Antiepileptic drugs and breastfeeding

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Davanzo et al Italian Journal of Pediatrics 2013 39 50 Page 2 of 11. http www ijponline net content 39 1 50, Table 1 Definitions and clinical relevance of the pharmacokinetic parameters used to assess the lactation risk. following maternal intake of medications,Pharmacokinetic parameter Definition. Half life or T The half life of a substance is the time it takes for its plasma concentration to halve If the half life is long 12 24 hrs. drugs may accumulate in maternal plasma and the time of drug transfer from plasma to breast milk is longer. Maternal plasma protein This parameter is expressed in percentage The higher the percentage of the drug bound to the maternal plasma. binding PB proteins the less the drug passes into breast milk An ideal drug to be taken during breastfeeding should have a. plasma protein binding 80, Milk to plasma ratio M P It denotes the ratio of the drug concentration in the mother s milk M divided by its concentration in the mother s. plasma P It is an indicator of drug transfer into breast milk A M P ratio greater than 1 0 suggests that the drug may. be present in breast milk in high concentrations, Oral bioavailability It describes the fraction of one orally administered dose of a drug that reaches the systemic circulation It is expressed. as a percentage of the administered dose When the intestinal absorption of a drug is impaired the risk of adverse. effects may be lower, absorption or the liver sequestration prior to entering the risk see below in order to have a clinical overview of.
plasma compartment Table 2 summarises each AED main each AED. pharmacokinetic characteristics TID is the maximum estimated amount of ingested drug. Beyond presenting pharmacokinetic parameters on with breast milk in other words it is the estimation in. AEDs we chose to collect more relevant clinical param milligrams per kilogram per day of the theoretical infant. eters such as the theoretical infant dose TID the thera dose TID We calculated it by using the formula by. peutic dose in the neonatal period and the relative infant Atkinson TID daily breast milk intake 150 ml kg day. dose RID All these parameters were reported in a table maximum breast milk concentration of medication 4. Table 3 together with the assessment of the lactation As AEDs may be used in the neonatal period as therapy. Table 2 Main pharmacokinetic characteristics of antiepileptic drugs. Bioavailability hours,Carbamazepine 74 100 18 54 0 69. Clonazepam 50 86 100 18 50 0 33,Diazepam 99 100 43 0 2 2 7. Ethosuximide NA 100 30 60 0 94,Gabapentin 3 50 60 5 7 0 7 1 3. Lamotrigine 55 98 29 0 057 1 47 33,Levetiracetam 10 100 6 8 0 76 1 55 37 38. Oxcarbazepine 40 100 9 oxcarbazepine metabolyte 0 5. Phenobarbital 51 80 100 20 133 0 4 0 6,45 500 in newborns 41.
Phenytoin 89 70 100 6 24 0 18 0 45,20 160 in preterm infants 48. Pregabalin NA 90 6 NA,Primidone 25 90 5 18 0 72,Tiagabine 96 90 7 9 NA. Topiramate 15 75 18 24 0 86 1 1 55,Valproate 94 100 14 0 42. Vigabatrin NA 50 7 1,Zonisamide 40 NA 63 0 93, PB maternal plasma protein binding expressed as percentage. Oral Bioavailability intestinal absorption after oral administration expressed as percentage of the administered dose. T half life of the drug,M P milk to plasma ratio of a drug concentration.
Data drawn from references 1 8 except where otherwise specified NA indicates that no data are available. Davanzo et al Italian Journal of Pediatrics 2013 39 50 Page 3 of 11. http www ijponline net content 39 1 50, Table 3 Clinical relevant parameters for each antiepileptic drug and assessment of their lactation risk. Drug TID Neonatal therapeutic RID Assessment of the lactation risk according to. mg kg day Hale LactMed 2013 Present study,mg kg day 2012. including adverse drug reactions, Carbamazepine 0 7 10 20 3 8 5 9 L2 CBZ levels are relatively high in breast milk Safe. Breastfed infants have serum levels that are usually. below the therapeutic range,Side effects were rarely reported as sedation. decreased suckling withdrawal reactions and 3 cases. of liver dysfunction,Infant should be monitored for jaundice.
