Drugs List

Therapeutic Indications

Uses

Short term (5-7 days) symptomatic relief of haemorrhoids
Short term (5-7 days) symptomatic relief of pruritus ani

Contraindications

Administration site infection

Precautions and Warnings

Infants
Pregnancy

Appropriate antibiotic therapy required in presence or if risk of infection
May mask symptoms or signs of infections
Avoid occlusive dressings
Adrenal suppression may occur even without occlusion
Prolonged continuous use increases the risk of systemic toxicity
Prolonged use may cause atrophic skin changes
Pregnancy: Avoid excessive or unduly prolonged administration
Avoid prolonged use in infants
Only recommended for short term use
Male & female: May damage latex condoms and diaphragms

Pregnancy and Lactation

Pregnancy

Use with caution as there is not enough evidence of safety in human pregnancy. Animal studies have shown that topical corticosteroids can cause abnormalities of foetal development, including cleft palate and intra-uterine growth retardation. There may therefore be a small risk of such effects on 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

Maternal use rectally with an ointment or by suppository for a short period of time poses very little risk to the breastfed infant.

Prednisolone does appear in small amounts in breast milk, but the relatively low doses involved in this preparation and the route of administration used would suggest that systemic effects in the infant are unlikely.

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

Adrenal suppression
Allergic skin reactions
Atrophy (localised)
Systemic steroid effects

Presentation

Suppositories and ointment containing cinchocaine hydrochloride and prednisolone caproate.

Drugs List

Therapeutic Indications

Uses

Short term (5-7 days) symptomatic relief of haemorrhoids
Short term (5-7 days) symptomatic relief of pruritus ani

Dosage

Adults

Children

Contraindications

Administration site infection

Precautions and Warnings

Infants
Pregnancy

Appropriate antibiotic therapy required in presence or if risk of infection
May mask symptoms or signs of infections
Avoid occlusive dressings
Adrenal suppression may occur even without occlusion
Prolonged continuous use increases the risk of systemic toxicity
Prolonged use may cause atrophic skin changes
Pregnancy: Avoid excessive or unduly prolonged administration
Avoid prolonged use in infants
Only recommended for short term use
Male & female: May damage latex condoms and diaphragms

Pregnancy and Lactation

Pregnancy

Use with caution as there is not enough evidence of safety in human pregnancy. Animal studies have shown that topical corticosteroids can cause abnormalities of foetal development, including cleft palate and intra-uterine growth retardation. There may therefore be a small risk of such effects on 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

Maternal use rectally with an ointment or by suppository for a short period of time poses very little risk to the breastfed infant.

Prednisolone does appear in small amounts in breast milk, but the relatively low doses involved in this preparation and the route of administration used would suggest that systemic effects in the infant are unlikely.

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

Adrenal suppression
Allergic skin reactions
Atrophy (localised)
Systemic steroid effects

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: October 2013

Reference Sources

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: Scheriproct ointment. Bayer plc. Revised April 2013

Summary of Product Characteristics: Scheriproct suppositories. Bayer plc. Revised May 2013

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 June 2017