Bupropion Hydrochloride (xl) | Bupropion Hydrochloride Tablet, Film Coated, Extended Release Breastfeeding

American Academy of Pediatrics and other medical experts exclusively recommend to breastfeed the baby for first 6 months. Once you introduce baby to other foods it is recommended to breastfeed for at least first year of babys life. Taking medication while breastfeeding could be tricky as most drugs pass in breast milk. In this article we will evaluate Bupropion Hydrochloride (xl) | Bupropion Hydrochloride Tablet, Film Coated, Extended Release for its safety in breastfeeding.

What is Bupropion Hydrochloride (xl) | Bupropion Hydrochloride Tablet, Film Coated, Extended Release ?


Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (1) 1.1 Major Depressive Disorder Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1)]. 1.2 Seasonal Affective Disorder Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets (XL) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies (14.2)].

Can I use Bupropion Hydrochloride (xl) | Bupropion Hydrochloride Tablet, Film Coated, Extended Release while breastfeeding?

Bupropion Hydrochloride (xl) | Bupropion Hydrochloride Tablet, Film Coated, Extended Release low risk for breastfeeding
Bupropion hydrochloride is the one and only active ingredient present in Bupropion Hydrochloride (xl) | 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 (xl) | 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
8.3 Nursing Mothers Bupropion and its metabolites are present in human milk. In a lactation study of ten women, levels of orally dosed bupropion and its active metabolites were measured in expressed milk. The average daily infant exposure (assuming 150 mL/kg daily consumption) to bupropion and its active metabolites was 2% of the maternal weight-adjusted dose. Exercise caution when bupropion hydrochloride extended-release tablets (XL) are administered to a nursing woman.

Bupropion Hydrochloride (xl) | Bupropion Hydrochloride Tablet, Film Coated, Extended Release Breastfeeding Analsys


Bupropion hydrochloride while Breastfeeding

Low Risk

CAS Number: 34911-55-2

Bupropion Hydrochloride (xl) | Bupropion Hydrochloride Tablet, Film Coated, Extended Release and breastfeeding

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 (xl) | 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.

Is Bupropion Hydrochloride (xl) | Bupropion Hydrochloride Tablet, Film Coated, Extended Release safe while breastfeeding

I already used Bupropion Hydrochloride (xl) | Bupropion Hydrochloride Tablet, Film Coated, Extended Release and meanwhile I breastfed my baby should I be concerned?

Bupropion Hydrochloride (xl) | 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 (xl) | Bupropion Hydrochloride Tablet, Film Coated, Extended Release so you should inform him based on your convenience.


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

Though Bupropion Hydrochloride (xl) | Bupropion Hydrochloride Tablet, Film Coated, Extended Release dose not comes in category of safe drugs rather it comes in category of low risk but if your doctor is aware that you are breastfeeding your baby and has still recommended it then its advantages must be outweighing the risks.


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

Not much monitoring required while using Bupropion Hydrochloride (xl) | Bupropion Hydrochloride Tablet, Film Coated, Extended Release


Who can I talk to if I have questions about usage of Bupropion Hydrochloride (xl) | 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

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