drowsiness adequate weight gain and,developmental milestones especially in premature. infants exclusively breastfed and in combination,with other antipsychotics. Clonazepam 0 002 0 1 0 2 2 8 L3 Monitor growth sedation developmental Contraindicated. milestones especially in preterm neonates,exclusively breastfed infants and if mother is. receiving psychotropic drugs,Monitoring of serum concentration in breastfed. infant if excessive sedation occurs, Diazepam 0 05 IV dose available 7 1 L3 Accumulates in maternal milk and serum of Contraindicated.
breastfed infant Other agents are preferred, 0 1 0 3 especially while nursing a newborn or preterm. Oral dose infant, 0 5 1 76 Single dose does not require delaying feeding. Ethosuximide 11 5 15 40 31 4 73 5 L4 Monitor infant for drowsiness adequate weight Contraindicated. gain and psychomotor development,Measurement of an infant serum level might help. rule out toxicity if there is a concern, Gabapentin 1 7 Only paediatric 1 3 6 6 L2 Monitor the infant for drowsiness adequate weight Moderately safe. dose available gain and developmental milestones especially in. younger exclusively breastfed infants and when,10 15 using combinations of anticonvulsant or.
psychotropic drugs, Lamotrigine 0 7 1 6 with valproate 5 15 9 2 L3 It is not necessary to discontinue Moderately safe. with enzyme breastfeeding but any adverse effects such as. inducing AEDs apnoea rash drowsiness decreased sucking are. to be monitored and serum levels are to be,Monitoring of the platelet count may also be. Levetiracetam 3 9 5 10 78 3 4 7 8 L3 Monitor infant for the appearance of sleepiness Moderately safe. increase appropriate weight normal psychomotor,development. Oxcarbazepine NA 27 7 50 1 5 1 7 L3 Monitor the infant for drowsiness and decreased Moderately safe. feeding and developmental milestones especially,18 years 72. in the first 2 months of life, Phenobarbital 0 4 3 4 24 L3 The presence of phenobarbital in breast milk may Safe.
mitigate possible neonatal abstinence,Monitor the breastfed infant for the possible. onset of drowsiness adequate weight gain and,developmental milestones especially in younger. exclusively breastfed infants and antiepileptic,polytherapy. Measurement of the infant s serum drug,concentration might help rule out toxicity. Davanzo et al Italian Journal of Pediatrics 2013 39 50 Page 4 of 11. http www ijponline net content 39 1 50, Table 3 Clinical relevant parameters for each antiepileptic drug and assessment of their lactation risk Continued.
Phenytoin 0 4 5 8 0 6 7 7 L2 The proportion ingested by infants is small and Safe. generally brings about no problems except in rare,cases of idiosyncratic reactions. Pregabalin NA 5 14 79 NA L3 Compatible with breastfeeding Moderately Safe. An alternate drug may be preferred especially,while nursing a newborn or preterm infant. Primidone 0 9 12 20 8 4 8 6 L3 The presence of phenobarbital in breast milk may. mitigate possible neonatal abstinence, Monitor the breastfed infant for the possible Safe. onset of drowsiness adequate weight gain and,developmental milestones especially in younger. exclusively breastfed infants and antiepileptic,polytherapy.
Measurement of the infant s serum drug,concentration might help rule out toxicity. Tiagabine NA 12 years limited data NA L3 Monitor the infant for the onset of drowsiness Moderately safe. available for adequate weight gain and for developmental. milestones especially in younger exclusively,breastfed infants and when using combinations. of anticonvulsant or psychotropic drugs,Other drugs should be preferred especially while. nursing a newborn or preterm infant, Topiramate 0 3 1 6 24 5 L3 Monitor the infant for the onset of diarrhea Moderately safe. drowsiness increase appropriate weight and,2 years 80.
psychomotor development, Valproate 0 7 Limited data available 1 4 1 7 L3 Breastfed infants are at risk for hepatotoxicity Safe. in the neonatal period,Monitor the infant for unusual bleeding. a case of thrombocytopenia has been reported, Vigabatrin 0 1 25 50 1 5 2 7 L3 Until more data are available vigabatrin should Moderately safe. only be used with careful monitoring during,S enantiomer. breastfeeding, Zonisamide 1 9 5 8 28 9 36 8 L4 Monitor infant for drowsiness adequate weight Contraindicated.
