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Medications and Lactation: Principles
for Safe Practice for the Clinician
Evelyn Fulmore, Pharm.D.
McLeod Regional Medical
Center
Florence, SC
Disclosures
 No financial relationships or duality of
interest to disclose
 I will be discussing use of agents to improve
milk supply (galactagogues)
Learning Objectives
 Basic physiology of lactation and
mechanisms of medication entry into
mother’s breast milk
 Factors to consider when selecting
medications during lactation
 Role of galactagogues in lactation induction
 Tips in utilizing and interpreting available
lactation drug information resources
Physiology of LactationPhysiology of Lactation
 Suckling stimulatesSuckling stimulates
nipplenipple →→ pituitary glandpituitary gland
secretes oxytocinsecretes oxytocin →→ letlet
down reflex results indown reflex results in
milk ejecting cellsmilk ejecting cells
contract forcing milkcontract forcing milk
from milk cells into milkfrom milk cells into milk
ducts.ducts.
Physiology of LactationPhysiology of Lactation
 Milk pools in laciferousMilk pools in laciferous
sinuses under thesinuses under the
areola. Sucklingareola. Suckling
stimulates milk to comestimulates milk to come
from the nipple.from the nipple.
Composition of BreastmilkComposition of Breastmilk
 ColostrumColostrum (Days #3-5)(Days #3-5)
high protein, immunoglobulins, minerals, low inhigh protein, immunoglobulins, minerals, low in
lactose and fatlactose and fat
 Transitional milkTransitional milk (Days #6-10)(Days #6-10)
high in fat, lactose; lower in protein and mineralshigh in fat, lactose; lower in protein and minerals
 Mature milkMature milk (Day #14)(Day #14)
60-80% whey protein, 50% fat, 40% lactose, growth60-80% whey protein, 50% fat, 40% lactose, growth
factor, low in Vitamin Dfactor, low in Vitamin D
Factors Affecting Amount of Drug
Received by the Infant
 Milk yield
 Colostrum versus Mature milk
 Concentration of drug in the milk
 How well the breast was emptied during the
previous feeding
 Infants ability to absorb, detoxify, and excrete
the drug
Transfer of Medications intoTransfer of Medications into
Breast MilkBreast Milk
 Concentration gradientConcentration gradient
– Passive diffusion of non-ionized and free (non-Passive diffusion of non-ionized and free (non-
protein bound) medsprotein bound) meds
– Maternal serum drug concentrationMaternal serum drug concentration
volume of distribution (Vd) and half-lifevolume of distribution (Vd) and half-life
- Retrograde diffusion of drug from breast milk toRetrograde diffusion of drug from breast milk to
plasmaplasma
Spencer JP et.al. Medications in the Breast-Feeding Mother. AFP 2001;Spencer JP et.al. Medications in the Breast-Feeding Mother. AFP 2001;
64:11964:119
Transfer of Medications intoTransfer of Medications into
Breast MilkBreast Milk
1.1. Lipid solubilityLipid solubility
2.2. Molecular weightMolecular weight
3.3. Maternal plasma levelsMaternal plasma levels
4.4. Maternal protein bindingMaternal protein binding
5.5. Oral bioavailability, half lifeOral bioavailability, half life
6.6. Ion trapping (pKa)Ion trapping (pKa)
Lipid SolubilityLipid Solubility
 Drugs that are highly lipid soluble penetrateDrugs that are highly lipid soluble penetrate
milk in higher concentrationsmilk in higher concentrations
 Avoid extremely lipid soluble drugs.Avoid extremely lipid soluble drugs.
 Examples: Diazepam, phenobarbitalExamples: Diazepam, phenobarbital
Molecular WeightMolecular Weight
 The lower the molecular weight (<200 D), theThe lower the molecular weight (<200 D), the
greater penetration into milkgreater penetration into milk
 Molecular weights <300 D : (eg. Alcohol,Molecular weights <300 D : (eg. Alcohol,
amphetamines, diet pills)amphetamines, diet pills)
 Molecular weightsMolecular weights ≥ 600 D : (eg. Heparin,≥ 600 D : (eg. Heparin,
Enoxaparin, Insulin, Remicade)Enoxaparin, Insulin, Remicade)
 Larger the molecular weight/size (preferred)Larger the molecular weight/size (preferred)
Maternal Plasma levelMaternal Plasma level
 The most important determinant of drugThe most important determinant of drug
penetration into milkpenetration into milk
 As maternal plasma levels rise, theAs maternal plasma levels rise, the
concentration in milk risesconcentration in milk rises
 Drug delivery systems that result in lowDrug delivery systems that result in low
maternal plasma levels are preferred inmaternal plasma levels are preferred in
breast feeding mother (eg. Inhaler med,breast feeding mother (eg. Inhaler med,
topicals)topicals)
Maternal Protein BindingMaternal Protein Binding
 Most important parameter in choosing aMost important parameter in choosing a
safe drug for a nursing mothersafe drug for a nursing mother
 Most drugs circulate in the maternalMost drugs circulate in the maternal
plasma bound to albuminplasma bound to albumin
 ““Free” or “Unbound” drug transfers intoFree” or “Unbound” drug transfers into
milkmilk
 Drugs that are highly protein boundDrugs that are highly protein bound
remain in the maternal plasma and don’tremain in the maternal plasma and don’t
penetrate tissues or breast milkpenetrate tissues or breast milk
Oral BioavailabilityOral Bioavailability
 The amount of drug that is absorbed by theThe amount of drug that is absorbed by the
infant’s GI tract and reaches the circulationinfant’s GI tract and reaches the circulation
 Low oral bioavailability: aminoglycosides,Low oral bioavailability: aminoglycosides,
heparin, insulin, omeprazoleheparin, insulin, omeprazole
 Action of a drug in the GI tract may produceAction of a drug in the GI tract may produce
SE: diarrhea, constipation, PMCSE: diarrhea, constipation, PMC
Ion Trapping (pKa)Ion Trapping (pKa)
 Ion trapping – drug becomes trapped in milkIon trapping – drug becomes trapped in milk
compartment (due to low pH milk)compartment (due to low pH milk)
 pKa is the pH where a drug is equally ionic orpKa is the pH where a drug is equally ionic or
nonionic (the more ionic, less transfer fromnonionic (the more ionic, less transfer from
milk to plasma)milk to plasma)
 Drugs with high pKa (>7.2), have higherDrugs with high pKa (>7.2), have higher
Milk/Plasma ratio (eg.Phenobarbital,Milk/Plasma ratio (eg.Phenobarbital,
iodinated drugs)iodinated drugs)
 Choose drugs with a low pKaChoose drugs with a low pKa
Drugs That Decrease Milk SupplyDrugs That Decrease Milk Supply
 NicotineNicotine
 AlcoholAlcohol
 Sedating Antihistamines (eg. Diphenhydramine)Sedating Antihistamines (eg. Diphenhydramine)
 Estrogen containing oral contraceptivesEstrogen containing oral contraceptives
 Progesterone contraceptives (if started earlyProgesterone contraceptives (if started early
postpartum before milk supply established)postpartum before milk supply established)
 Bromocriptine (Parlodel)Bromocriptine (Parlodel)
Drugs That Aid in Milk Production:
Galactagogues
 Herbals: Fenugreek
 Metoclopramide (Reglan)
 Domperidone (Motillium)
 Synthetic Oxytocin nasal spray
Galactagogues
 Used to increase breast milk supply
 Need to determine the etiology of low milk
supply
 Ensure proper breastfeeding technique
 Only use with adequate milk removal
 Must evaluate for medical co-morbidities
(e.g. hypothyroidism, retained placenta)
Herbal: Fenugreek
 Trigonella foenum graecum
 MOA: stimulate sweat production;
Phytoestrogen and Diosgenin - increase
milk flow
 Tea (bitter taste), capsule or tablet
 Sweat and urine (maple syrup smell)
 Caution use in Asthma or diabetes
 Contains coumarin (interact with
NSAIDS)
 No scientific data
Domperidone (Motillium)
 Not approved for use in the US
 MOA: increase prolactin → milk production
 Maternal safety has not been established
 FDA warning concerning reports of QT
interval prolongation, cardiac arrest, sudden
death (IV formulation)
 Clinical trial showed increase breastmilk
volume without affecting nutrient composition
Campbell-Yeo M. Effect of Domperidone on Compositiono of Preterm Human
Breast Milk. Pediatrics 2010; 125 (1):e107-e114
Metoclopramide (Reglan)
 Most commonly used
 MOA: increase prolactin
 Caution: clearance of metoclopramide in the
neonate is prolonged can result in side
effects (methemoglobinemia)
 Short term use recommended (1-3 weeks)
 Common dosing: 1st
day – 10 mg, 2nd
day – 10
mg bid, thereafter 10 mg tid
Synthetic Oxytocin Nasal Spray
 Hormone (synthetically derived)
 MOA: causes release of milk from milk
glands to the ducts (helps empty the breast)
 Prepared by compounding Rx (10 unit/ml)
 Dose: 1-2 sprays each nostril before breast
feeding or pumping
Synthetic Oxytocin Nasal Spray:
Mean Daily Milk Production
Fewtrell MS. Arch Dis Child Fetal Neonatal Ed. 2006 May; 91(3): F169–F174.
