Drugs List

Therapeutic Indications

Uses

Aphthous ulcers

Contraindications

Administration site infection
Galactosaemia

Precautions and Warnings

Children under 12 years
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Lactose intolerance
Pregnancy

Contains lactose
Advise patient to seek medical advice if symptoms persist for > 5 days

Pregnancy and Lactation

Pregnancy

Use hydrocortisone muco-adhesive buccal tablets with caution in pregnancy.

Hydrocortisone and its active precursor, cortisone, appear to present a small risk to humans. Cleft palate, cataracts, spontaneous abortion, IUGr and polycystic kidney disease have been observed when corticosteroids have been given to animals. Although the large number of data does not support these effects in the great majority of human pregnancies, adverse outcomes have been seen and may have been caused by corticosteroids. Briggs (2008) states that human data suggests there is a risk associated with hydrocortisone.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use hydrocortisone muco-adhesive buccal tablets with caution in breastfeeding.

Topical hydrocortisone has not been studied during breastfeeding. It is unlikely that the short term application of topical hydrocortisone would pose a risk to the nursing infant because only extensive application of the most potent corticosteroids may cause systemic effects in the mother.

No reports describing the excretion of hydrocortisone into human breast milk have been found. It not thought that these agents pose a risk to the nursing infant though. A review in 1997 stated that corticosteroids have been used safely during lactation. Prednisone, which is a more potent corticosteroid than hydrocortisone, is excreted in small amounts into milk and is classified as compatible with breast feeding (Briggs 2008).

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Exacerbation of diabetes
Exacerbation of infection

Presentation

Muco-adhesive buccal tablets containing hydrocortisone in the form of the ester hydrocortisone sodium succinate

Drugs List

Therapeutic Indications

Uses

Aphthous ulcers

Dosage

Adults

Elderly

Children

Contraindications

Administration site infection
Galactosaemia

Precautions and Warnings

Children under 12 years
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Lactose intolerance
Pregnancy

Contains lactose
Advise patient to seek medical advice if symptoms persist for > 5 days

Pregnancy and Lactation

Pregnancy

Use hydrocortisone muco-adhesive buccal tablets with caution in pregnancy.

Hydrocortisone and its active precursor, cortisone, appear to present a small risk to humans. Cleft palate, cataracts, spontaneous abortion, IUGr and polycystic kidney disease have been observed when corticosteroids have been given to animals. Although the large number of data does not support these effects in the great majority of human pregnancies, adverse outcomes have been seen and may have been caused by corticosteroids. Briggs (2008) states that human data suggests there is a risk associated with hydrocortisone.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use hydrocortisone muco-adhesive buccal tablets with caution in breastfeeding.

Topical hydrocortisone has not been studied during breastfeeding. It is unlikely that the short term application of topical hydrocortisone would pose a risk to the nursing infant because only extensive application of the most potent corticosteroids may cause systemic effects in the mother.

No reports describing the excretion of hydrocortisone into human breast milk have been found. It not thought that these agents pose a risk to the nursing infant though. A review in 1997 stated that corticosteroids have been used safely during lactation. Prednisone, which is a more potent corticosteroid than hydrocortisone, is excreted in small amounts into milk and is classified as compatible with breast feeding (Briggs 2008).

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Exacerbation of diabetes
Exacerbation of infection

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: May 2015.

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 14 May 2015.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 14 May 2015.

Summary of Product Characteristics: Hydrocortisone 2.5 mg Muco-Adhesive Buccal tablets. Revised May 2012.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Hydrocortisone Last revised: 06.12.2013
Last accessed: 14 May 2015