Prednisolone suppositories 5mg
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Suppositories containing prednisolone.
Drugs List
Therapeutic Indications
Uses
Crohn's disease : rectal complications
Proctitis
Dosage
Adults
One 5mg suppository inserted at night and one in the morning.
If improvement is shown, treatment can be continued for some months.
If symptoms recur, treatment can be resumed.
Children
Children aged 2 to 18 years
One 5mg suppository inserted at night and one in the morning.
If improvement is shown, treatment can be continued for some months.
If symptoms recur, treatment can be resumed.
Administration
For rectal use only.
Where possible, suppositories should be inserted after defecation.
Contraindications
Administration site infection
Children under 2 years
Uncontrolled systemic infection
Gastrointestinal obstruction
Gastrointestinal perforation
Rectal fistula
Precautions and Warnings
Elderly
Breastfeeding
Congestive cardiac failure
Diabetes mellitus
Diverticulitis
Epileptic disorder
Glaucoma
Hepatic impairment
History of tuberculosis
Hypertension
Hypothyroidism
Myasthenia gravis
Osteoporosis
Peptic ulcer
Pregnancy
Recent gastrointestinal anastomosis
Recent myocardial infarction
Renal impairment
Severe affective disorders
Ulcerative colitis
May mask symptoms or signs of infections
Passive immunisation of chicken pox / herpes zoster may be required
Clinical presentations of infections may be atypical
Frequent review needed to titrate dose to disease activity
If visual disturbances occur, perform ophthalmic evaluation
Possible systemic absorption of steroid
Advise patient to report any blurred vision or any other eye symptoms
Advise patient to report symptoms of infection immediately
Advise patients/carers to seek medical advice if suicidal intent develops
Antibody response to vaccines may be reduced
Oversuppression of immune system may increase susceptibility to infection
Prolonged/excessive use may lead to adrenal suppression
Withdraw gradually after long-term 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
Passive immunisation with varicella zoster immunoglobulin is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox.
Confirmed chickenpox warrants specialist care and urgent treatment. Corticosteroids should not be stopped and dosage may need to be temporarily increased.
Pregnancy and Lactation
Pregnancy
Use prednisolone with caution during pregnancy.
The manufacturer advises caution if prednisolone is used during pregnancy. Close monitoring is required in patients with pre-eclampsia or fluid retention. At the time of writing there is limited published information regarding the systemic use of prednisolone during pregnancy. Potential risks are unknown.
Lactation
Use prednisolone with caution during breastfeeding.
The manufacturer advises caution if prednisolone is used when breastfeeding. Corticosteroids are excreted in small amounts in breast milk. Exposed infants should be monitored for signs or adrenal suppression.
Counselling
Advise patient of importance of reading the Patient Information Leaflet before use.
Advise patient to carry a Steroid Treatment Card if necessary.
Advise patients exposed to, or suffering from, chickenpox and/or measles to seek urgent medical attention.
Advise patient to seek medical attention at the first sign of any infection if on prolonged treatment.
Advise patient to seek medical advice if worrying psychological symptoms develop, especially depressed mood or suicidal ideation.
Advise patient to report any blurred vision or any other eye symptoms.
Side Effects
Acne
Acute pancreatitis
Adrenal suppression
Aggravation of schizophrenia
Altered serum lipid profile
Amenorrhoea
Amnesia
Anaphylaxis
Anxiety
Avascular osteonecrosis
Behavioural disturbances
Bruising
Candidiasis
Confusion
Corneal thinning
Cushing's syndrome
Delusions
Depression
Dyspepsia
Emotional lability
Euphoria
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Growth suppression in infancy, childhood and adolescence
Hallucinations
Hiccups
Hirsutism
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
Insomnia
Irritability
Irritation (localised)
Leucocytosis
Leukocytosis
Mania
Menstrual disturbances
Myocardial rupture following recent myocardial infarction
Nausea
Negative calcium balance
Negative nitrogen balance
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Posterior subcapsular cataracts
Potassium loss
Proximal myopathy
Psychological dependence
Psychosis
Recurrence of dormant tuberculosis
Scleral thinning
Skin atrophy
Sodium/water retention
Striae
Suicidal tendencies
Suppression of clinical signs of infection
Telangiectasia
Tendon rupture
Thromboembolism
Vertebral and long bone fractures
Weight gain
Overdosage
Unlikely with this route of administration.
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: September 2019
Reference Sources
Summary of Product Characteristics: Prednisolone 5mg Suppositories. RPH Pharmaceuticals AB Ltd. Revised December 2011.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 26 September 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.