Prednisolone oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of prednisolone.
Drugs List
Therapeutic Indications
Uses
Inflammatory or allergic conditions
Myasthenia gravis
Nephrotic syndrome
Nephrotic syndrome - prevention of relapse
Treatment of allergic or inflammatory conditions including the following.
Allergy and anaphylaxis
Bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema, anaphylaxis.
Arteritis/collagenosis
Giant cell arteritis/polymyalgia rheumatica, mixed connective tissue disease (excluding systemic sclerosis), polyarteritis nodosa, polymyositis.
Blood disorders
Haemolytic anaemia (autoimmune), leukaemia (acute monocytic, acute granulocytic, acute lymphoblastic and chronic lymphocytic), malignant lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura.
Cardiovascular disorders
Post myocardial infarction syndrome, rheumatic fever with severe carditis.
Endocrine disorders
Primary and secondary adrenal insufficiency, congenital adrenal hyperplasia.
Gastrointestinal disorders
Crohn's disease, ulcerative colitis, persistent coeliac syndrome (coeliac disease unresponsive to gluten withdrawal), autoimmune chronic active hepatitis, multisystem disease affecting liver, biliary peritonitis.
Hypercalcaemia
Sarcoidosis, vitamin D excess.
Infections (with appropriate chemotherapy)
Helminthic infestations, Herxheimer reaction, infectious mononucleosis, miliary tuberculosis, mumps orchitis (adult), tuberculous meningitis, rickettsial disease.
Muscular disorders
Polymyositis, dermatomyositis.
Neurological disorders
Infantile spasms, Shy-Drager syndrome, subacute demyelinating polyneuropathy.
Ocular disease
Scleritis, posterior uveitis, retinal vasculitis, pseudo tumours of the orbit, giant cell arteritis, malignant ophthalmic Graves disease.
Renal disorders
Lupus nephritis, acute interstitial nephritis, minimal change glomerulonephritis, nephrosis.
Respiratory disease
Allergic pneumonitis, asthma, occupational asthma, pulmonary aspergillosis, pulmonary fibrosis, pulmonary alveolitis, aspiration of foreign body, aspiration of stomach contents, pulmonary sarcoid, drug induced lung disease, adult respiratory distress syndrome, spasmodic croup.
Rheumatic disorders
Rheumatoid arthritis, polymyalgia rheumatica, juvenile chronic arthritis, psoriatic arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease, rheumatic carditis, acute rheumatic fever.
Skin disorders
Pemphigus vulgaris, exfoliative dermatitis, bullous pemphigoid, systemic lupus erythematosus, pyoderma gangrenosum, inflammatory skin disorders.
Miscellaneous
Sarcoidosis, hyperpyrexia, Behcet's disease, immunosuppression in organ transplantation.
Dosage
The lowest effective dose should be used for the minimum period. The dose depends on the disease, disease severity and clinical response.
An intermittent dosage regimen may be used in some patients, taking a single dose on alternate days or at longer intervals.
Adults
Initial dosage varies between 5mg to 60mg daily depending on the condition, severity and clinical response.
Maintenance dose varies between 2.5mg to 15mg daily, higher doses may be required.
Short term therapy
20mg to 30mg daily. Dose may be reduced gradually by 2.5mg to 5mg every 2 to 5 days depending on response.
Daily doses of 75mg or higher may be required initially in acute conditions.
Allergic and Skin disorders
5mg to 15mg daily.
Collagenosis
20mg to 30mg daily.
Higher doses may be required in severe cases.
Rheumatoid arthritis
Initial dose of 10mg to 15mg daily. For maintenance therapy, the lowest effective dosage should be used.
Blood disorders and lymphoma
15mg to 60mg daily reducing once an adequate clinical or haematological response is achieved. Higher doses may be required in order to induce remission in leukaemia.
Suppression of inflammatory response and allergic disorders
Initial dose of 10mg to 20mg daily.
In severe disease state an initial dose maximum 60mg daily, can be continued for several weeks or months.
