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Prednisolone sodium phosphate oral

Updated 2 Feb 2023 | Glucocorticoid therapy


Oral formulations of prednisolone sodium phosphate.

Drugs List

  • prednisolone (as sodium phosphate) 10mg/ml oral solution sugar-free
  • prednisolone (as sodium phosphate) 5mg soluble tablet
  • prednisolone (as sodium phosphate) 5mg/5ml oral solution
  • Therapeutic Indications


    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.


    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.


    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.


    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.

    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.


    Uncontrolled systemic infection
    Ocular herpes simplex infection

    Precautions and Warnings

    Children under 18 years
    Family history of diabetes mellitus
    Family history of glaucoma
    Restricted sodium intake
    Congestive cardiac failure
    Cushing's disease
    Diabetes mellitus
    Duchenne muscular dystrophy
    Epileptic disorder
    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
    Myasthenia gravis
    Peptic ulcer
    Recent myocardial infarction
    Renal impairment
    Severe affective disorders

    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


    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 ( ) or if this is unavailable at the backup site ( ).


    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

    Side Effects

    Abdominal distension
    Abdominal pain
    Acute pancreatitis
    Aggravation of schizophrenia
    Avascular osteonecrosis
    Behavioural disturbances
    Blurred vision
    Central serous chorioretinopathy
    Cognitive impairment
    Congestive cardiac failure
    Corneal thinning
    Cushing's syndrome
    Cushingoid facies
    Cutaneous atrophy
    Emotional lability
    Exacerbation of diabetes
    Exacerbation of epilepsy
    Exacerbation of ophthalmic fungal disease
    Exacerbation of ophthalmic viral disease
    Growth suppression in infancy, childhood and adolescence
    Hypersensitivity reactions including anaphylaxis
    Hypokalaemic alkalosis
    Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
    Impaired healing
    Increased appetite
    Increased susceptibility and severity of infections
    Irregular menstruation
    Kaposi's Sarcoma
    Muscle weakness
    Myocardial rupture following recent myocardial infarction
    Negative calcium balance
    Negative nitrogen balance
    Oesophageal candidiasis
    Oesophageal ulceration
    Opportunistic infections
    Peptic ulceration with perforation and haemorrhage
    Posterior subcapsular cataracts
    Potassium loss
    Pseudotumour cerebri syndrome (mainly in children)
    Psychological dependence
    Psychotic reactions
    Raised intracranial pressure
    Recurrence of dormant tuberculosis
    Retinal detachment
    Scleral thinning
    Scleroderma renal crisis
    Skin atrophy
    Sleep disturbances
    Sodium/water retention
    Suicidal tendencies
    Suppression of reactions to skin tests
    Suppression of the hypothalamic-pituitary-adrenal axis
    Tendon rupture
    Tumour lysis syndrome
    Vertebral and long bone fractures
    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.


    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 ( ) or if this is unavailable at the backup site ( ).

    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: Last accessed: 9th April 2018.

    The Norwegian Porphyria Centre (NAPOS).
    Available at:
    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:
    Last accessed: 9th April 2018.

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