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Prednisolone retention enema 20mg/100ml

Presentation

Single dose enema containing prednisolone as prednisolone sodium phosphate.

Drugs List

  • prednisolone 20mg/100ml retention enema
  • Therapeutic Indications

    Uses

    Crohn's disease
    Ulcerative colitis

    Dosage

    Adults

    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.

    Administration

    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.

    Contraindications

    Administration site infection
    Children under 18 years
    Uncontrolled systemic infection
    Gastrointestinal obstruction
    Gastrointestinal perforation
    Recent gastrointestinal anastomosis
    Rectal fistula

    Precautions and Warnings

    Elderly
    Family history of diabetes mellitus
    Family history of glaucoma
    Breastfeeding
    Congestive cardiac failure
    Diabetes mellitus
    Diverticulitis
    Epileptic disorder
    Glaucoma
    Hepatic impairment
    History of severe affective disorders
    History of steroid myopathy
    History of tuberculosis
    Hypertension
    Hypothyroidism
    Myasthenia gravis
    Osteoporosis
    Peptic ulcer
    Pregnancy
    Recent myocardial infarction
    Renal impairment
    Severe affective disorders
    Ulcerative colitis

    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

    Pregnancy

    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 ).

    Lactation

    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

    Side Effects

    Abdominal distension
    Acne
    Acute pancreatitis
    Adrenal suppression
    Aggravation of schizophrenia
    Amenorrhoea
    Anaphylaxis
    Avascular osteonecrosis
    Behavioural disturbances
    Blood lipid changes
    Blurred vision
    Bruising
    Candidiasis
    Chorioretinopathy
    Congestive cardiac failure
    Conjunctivitis
    Corneal thinning
    Cushing's syndrome
    Cushingoid facies
    Depression
    Dermatitis
    Diabetes mellitus
    Dyspepsia
    Ecchymosis
    Euphoria
    Exacerbation of epilepsy
    Exacerbation of ophthalmic fungal disease
    Exacerbation of ophthalmic viral disease
    Exophthalmos
    Facial erythema
    Glaucoma
    Granulomatous chorioretinitis
    Growth suppression in infancy, childhood and adolescence
    Headache
    Hiccups
    Hirsutism
    Hyperglycaemia
    Hypersensitivity reactions
    Hypertension
    Hypokalaemic alkalosis
    Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
    Impaired healing
    Increased appetite
    Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
    Increased intra-ocular pressure
    Increased susceptibility and severity of infections
    Increased sweating
    Insomnia
    Irritation (localised)
    Leucocytosis
    Leukocytosis
    Malaise
    Menstrual disturbances
    Muscle weakness
    Myocardial rupture following recent myocardial infarction
    Nausea
    Negative calcium balance
    Negative nitrogen balance
    Oesophageal ulceration
    Osteoporosis
    Papilloedema
    Peptic ulceration with perforation and haemorrhage
    Petechiae
    Porphyria
    Posterior subcapsular cataracts
    Potassium loss
    Proximal myopathy
    Psychological dependence
    Recurrence of dormant tuberculosis
    Scleral thinning
    Skin atrophy
    Sodium/water retention
    Striae
    Suicidal tendencies
    Suppression of clinical signs of infection
    Suppression of reactions to skin tests
    Telangiectasia
    Tendon rupture
    Thromboembolism
    Toxic epidermal necrolysis
    Urticaria
    Vertebral and long bone fractures
    Vertigo
    Weight gain

    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: November 2018

    Reference Sources

    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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