Minor Ailments Scheme
The safety of the Formulary drugs during breastfeeding
Wendy Jones PhD MRPharmS
Pharmacist East Hants PCT
Drugs in Breastmilk Helpline, BfN
Breastfeeding mothers have exemption from prescription charges for twelve months
after the birth of their baby and may therefore wish to access the minor ailment
scheme. Mothers with babies should be asked if they are breastfeeding before a
recommendation is made. Assumptions that the baby is older and so unlikely to be
breastfeeding may be inappropriate as the duration of lactation is extending.
The patient information leaflet (PIL) in some of the products may suggest that the
drug should not be taken during breastfeeding. This does not necessarily mean that the
drug is unsafe, merely that the manufacturers have not included breastfeeding in the
product licence application. Mothers may need to be reassured of the safety or have
the choice of not taking medication, leaving you able to provide them with
professional advice.

Pseudoephedrine is secreted into breastmilk in low levels. With a dose of 60mg
tds the baby would receive 264 microgrammes/litre of milk. Whilst this level of
pseudoephedrine in the milk is clinically irrelevant to the baby, there is some
evidence that some mothers (in general those with a well-established supply) may
experience a reduction in milk volume.

Loratadine transfers into breastmilk at a level of 2.9 microgrammes/kg/day, an
insignificant amount for a breastfed baby when compared to the licensed dose of
5mg for a 2-year-old child. It is very unlikely to produce any side effects in the
baby.

Beclomethasone nasal spray - intra-nasal absorption is very low and is unlikely to
be clinically significant to a breastfed baby.

Sodium cromoglycate eye drops absorption from the eye is unlikely to be
significant

Oral thrush - if a breastfed baby develops oral thrush the mother is very likely to
develop thrush on the nipple. This is excruciatingly painful but can be treated with
topical miconazole cream after each feed. Application of miconazole gel to the
nipples is unlikely to effect a cure as it is not pharmacologically designed to
penetrate the skin. The mother should be advised to consult her GP as soon as
possible. If a mother presents with sore nipples after a period of pain free
breastfeeding, she may have developed a candidal infection particularly if she has
recently taken a course of antibiotics. She should see her health visitor to check
good positioning and attachment of the baby at the breast as soon as possible and
seek appropriate treatment for herself and her baby as many women cease
breastfeeding sooner than they intended as a result of the severity of the pain. (For
further
information
see
Breastfeeding
and
Thrush
leaflet
at
www.breastfeedingnetwork.org.uk)

Loperamide is only minimally absorbed and only very small doses are excreted
into breastmilk. Following a 4mg dose the milk levels after 6 hours have been
measured as 0,27 microgrammes/litre. The mother should be advised to drink
plenty of fluids.

Diarrhoea in exclusively breastfed infants is very unlikely. If the baby appears to
have diarrhoea breastfeeding should be continued as normal. Any complimentary
formula should be replaced by oral re-hydration or additional breastfeeds.
Maternal use of antibiotics may be responsible for the change in bowel habits.

Fluconazole is 90% absorbed orally and peak plasma levels are present 1-2 hours
after the dose is taken. It is used clinically to treat infants at a dose of 6mg/kg/day
whilst the dose passing through breastmilk is 0.34mg/kg/day. Long-term courses
may be used to treat deep breast thrush. Single treatments to treat vaginal candida
are unlikely to affect the baby. Longer treatment may produce excess wind and
stomach pains in mother and baby.

Treating children with head lice -mothers may need to apply head lice treatment to
several children. Whilst systemic absorption is unlikely it may be prudent to wear
rubber/latex gloves and apply solutions in a well-ventilated room. Mothers who
are breastfeeding should be treated with Permethrim to reduce contact time with
the chemical where possible.

Mebendazole is poorly absorbed orally. Although there is little data on levels in
breastmilk it is unlikely to be transmitted in clinically relevant amounts.
Manufacturers inserts recommend taking the dose before the longest period
without breastfeeding and to avoid feeding for 12 hours. This is difficult for many
mothers to achieve and in light of the pharmacological data is probably over
cautious.

Chlorpheniramine has little data on transfer into breastmilk. It is likely to produce
sedation in the baby but with short courses to treat a histamine reaction to bites
and stings this is unlikely to be significant. Levels are unlikely to reach the levels
licensed to be given directly to babies over 1 year.
A leaflet for mothers has been produced to provide simple information on this subject
but pharmacists should be able to reassure them that all drugs in the formulary can
safely be given to breastfeeding women.
References

Briggs GG , Freeman RK and Yaffe SJ . Drugs In pregnancy and Lactation (5th
Ed) 1998. Williams and Wilkins, Baltimore.

Hale TW. Medications in Mother's Milk (10th Ed) 2002; Pharmasoft, Texas

Hale TW Clinical Therapy in Breastfeeding Patients 1999, Pharmasoft, Texas
For further information please contact Wendy Jones, East Hants PCT on
Wendyjones28@aol.com or
02392 598604