Medications and Lactation: Principles for Safe Practice for the Clinician
Safety Data and Breast FeedingSafety Data and Breast Feeding
 Breast feeding lacks standardized riskBreast feeding lacks standardized risk
categoriescategories
 Most of the data on meds and breast feedingMost of the data on meds and breast feeding
are from scientific literatureare from scientific literature
 Given the lack of standardization, otherGiven the lack of standardization, other
recommendations for using meds whilerecommendations for using meds while
breast feeding have been used by healthbreast feeding have been used by health
care providerscare providers
Master KP et.al. Breast Feeding and OTC medications. US Pharm 2007; 32 (7): 8-12Master KP et.al. Breast Feeding and OTC medications. US Pharm 2007; 32 (7): 8-12
Lactation ResourcesLactation Resources
 BooksBooks
– Gerald G. Briggs. “Gerald G. Briggs. “DrugsDrugs
in Pregnancy andin Pregnancy and
Lactation: A referenceLactation: A reference
Guide to Fetal andGuide to Fetal and
Neonatal Risk”, 9Neonatal Risk”, 9thth
edition; 2012edition; 2012
Briggs GG et. al. Drugs in Pregnancy andBriggs GG et. al. Drugs in Pregnancy and
Lactation, 2008; 8th editionLactation, 2008; 8th edition
Definitions of Breast Feeding
Recommendations
 Compatible
 Hold Breast Feeding
 No (limited) Human Data – Probably Compatible
 No (limited) Human Data – Potential Toxicity
 No (limited) Human Data – Potential Toxicity
(Mother)
 Contraindicated
Lactation ResourcesLactation Resources
 BooksBooks
– Thomas W. Hale.Thomas W. Hale.
““Medications andMedications and
Mothers’ Milk” 2012, 15Mothers’ Milk” 2012, 15thth
editionedition
Hale TW. Medications and Mothers' Milk, 2010;Hale TW. Medications and Mothers' Milk, 2010;
14th edition.14th edition.
Dr. Hale’s Lactation Risk Category
 L1 Safest
 L2 Safer
 L3 Moderately Safe
 L4 Potentially Hazardous
 L5 Contraindicated
Dr. Hale’s Lactation Risk CategoryDr. Hale’s Lactation Risk Category
 L1L1 SafestSafest: Drug taken by larger # of breast: Drug taken by larger # of breast
feeding women without any observedfeeding women without any observed
adverse effects in infantadverse effects in infant
 L2L2 SaferSafer: Drug studied in a limited # of: Drug studied in a limited # of
breast feeding women without any observedbreast feeding women without any observed
adverse events in infantsadverse events in infants
 L3L3 Moderately SafeModerately Safe: No controlled trials in: No controlled trials in
breast feeding women, but risk of untowardbreast feeding women, but risk of untoward
effects is possibleeffects is possible
Dr. Hale’s Lactation Risk CategoryDr. Hale’s Lactation Risk Category
 L3L3 Moderately SafeModerately Safe: No controlled trials in: No controlled trials in
breast feeding women, but risk of untowardbreast feeding women, but risk of untoward
effects is possibleeffects is possible OROR controlled studiescontrolled studies
show only minimal non-threatening adverseshow only minimal non-threatening adverse
effectseffects
 L4L4 Potentially HazardousPotentially Hazardous: Positive: Positive
evidence of risk to the breastfed infantevidence of risk to the breastfed infant OROR toto
the breast milk production but benefitthe breast milk production but benefit
outweighs the riskoutweighs the risk
Dr. Hale’s Lactation Risk CategoryDr. Hale’s Lactation Risk Category
 L5L5 ContraindicatedContraindicated: Studies in: Studies in
breastfeeding women have demonstratedbreastfeeding women have demonstrated
significant and documented risk to the infant.significant and documented risk to the infant.
Risk clearly outweighs benefits of breastRisk clearly outweighs benefits of breast
feeding.feeding.
Values Used to Estimate Infant Drug
Exposure
 Milk to Plasma Ratio (M/P)
– Ratio of the concentration of drug in mother’s milk divided by the
concentration in the mother’s plasma
– M/P <1 is preferred
 Theoretical Infant Dose (TID)
– Multiply the milk concentration x daily milk intake of the infant
– Compared to the usual maintenance pediatric dose
 Relative Infant Dose (RID)
– Divide the infant’s dose via milk (mg/kg/day) by the mother’s dose
(mg/kg/day)
– Assumes daily milk intake of 150 ml/kg/day
– RID<10% is considered safe
– Exception: fluconazole, metronidazole (have a high RID but are
non toxic)
Lactation ResourcesLactation Resources
 InternetInternet
– Dr. Hale’s BreastfeedingDr. Hale’s Breastfeeding
Pharmacology pagePharmacology page ((
http://www.neonatal.ttuhsc.edu/facthttp://www.neonatal.ttuhsc.edu/fact))
Lactation ResourcesLactation Resources
 InternetInternet
– U.S. National Library ofU.S. National Library of
Medicine.Medicine. LactMedLactMed
(http://toxnet.nlm.nih.gov/cgi-(http://toxnet.nlm.nih.gov/cgi-
bin/sis/htmlgen?)/LACT)bin/sis/htmlgen?)/LACT)
LactMed
LactMed
Linezolid (Zyvox)
The Transfer of Drugs and Other Chemicals Into Human Milk
Committee on Drugs
Pediatrics 2001;108;776
CLINICAL REPORT
The Transfer of Drugs and Therapeutics Into Human
Breast Milk: An Update on Selected Topics
Hari Cheryl Sachs, MD, FAAP* and COMMITTEE ON DRUGS
Pediatrics; originally published online August 26, 2013;
