Prednisolone retention enema 20mg/100ml
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Single dose enema containing prednisolone as prednisolone sodium phosphate.
One enema to be used each night for 2 to 4 weeks.
If progressive improvement is shown, the course may be extended.
Additional Dosage Information
Some patients relapse after an interval but are likely to respond equally well to a repeated course of treatment.
For rectal administration.
The enema should be administered each night at bedtime.
It may be used at room temperature or after warming for a few minutes in warm water.
Administration site infection
Children under 18 years
Uncontrolled systemic infection
Recent gastrointestinal anastomosis
Precautions and Warnings
Family history of diabetes mellitus
Family history of glaucoma
Congestive cardiac failure
History of severe affective disorders
History of steroid myopathy
History of tuberculosis
Recent myocardial infarction
Severe affective disorders
Exposure to measles may require prophylaxis with normal immunoglobulin
May mask symptoms or signs of infections
Clinical presentations of infections may be atypical
Frequent review needed to titrate dose to disease activity
Perform eye tests in any patient with vision change/ophthalmologic symptoms
Possible systemic absorption of steroid
Advise patient to report symptoms of infection immediately
Antibody response to vaccines may be reduced
Oversuppression of immune system may increase susceptibility to infection
Patient should report worrying psychological changes esp. suicidal thoughts
Prolonged/excessive use may lead to adrenal suppression
Withdraw gradually after long-term use
Avoid prolonged use
Advise patient to read the leaflet in the pack
Advise patients to avoid chickenpox, measles etc - see doctor if exposed
Consider issuing Steroid Treatment/Steroid Emergency Card
Substantial systemic absorption is likely especially when the bowel is inflamed. Use for the minimum period only, to limit potential for corticosteroid side-effects.
During prolonged therapy any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage. If corticosteroids have been stopped following prolonged therapy they may need to be temporarily re-introduced.
Patients presenting with blurred vision or other visual disturbances should be referred to an ophthalmologist for evaluation as possible causes may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Pregnancy and Lactation
Prednisolone retention enema should be used with caution during pregnancy.
There is no convincing evidence that systemic corticosteroids increase the incidence of congenital abnormalities, although prolonged administration may increase the risk of intra-uterine growth restriction.
88% of prednisolone is thought to be inactivated as it crosses the placenta.
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 ).
Prednisolone retention enema should be used with caution during breastfeeding.
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
Aggravation of schizophrenia
Blood lipid changes
Congestive cardiac failure
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Growth suppression in infancy, childhood and adolescence
Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
Increased intra-ocular pressure
Increased susceptibility and severity of infections
Myocardial rupture following recent myocardial infarction
Negative calcium balance
Negative nitrogen balance
Peptic ulceration with perforation and haemorrhage
Posterior subcapsular cataracts
Recurrence of dormant tuberculosis
Suppression of clinical signs of infection
Suppression of reactions to skin tests
Toxic epidermal necrolysis
Vertebral and long bone fractures
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 ).
Last Full Review Date: November 2018
Summary of Product Characteristics: Prednisolone 20mg/100ml Rectal Solution. RPH Pharmaceuticals AB. Revised June 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 November 2018
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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