gain and psychomotor development,Measurement of an infant serum level might help. rule out toxicity if there is a concern,TID theoretical infant dose. RID relative infant dose, Hale lactaction risk categories L1 safe drugs at the highest level L2 safe L3 moderately safe L4 possibly dangerous L5 contraindicated Present study risk categories The. moderately safe category has a less documented safety profile due to a short clinical experience and lack of studies The moderately safe AEDs can be used but the lowest. dose of the drug should be chosen and the nursing infant should be clinically monitored and when possible his her plasma level should be checked. Data drawn from reference 1 41 except where otherwise specified NA indicates that no data are available. we presented their therapeutic dose expressed in mg kg TOXNET 6 of the National Library of Medicine In. day in order to have a direct comparison with the TID A his textbook updated every two years Hale collects data. therapeutic dose which is higher than the TID reassures of on many current medications and their use during. the drug safety during breastfeeding RID represents one breastfeeding After evaluating information on pharma. of the most useful parameters for assessing the lactation cokinetics and what is currently published in the scien. risk RID is calculated by dividing the infant dose via milk tific literature for each drug including its reported side. in mg kg day by maternal dose in mg kg day assum effects he makes a personal recommendation using a 5. ing a 70 kg weight 5 Many authors agree that anything categories of lactation risk L1 safe drugs at the highest. less than 10 of the maternal dose is considered probably level L2 safe drugs L3 moderately safe drugs L4 drugs. safe 5 possibly dangerous L5 contraindicated drugs LactMed. To review the lactation risk of AEDs we consulted the database is part of the National Library of Medicine s. following two most accredited English sources Medica Toxicology Data Network TOXNET and it includes. tions and Mother s Milk 2012 a Manual of Lactational information on the levels of drugs and other chemicals. Pharmacology 1 and the 2013 Lactmed database in to which breastfeeding mothers may be exposed in. Davanzo et al Italian Journal of Pediatrics 2013 39 50 Page 5 of 11. http www ijponline net content 39 1 50, breast milk and infant blood together with the possible 9 Its active metabolite tends to accumulate during. adverse effects in the nursing infant All data published prolonged lactation Lethargy and difficult feeding have. in LactMed are derived from the scientific literature and been attributed to diazepam during breastfeeding 10. fully referenced Maternal plasma peak usually occurs within 2 h By. To complete our synopsis we have also performed a delaying feeding the infant exposure to diazepam with. non systematic Medline search of the literature with the maternal milk can be reduced. keywords antiepileptic drugs AND breastfeeding re Despite its scarce transfer into maternal milk clonaze. trieving studies from 2004 to April 9th 2013 including pam was reported to cause irregular breathing apnea and. the most relevant and up dated studies on lactation risk cyanosis in the first 10 days of life in an infant whose. Data from the Committee on Drugs of the American mother had been taking the drug also during pregnancy. Academy of Pediatrics AAP 7 and the Goodman The child psychomotor development at 5 months was. Gilman s Textbook of Pharmacology 8 were also included normal 11 On the contrary in the study of Birnbaum. in our review no side effects on breastfed infants were reported by. For each AED we organized the relevant data into mothers treated with benzodiazepines in association with. small summaries antidepressants 12 Clonazepam has a later plasma peak. As the result of our review we classified AEDs in 3 2 6 hours which limits the feasibility of delaying feeding. categories safe moderately safe and contraindicated in order to reduce the infant exposure. during breastfeeding The moderately safe category has a. less documented safety profile due to a short clinical Carbamazepine. experience and lack of studies However the moderately Carbamazepine CBZ is a broad spectrum anticonvul. safe AEDs can be used with caution The lowest dose of sant also used in psychiatric disorders such as schizo. the drug should be chosen and the nursing infant should phrenia and in trigeminal neuralgia If taken during. be monitored and when possible his her plasma level pregnancy its concentration compared to the maternal. should be checked serum level ranges 60 76 in the umbilical cord and 32. 80 in breast milk 13 Most available studies on carba. Results mazepine in human milk usually refer to women under. Benzodiazepines anticonvulsant polytherapy with possible interference. Benzodiazepines BDZ are multiple action psychoactive between drugs. compounds Therefore they may be used as anxiolytics The CBZ and its active epoxide metabolite ECBZ are. antiepileptic drugs AEDs some concerns on infant health may raise The decision to encourage breast feeding in those women should be taken after a careful evaluation of the possible side effects on the infant caused by the indirect exposure to AEDs via breast milk Data on the use of AEDs by the nursing woman are mainly represented by single pharmacologic or pharma cokinetic studies and or

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