Prednisolone sodium phosphate oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of prednisolone sodium phosphate.
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:
Bronchial asthma, severe hypersensitivity reactions, anaphylaxis.
Rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective disease excluding systemic sclerosis, polyarteritis.
Inflammatory skin disorders, including pemphigus vulgaris, bullous pemphigoid and pyoderma gangrenosum.
Minimal change nephotic syndrome, acute interstitial nephritis.
Ulcerative colitis, Crohn's disease.
Rheumatic carditis.
Haemolytic anaemia (autoimmune), acute lymphoblastic and chronic lymphocytic leukaemia, malignant lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura.
Immunosuppression in transplantation.
Dosage
The dose depends on the disease, disease severity and the clinical response.
The lowest effective dose should be used for the minimum period.
An intermittent dosage regimen may be used in some patients, taking a single dose on alternate days or at longer intervals.
Adults
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.
Rheumatoid arthritis
7.5mg to 10mg daily, for maintenance the lowest effective dose is used.
Acute asthma
40mg to 50mg daily for at least 5 days.
Acute exacerbation of chronic obstructive pulmonary disease
30mg daily for 1 to 2 weeks.
Most other conditions
10mg to 100mg daily for 1 to 3 weeks, the reduced to the minimum effective dose.
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
Treatment of three days is usually sufficient and no tapering of dose is necessary.
Those already receiving maintenance steroid tablets should receive 2mg/kg, up to a maximum dose of 60mg.
Over 5 years old
30mg to 40mg daily.
2 to 5 years old
20mg daily.
Under 2 years old
10mg daily for up to 3 days, in moderate to severe episodes in a hospital setting.
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 40 mg 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.
In some cases the total dose for two days may be taken as a single dose on alternate days to reduce pituitary adrenal suppression although this may not be successful in the management of asthma.
Contraindications
Uncontrolled systemic infection
Ocular herpes simplex infection
Precautions and Warnings
Children under 18 years
Elderly
Family history of diabetes mellitus
Family history of glaucoma
Restricted sodium intake
Breastfeeding
Congestive cardiac failure
Cushing's disease
Diabetes mellitus
Duchenne muscular dystrophy
Epileptic disorder
Glaucoma
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of severe affective disorders
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Hypertension
Hypothyroidism
Myasthenia gravis
Osteoporosis
Peptic ulcer
Porphyria
Pregnancy
Recent myocardial infarction
Renal impairment
Scleroderma
Severe affective disorders
Tuberculosis
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 symptoms or signs of infections
Sodium content of formulation may be significant
Systemic sclerosis: Scleroderma renal crisis risk in doses above 15mg daily
Temporary increase in dose may be needed during illness, trauma or surgery
Passive immunisation of chicken pox / herpes zoster may be required
Some formulations contain sucrose
Some preps contain methyl & propylparaben; may cause allergic reactions
Frequent review needed to titrate dose to disease activity
Monitor regularly the height of children receiving prolonged treatment
Perform eye tests in any patient with vision change/ophthalmologic symptoms
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
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
Sudden withdrawal may be inadvisable -see product information/SPC
Maintain treatment at the lowest effective dose
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.
Pregnancy and Lactation
Pregnancy
Use prednisolone with caution in pregnancy.
Corticosteroids are able to cross the placenta but 88% of prednisolone is inactivated as it crosses the placenta. Repeated or prolonged administration of prednisolone during pregnancy may increase the risk of intra-uterine growth retardation. Although administration of corticosteroids to pregnant animals caused abnormalities of foetal development, there is no evidence of an increased incidence of congenital abnormalities e.g. cleft palate in humans. However, Briggs et al (2015) states that prednisolone poses a small risk to the foetus of developing orofacial clefts.
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.
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
Use prednisolone with caution in breastfeeding.
Corticosteroids are secreted in breast milk in small amounts. Doses of up to 40mg 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 markedly decrease the dose received by the infant. This is not necessary in short term treatments.
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
Abdominal pain
Acne
Acute pancreatitis
Aggravation of schizophrenia
Amenorrhoea
Amnesia
Anxiety
Avascular osteonecrosis
Behavioural disturbances
Blurred vision
Bruising
Candidiasis
Central serous chorioretinopathy
Cognitive impairment
Confusion
Congestive cardiac failure
Corneal thinning
Cushing's syndrome
Cushingoid facies
Cutaneous atrophy
Delusions
Depression
Diarrhoea
Dizziness
Dyspepsia
Embolism
Emotional lability
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
Hiccups
Hirsutism
Hyperglycaemia
Hyperhidrosis
Hypersensitivity reactions including anaphylaxis
Hypertension
Hypokalaemic alkalosis
Immunosuppression
Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
Impaired healing
Increased appetite
Increased susceptibility and severity of infections
Insomnia
Irregular menstruation
Irritability
Kaposi's Sarcoma
Leucocytosis
Malaise
Mania
Muscle weakness
Myalgia
Myocardial rupture following recent myocardial infarction
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
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
Skin atrophy
Sleep disturbances
Sodium/water retention
Striae
Suicidal tendencies
Suppression of reactions to skin tests
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Tendon rupture
Tumour lysis syndrome
Urticaria
Vertebral and long bone fractures
Vertigo
Vomiting
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
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Prednisolone Dompe 1.0mg/ml Oral Solution. Logixx Pharma Solutions Ltd. Revised November 2017.
Summary of Product Characteristics: Prednisolone 10mg/ml Oral Solution. Focus Pharmaceuticals Ltd. Revised November 2017.
Summary of Product Characteristics: Soluble Prednisolone Tablets 5 mg. Focus Pharmaceuticals Ltd. Revised November 2017.
Summary of Product Characteristics: Soluble Prednisolone Tablets 5 mg. Actavis UK Ltd. Revised November 2017.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 9th April 2018.
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last revised: 11 February 2012.
Last accessed: 04 May 2018.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Last accessed: 9th April 2018.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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