DOI: 10.1542/peds.2013-1985
BeforeBefore Prescribing Drug Therapy in thePrescribing Drug Therapy in the
Lactating WomanLactating Woman
1.1. Is drug therapy really necessary?Is drug therapy really necessary?
2.2. The safest drug should be chosen.The safest drug should be chosen.
3.3. If there is a possibility that a drug mayIf there is a possibility that a drug may
present a risk to the infant, then considerpresent a risk to the infant, then consider
measuring blood levelsmeasuring blood levels
4.4. Drug exposure in the infant may be limitedDrug exposure in the infant may be limited
by timing of med and breastfeedingby timing of med and breastfeeding
AAP Committee on Drugs. The transfer of drugs and other chemicalsAAP Committee on Drugs. The transfer of drugs and other chemicals
into human milk. Pediatrics 2001;108 (3):777into human milk. Pediatrics 2001;108 (3):777
AnalgesicsAnalgesics
 Acetaminophen (Tylenol) is compatible with breastAcetaminophen (Tylenol) is compatible with breast
feedingfeeding
 Nonsteroidal antiinflammatory drugs (NSAIDS) –Nonsteroidal antiinflammatory drugs (NSAIDS) –
ibuprofen is preferredibuprofen is preferred
– Naprosyn, sulindac, piroxicam should be avoidedNaprosyn, sulindac, piroxicam should be avoided
 Narcotic/Opiates – morphine, codeine, oxycodone,Narcotic/Opiates – morphine, codeine, oxycodone,
and hydrocodone are compatible with breast feedingand hydrocodone are compatible with breast feeding
– Meperidine (Demerol) should be avoidedMeperidine (Demerol) should be avoided
Narcotics/Opiates
 Case controlled studies evaluating long term
developmental outcomes are needed
 Breastfeeding should be supported if:
– “stable” and compliant with methadone or
buprenorphine +/- naloxone (Subutex®, Suboxone®)
– negative maternal urine toxicology test at delivery
except for prescribed medications
– plan to continue substance abuse treatment in the
postpartum period
– do not have medical contraindication to breastfeeding
Breastfeeding Medicine 2009; 4(4):225-228
AntibioticsAntibiotics
 Penicillins and cephalosporins are compatible with breastPenicillins and cephalosporins are compatible with breast
feedingfeeding
– Monitor infant for diarrhea (change in gut flora)Monitor infant for diarrhea (change in gut flora)
 Tetracycline is compatible with breast feedingTetracycline is compatible with breast feeding
– Calcium in breast milk limits absorption ; avoid doxycyline andCalcium in breast milk limits absorption ; avoid doxycyline and
minocyclineminocycline
 Quinolones have not been rated by AAPQuinolones have not been rated by AAP
– Levaquin is compatible with breast feedingLevaquin is compatible with breast feeding
 Trimethoprim-sulfamethoxazole (Bactrim) is compatible withTrimethoprim-sulfamethoxazole (Bactrim) is compatible with
breast feedingbreast feeding
– Not recommended in infants < 2 month (deplacement of bilirubin)Not recommended in infants < 2 month (deplacement of bilirubin)
AntidepressantsAntidepressants
 Tricyclic antidepressants – little or no effect on breast feedingTricyclic antidepressants – little or no effect on breast feeding
infantinfant
– AAP lists as possible concern with exposure long-termAAP lists as possible concern with exposure long-term
 Selective serotonin reuptake inhibitors (SSRIs) – generally 1Selective serotonin reuptake inhibitors (SSRIs) – generally 1stst
choicechoice
– Paroxetine (Paxil) or Sertraline (Zoloft) preferred toParoxetine (Paxil) or Sertraline (Zoloft) preferred to
Fluoxetine (Prozac)Fluoxetine (Prozac)
 Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)
– Venlafaxine (Effexor)Venlafaxine (Effexor)
 Take dose at bedtime to limit exposure to infantTake dose at bedtime to limit exposure to infant
Antidepressants:
SSRIs and SNRIs
 Limited to small case studies
 Paroxetine and sertraline produced low RID 0.5-3%
 Fluoxetine, citalopram, venlafaxine have variable
RID near to equal 10%
 Preference hierarchy: sertraline, paroxetine,
citalopram, venlafaxine, fluoxetine
 Watch for uneasy sleep, colic, irritability, poor
feeding, drowsiness
Breastfeeding Medicine 2008; 3 (1): 44-52
Relative Infant Dose (RID) of Commonly
Prescribed Antidepressants
Antidepressant Relative Infant Dose (%)
Buproprion (Wellbutrin) 2
Citalopram (Celexa) 3-10
Desvenlafaxine (Khedezla) 5.5-8.1
Duloxetine (Cymbalta) <1
Escitalopram (Lexapro) 3-6
Fluoxetine (Prozac) <12
Fluvoxamine (Luvox) <2
Mirtazapine (Remeron) 0.5-3
Paroxetine (Paxil) 0.5-3
Sertraline (Zoloft) 0.5-3
Venlafaxine (Effexor) 6-9
Chad L et.al. Update on antidepressant use during breastfeeding. Canadian Fam Physician 2013; 59: 633-634.
Antiepileptic MedsAntiepileptic Meds
 Phenytoin, Carbamazepine, and Valproic acid arePhenytoin, Carbamazepine, and Valproic acid are
compatible with breast feedingcompatible with breast feeding
– Caution in use due to risk for hepatotoxicityCaution in use due to risk for hepatotoxicity
(Valproate)(Valproate)
 Lamotrigine (Lamictal), Primadone (Mysoline),Lamotrigine (Lamictal), Primadone (Mysoline),
Phenobarbital are compatible with breast feedingPhenobarbital are compatible with breast feeding
– not preferred due to slow metabolism in the infantnot preferred due to slow metabolism in the infant
resulting in sedationresulting in sedation
 Levetiracetam (Keppra) and Topiramate (Topamax)Levetiracetam (Keppra) and Topiramate (Topamax)
appear compatible with breastfeedingappear compatible with breastfeeding
Antiepileptic meds:
Topiramate and Levetiracetam
 5 mother child pairs on Topiramate
– mean milk:plasma ratio 0.86
– Topiramate concentrations in infant were low
– 4 of 5 mothers also taking carbamazepine (inducer)
 8 women on Levetiracetam
– Milk and plasma concentration equal
– Levetiracetam concentrations in infants were low
Ohman I et.al. Topiramate kinetics during delivery and lactation. Epilepsia 2002; 43:
1157-1160
Johannasen SI et.al. Levetiracetam concentrations in serum and breast milk at birth and
during lactaction. Epilepsia 2005; 46: 775-777
AntihistaminesAntihistamines
 All sedating antihistamines have theAll sedating antihistamines have the
possibility of causing sedation in the infantpossibility of causing sedation in the infant
 Sedating antihistamines (esp. withSedating antihistamines (esp. with
decongestant) can decrease milk supplydecongestant) can decrease milk supply
 Nonsedating antihistamines are compatibleNonsedating antihistamines are compatible
with breast feedingwith breast feeding
– Loratadine (Claritin) preferredLoratadine (Claritin) preferred
Blood Pressure MedsBlood Pressure Meds
 Diuretics are compatible with breast feedingDiuretics are compatible with breast feeding
– Avoid high dosesAvoid high doses
 Beta blockers are compatible with breast feedingBeta blockers are compatible with breast feeding
– Propranolol, metoprolol, and labetalol preferredPropranolol, metoprolol, and labetalol preferred
– Atenolol, nadolol, and sotalol can lead to SE (hypotension,Atenolol, nadolol, and sotalol can lead to SE (hypotension,
bradycardia, tachypnea)bradycardia, tachypnea)
 Calcium channel blockers (CCBs) are compatibleCalcium channel blockers (CCBs) are compatible
with breast feedingwith breast feeding
– Nifedipine (Procardia) is preferredNifedipine (Procardia) is preferred
 ACE inhibitors and ARBs must use with cautionACE inhibitors and ARBs must use with caution
Diabetes MedsDiabetes Meds
 Insulin is compatible with breast feedingInsulin is compatible with breast feeding
 22ndnd
Generation sulfonylureas (eg. glyburide,Generation sulfonylureas (eg. glyburide,
glipizide, glimeperide) are compatible with breastglipizide, glimeperide) are compatible with breast
feedingfeeding
 Metformin is compatible with breast feedingMetformin is compatible with breast feeding
 Limited data with use of thioglitazones (eg.Limited data with use of thioglitazones (eg.
