Drugs List

Therapeutic Indications

Uses

Treatment of proctitis and distal ulcerative colitis.

Administration

For rectal administration.

The patient should be advised to follow the manufacturer's instructions.

Contraindications

Local conditions where infection might be masked or healing impaired, for example bowel obstruction, peritonitis, gastrointestinal fistulae, or perforation of the bowel.

Untreated infection.

Children under 12 years of age (see 'Dosage; Children' section)

Precautions and Warnings

Children aged 12-18 years (see 'Dosage; Children' section)

Severe ulcerative colitis

Long term continuous use should be avoided. If the product is used for longer than recommended, then consider the consequence of systemic absorption and adrenal suppression.

May mask signs and symptoms of infection.

Pregnancy (see 'Pregnancy' section)

Breastfeeding (see 'Lactation' section)

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy.

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. Therefore there may be a very 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 14-17 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 with caution in lactation.

Prednisolone appears 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

Prolonged use may give result in the adverse effects of systemic corticosteroids, including adrenal suppression.

Presentation

Aerosol foam containing prednisolone metasulfobenzoate sodium equivalent to 20mg prednisolone per metered dose.

Drugs List

Therapeutic Indications

Uses

Treatment of proctitis and distal ulcerative colitis.

Dosage

Adults

Children

Administration

For rectal administration.

The patient should be advised to follow the manufacturer's instructions.

Contraindications

Local conditions where infection might be masked or healing impaired, for example bowel obstruction, peritonitis, gastrointestinal fistulae, or perforation of the bowel.

Untreated infection.

Children under 12 years of age (see 'Dosage; Children' section)

Precautions and Warnings

Children aged 12-18 years (see 'Dosage; Children' section)

Severe ulcerative colitis

Long term continuous use should be avoided. If the product is used for longer than recommended, then consider the consequence of systemic absorption and adrenal suppression.

May mask signs and symptoms of infection.

Pregnancy (see 'Pregnancy' section)

Breastfeeding (see 'Lactation' section)

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy.

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. Therefore there may be a very 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 14-17 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 with caution in lactation.

Prednisolone appears 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

Effects on Ability to Drive and Operate Machinery

None known

Counselling

Advise patients to follow the manufacturer's instructions for the use of this product.

Side Effects

Prolonged use may give result in the adverse effects of systemic corticosteroids, including adrenal suppression.

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 ).

Shelf Life and Storage

Do not store above 25 degrees C
Protect from sunlight and do not expose to temperatures exceeding 50 degrees centigrade
Do not refrigerate
Flammable - avoid naked flames and heat
Do not pierce or burn even after use

Further Information

Last Full Review Date: May 2012

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: Prednisolone 20mg/dose Rectal Foam. Chemidex Pharma Limited. March 2011.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 September 2017