Lamotrigine | Unit Dose Services 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 Lamotrigine | Unit Dose Services for its safety in breastfeeding.

What is Lamotrigine | Unit Dose Services used for?


Lamotrigine tablets, USP 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, 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 in the acute treatment of mood episodes has not been established. 1.1 Epilepsy Adjunctive Therapy Lamotrigine tablets, USP is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: Monotherapy Lamotrigine tablets, USP is 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, USP 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, USP is 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 (14.1)]. Limitations of Use Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine tablets, USP in the acute treatment of mood episodes has not been established.

Lamotrigine | Unit Dose Services while breastfeeding safe or not? Can there be any side effects for infant while using it during breastfeeding?

Lamotrigine | Unit Dose Services low risk for breastfeeding
Lamotrigine is the one and only active ingredient present in Lamotrigine | Unit Dose Services. Lamotrigine in itself is a low risk drug for lactation so it is easy to understand that Lamotrigine | Unit Dose Services 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 tablets. 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 tablet is administered to a nursing woman.

Lamotrigine | Unit Dose Services 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 | Unit Dose Services Breastfeeding Analsys - 2


Lamotrigine while Breastfeeding

CAS Number: 84057-84-1

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 already used Lamotrigine | Unit Dose Services 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 Lamotrigine | Unit Dose Services then you shall inform your doctor, But you should not be worried too much as Lamotrigine | Unit Dose Services comes in category of low risk drug.


I am nursing mother and my doctor has suggested me to use Lamotrigine | Unit Dose Services, is it safe?

Though Lamotrigine | Unit Dose Services 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 | Unit Dose Services, will my baby need extra monitoring?

Not much


Who can I talk to if I have questions about usage of Lamotrigine | Unit Dose Services 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