AvandiaAvandia®®, Actos, Actos®®))
 Monitor infants for symptoms of hypoglycemiaMonitor infants for symptoms of hypoglycemia
Diabetes Meds:
Glyburide and Glipizide
 Nonrandomized controlled study
 Single dose of glyburide (5 or 10 mg, n=8)
 Daily dose of glyburide or glipizide (5 mg; n=5)
 No glyburide was found in milk
 Mean infant exposure < 1.5%
 Blood glucose levels were normal
 Glyburide and glipizide compatible with
breastfeeding
Feig DS et.al. Transfer of glyburide and glipizide into
breast milk. Diabetes Care 2005; 28:1851-5
Diabetes Meds: MetforminDiabetes Meds: Metformin
 Prospective studyProspective study
 61 breast fed, 50 formula fed infants61 breast fed, 50 formula fed infants
 Evaluate growth, motor-social development orEvaluate growth, motor-social development or
illnessillness
 Median metformin dose 2.55 grams per dayMedian metformin dose 2.55 grams per day
 6 months of life - no difference in weight, ht, motor-6 months of life - no difference in weight, ht, motor-
social development, illness (psocial development, illness (p ≥ 0.06)≥ 0.06)
 Mean infant exposure 0.28-1.08%Mean infant exposure 0.28-1.08%
 Metformin safe in 1Metformin safe in 1stst
6 months of life6 months of life
Glueck CJ et.al. J Pediatrics 2006; 148 (5): 628-632
Medications Contraindicated inMedications Contraindicated in
Breast FeedingBreast Feeding
 AntineoplasticsAntineoplastics
 Immune suppressantsImmune suppressants
 Ergot alkaloidsErgot alkaloids
 GoldGold
 Iodine/Radiocontrast mediaIodine/Radiocontrast media
 Lithium carbonateLithium carbonate
 Certain antibioticsCertain antibiotics
 Social drugs and drugs of abuseSocial drugs and drugs of abuse
Minimizing Potential Risk to NursingMinimizing Potential Risk to Nursing
Infants from Maternal MedicationsInfants from Maternal Medications
 General ConsiderationsGeneral Considerations
– Avoid drug therapy when possibleAvoid drug therapy when possible
– Use topical therapy when possibleUse topical therapy when possible
– Meds that are safe for use in the infant ARE generally safeMeds that are safe for use in the infant ARE generally safe
for the breast-fed motherfor the breast-fed mother
– Meds that are safe in pregnancy are NOT always safe inMeds that are safe in pregnancy are NOT always safe in
breast-feedingbreast-feeding
– Use reliable references for obtaining info on meds in breastUse reliable references for obtaining info on meds in breast
milkmilk
Spencer JP et. al. Medications in the Breast-Feeding Mother. AFPSpencer JP et. al. Medications in the Breast-Feeding Mother. AFP
2001,64:1202001,64:120
Minimizing Potential Risk to NursingMinimizing Potential Risk to Nursing
Infants from Maternal MedicationsInfants from Maternal Medications
 Medication dosingMedication dosing
– Administer single daily dose meds justAdminister single daily dose meds just beforebefore thethe
longest sleep interval for the infant, usually afterlongest sleep interval for the infant, usually after
the bedtime feedingthe bedtime feeding
– Breastfeed infant immediatelyBreastfeed infant immediately beforebefore med dosemed dose
when multiple daily doses are neededwhen multiple daily doses are needed
Spencer JP. Medications in the Breast-Feeding Mother.AFP, 2001:Spencer JP. Medications in the Breast-Feeding Mother.AFP, 2001:
64:12064:120
ConclusionConclusion
 Healthcare providers should encourageHealthcare providers should encourage
mothers to breast feedmothers to breast feed
 Evidence supports most commonlyEvidence supports most commonly
prescribed meds in breast feeding mothersprescribed meds in breast feeding mothers
can be taken safelycan be taken safely
 Utilize available lactation referencesUtilize available lactation references
 Further help can be provided by yourFurther help can be provided by your
lactation consultant and clinical pharmacistlactation consultant and clinical pharmacist
References
1. Buck, ML. Drugs in Pregnancy and Lactation: Literature an Resource Update. Pediatric
Pharm., 2010;16 (1): 1-5.
2. Burkey BW. Evaluating Medication Use in Pregnancy and Lactation: What Every
Pharmacist Should Know. J Pediatric Pharmacol Ther 2013; 18(3):247-258.
3. Chad L et.al. Update on Antidepressant Use During Breastfeeding. Canadian Family
Physician, 2013; 59: 633-634.
4. Feig DS et. al. Oral Antidiabetic Agents in Pregnancy and Lactation: A Paradigm Shift?
The Annals of Pharmacotherapy, 2007:41(7): 1174-1180.
5. Glatstein MM et. al. Use of Hypoglycemic Drugs During Lactation. Canadian Family
Physician, 2009; 55: 371-373.
6. Glueck CJ et.al. Growth, Motor, and Social Development in Breast and Formula-fed
Infants of Metformin-treated Women with Polycystic Ovarian Syndrome. J Pediatrics,
2006; 148(5):628-32.
7. Sachs et.al. AAP Committee on Drugs: The Transfer of Drugs and Therapeutics Into
Human Breast Milk: An Update on Selected Topics. Pediatrics, 2013; 132 (3): e796-
e809.
8. Mathhew JL. Effect of Maternal Antibiotics on Breast feeding Infants. Postgrad Med
Journal, 2004; 80:196-200.
References
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Thank you!

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Medications and Lactation: Principles for Safe Practice for the Clinician

  • 1. Medications and Lactation: Principles for Safe Practice for the Clinician Evelyn Fulmore, Pharm.D. McLeod Regional Medical Center Florence, SC
  • 2. Disclosures  No financial relationships or duality of interest to disclose  I will be discussing use of agents to improve milk supply (galactagogues)
  • 3. Learning Objectives  Basic physiology of lactation and mechanisms of medication entry into mother’s breast milk  Factors to consider when selecting medications during lactation  Role of galactagogues in lactation induction  Tips in utilizing and interpreting available lactation drug information resources
  • 4. Physiology of LactationPhysiology of Lactation  Suckling stimulatesSuckling stimulates nipplenipple →→ pituitary glandpituitary gland secretes oxytocinsecretes oxytocin →→ letlet down reflex results indown reflex results in milk ejecting cellsmilk ejecting cells contract forcing milkcontract forcing milk from milk cells into milkfrom milk cells into milk ducts.ducts.
  • 5. Physiology of LactationPhysiology of Lactation  Milk pools in laciferousMilk pools in laciferous sinuses under thesinuses under the areola. Sucklingareola. Suckling stimulates milk to comestimulates milk to come from the nipple.from the nipple.
  • 6. Composition of BreastmilkComposition of Breastmilk  ColostrumColostrum (Days #3-5)(Days #3-5) high protein, immunoglobulins, minerals, low inhigh protein, immunoglobulins, minerals, low in lactose and fatlactose and fat  Transitional milkTransitional milk (Days #6-10)(Days #6-10) high in fat, lactose; lower in protein and mineralshigh in fat, lactose; lower in protein and minerals  Mature milkMature milk (Day #14)(Day #14) 60-80% whey protein, 50% fat, 40% lactose, growth60-80% whey protein, 50% fat, 40% lactose, growth factor, low in Vitamin Dfactor, low in Vitamin D
  • 7. Factors Affecting Amount of Drug Received by the Infant  Milk yield  Colostrum versus Mature milk  Concentration of drug in the milk  How well the breast was emptied during the previous feeding  Infants ability to absorb, detoxify, and excrete the drug
  • 8. Transfer of Medications intoTransfer of Medications into Breast MilkBreast Milk  Concentration gradientConcentration gradient – Passive diffusion of non-ionized and free (non-Passive diffusion of non-ionized and free (non- protein bound) medsprotein bound) meds – Maternal serum drug concentrationMaternal serum drug concentration volume of distribution (Vd) and half-lifevolume of distribution (Vd) and half-life - Retrograde diffusion of drug from breast milk toRetrograde diffusion of drug from breast milk to plasmaplasma Spencer JP et.al. Medications in the Breast-Feeding Mother. AFP 2001;Spencer JP et.al. Medications in the Breast-Feeding Mother. AFP 2001; 64:11964:119
  • 9. Transfer of Medications intoTransfer of Medications into Breast MilkBreast Milk 1.1. Lipid solubilityLipid solubility 2.2. Molecular weightMolecular weight 3.3. Maternal plasma levelsMaternal plasma levels 4.4. Maternal protein bindingMaternal protein binding 5.5. Oral bioavailability, half lifeOral bioavailability, half life 6.6. Ion trapping (pKa)Ion trapping (pKa)
  • 10. Lipid SolubilityLipid Solubility  Drugs that are highly lipid soluble penetrateDrugs that are highly lipid soluble penetrate milk in higher concentrationsmilk in higher concentrations  Avoid extremely lipid soluble drugs.Avoid extremely lipid soluble drugs.  Examples: Diazepam, phenobarbitalExamples: Diazepam, phenobarbital
