Lamotrigine Chewable Dispersible Tablet, For Suspension Breastfeeding

Modern medicine has evolved so much so that sooner or later every breastfeeding mother needs to take it in one form or other. Medication that is present in mothers blood will transfer into her breast milk to some extent. Most drugs do so at low levels and pose no real risk to infants but then there are some exceptions. In This post will discuss whether Lamotrigine Chewable Dispersible Tablet, For Suspension is safe in breast-feeding or not.

What is Lamotrigine Chewable Dispersible Tablet, For Suspension used for?


1. INDICATIONS AND USAGE Lamotrigine tablet for oral suspension USP (chewable dispersible tablet) is indicated for: Epilepsy - adjunctive therapy in patients aged 2 years and older: · partial-onset seizures. · primary generalized tonic-clonic seizures. · generalized seizures of Lennox-Gastaut syndrome. (1.1) Epilepsy - monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, phenytoin, primidone, or valproate as the single AED. (1.1) Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets for oral suspension USP (chewable dispersible tablets) in the acute treatment of mood episodes has not been established. 1.1. Epilepsy Adjunctive Therapy Lamotrigine tablets for oral suspension USP (chewable dispersible tablets) are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. Monotherapy Lamotrigine tablets for oral suspension USP (chewable dispersible tablets) are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine tablets for oral suspension USP (chewable dispersible tablets)have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.2. Bipolar Disorder Lamotrigine tablets for oral suspension USP (chewable dispersible tablets) are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies (14.2)]. Limitations of Use Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets for oral suspension USP (chewable dispersible tablets) in the acute treatment of mood episodes has not been established.

Is Lamotrigine Chewable Dispersible Tablet, For Suspension safe to use while breastfeeding? Can it interfere with growth and development of my kid?

Lamotrigine Chewable Dispersible Tablet, For Suspension low risk for breastfeeding
Lamotrigine is the one and only active ingredient present in Lamotrigine Chewable Dispersible Tablet, For Suspension. Lamotrigine in itself is a low risk drug for lactation so it is easy to understand that Lamotrigine Chewable Dispersible Tablet, For Suspension 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. Data from 904 multiple small studies indicate that lamotrigine plasma levels in human milk-fed infants have 905 been reported to be as high as 50% of the maternal serum levels. Neonates and young infants are 906 at risk for high serum levels because maternal serum and milk levels can rise to high levels 907 postpartum if lamotrigine dosage has been increased during pregnancy but not later reduced to 908 the pre-pregnancy dosage. Lamotrigine exposure is further increased due to the immaturity of the 909 infant glucuronidation capacity needed for drug clearance. Events including apnea, drowsiness, 910 and poor sucking have been reported in infants who have been human milk-fed by mothers using 911 lamotrigine; whether or not these events were caused by lamotrigine is unknown. Human 912 milk-fed infants should be closely monitored for adverse events resulting from lamotrigine. 913 Measurement of infant serum levels should be performed to rule out toxicity if concerns arise. 914 Human milk-feeding should be discontinued in infants with lamotrigine toxicity. Caution should 915 be exercised when lamotrigine is administered to a nursing woman.

Lamotrigine Chewable Dispersible Tablet, For Suspension 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 Chewable Dispersible Tablet, For Suspension Breastfeeding Analsys - 2


Lamotrigine while Breastfeeding

CAS Number: 84057-84-1

Is Lamotrigine Chewable Dispersible Tablet, For Suspension safe while 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.



I am nursing mother and I have already used Lamotrigine Chewable Dispersible Tablet, For Suspension, what should I do?

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 Lamotrigine Chewable Dispersible Tablet, For Suspension then you shall inform your doctor, But you should not be worried too much as Lamotrigine Chewable Dispersible Tablet, For Suspension comes in category of low risk drug.


My health care provider has asked me to use Lamotrigine Chewable Dispersible Tablet, For Suspension, what to do?

Though Lamotrigine Chewable Dispersible Tablet, For Suspension 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 Lamotrigine Chewable Dispersible Tablet, For Suspension, will my baby need extra monitoring?

Not much


Who can I talk to if I have questions about usage of Lamotrigine Chewable Dispersible Tablet, For Suspension 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