride Tablet, Film Coated, Extended Release also comes in category of Low Risk item while breastfeeding. Below is the summary of Bupropion hydrochloride in breastfeeding.

Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers Like many other drugs, bupropion and its metabolites are secreted in human milk. Because of the potential for serious adverse reactions in nursing infants from bupropion hydrochloride extended-release tablets (SR), 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.

Bupropion Hydrochloride Tablet, Film Coated, Extended Release Breastfeeding Analsys

Bupropion hydrochloride while Breastfeeding

Low Risk

CAS Number: 34911-55-2

Selective inhibitor of the neuronal reuptake of catecholamines (noradrenaline and dopamine). It is used as an antidepressant and to help stop smoking (Baraona 2017). Administered orally, one daily dose. Although the concentration in milk is much higher than the plasma concentration, it is excreted in breast milk in very small amounts (Neuman 2014, Davis 2009, Haas 2004, Briggs 1993). The plasma levels of infants whose mothers were taking it were undetectable or very low (Neuman 2014, Davis 2009, Baab 2002, Briggs 1993). Given the negligible excretion in milk, the absence of plasma levels in infants and the fact that no problems were observed in infants in several publications (Nonacs 2005, Baab 2002, Briggs 1993), two cases of seizures in infants whose mothers were taking bupropion are difficult to explain, whether in monotherapy (Chaudron 2004) or associated with other antidepressants (Neuman 2014). Progress was satisfactory. Bupropion does not alter prolactin levels (Whiteman 1982). Avoid in mothers with a history of epilepsy since it decreases the seizure threshold. Until there is more published data on this drug in relation to breastfeeding, safer alternatives known may be preferable (Sriraman 2015, Carson 2013, Berle 2011, Davanzo 2011), especially during the neonatal period and in case of prematurity. See below the information of these related products:

Bupropion Hydrochloride Tablet, Film Coated, Extended Release Breastfeeding Analsys - 2

Bupropion hydrochloride while Breastfeeding

CAS Number: 34911-55-2

Limited information indicates that maternal bupropion doses of up to 300 mg daily produce low levels in breastmilk and would not be expected to cause any adverse effects in breastfed infants. However, there is little reported use in breastfed newborn infants and case reports of a possible seizure in partially breastfed 6-month-olds. If bupropion is required by a nursing mother, it is not a reason to discontinue breastfeeding. However, another drug may be preferred, especially while nursing a newborn or preterm infant. Infants exposed to bupropion and an SSRI through breastfeeding should be closely monitored for vomiting, diarrhea, jitteriness, or sedation and possibly measurement of serum levels to rule out toxicity if there is a concern.

What should I do if already breastfed my kid after using Bupropion Hydrochloride Tablet, Film Coated, Extended Release?

Bupropion Hydrochloride Tablet, Film Coated, Extended Release is in the category of low risk, if you have already used it then its not a big deal if health and behavior of baby is good. However your health care provider shall be aware of the fact that you have used Bupropion Hydrochloride Tablet, Film Coated, Extended Release so you should inform him based on your convenience.

My doctor has prescribed me Bupropion Hydrochloride Tablet, Film Coated, Extended Release, what should I do?

Bupropion Hydrochloride Tablet, Film Coated, Extended Release comes in category of low risk and if your doctor is aware that you are breastfeeding it should be ok to use without much concerns.

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

Not much monitoring required while using Bupropion Hydrochloride Tablet, Film Coated, Extended Release

Who can I talk to if I have questions about usage of Bupropion Hydrochloride 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