  • 11. Molecular WeightMolecular Weight  The lower the molecular weight (<200 D), theThe lower the molecular weight (<200 D), the greater penetration into milkgreater penetration into milk  Molecular weights <300 D : (eg. Alcohol,Molecular weights <300 D : (eg. Alcohol, amphetamines, diet pills)amphetamines, diet pills)  Molecular weightsMolecular weights ≥ 600 D : (eg. Heparin,≥ 600 D : (eg. Heparin, Enoxaparin, Insulin, Remicade)Enoxaparin, Insulin, Remicade)  Larger the molecular weight/size (preferred)Larger the molecular weight/size (preferred)
  • 12. Maternal Plasma levelMaternal Plasma level  The most important determinant of drugThe most important determinant of drug penetration into milkpenetration into milk  As maternal plasma levels rise, theAs maternal plasma levels rise, the concentration in milk risesconcentration in milk rises  Drug delivery systems that result in lowDrug delivery systems that result in low maternal plasma levels are preferred inmaternal plasma levels are preferred in breast feeding mother (eg. Inhaler med,breast feeding mother (eg. Inhaler med, topicals)topicals)
  • 13. Maternal Protein BindingMaternal Protein Binding  Most important parameter in choosing aMost important parameter in choosing a safe drug for a nursing mothersafe drug for a nursing mother  Most drugs circulate in the maternalMost drugs circulate in the maternal plasma bound to albuminplasma bound to albumin  ““Free” or “Unbound” drug transfers intoFree” or “Unbound” drug transfers into milkmilk  Drugs that are highly protein boundDrugs that are highly protein bound remain in the maternal plasma and don’tremain in the maternal plasma and don’t penetrate tissues or breast milkpenetrate tissues or breast milk
  • 14. Oral BioavailabilityOral Bioavailability  The amount of drug that is absorbed by theThe amount of drug that is absorbed by the infant’s GI tract and reaches the circulationinfant’s GI tract and reaches the circulation  Low oral bioavailability: aminoglycosides,Low oral bioavailability: aminoglycosides, heparin, insulin, omeprazoleheparin, insulin, omeprazole  Action of a drug in the GI tract may produceAction of a drug in the GI tract may produce SE: diarrhea, constipation, PMCSE: diarrhea, constipation, PMC
  • 15. Ion Trapping (pKa)Ion Trapping (pKa)  Ion trapping – drug becomes trapped in milkIon trapping – drug becomes trapped in milk compartment (due to low pH milk)compartment (due to low pH milk)  pKa is the pH where a drug is equally ionic orpKa is the pH where a drug is equally ionic or nonionic (the more ionic, less transfer fromnonionic (the more ionic, less transfer from milk to plasma)milk to plasma)  Drugs with high pKa (>7.2), have higherDrugs with high pKa (>7.2), have higher Milk/Plasma ratio (eg.Phenobarbital,Milk/Plasma ratio (eg.Phenobarbital, iodinated drugs)iodinated drugs)  Choose drugs with a low pKaChoose drugs with a low pKa
  • 16. Drugs That Decrease Milk SupplyDrugs That Decrease Milk Supply  NicotineNicotine  AlcoholAlcohol  Sedating Antihistamines (eg. Diphenhydramine)Sedating Antihistamines (eg. Diphenhydramine)  Estrogen containing oral contraceptivesEstrogen containing oral contraceptives  Progesterone contraceptives (if started earlyProgesterone contraceptives (if started early postpartum before milk supply established)postpartum before milk supply established)  Bromocriptine (Parlodel)Bromocriptine (Parlodel)
  • 17. Drugs That Aid in Milk Production: Galactagogues  Herbals: Fenugreek  Metoclopramide (Reglan)  Domperidone (Motillium)  Synthetic Oxytocin nasal spray
  • 18. Galactagogues  Used to increase breast milk supply  Need to determine the etiology of low milk supply  Ensure proper breastfeeding technique  Only use with adequate milk removal  Must evaluate for medical co-morbidities (e.g. hypothyroidism, retained placenta)
  • 19. Herbal: Fenugreek  Trigonella foenum graecum  MOA: stimulate sweat production; Phytoestrogen and Diosgenin - increase milk flow  Tea (bitter taste), capsule or tablet  Sweat and urine (maple syrup smell)  Caution use in Asthma or diabetes  Contains coumarin (interact with NSAIDS)  No scientific data
  • 20. Domperidone (Motillium)  Not approved for use in the US  MOA: increase prolactin → milk production  Maternal safety has not been established  FDA warning concerning reports of QT interval prolongation, cardiac arrest, sudden death (IV formulation)  Clinical trial showed increase breastmilk volume without affecting nutrient composition Campbell-Yeo M. Effect of Domperidone on Compositiono of Preterm Human Breast Milk. Pediatrics 2010; 125 (1):e107-e114
  • 21. Metoclopramide (Reglan)  Most commonly used  MOA: increase prolactin  Caution: clearance of metoclopramide in the neonate is prolonged can result in side effects (methemoglobinemia)  Short term use recommended (1-3 weeks)  Common dosing: 1st day – 10 mg, 2nd day – 10 mg bid, thereafter 10 mg tid
  • 22. Synthetic Oxytocin Nasal Spray  Hormone (synthetically derived)  MOA: causes release of milk from milk glands to the ducts (helps empty the breast)  Prepared by compounding Rx (10 unit/ml)  Dose: 1-2 sprays each nostril before breast feeding or pumping
  • 23. Synthetic Oxytocin Nasal Spray: Mean Daily Milk Production Fewtrell MS. Arch Dis Child Fetal Neonatal Ed. 2006 May; 91(3): F169–F174.
  • 25. Safety Data and Breast FeedingSafety Data and Breast Feeding  Breast feeding lacks standardized riskBreast feeding lacks standardized risk categoriescategories  Most of the data on meds and breast feedingMost of the data on meds and breast feeding are from scientific literatureare from scientific literature  Given the lack of standardization, otherGiven the lack of standardization, other recommendations for using meds whilerecommendations for using meds while breast feeding have been used by healthbreast feeding have been used by health care providerscare providers Master KP et.al. Breast Feeding and OTC medications. US Pharm 2007; 32 (7): 8-12Master KP et.al. Breast Feeding and OTC medications. US Pharm 2007; 32 (7): 8-12
  • 26. Lactation ResourcesLactation Resources  BooksBooks – Gerald G. Briggs. “Gerald G. Briggs. “DrugsDrugs in Pregnancy andin Pregnancy and Lactation: A referenceLactation: A reference Guide to Fetal andGuide to Fetal and Neonatal Risk”, 9Neonatal Risk”, 9thth edition; 2012edition; 2012
  • 27. Briggs GG et. al. Drugs in Pregnancy andBriggs GG et. al. Drugs in Pregnancy and Lactation, 2008; 8th editionLactation, 2008; 8th edition Definitions of Breast Feeding Recommendations  Compatible  Hold Breast Feeding  No (limited) Human Data – Probably Compatible  No (limited) Human Data – Potential Toxicity  No (limited) Human Data – Potential Toxicity (Mother)  Contraindicated
  • 28. Lactation ResourcesLactation Resources  BooksBooks – Thomas W. Hale.Thomas W. Hale. ““Medications andMedications and Mothers’ Milk” 2012, 15Mothers’ Milk” 2012, 15thth editionedition
  • 29. Hale TW. Medications and Mothers' Milk, 2010;Hale TW. Medications and Mothers' Milk, 2010; 14th edition.14th edition. Dr. Hale’s Lactation Risk Category  L1 Safest  L2 Safer  L3 Moderately Safe  L4 Potentially Hazardous  L5 Contraindicated
  • 30. Dr. Hale’s Lactation Risk CategoryDr. Hale’s Lactation Risk Category  L1L1 SafestSafest: Drug taken by larger # of breast: Drug taken by larger # of breast feeding women without any observedfeeding women without any observed adverse effects in infantadverse effects in infant  L2L2 SaferSafer: Drug studied in a limited # of: Drug studied in a limited # of breast feeding women without any observedbreast feeding women without any observed adverse events in infantsadverse events in infants  L3L3 Moderately SafeModerately Safe: No controlled trials in: No controlled trials in breast feeding women, but risk of untowardbreast feeding women, but risk of untoward effects is possibleeffects is possible
  • 31. Dr. Hale’s Lactation Risk CategoryDr. Hale’s Lactation Risk Category  L3L3 Moderately SafeModerately Safe: No controlled trials in: No controlled trials in breast feeding women, but risk of untowardbreast feeding women, but risk of untoward effects is possibleeffects is possible OROR controlled studiescontrolled studies show only minimal non-threatening adverseshow only minimal non-threatening adverse effectseffects  L4L4 Potentially HazardousPotentially Hazardous: Positive: Positive evidence of risk to the breastfed infantevidence of risk to the breastfed infant OROR toto the breast milk production but benefitthe breast milk production but benefit outweighs the riskoutweighs the risk
  • 32. Dr. Hale’s Lactation Risk CategoryDr. Hale’s Lactation Risk Category  L5L5 ContraindicatedContraindicated: Studies in: Studies in breastfeeding women have demonstratedbreastfeeding women have demonstrated significant and documented risk to the infant.significant and documented risk to the infant. Risk clearly outweighs benefits of breastRisk clearly outweighs benefits of breast feeding.feeding.