Maintenance dose of 2.5mg to 15mg daily, higher doses may be required.
Ulcerative colitis or Crohn's disease
Initial dose of 20mg to 40mg a day (up to 60mg daily in some cases).
Severe acute asthma
Give 40mg to 50mg for at least 5 days.
Children
The manufacturers state that fractions of the adult dosage may be used (e.g. 75% at 12 years, 50% at 7 years and 25% at 1 year), but clinical factors must be given due weight. Soluble prednisolone tablets and oral liquid are licensed for use in children; see product literature.
Acute asthma attacks
Children aged 12 to 18 years
40mg to 50mg daily for at least 5 days.
Patients already receiving maintenance steroid therapy should receive 2mg/kg (up to a maximum of 60mg).
Children aged 1 month to 12 years
1mg/kg to 2mg/kg once a day for up to 3 days. Maximum of 40mg once a day. Duration of treatment may be longer, if considered necessary.
If the child has been given oral corticosteroid for more than a few days, then give prednisolone 2mg/kg once a day. Maximum of 60mg once a day.
Croup
1mg/kg to 2mg/kg.
Autoimmune inflammatory disorders
Initial dose of 1mg/kg to 2mg/kg once a day, up to a maximum of 60mg. If appropriate, dose should be reduced after a few days.
Autoimmune hepatitis
Initial dose of 2mg/kg once a day, up to a maximum of 40mg.
Corticosteroid replacement therapy
Children aged 12 to 18 years
2mg to 2.5mg per square metre daily, either as a single dose or in two divided doses.
Idiopathic thrombocytopenic purpura
Children aged 1 to 10 years
1mg/kg to 2mg/kg daily for a maximum of 14 days.
Alternatively, 4mg/kg daily for a maximum of 4 days may be used.
Nephrotic syndrome
Initial dose of 60mg per square metre once a day, up to a maximum of 80mg daily, for 4 to 6 weeks until proteinuria ceases. Reduce dose to 40mg per square metre on alternate days for 4 to 6 weeks, withdraw dose gradually.
To prevent a relapse, it is recommended 0.5mg/kg to 1mg/kg once a day or on alternate days for 3 to 6 months.
Infantile spasms
Children aged 1 month to 1 year
Initial dose of 10mg four times daily for 2 weeks then reduce dose gradually over 15 days until stopped.
If seizures are not controlled after 7 days of therapy, increase dose to 20mg three times daily for 7 days.
For patients taking 40mg a day, reduce dose in steps of 10mg every 5 days, until treatment is stopped.
For patients taking 60 mg a day, reduce dose in stages down to 40mg a day for 5 days, then 20mg a day for 5 days, then 10mg a day for 5 days, then stop treatment.
Moderate to severe pneumocystis infections associated with HIV infection (adjunctive therapy)
2mg/kg once a day for 5 days, up to a maximum of 80mg a day. Reduce dose gradually over 16 days until stopped.
Corticosteroid treatment should be started at the same time as the anti-pneumocystis therapy or no later than 24 to 72 hours after initial dose. Corticosteroid treatment should be withdrawn before anti-pneumocystis treatment is completed.
Ulcerative colitis and Crohn's disease
Children aged 2 to 18 years
2m/kg once daily until remission occurs then reduce dose. Maximum dose of 60mg.
Additional Dosage Information
If patients have been receiving a dose higher than the physiological dose (7.5mg) for longer than 3 weeks, withdrawal should not be abrupt. A dose reduction regime should be carried out depending on the likelihood of disease relapse and the level of risk of hypothalamic-pituitary-adrenal (HPA) suppression.
In patients using doses up to 40mg for up to 3 weeks for a disease unlikely to relapse, abrupt withdrawal should be appropriate due to low risk of HPA suppression. However, if there is uncertainty about HPA suppression these patients should have the dose reduced to 7.5mg and then gradually reduce to allow HPA axis recovery.
