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

What is Lamotrigine Tablet, Film Coated, Extended Release used for?


Lamotrigine extended-release tablets are indicated for: Adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1) Conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single AED. ( 1.2) Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. ( 1.3) 1.1 Adjunctive Therapy Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. 1.2 Monotherapy Lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Safety and effectiveness of lamotrigine extended-release tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.3 Limitation of Use Safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established.

Is using Lamotrigine Tablet, Film Coated, Extended Release unsafe in breastfeeding? Can there be bad consequences for baby if I use it while breastfeeding?

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

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Lamotrigine is present in milk from lactating women taking lamotrigine extended-release. Data from multiple small studies indicate that lamotrigine plasma levels in human milk-fed infants have been reported to be as high as 50% of the maternal serum levels. Neonates and young infants are at risk for high serum levels because maternal serum and milk levels can rise to high levels postpartum if lamotrigine dosage has been increased during pregnancy but not later reduced to the pre-pregnancy dosage. Lamotrigine exposure is further increased due to the immaturity of the infant glucuronidation capacity needed for drug clearance. Events including apnea, drowsiness, and poor sucking have been reported in infants who have been human milk-fed by mothers using lamotrigine; whether or not these events were caused by lamotrigine is unknown. Human milk-fed infants should be closely monitored for adverse events resulting from lamotrigine. Measurement of infant serum levels should be performed to rule out toxicity if concerns arise. Human milk-feeding should be discontinued in infants with lamotrigine toxicity. Caution should be exercised when lamotrigine extended-release is administered to a nursing woman.

Lamotrigine Tablet, Film Coated, Extended Release Breastfeeding Analsys


Lamotrigine while Breastfeeding

Low Risk

CAS Number: 84057-84-1

As high as therapeutic levels of this drug have been found in the serum of infants (35-50% of maternal serum level). Side-effects were not observed, neither developmental nor IC derangements at long term follow-up among hundreds of children of treated mothers. A case was published of apnea in a newborn baby whose mother was on a very high dose of Lamotrigine (850 mg a-day). During pregnancy, it increases the clearance of Lamotrigine and other antiepileptic medication that warrants an increase in dosage in this period. After birth, the serum level rapidly increases with a risk of harm on both the mother and the infant, whenever dose is not reduced to that previous from pregnancy. An infant, 1 1/2 months old, whose mother was on Lamotrigine, resulted affected with Abstinence Syndrome soon after sudden weaning.


Lamotrigine Tablet, Film Coated, Extended Release Breastfeeding Analsys - 2


Lamotrigine while Breastfeeding

CAS Number: 84057-84-1

Lamotrigine Tablet, Film Coated, Extended Release and breastfeeding

Occasional adverse reactions have been reported in infants who receive lamotrigine in milk, but long-term exposure does not appear to affect infant growth and development. Breastfed infants whose mothers are taking lamotrigine have relatively high plasma lamotrigine levels. Neonates are particularly at risk for high plasma levels because their ability to metabolize the drug by glucuronidation is limited, plasma protein binding is relatively low, and maternal plasma and milk levels can rise dramatically in the immediate postpartum period if the dosage is not reduced to the prepregnancy dosage.[1][2] If lamotrigine is required by the mother, it is not necessarily a reason to discontinue breastfeeding, because many infants have been breastfed without adverse reactions. However, breastfed infants should be carefully monitored for side effects such as apnea, rash, drowsiness or poor sucking, including measurement of serum levels to rule out toxicity if there is a concern. Monitoring of the platelet count and liver function may also be advisable. If an infant rash occurs, breastfeeding should be discontinued until the cause can be established.


Is Lamotrigine Tablet, Film Coated, Extended Release safe while breastfeeding

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

Lamotrigine 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 Lamotrigine Tablet, Film Coated, Extended Release so you should inform him based on your convenience.


My health care provider has asked me to use Lamotrigine Tablet, Film Coated, Extended Release, what to do?

Lamotrigine 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 Lamotrigine Tablet, Film Coated, Extended Release, will my baby need extra monitoring?

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


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