  • 33. Values Used to Estimate Infant Drug Exposure  Milk to Plasma Ratio (M/P) – Ratio of the concentration of drug in mother’s milk divided by the concentration in the mother’s plasma – M/P <1 is preferred  Theoretical Infant Dose (TID) – Multiply the milk concentration x daily milk intake of the infant – Compared to the usual maintenance pediatric dose  Relative Infant Dose (RID) – Divide the infant’s dose via milk (mg/kg/day) by the mother’s dose (mg/kg/day) – Assumes daily milk intake of 150 ml/kg/day – RID<10% is considered safe – Exception: fluconazole, metronidazole (have a high RID but are non toxic)
  • 34. Lactation ResourcesLactation Resources  InternetInternet – Dr. Hale’s BreastfeedingDr. Hale’s Breastfeeding Pharmacology pagePharmacology page (( http://www.neonatal.ttuhsc.edu/facthttp://www.neonatal.ttuhsc.edu/fact))
  • 35. Lactation ResourcesLactation Resources  InternetInternet – U.S. National Library ofU.S. National Library of Medicine.Medicine. LactMedLactMed (http://toxnet.nlm.nih.gov/cgi-(http://toxnet.nlm.nih.gov/cgi- bin/sis/htmlgen?)/LACT)bin/sis/htmlgen?)/LACT)
  • 39. The Transfer of Drugs and Other Chemicals Into Human Milk Committee on Drugs Pediatrics 2001;108;776 CLINICAL REPORT The Transfer of Drugs and Therapeutics Into Human Breast Milk: An Update on Selected Topics Hari Cheryl Sachs, MD, FAAP* and COMMITTEE ON DRUGS Pediatrics; originally published online August 26, 2013; DOI: 10.1542/peds.2013-1985
  • 40. BeforeBefore Prescribing Drug Therapy in thePrescribing Drug Therapy in the Lactating WomanLactating Woman 1.1. Is drug therapy really necessary?Is drug therapy really necessary? 2.2. The safest drug should be chosen.The safest drug should be chosen. 3.3. If there is a possibility that a drug mayIf there is a possibility that a drug may present a risk to the infant, then considerpresent a risk to the infant, then consider measuring blood levelsmeasuring blood levels 4.4. Drug exposure in the infant may be limitedDrug exposure in the infant may be limited by timing of med and breastfeedingby timing of med and breastfeeding AAP Committee on Drugs. The transfer of drugs and other chemicalsAAP Committee on Drugs. The transfer of drugs and other chemicals into human milk. Pediatrics 2001;108 (3):777into human milk. Pediatrics 2001;108 (3):777
  • 41. AnalgesicsAnalgesics  Acetaminophen (Tylenol) is compatible with breastAcetaminophen (Tylenol) is compatible with breast feedingfeeding  Nonsteroidal antiinflammatory drugs (NSAIDS) –Nonsteroidal antiinflammatory drugs (NSAIDS) – ibuprofen is preferredibuprofen is preferred – Naprosyn, sulindac, piroxicam should be avoidedNaprosyn, sulindac, piroxicam should be avoided  Narcotic/Opiates – morphine, codeine, oxycodone,Narcotic/Opiates – morphine, codeine, oxycodone, and hydrocodone are compatible with breast feedingand hydrocodone are compatible with breast feeding – Meperidine (Demerol) should be avoidedMeperidine (Demerol) should be avoided
  • 42. Narcotics/Opiates  Case controlled studies evaluating long term developmental outcomes are needed  Breastfeeding should be supported if: – “stable” and compliant with methadone or buprenorphine +/- naloxone (Subutex®, Suboxone®) – negative maternal urine toxicology test at delivery except for prescribed medications – plan to continue substance abuse treatment in the postpartum period – do not have medical contraindication to breastfeeding Breastfeeding Medicine 2009; 4(4):225-228
  • 43. AntibioticsAntibiotics  Penicillins and cephalosporins are compatible with breastPenicillins and cephalosporins are compatible with breast feedingfeeding – Monitor infant for diarrhea (change in gut flora)Monitor infant for diarrhea (change in gut flora)  Tetracycline is compatible with breast feedingTetracycline is compatible with breast feeding – Calcium in breast milk limits absorption ; avoid doxycyline andCalcium in breast milk limits absorption ; avoid doxycyline and minocyclineminocycline  Quinolones have not been rated by AAPQuinolones have not been rated by AAP – Levaquin is compatible with breast feedingLevaquin is compatible with breast feeding  Trimethoprim-sulfamethoxazole (Bactrim) is compatible withTrimethoprim-sulfamethoxazole (Bactrim) is compatible with breast feedingbreast feeding – Not recommended in infants < 2 month (deplacement of bilirubin)Not recommended in infants < 2 month (deplacement of bilirubin)
  • 44. AntidepressantsAntidepressants  Tricyclic antidepressants – little or no effect on breast feedingTricyclic antidepressants – little or no effect on breast feeding infantinfant – AAP lists as possible concern with exposure long-termAAP lists as possible concern with exposure long-term  Selective serotonin reuptake inhibitors (SSRIs) – generally 1Selective serotonin reuptake inhibitors (SSRIs) – generally 1stst choicechoice – Paroxetine (Paxil) or Sertraline (Zoloft) preferred toParoxetine (Paxil) or Sertraline (Zoloft) preferred to Fluoxetine (Prozac)Fluoxetine (Prozac)  Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) – Venlafaxine (Effexor)Venlafaxine (Effexor)  Take dose at bedtime to limit exposure to infantTake dose at bedtime to limit exposure to infant
  • 45. Antidepressants: SSRIs and SNRIs  Limited to small case studies  Paroxetine and sertraline produced low RID 0.5-3%  Fluoxetine, citalopram, venlafaxine have variable RID near to equal 10%  Preference hierarchy: sertraline, paroxetine, citalopram, venlafaxine, fluoxetine  Watch for uneasy sleep, colic, irritability, poor feeding, drowsiness Breastfeeding Medicine 2008; 3 (1): 44-52
  • 46. Relative Infant Dose (RID) of Commonly Prescribed Antidepressants Antidepressant Relative Infant Dose (%) Buproprion (Wellbutrin) 2 Citalopram (Celexa) 3-10 Desvenlafaxine (Khedezla) 5.5-8.1 Duloxetine (Cymbalta) <1 Escitalopram (Lexapro) 3-6 Fluoxetine (Prozac) <12 Fluvoxamine (Luvox) <2 Mirtazapine (Remeron) 0.5-3 Paroxetine (Paxil) 0.5-3 Sertraline (Zoloft) 0.5-3 Venlafaxine (Effexor) 6-9 Chad L et.al. Update on antidepressant use during breastfeeding. Canadian Fam Physician 2013; 59: 633-634.