In the following patient groups, gradual reduction of prednisolone therapy should be considered (even after courses lasting less than 3 weeks):
Repeated courses of systemic corticosteroids, particularly if taken for longer than 3 weeks.
Within one year of a long-term corticosteroid therapy course.
Adrenocortical insufficiency (other than exogenous corticosteroid therapy).
Systemic corticosteroid doses greater than 40mg daily of prednisolone (or equivalent).
Patient taking repeated doses in the evening.
If there is a lack of satisfactory clinical response to prednisolone, gradually discontinue treatment and transfer patient to alternative therapy.
Contraindications
Uncontrolled systemic infection
Galactosaemia
Ocular herpes simplex infection
Precautions and Warnings
Children under 18 years
Elderly
Family history of diabetes mellitus
Family history of glaucoma
Infection
Breastfeeding
Congestive cardiac failure
Cushing's disease
Diabetes mellitus
Disorder of lipid metabolism
Duchenne muscular dystrophy
Epileptic disorder
Glaucoma
Glucose-galactose malabsorption syndrome
Hepatic cirrhosis
Hepatic impairment
History of severe affective disorders
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Hypertension
Hypothyroidism
Lactose intolerance
Myasthenia gravis
Osteoporosis
Peptic ulcer
Pregnancy
Recent myocardial infarction
Renal impairment
Scleroderma
Severe affective disorders
Thromboembolic disorder
Tuberculosis
Ulcerative colitis
Consider reintroducing steroids temporarily during illness/trauma/surgery
Disease reactivation may occur in patients with latent TB
Exposure to measles may require prophylaxis with normal immunoglobulin
Live virus vaccine should not be given for 3 months after treatment
May mask peritonitis or other signs or symptoms of GI disorders
May mask symptoms or signs of infections
Patients with diabetes may experience fluctuations in blood glucose
Systemic sclerosis: Scleroderma renal crisis risk in doses above 15mg daily
Temporary increase in dose may be needed during illness, trauma or surgery
Use enteric coated tablets with caution in Crohn's disease or IBS patients
Consider prophylactic anti-tuberculosis therapy if appropriate
Passive immunisation of chicken pox / herpes zoster may be required
Contains lactose
Some products may contain soya or soya derivative
Frequent review needed to titrate dose to disease activity
Monitor blood pressure regularly
Monitor regularly the height of children receiving prolonged treatment
Possible mineralocorticoid secretion suppression & need for supplementation
Post menopausal women at increased risk of osteoporosis
Pregnancy: Monitor closely patients with pre-eclampsia or fluid retention
Prolonged or high dose may lead to adrenal suppression
Psychological changes may occur during initiation & withdrawal of treatment
Supervise patient closely during drug withdrawal
Adrenal cortical atrophy may persist for years after stopping drug
Advise patient to report new visual problems and symptoms
Antibody response to vaccines may be reduced
Breastfeeding: Risk of adrenal suppression in breastfed infant
Corticosteroids may cause growth retardation in children under 18 years
Immunosuppressive drugs may increase risk of malignancy
May cause activation of latent psychosis
Oversuppression of immune system may increase susceptibility to infection
Patient should report worrying psychological changes esp. suicidal thoughts
Refer immediately visual disturbances to a specialist
Sudden withdrawal may be inadvisable -see product information/SPC
Advise patient not to take St John's wort concurrently
Advise patient to avoid exposure to measles
Advise patient to seek urgent medical attention if exposed to measles
Advise those on systemic corticosteroids to avoid chickenpox/H zoster
Consider issuing Steroid Treatment/Steroid Emergency Card
If exposed to chickenpox or Herpes zoster seek urgent medical attention
Patients (or parents of children) without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and seek urgent medical attention if exposed as chickenpox can prove fatal in immunocompromised patients. If exposed while on prednisolone or within three months of previous use, passive immunisation with varicella/zoster immunoglobulin (VZIG) should be administered within 10 days of the exposure. If chickenpox occurs, treat urgently under specialist care. Do not stop prednisolone therapy, an upward dosage adjustment may be required.
Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin. Close clinical supervision is required especially during long term therapy.
Pregnancy and Lactation
Pregnancy
Use prednisolone with caution in pregnancy.
The manufacturer advises caution if prednisolone is used during pregnancy.
Animal studies have shown teratogenic effects (palate gap and skeletal malformations). Human data is limited and as such a potential risk cannot be ruled out.
Corticosteroids are able to cross the placenta but 88% of prednisolone is inactivated as it crosses the placenta. Prolonged treatment may increase the risk of intra-uterine growth retardation and imposes a risk of adrenal insufficiency in the newborn. Stillbirth could be a result of use. Reduced placental and birth weight have been reported in human after long term treatment.
Hypoadrenalism may occur in the neonate following pre-natal exposure to corticosteroids but this usually resolves spontaneously after birth.
Cataracts have been observed in infants born to mothers treated with long term prednisolone during pregnancy.
Lactation
Use prednisolone with caution during breastfeeding.
The manufacturer advises caution if prednisolone is used when breastfeeding.
Corticosteroids are secreted in breast milk in small amounts. Doses of up to 40 mg daily of prednisolone are unlikely to cause systemic effects in the infant.
Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breastfeeding are likely to outweigh any theoretical risk.
In patients with high maternal doses, breastfeeding should be avoided for 4 hours as this should be markedly decrease the dose recieved by the infant. This is not necessary in short term treatments.
Side Effects
Abdominal distension
Acne
Acute pancreatitis
Aggravation of schizophrenia
Amenorrhoea
Amnesia
Anxiety
Avascular osteonecrosis
Behavioural disturbances
Blurred vision
Bruising
Calciphylaxis
Candidiasis
Central serous chorioretinopathy
Cognitive impairment
Confusion
Congestive cardiac failure
Corneal thinning
Cushing's syndrome
Cushingoid facies
Cutaneous atrophy
Delusions
Depression
Diarrhoea
Dizziness
Dyslipidaemia
Dyspepsia
Ecchymosis
Emotional lability
Epidural lipomatosis
Euphoria
Exacerbation of diabetes
Exacerbation of epilepsy
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Exophthalmos
Fatigue
Glaucoma
Growth suppression in infancy, childhood and adolescence
Hallucinations
Headache
Hirsutism
Hyperglycaemia
Hypersensitivity reactions including anaphylaxis
Hypertension
Hypokalaemic alkalosis
Immunosuppression
Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
Impaired healing
Increased intra-ocular pressure
Increased susceptibility and severity of infections
Increased sweating
Irregular menstruation
Irritability
Kaposi's Sarcoma
Leucocytosis
Malaise
Mania
Myalgia
Myopathy
Nausea
Negative calcium balance
Negative nitrogen balance
Oesophageal candidiasis
Oesophageal ulceration
Opportunistic infections
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Posterior subcapsular cataracts
Potassium loss
Proximal myopathy
Pruritus
Pseudotumour cerebri syndrome (mainly in children)
Psychological dependence
Psychotic reactions
Raised intracranial pressure
Rash
Recurrence of dormant tuberculosis
Retinal detachment
Scleral thinning
Scleroderma renal crisis
Sleep disturbances
Sodium/water retention
Stevens-Johnson syndrome
Striae
Suicidal tendencies
Suppression of reactions to skin tests
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Tendon rupture
Thromboembolism
Toxic epidermal necrolysis
Tumour lysis syndrome
Urticaria
Vertebral and long bone fractures
Vertigo
Weight gain
Withdrawal Symptoms and Signs
Withdrawal symptoms may involve or resemble a clinical relapse of the disease for which the patient has been undergoing treatment. Other effects that may occur during withdrawal or change of corticosteroid therapy include benign intracranial hypertension with headache and vomiting and papilloedema caused by cerebral oedema. Latent rhinitis or eczema may be unmasked.
Withdrawal symptoms due to a rapid reduction of corticosteroid doses may lead to adrenal insufficiency, hypotension and death.
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: May 2018
Reference Sources
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