Forfivo Xl | Bupropion Hydrochloride Tablet, Film Coated, Extended Release Breastfeeding

It is a well known fact that breastfeeding is best source of nutrition for infants. Breast milk provides minerals, vitamins and antibodies in most acceptable format when they need it. Nutrition taken by mother passes to breast-milk and same thing applies to medicines taken by mothers. Not all drugs cause problem for baby but some do. Lets analyze if Forfivo Xl | Bupropion Hydrochloride Tablet, Film Coated, Extended Release is safe for baby while breastfed.

What is Forfivo Xl | Bupropion Hydrochloride Tablet, Film Coated, Extended Release ?


FORFIVO XL (bupropion hydrochloride extended-release tablets) is 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)]. The physician who elects to use FORFIVO XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. FORFIVO XL is an aminoketone antidepressant indicated for the treatment of major depressive disorder (MDD) (1). The efficacy was established in two 4-week trials, one 6-week trial with bupropion immediate-release formulation, and one maintenance trial with bupropion sustained-release formulation, all in adults (14). Periodically re-evaluate long-term usefulness for the individual patient (1).

Is using Forfivo Xl | Bupropion Hydrochloride Tablet, Film Coated, Extended Release safe or dangerous while breastfeeding?

Forfivo Xl | Bupropion Hydrochloride Tablet, Film Coated, Extended Release low risk for breastfeeding
Forfivo Xl | Bupropion Hydrochloride Tablet, Film Coated, Extended Release contains only one active ingredient that is Bupropion hydrochloride. We have analyzed the usage of Bupropion hydrochloride in breastfeeding and our analysis suggest that Bupropion hydrochloride poses Low risk for infant while breastfeeding and hence Forfivo Xl | Bupropion Hydrochloride Tablet, Film Coated, Extended Release itself shall be considered Low risk item for 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 10 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 FORFIVO XL is administered to a nursing woman.

Forfivo Xl | Bupropion Hydrochloride Tablet, Film Coated, Extended Release Breastfeeding Analsys


Bupropion hydrochloride while Breastfeeding

Low Risk

CAS Number: 34911-55-2

Is Forfivo Xl | Bupropion Hydrochloride Tablet, Film Coated, Extended Release safe while 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:

Forfivo 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.


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

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 Forfivo Xl | Bupropion Hydrochloride Tablet, Film Coated, Extended Release then you shall inform your doctor, But you should not be worried too much as Forfivo Xl | Bupropion Hydrochloride Tablet, Film Coated, Extended Release comes in category of low risk drug.


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

Though Forfivo 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 Forfivo Xl | Bupropion Hydrochloride Tablet, Film Coated, Extended Release, will my baby need extra monitoring?

Not much


Who can I talk to if I have questions about usage of Forfivo 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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