  • 47. Antiepileptic MedsAntiepileptic Meds  Phenytoin, Carbamazepine, and Valproic acid arePhenytoin, Carbamazepine, and Valproic acid are compatible with breast feedingcompatible with breast feeding – Caution in use due to risk for hepatotoxicityCaution in use due to risk for hepatotoxicity (Valproate)(Valproate)  Lamotrigine (Lamictal), Primadone (Mysoline),Lamotrigine (Lamictal), Primadone (Mysoline), Phenobarbital are compatible with breast feedingPhenobarbital are compatible with breast feeding – not preferred due to slow metabolism in the infantnot preferred due to slow metabolism in the infant resulting in sedationresulting in sedation  Levetiracetam (Keppra) and Topiramate (Topamax)Levetiracetam (Keppra) and Topiramate (Topamax) appear compatible with breastfeedingappear compatible with breastfeeding
  • 48. Antiepileptic meds: Topiramate and Levetiracetam  5 mother child pairs on Topiramate – mean milk:plasma ratio 0.86 – Topiramate concentrations in infant were low – 4 of 5 mothers also taking carbamazepine (inducer)  8 women on Levetiracetam – Milk and plasma concentration equal – Levetiracetam concentrations in infants were low Ohman I et.al. Topiramate kinetics during delivery and lactation. Epilepsia 2002; 43: 1157-1160 Johannasen SI et.al. Levetiracetam concentrations in serum and breast milk at birth and during lactaction. Epilepsia 2005; 46: 775-777
  • 49. AntihistaminesAntihistamines  All sedating antihistamines have theAll sedating antihistamines have the possibility of causing sedation in the infantpossibility of causing sedation in the infant  Sedating antihistamines (esp. withSedating antihistamines (esp. with decongestant) can decrease milk supplydecongestant) can decrease milk supply  Nonsedating antihistamines are compatibleNonsedating antihistamines are compatible with breast feedingwith breast feeding – Loratadine (Claritin) preferredLoratadine (Claritin) preferred
  • 50. Blood Pressure MedsBlood Pressure Meds  Diuretics are compatible with breast feedingDiuretics are compatible with breast feeding – Avoid high dosesAvoid high doses  Beta blockers are compatible with breast feedingBeta blockers are compatible with breast feeding – Propranolol, metoprolol, and labetalol preferredPropranolol, metoprolol, and labetalol preferred – Atenolol, nadolol, and sotalol can lead to SE (hypotension,Atenolol, nadolol, and sotalol can lead to SE (hypotension, bradycardia, tachypnea)bradycardia, tachypnea)  Calcium channel blockers (CCBs) are compatibleCalcium channel blockers (CCBs) are compatible with breast feedingwith breast feeding – Nifedipine (Procardia) is preferredNifedipine (Procardia) is preferred  ACE inhibitors and ARBs must use with cautionACE inhibitors and ARBs must use with caution
  • 51. Diabetes MedsDiabetes Meds  Insulin is compatible with breast feedingInsulin is compatible with breast feeding  22ndnd Generation sulfonylureas (eg. glyburide,Generation sulfonylureas (eg. glyburide, glipizide, glimeperide) are compatible with breastglipizide, glimeperide) are compatible with breast feedingfeeding  Metformin is compatible with breast feedingMetformin is compatible with breast feeding  Limited data with use of thioglitazones (eg.Limited data with use of thioglitazones (eg. AvandiaAvandia®®, Actos, Actos®®))  Monitor infants for symptoms of hypoglycemiaMonitor infants for symptoms of hypoglycemia
  • 52. Diabetes Meds: Glyburide and Glipizide  Nonrandomized controlled study  Single dose of glyburide (5 or 10 mg, n=8)  Daily dose of glyburide or glipizide (5 mg; n=5)  No glyburide was found in milk  Mean infant exposure < 1.5%  Blood glucose levels were normal  Glyburide and glipizide compatible with breastfeeding Feig DS et.al. Transfer of glyburide and glipizide into breast milk. Diabetes Care 2005; 28:1851-5
  • 53. Diabetes Meds: MetforminDiabetes Meds: Metformin  Prospective studyProspective study  61 breast fed, 50 formula fed infants61 breast fed, 50 formula fed infants  Evaluate growth, motor-social development orEvaluate growth, motor-social development or illnessillness  Median metformin dose 2.55 grams per dayMedian metformin dose 2.55 grams per day  6 months of life - no difference in weight, ht, motor-6 months of life - no difference in weight, ht, motor- social development, illness (psocial development, illness (p ≥ 0.06)≥ 0.06)  Mean infant exposure 0.28-1.08%Mean infant exposure 0.28-1.08%  Metformin safe in 1Metformin safe in 1stst 6 months of life6 months of life Glueck CJ et.al. J Pediatrics 2006; 148 (5): 628-632
  • 54. Medications Contraindicated inMedications Contraindicated in Breast FeedingBreast Feeding  AntineoplasticsAntineoplastics  Immune suppressantsImmune suppressants  Ergot alkaloidsErgot alkaloids  GoldGold  Iodine/Radiocontrast mediaIodine/Radiocontrast media  Lithium carbonateLithium carbonate  Certain antibioticsCertain antibiotics  Social drugs and drugs of abuseSocial drugs and drugs of abuse
  • 55. Minimizing Potential Risk to NursingMinimizing Potential Risk to Nursing Infants from Maternal MedicationsInfants from Maternal Medications  General ConsiderationsGeneral Considerations – Avoid drug therapy when possibleAvoid drug therapy when possible – Use topical therapy when possibleUse topical therapy when possible – Meds that are safe for use in the infant ARE generally safeMeds that are safe for use in the infant ARE generally safe for the breast-fed motherfor the breast-fed mother – Meds that are safe in pregnancy are NOT always safe inMeds that are safe in pregnancy are NOT always safe in breast-feedingbreast-feeding – Use reliable references for obtaining info on meds in breastUse reliable references for obtaining info on meds in breast milkmilk Spencer JP et. al. Medications in the Breast-Feeding Mother. AFPSpencer JP et. al. Medications in the Breast-Feeding Mother. AFP 2001,64:1202001,64:120
  • 56. Minimizing Potential Risk to NursingMinimizing Potential Risk to Nursing Infants from Maternal MedicationsInfants from Maternal Medications  Medication dosingMedication dosing – Administer single daily dose meds justAdminister single daily dose meds just beforebefore thethe longest sleep interval for the infant, usually afterlongest sleep interval for the infant, usually after the bedtime feedingthe bedtime feeding – Breastfeed infant immediatelyBreastfeed infant immediately beforebefore med dosemed dose when multiple daily doses are neededwhen multiple daily doses are needed Spencer JP. Medications in the Breast-Feeding Mother.AFP, 2001:Spencer JP. Medications in the Breast-Feeding Mother.AFP, 2001: 64:12064:120
  • 57. ConclusionConclusion  Healthcare providers should encourageHealthcare providers should encourage mothers to breast feedmothers to breast feed  Evidence supports most commonlyEvidence supports most commonly prescribed meds in breast feeding mothersprescribed meds in breast feeding mothers can be taken safelycan be taken safely  Utilize available lactation referencesUtilize available lactation references  Further help can be provided by yourFurther help can be provided by your lactation consultant and clinical pharmacistlactation consultant and clinical pharmacist
  • 58. References 1. Buck, ML. Drugs in Pregnancy and Lactation: Literature an Resource Update. Pediatric Pharm., 2010;16 (1): 1-5. 2. Burkey BW. Evaluating Medication Use in Pregnancy and Lactation: What Every Pharmacist Should Know. J Pediatric Pharmacol Ther 2013; 18(3):247-258. 3. Chad L et.al. Update on Antidepressant Use During Breastfeeding. Canadian Family Physician, 2013; 59: 633-634. 4. Feig DS et. al. Oral Antidiabetic Agents in Pregnancy and Lactation: A Paradigm Shift? The Annals of Pharmacotherapy, 2007:41(7): 1174-1180. 5. Glatstein MM et. al. Use of Hypoglycemic Drugs During Lactation. Canadian Family Physician, 2009; 55: 371-373. 6. Glueck CJ et.al. Growth, Motor, and Social Development in Breast and Formula-fed Infants of Metformin-treated Women with Polycystic Ovarian Syndrome. J Pediatrics, 2006; 148(5):628-32. 7. Sachs et.al. AAP Committee on Drugs: The Transfer of Drugs and Therapeutics Into Human Breast Milk: An Update on Selected Topics. Pediatrics, 2013; 132 (3): e796- e809. 8. Mathhew JL. Effect of Maternal Antibiotics on Breast feeding Infants. Postgrad Med Journal, 2004; 80:196-200.
