Drugs List

Therapeutic Indications

Uses

Anal fissure
Haemorrhoids - external
Proctitis
Pruritus ani
Pruritus vulvae

Contraindications

Administration site infection
Fragile skin

Precautions and Warnings

Porphyria
Pregnancy

Appropriate antibiotic therapy required in presence or if risk of infection
Exclude malignancy before treatment
Avoid instillation of excess amounts via applicator especially in children
Do not apply to atrophic skin
Discontinue if rectal bleeding or irritation occurs
Avoid long term use

Convulsions have been reported in children with large doses.

The manufacturer advises to use with caution in acute porphyria. The ointment is possibly porphyrinogenic and should only be prescribed when no other alternative is available.

In hospitalised patients, consider ECG monitoring in patients treated with anti-arrhythmic drugs class III, since cardiac effects may be additive.

Pregnancy and Lactation

Pregnancy

Use lidocaine with hydrocortisone acetate with caution in pregnancy.

Manufacturer advises to avoid unless considered essential.

Briggs (2011) and Schaefer (2007) both indicate that lidocaine when administered systemically to a pregnant women is able to cross the placenta without any adverse effect on pregnancy. As the ointment is administered topically, systemic absorption of lidocaine is likely to be minimal, further reducing any risk during pregnancy.

Topical application of corticosteroids to pregnant animals however, can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

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

Lidocaine with hydrocortisone is considered safe for use in breastfeeding.

Lidocaine and hydrocortisone are excreted into breast milk but in such small quantities that adverse effects on the child are unlikely at therapeutic doses.

Since only extensive application of the most potent corticosteroids may cause systemic effects in the mother, it is unlikely that short term application of topical hydrocortisone would pose a risk to the breastfed infant by pasage into breast milk. It is particularly important to ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated.

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

Allergic reaction
Anaphylactic shock
Contact sensitisation
Skin reactions

Presentation

Topical formulation of lidocaine and hydrocortisone acetate

Drugs List

Therapeutic Indications

Uses

Anal fissure
Haemorrhoids - external
Proctitis
Pruritus ani
Pruritus vulvae

Dosage

Adults

Elderly

Children

Contraindications

Administration site infection
Fragile skin

Precautions and Warnings

Porphyria
Pregnancy

Appropriate antibiotic therapy required in presence or if risk of infection
Exclude malignancy before treatment
Avoid instillation of excess amounts via applicator especially in children
Do not apply to atrophic skin
Discontinue if rectal bleeding or irritation occurs
Avoid long term use

Convulsions have been reported in children with large doses.

The manufacturer advises to use with caution in acute porphyria. The ointment is possibly porphyrinogenic and should only be prescribed when no other alternative is available.

In hospitalised patients, consider ECG monitoring in patients treated with anti-arrhythmic drugs class III, since cardiac effects may be additive.

Pregnancy and Lactation

Pregnancy

Use lidocaine with hydrocortisone acetate with caution in pregnancy.

Manufacturer advises to avoid unless considered essential.

Briggs (2011) and Schaefer (2007) both indicate that lidocaine when administered systemically to a pregnant women is able to cross the placenta without any adverse effect on pregnancy. As the ointment is administered topically, systemic absorption of lidocaine is likely to be minimal, further reducing any risk during pregnancy.

Topical application of corticosteroids to pregnant animals however, can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

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

Lidocaine with hydrocortisone is considered safe for use in breastfeeding.

Lidocaine and hydrocortisone are excreted into breast milk but in such small quantities that adverse effects on the child are unlikely at therapeutic doses.

Since only extensive application of the most potent corticosteroids may cause systemic effects in the mother, it is unlikely that short term application of topical hydrocortisone would pose a risk to the breastfed infant by pasage into breast milk. It is particularly important to ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated.

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

Allergic reaction
Anaphylactic shock
Contact sensitisation
Skin reactions

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: June 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.

Summary of Product Characteristics: Xyloproct 5%/0.275% Ointment. AstraZeneca UK Limited. Revised April 2015.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 September 2017

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, Topical Last revised: 10 March 2015
Last accessed: 25 June 2015

The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last revised: 14 April 2010
Last accessed: 25 June 2015