Drugs

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Breastfeeding Medication
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Breastfeeding Medication

• The benefits of breastfeeding are
• sufficiently important to recommend that
• breastfeeding should be discouraged only
• when there is substantial evidence that
• - The drug taken by the mother will be
• harmful to infant
• - No therapeutic equivalent can be given

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General Informations

• lt 1 of a drug will pass through breastmilk
  lt therapeutic dose level for infants
• Only few drugs are totally contraindicated
• Cautions required in
• - premature infants
• - low birth weight
• - infants c impaired ability to metabolize
  /excrete drugs eg. sick babies
• - infants c G6PD deficiency

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Factors Influencing Drug Safety
Drugs factors -

• Diffusion / active transport
• Plasma level
• Lipid solubility
• Drug pH
• Molecular weight

• Protein binding
• Half life
• Oral bioavailability
• Non-dose-related toxicity

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Factors Influencing Drug Safety
Infants factors -
Maternal factors -

• Age
• Body weight
• Health status

• Dose
• Route of administration
• Health status

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(No Transcript)
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Factors to be Considered before
Prescription

• Need for Rx any particular drug
• Age maturity of baby
• Volume of breast milk taken daily
• Available drug information

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General Principles (1)

• Choose a route of admin. which minimizes maternal
  drug level - topical, local, inhalation.
• Choose medications - shortest T1/2 , highest
  protein binding ability, poorest oral
  absorption,lowest lipid solubility, well-studied
  in infants.
• Use the lowest effective dose for the shortest
  time.
• To minimize drug level in the milk - administer
  the drug at / immediately after the infant feeds.

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General Principles (2)

• Avoid long-acting drug.
• In case of no available alternative,
  medication is best taken just prior to the
  longest sleep of the infant.
• Infants should be monitored for AE - feeding,
  sedation, irritability, rash, etc.
• For some medications with potential harm,
  temporary suspension of breastfeeding may be
  necessary. ( Advice the mother about milk
  expression cup feeding instead of bottle
  feeding to avoid nipple confusion)

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Lactation Risk Category

• L1 Safest taken by large No. of BF mothers
  without any observed SE
• L2 Safer studied in limited No. of BF mothers
  without any observed SE
• L3 Mod.safe no controlled studies, but poss.
  untoward effects / controlled
  studies--gtmin. non-threatening AE
• L4 Poss.hazardous ve evidence of risk to BF
  infant / to breast milk production
• L5 Contraindicated studies--gt sig./ high
  risk to infants

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Antimicrobials (1)

• Ciprofloxacin- L4 ( Arthropathies reported in
  animal embryo, no evidence in humans)
• Nalidixic acid - L4 (reported case of hemolysis
  in infants with G6PD def.
• Clindamycin - L3 (1 case of pseudomemb.colitis
  but rare, observe for diarrhoea, approved by
  AAP for use in BF mother

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Antimicrobials (1)

• Sulfonamides - L2-3 (avoid in sick infants,
  prematurity, stress, hyperbilirubinemia,
  G6PD def.
• Cotrimoxaxole - L3 (non reported, caution in
  hyperbilirubinemia G6PD def.)
• Metronidazole - L2 (BF should be withheld
  until 12-24 hr after 2 g dose)

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Antimicrobials (2)

• Metronidazole T1/2 8.5 hr
• In mother receiving 2 g dose
• Av. drug conc. 2 hr 45.8 mg/L
• 8 hr 27.9 mg/L
• 12 hr 19.1 mg/L
• 12 -24 hr 12.6 mg/L
• Rx level in infants /children 7.5-30 mg/L
• No report of AE in breastfed infants for 2 g dose
  or 250 mg X 3 /d X 10 d

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Analgesics NSAIDS

• Codeines- L3 (rare cases of neonatal apnea at
  high dose
• Aspirin - L3 (metabolic acidosis 1 case, at high
  dose)
• Indomethacin - L3 (seizure 1 case)
• Cox-2 inhibitors - No available information
• Diclofenac - L2 (non reported via milk)
  (Voltaren)

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Antidepressants (1)

• SSRI
• Fluoxetine -L3 in newborn, L2 in olders
  (Prozac) longer T1/2 --gt
  relatively greater amount in breastmilk gt
  sertraline (Zoloft) paroxetine(Paxil)
• Citalopram -L3 (2 cases of excessive somnolence,
  (Celexa) decreased feeding, wt. loss )

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Antidepressants (2)

• Tricyclic antidepressants
• Doxepin - L5 (1 case of resp. depression
  (Sinequan) sedation)
• Nortryptilene (Aventyl )
• Dothiepin (Prothiaden)
• Nefazodone, reboxetine, venlafaxine, monoamine
  oxidase inhibitors - lack of published data

L2 - safer
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Antipsychotics

• Haloperidol - L2 ( dose lt 10 mg / d safe)
• Diazepam - L3, L4 in chronic use (hypotonia,
  lethargy reduced suckling)
• Temazepam - L3 (safer than diazepam for
  (Restoril) shorter T 1/2 )
• Clozapine, olanzapine,quetiapine, risperidone -
  lack of published data

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Immunological drugs

• Sera and immunoglobulins
• Vaccines

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Other drugs commonly used
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Others (1)

