Drugs List

Therapeutic Indications

Uses

Pruritus ani
Symptomatic relief of pain and irritation associated with haemorrhoids

Contraindications

Administration site infection
Children under 12 years
Breastfeeding
Hypersensitivity to lanolin
Pregnancy

Precautions and Warnings

Children aged 12 to 18 years

Some formulations contain lanolin
If visual disturbances occur, perform ophthalmic evaluation
Possible systemic absorption of steroid
Discontinue if rectal bleeding or irritation occurs
Treatment should be for a maximum period of 7 days
Advise patient to see doctor if symptoms persist for 7 days with treatment

Pregnancy and Lactation

Pregnancy

The manufacturer recommends that this product is contraindicated in pregnancy.

There is inadequate evidence of safety in human pregnancy. There may be a small risk of cleft palate, intrauterine growth retardation and suppression of the neonatal HPA axis as shown in animal studies.

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

The manufacturer recommends that this product is contraindicated in breastfeeding.

The US National Library of Medicine, Drugs and Lactation Database (LactMed) however, consider it is unlikely that short-term application of topical hydrocortisone would pose a risk to the breastfed infant by passage into breast milk.

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

Anal irritation
Anal pain
Anal pruritus
Blurred vision
Burning sensation (local)
Contact dermatitis
Erythema at application site
Hypersensitivity reactions
Localised exfoliation
Localised rash
Localised urticaria
Sensitisation

Presentation

Rectal formulations containing hydrocortisone with benzyl benzoates and soothing agents

Drugs List

Therapeutic Indications

Uses

Pruritus ani
Symptomatic relief of pain and irritation associated with haemorrhoids

Dosage

Adults

Adolescents

Contraindications

Administration site infection
Children under 12 years
Breastfeeding
Hypersensitivity to lanolin
Pregnancy

Precautions and Warnings

Children aged 12 to 18 years

Some formulations contain lanolin
If visual disturbances occur, perform ophthalmic evaluation
Possible systemic absorption of steroid
Discontinue if rectal bleeding or irritation occurs
Treatment should be for a maximum period of 7 days
Advise patient to see doctor if symptoms persist for 7 days with treatment

Pregnancy and Lactation

Pregnancy

The manufacturer recommends that this product is contraindicated in pregnancy.

There is inadequate evidence of safety in human pregnancy. There may be a small risk of cleft palate, intrauterine growth retardation and suppression of the neonatal HPA axis as shown in animal studies.

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

The manufacturer recommends that this product is contraindicated in breastfeeding.

The US National Library of Medicine, Drugs and Lactation Database (LactMed) however, consider it is unlikely that short-term application of topical hydrocortisone would pose a risk to the breastfed infant by passage into breast milk.

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

Anal irritation
Anal pain
Anal pruritus
Blurred vision
Burning sensation (local)
Contact dermatitis
Erythema at application site
Hypersensitivity reactions
Localised exfoliation
Localised rash
Localised urticaria
Sensitisation

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 2014

Reference Sources

Summary of Product Characteristics: Anusol HC Ointment. McNeil Products Ltd. Revised April 2016

Summary of Product Characteristics: Anusol HC Suppositories. McNeil Products Ltd. Revised April 2016

Summary of Product Characteristics: Anusol Plus HC Ointment. McNeil Products Ltd. Revised April 2016

Summary of Product Characteristics: Anusol Plus HC Suppositories. McNeil Products Ltd. Revised April 2016

Summary of Product Characteristics: Anusol Soothing Relief Ointment. McNeil Products Ltd. Revised April 2016

Summary of Product Characteristics: Anusol Soothing Relief Suppositories. McNeil Products Ltd. Revised April 2016

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: 16 June 2016

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 August 2017