Aplenzin Er | Bupropion Hydrobromide Tablet, 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 Aplenzin Er | Bupropion Hydrobromide Tablet, Extended Release for its safety in breastfeeding.

What is Aplenzin Er | Bupropion Hydrobromide Tablet, Extended Release used for?


Aplenzin™ (bupropion hydrobromide extended-release tablets) is 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 inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) [see CLINICAL STUDIES (14) ]. 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 in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion [see CLINICAL STUDIES (14) ]. Nevertheless, the physician who elects to use Aplenzin for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. Aplenzin is an aminoketone antidepressant indicated for the treatment of: Major depressive disorder (1) Periodically reevaluate long-term usefulness for the individual patient. (1)

Can I continue breastfeeding if I am using Aplenzin Er | Bupropion Hydrobromide Tablet, Extended Release? How long does it stays in breast milk?

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

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 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 Aplenzin Tablets, 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.

Aplenzin Er | Bupropion Hydrobromide Tablet, Extended Release Breastfeeding Analsys


Bupropion hydrobromide 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:

Aplenzin Er | Bupropion Hydrobromide Tablet, Extended Release Breastfeeding Analsys - 2


Bupropion hydrobromide 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.


I already used Aplenzin Er | Bupropion Hydrobromide Tablet, Extended Release and meanwhile I breastfed my baby should I be concerned?

During whole lactation period you shall first discuss with your doctor and then together you shall decide whether you shall take that drug or not however if you have already taken Aplenzin Er | Bupropion Hydrobromide Tablet, Extended Release then you shall inform your doctor, But you should not be worried too much as Aplenzin Er | Bupropion Hydrobromide Tablet, Extended Release comes in category of low risk drug.


My doctor has prescribed me Aplenzin Er | Bupropion Hydrobromide Tablet, Extended Release, what should I do?

Though Aplenzin Er | Bupropion Hydrobromide Tablet, 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 Aplenzin Er | Bupropion Hydrobromide Tablet, Extended Release, will my baby need extra monitoring?

Not much


Who can I talk to if I have questions about usage of Aplenzin Er | Bupropion Hydrobromide Tablet, 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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