• PTU L2 (non reported, observe
  closely for thyroid
  function
• Thyroxine L1 (extremely low in breastmilk)
  (Eltroxin)
• Prednisolone L2, L4 for chronic high dose
• Propanolol L3 (none reported via
  breastmilk in numerous studies)
• Phenobarbital L3 ( Sedation, infantile spasm
  after weaning from milk containing
  phenobarbital,
  methemoglobinuria 1 case)

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Others (2)

• Domperidone L2
  (Motilium)
  (Galactagogue dose10-20 mg X 3-4/d)
• Gliabendazide L3 (non reported, observe for
  (Daonil) hypoglycemia)
• Clemastine L4 ( Drowsiness, irritability,
  (Tavist) feeding refusal, high pitch
  cry, nuchal rigidity 1 case)
• Primidone L3 ( Sedation, feeding problem )
  (Mysoline )
• Flunarizine L4 (non reported, use with caution
  ) (Sibelium)

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Others (3)

• Dopamine / Dobutamine L2
• Oxytocin L2
• Cisapride (Prepulsid) L2
• Cimetidine (Tagamet) L2
• Bisacodil ( Dulcolax ) L2
• Loperamide (Imodium) L2
• Metopropamide (Plasil) L2

• Loratadine ( Claritine ) L2
• Loraxepam ( Ativan) L 3
• Metyldopa (Aldomet) L2
• Nifedipine (Adalat) L2
• Griseofulvin L2
• Furosemide (Lasix) L3

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Drugs contraindicated
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Drugs Contraindicated During Breastfeeding

• Amiodarone
• Antineoplastic agents
• Chloramph. .
• Ergotamine .
• Gold salts .
• Lithium
• Phenindione

• Hypothyroidism reported
• Possible immune suppression, effect on growth
• (May--gtidiosyncratic BM supp. at high conc. in
  breast milk )
• Vomiting,diarr.,convulsion (dosegtmigraine)
• Possible facial edema in one infant 3 mo. after
  Rx in mother
• Severe rash reported
• Increased PT PTT in 1 infant

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Drugs Contraindicated

• Retinoids .
  .
• Tetracycline (chronic-months)
• Pseudoephedrine .
  .
• Radioactives .
• Combined oral contraceptives

• Very lipid soluble,wide range of AEs in adult,
  mutagenic carcinogenic in animals
• Staining immature teeth, change in epiphyseal
  bone growth
• Unpublished result, may inhibit prolactin milk
  production significantly
• Temporary cessation of BF, based on presence of
  radioactivity in milk
• Dec.breast milk productn, dec.protein nitrogen
  content of milk

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Drugs of Abuse Contraindicated (1)

• Amphetamine
• .
• Cocaine. .
• Heroin .
• Marihuana
• Nicotine (smoking) .
  
• Phencyclidine

• Irritability, poor sleeping pattern (
  conc. in human milk )
• Cocaine intoxication (N/V, diarrhea,
  tremulousness, agitatn, gasping,HT, inc.HR)
• Tremor, restlessness, vomiting, poor feeding
• Only 1 report no effect mentioned
• Shock,vomiting,diarrhea, rapid HR, restlessness,
  dec.milk production
• Potent hallucinogen

Committee on drugs hazardous to infant,
detrimental to physical mental health of mother
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Drugs of Abuse Contraindicated(2)

• Alcohol( Acetaldehyde)
• Caffeine

• milk production
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Drugs having been associated with sig. effects on
some nursing infants, use with caution

• Drugs
• 
  
  

• Reported effects

• 5- Aminosalicylic a.
• Aspirin
• Clemastine .
• Phenobarbital .
  .
• Primidone
• Sulfasalazine

Diarrhea (1 case) Metabolic acidosis (1 case,
high dose) Drowsiness, irritability, feeding
refusal, high pitch cry, nuchal rigidity (1
case) Sedation, infantile spasm after weaning
from milk containing phenobarbital,
methemoglobinuria (1 case) Sedation, feeding
problem Bloody diarrhea (1 case)
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Drugs in Specific Conditions
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Drugs commonly prescribed (1)

• Condition Recommended Alternative Caution
• Allerg.rhinitis Beclomethasone Cetrizine
  (Beconase) Loratadine
  (Claritine)
• Fluticasone Sedating antihist.
  (Flonase) Decongestants
• Cromolyn
• CVS Hydrochlothiazide Nifedipine Atenolol
  (Tenormin)
• Metoprolol tartrate Verapamil Soralol
  (Lopressor) Hydralazine Diltiazem
  Propanolol (Apresoline)
  Labetalol Captopril
  Enalapril

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Drugs commonly prescribed (2)

• Condition Recommended Alternative Caution
• Depression Sertraline Nortriptyline Fluoxetine
  (Zoloft) (Pamelor)
  (Prozac)
  Paroxetine Desipramine
  (Paxil) (Norpramin)
• DM Insulin Acarbose Metformin
  (Precose) (Glucophage) Glyburide
  (Micronase) Thiazolinediones
  
  Glipizide (Glucotrol)
  Tolbutamide (Orinase)

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Drugs commonly prescribed (3)

• Condition Recommended Alternative Caution
• Epilepsy Phenytoin Ethosuximide Phenobarbital
  (Dilantin) (Zarontin)
• Carbamazepine Valproic sodium
  (Tegretol) (Depakine)
• Pain Ibuprofen Naproxen
  (Brufen) (Naprosyn)
  Morphine Meperidine
  Acetaminophen (Demerol)
  (paracetamol)
• Asthma Cromolyn Fluticasone
  Nedocromil Beclomethasone

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