  • 59. References 9. Mortel M and Mehta SD. Systematic Review of the Efficacy of Herbal Galactogogues. Journal of Human Lactation,2013;29(2):154-162. 10. Pack AM. Therapy Insight: Clinical Management of Pregnant Women with Epilepsy. Nat Clin Pract Neurol, 2006; 2(4):190-200. 11. Wagner CL. Human Milk and Lactation. Medscape, 2012. 12. The Academy of Breastfeeding Medicine (ABM) Protocol Committee. ABM Clinical Protocol #18: Use of Antidepressants in Nursing Mothers. Breast Feeding Medicine, 2008;3(1):44-52. 13. The Academy of Breastfeeding Medicine (ABM) Protocol Committee. ABM Clinical Protocol #21: Guidelines for Breastfeeding and the Drug-Dependent Woman. Breast Feeding Medicine, 2009;4(4):225-228. 14. The Academy of Breastfeeding Medicine (ABM) Protocol Committee. ABM Clinical Protocol #9. Use of Galactogogues in Initiating or Augmenting the Rate of Maternal Milk Secretion. Breast Feeding Medicine, 2011;6(1):41-49.

Notas do Editor

  1. During the 1st 10-14 days, large gaps exist between alveolar cells which enhance drug absorption. This will be important in considering breastfeeding the preterm infant.
  2. The most important factor in infant exposure through breast milk is the amount of medication in the mother’s serum.Pass from the maternal plasma compartment through capillary wall into the alveolar cells to penetrate the breast milk.
  3. We will spend a few moments to review each of these factors that determine penetration into medications into breast milk.
  4. Drugs that are very lipid soluble penetrate in milk in higher concentrations almost without exception. Of particular interest are the drugs that are active in the CNS. CNS active drugs invariably have the unique characteristics required to enter milk. Therefore, if a drug is active in the CNS, higher levels in milk are expected; although the amounts still are often subclinical. Examples include drugs like Diazepam and Phenobarbital.
  5. The molecular weight of a medication is a significant determinant as to the entry of that medication into human milk. Medications with small MWs (&amp;lt;200 daltons) can easily pass into milk traversing small pores in the cell walls of the mammary epithelium. Examples of low MW drugs include: alcohol, amphetemines, diet pills. Drugs with higher molecular weights must traverse the membrane by dissolving in the cell’s lipid membranes, which may significantly reduce milk levels. Examples include Heparin, Enoxaparin, Insulin, Remicade. Larger molecular weight or size agents are preferred due to the reduced amounts that enter into the milk compartment.
  6. Protein binding also plays an important role. Drugs circulate in the maternal plasma, either bound to albumin or freely soluble in the plasma. It is the free component “unbound fraction” that transfers into milk, while the bound fraction stays in the maternal circulation. Examples: warfarin and many NSAIDs. Levels are reduced in milk simply because they are excluded from the milk compartment. This is one of the single most important physiologic parameters to consider when choosing a safe medication for a nursing mother.
  7. Once a drug has entered the mother’s milk and has been ingested by the infant, it must traverse or pass through the infant’s GI tract prior to absorption. Some drugs are poorly stable in this environment due to the proteolytic enzymes and acids present in the infant’s stomach. Examples of drugs with low oral bioavailability in the infant include. Aminoglycosides, heparin, insulin, omeprazole, and other large peptide drugs. Other drugs are poorly absorbed by the infant’s gastrointestinal tract and do not enter the infant’s blood stream. Thus oral bioavailability is a useful tool to estimate just how much of the drug will be absorbed by the infant. Realize also that some drugs that exert their action in the GI tract may produce local side effects in the infant causing diarrhea, constipation, or PMC.
  8. Drugs are trapped in milk (ion trapping) due to the low pH of human milk (7-7.2). With drugs with a high pKa, the ionic state of the drug changes and stops its exit back into the maternal circulation. This is important for weak basic drugs, such as barbiturates (like phenobarbital with high pKa).
  9. In the US it is estimated that 15% of breast feediing mothers use herbal galactagogues. Four herbs (shatavari, tobangun, fenugreek, milk thistle) with potential use as galactagogues have been studied. Currently the Academy of Breast feeding Medicine does not recommend use of herbals as galactagogues.
  10. Fenugreek seeds contain hormone precursors that increase milk supply. Scientists do not know for sure how this happens. Some believe it is possible because breasts are modified sweat glands, and fenugreek stimulates sweat production. It has been found that fenugreek can increase a nursing mother&amp;apos;s milk supply within 24 to 72 hours after first taking the herb. Once an adequate level of milk production is reached, most women can discontinue the fenugreek and maintain the milk supply with adequate breast stimulation. Many women today take fenugreek in a pill form (ground seeds placed in capsules). The pills can be found at most vitamin and nutrition stores and at many supermarkets and natural foods stores. Fenugreek can also be taken in tea form, although tea is believed to be less potent than the pills and the tea comes with a bitter taste that can be hard to stomach. Fenugreek is not right for everyone. The herb has caused aggravated asthma symptoms in some women and has lowered blood glucose levels in some women with diabetes.
  11. The Milk to Plasma Ratio is the ratio of the concentration of the drug in the mother’s milk divided by the concentration in the mother’s plasma. If high (&amp;gt;1-5), it is useful as an indicator of drugs that may sequester in milk in high levels. If low (&amp;lt;1), it is a good indicator that only minimal levels of the drug are transferred into milk. While it is best to choose drugs with low M/P ratios, the amount of the drug which transfers is largely determined by the level of drug in the mother’s plasma compartment. Even with high M/P ratios and low maternal plasma levels, the amount of drug that transfers can be low. The Theoretical Infant Dose is a value calculated by multiplying the milk concentration x the daily milk intake of the infant. This value is then compared to published usual maintenance pediatric doses. Lastly, the Relative Infant Dose (RID) is a value calculated by dividing the infant’s dose via milk (mg/kg/day) by the maternal dose (mg/kg/day). This weight normalizing method indicates approximately how much of the “maternal dose” the infant is receiving. In the literature, some investigators do not normalize this value by weight so be careful we making comparisons.
  12. The transfer of venlafaxine into breastmilk studied by Newport and colleagues in 13 infant-mother pairs showed a mean milk:plasma ratio of 275.3%. The highest venlafaxine and desvenlafaxine concentration in breastmilk occurred an average of 8 hours after a maternal dose. Infant plasma concentrations of venlafaxine/desvenalfaxine were 37.1% of the maternal plasma concentrations, with a theoretical infant dose of 0.208 mg/kg/day. No adverse effects were reported. The considerable transfer of drug into breastmilk suggests the need for confirmatory studies and caution when prescribing this drug in clinical practice.
  13. On the basis of small studies, including single-dose studies, case reports and short-term studies, phenytoin, carbamazepine and valproate are probably safe. These AEDs are all moderately to highly protein-bound, and are not transferred in high concentrations in breast milk. A small study of four infants indicates that lamotrigine might be transferred to the infant through breast milk in concentrations similar to those seen in the mother, as lamotrigine is extensively metabolized by glucuronidation, which is immature in infants. Given these findings, infants who are breastfed by mothers receiving lamotrigine should be monitored.
  14. In eight women receiving levetiracetam, concentrations of the drug were approximately equal in milk and plasma.[51] In their babies, however, levels of levetiracetam in the serum were very low, indicating extensive transfer in milk and rapid elimination of levetiracetam in infants. Similarly, 2-3 weeks after delivery in five mother-child pairs in which the mother was treated with topiramate, the mean milk : maternal plasma concentration ratio of topiramate was 0.86,[52] yet topiramate concentrations of the drug in the infants were very low, indicating efficient elimination by the infant. It should be noted, however, that in this small study four of the five mothers were also taking carbamazepine, which induces metabolism of topiramate, as well as inducing fetal metabolism in general (including metabolism of carbamazepine).