- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Tablets containing 2mg methylprednisolone
Tablets containing 4mg methylprednisolone
Tablets containing 16mg methylprednisolone
Tablets containing 100mg methylprednisolone
For the treatment of conditions requiring glucocorticoid activity including allergic and inflammatory conditions and replacement therapy in primary or secondary adrenal insufficiency.
Undesirable effects may be minimised by using the lowest effective dose for the minimum period.
Dosage should be individualised and depends on condition being treated and its severity. Frequent patient review is needed to titrate dose against disease activity.
The average total daily dose recommended may be given either as a single dose or in divided doses. In alternate-day therapy, the minimum daily corticosteroid requirement is doubled and given as a single dose every other day at 8.00am.
Initial suppressive dose levels is dependant on the disease being treated. A satisfactory clinical response is usually seen within three to seven days in the cases of rheumatic conditions (except for acute rheumatic carditis), allergic conditions affecting the skin or respiratory tract and ophthalmic diseases.
As soon as a satisfactory clinical response is obtained, reduce daily dose gradually either to termination of treatment in case of acute conditions (e.g. acute ocular inflammation, seasonal asthma, exfoliative dermatitis) or to the minimal effective maintenance dose in the case of chronic conditions (e.g. systemic lupus erythematosus, atopic dermatitis, rheumatoid arthritis, bronchial asthma). Dose reduction in chronic conditions from initial to maintenance dose levels should be carried out as clinically appropriate. Suggested decrement - not more that 2mg at intervals of seven to ten days.
Condition specific initial daily doses
Rheumatoid arthritis: Severe 12mg to 16mg, moderately severe 8mg to 12mg, moderate 4mg to 8mg.
Systemic dermatomyositis: 48mg.
Systemic lupus erythematosus: 20mg to 100mg.
Acute rheumatic fever: 48mg until ESR normal for one week.
Allergic diseases: 12mg to 40mg.
Bronchial asthma: Up to 64mg single dose on alternate days, up to a maximum of 100mg.
Ophthalmic diseases: 12mg to 40mg.
Haematological disorders and leukaemias: 16mg to 100mg.
Malignant lymphoma: 16mg to 100mg.
Ulcerative colitis: 16mg to 60mg.
Crohn's disease: Up to 48mg per day in acute episodes.
Organ transplantation: Up to 3.6mg/kg per day.
Pulmonary sarcoid: 32mg to 48mg on alternate days.
Giant cell arteritis/polymyalgia rheumatica: 64mg.
Pemphigus vulgaris: 80mg to 360mg.
Caution is advised in elderly patients.
Treatment should be planned and supervised bearing in mind the more serious side effects of corticosteroids in old age, particularly diabetes, hypertension, osteoporosis and susceptibility to infection and thinning of skin. Close patient supervision may be required to avoid life-threatening reactions.
Caution is advised when treating children as corticosteroids can cause growth retardation in infancy, childhood and adolescence.
Treatment should be based upon clinical response and should be limited to the minimum dosage for the shortest period of time. If possible, treatment should be administered as a single dose on alternate days in order to minimise suppression of the hypothalamic-pituitary-adrenal axis and risk of growth retardation.
The following dosing schedules may be suitable:
Initial dose: 4mg to 8mg daily
Inflammatory and allergic disorders
0.5 to 1.7mg/kg daily, given in two to four divided doses depending on disease condition and patient response.
Patients with Renal Impairment
Caution is advised in patients with renal impairment and more frequent patient monitoring may be required.
Patients with Hepatic Impairment
Caution is advised in patients with hepatic impairment and hepatic cirrhosis. More frequent patient monitoring may be required.
Additional Dosage Information
Withdrawal of corticosteroid:
Adrenal cortical atrophy develops during prolonged therapy and may persist for many months after stopping treatment.
Too rapid a reduction of corticosteroid dosage following prolonged therapy can lead to acute adrenal insufficiency, hypotension and death. However, this is more applicable to corticosteroids with an indication
where continuous therapy is given.
Patients receiving doses greater than approximately 6mg of methylprednisolone (approximately normal physiological levels) for more than 3 weeks should be withdrawn gradually. Reduction method will depend on the likelihood of disease relapse during dose reduction. Clinical assessment of disease activity may be required during withdrawal. If relapse is unlikely but there is uncertainty about HPA suppression, the dose may be reduced rapidly to 6mg methylprednisolone and then reduced more slowly to allow HPA-axis recovery.
If the relapse is unlikely and up to 32mg methylprednisolone has been given for less than 3 weeks then abrupt withdrawal is unlikely to result in clinically relevant HPA-axis suppression in the majority of patients.
Even after less than 3 weeks treatment, gradual withdrawal should be considered in the following patient groups :
-Patients who have had repeated systemic steroid courses especially if courses were longer for than 3 weeks.
-When a short course has been prescribed within one year of stopping a course that had lasted for months or years.
-Patients at risk of adrenocortical insufficiency other than exogenous corticosteroid therapy.
-Patients receiving doses greater than 32mg daily of methylprednisolone.
-Patients repeatedly taking doses in the evenings.
For oral administration either as a single daily dose, a single dose on alternate days or in divided daily doses.
Systemic infections in the absence of anti-infective therapy
Hereditary fructose intolerance
Precautions and Warnings
The lowest effective dose should always be used for the minimum possible period. Frequent patient review is required to appropriately titrate the dose against disease activity. When reduction in dosage is possible, the reduction should be gradual.
In acute, life-threatening situations, administration of dosages exceeding the usual level may be justified.
All patients should carry a steroid treatment card containing information on precautions to be taken to minimise risks and details of the prescriber, drug, dosage and duration of treatment.
Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may be atypical, and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised. Appropriate anti-microbial therapy should accompany glucocorticoid therapy when necessary e.g. in tuberculosis and viral and fungal infections of the eye.
Patients without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster, and if exposed should seek urgent medical attention. Exposed non-immune patients who are receiving systemic corticosteroids, or who have used them within the past 3 months, should receive passive immunisation with varicella zoster immunoglobulin (VZIG) within 10 days of exposure to chicken pox. If chickenpox infection is confirmed, specialist care and urgent treatment is required. Corticosteroid therapy should not be stopped and the dose may need to be increased.
Adults and children should also take particular care to avoid exposure to measles. If exposed, prophylaxis with intramuscular pooled immunoglobulin may be indicated. Exposed patients should be advised to seek urgent medical attention.
Corticosteroids may activate latent tuberculosis, amoebiasis or strongyloidiasis or exacerbate active disease. It is recommended that these are excluded before initiating therapy, particularly in patients with unexplained diarrhoea or who have recently spent time in the tropics. For patients with latent tuberculosis, an appropriate antituberculous regimen should be taken in conjunction with the use of methylprednisolone.
Live vaccines should not be given to immunocompromised patients.
Antibody response to other vaccines may be diminished.
Treatment may result in impaired mineralocorticoid secretion, supplementation with salt or a mineralocorticoid is recommended during therapy.
Patients should be monitored for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress ( e.g. surgery, infection, trauma ). During stress it may be necessary to increase dosage temporarily. Corticosteroid therapy may need to be temporarily re-introduced if treatment has been stopped following prolonged therapy.
Corticosteroids should not be used for the management of head injury or stroke as there is unlikely to be any benefit and may be harmful.
Severe anaphylactoid reactions have occurred after administration of corticosteroids, especially in patients with a history of allergy.
Systemic corticosteroids, particularly in high doses, are linked to psychiatric reactions, both during treatment and whilst the corticosteroid is being withdrawn. A serious paranoid state or depression with risk of suicide can be induced and patients with a history of mental disorder are at particular risk. These reactions often subside on dose reduction or withdrawal of treatment but some may require specific management. Patients should be advised to seek medical advice if psychiatric symptoms occur, especially depression or ideas of suicide.
Particular caution is advised in patients with existing or history of severe affective disorders (such as depressive or manic-depressive illness or previous steroid-induced psychosis) in themselves or in their first-degree relatives.
Particular care and frequent monitoring is required when treating patients with the following conditions:
Osteoporosis (post menopausal females are particularly at risk)
Recent myocardial infarction (left ventricular free wall rupture after MI associated with corticosteroid use)
Diabetes mellitus or a family history of diabetes mellitus
History of tuberculosis
Severe affective disorders or a history of severe affective disorders
Glaucoma or a family history of glaucoma.
Previous steroid-induced psychosis
Previous corticosteroid induced myopathy
Recent intestinal anastomosis
Predisposition to thrombophlebitis
Abscess or other pyogenic infections
Ulcerative colitis (unless for treatment)
Ocular herpes simplex
Congestive cardiac failure and those patients receiving cardioactive drugs.
Kaposi's sarcoma may occur in patients on corticosteroid therapy. Discontinuation of the corticosteroid may result in remission of the sarcoma.
Prolonged use of pharmacological doses of corticosteroids can lead to hypothalamic-pituitary-adrenal (HPA) suppression. The duration and severity of adrenocortical insufficiency is dependant on dose, frequency, duration of glucocorticoid therapy and time of administration. Acute adrenal insufficiency may be fatal if glucocorticoid treatment is withdrawn too rapidly. A gradual reduction in dosage can help to minimise the effects of drug-induced secondary adrenocortical insufficiency. However, this type of relative insufficiency can persist for many months to years after treatment has been discontinued. Reinstitution of hormone therapy may be required in times of stress during this period.
Abrupt withdrawal may be acceptable if therapy has been shorter than 3 weeks and the condition is unlikely to relapse ( see also Additional dosage ).
Prolonged use of corticosteroids may produce subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Large doses of corticosteroids may mask the symptoms of gastro intestinal perforation.
Monitor linear growth in infants and children on prolonged corticosteroid therapy. Corticosteroids may cause growth retardation in infancy, childhood and adolescence.
Caution should be taken when treating elderly patients. Any serious consequences of common side effects (e.g. osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin) must be taken into consideration.
This medication contains lactose and sucrose and therefore patients with glucose-galactose malabsorption syndrome or those who are lactose intolerant should not take this drug.
Pregnancy and Lactation
Caution is advised during pregnancy.
Methylprednisolone crosses the placenta. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development.
Schaefer (2007) suggests that there is inconclusive evidence that corticosteroids result in an increased incidence of congenital abnormalities however, a possible association with clefts cannot excluded. When administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. Hypoadrenalism may occur in the neonate following prenatal exposure but usually resolves spontaneously following birth and is rarely clinically important.
Corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, patients with normal pregnancies may be treated as though they were in a non-gravid state.
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 14-17 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 ).
Caution is advised during lactation.
Corticosteroids are excreted in small amounts in breast milk, however doses up to 40mg daily of methylprednisolone are unlikely to cause systemic effects in the infant.
Infants of mothers taking higher doses may have a degree of adrenal suppression, but the benefits of breastfeeding are likely to outweigh any theoretical risk.
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
Drug excreted in breast milk? - yes in small amounts
Considered suitable or recommended by manufacturer? - Yes
UK Drugs in Lactation Advisory Service Classification - Gives very low levels in infant with no apparent effects.
Drug substance licensed in infants? - From 1 month of age
Effects on Ability to Drive and Operate Machinery
All patients should carry a steroid treatment card containing information on precautions to be taken to minimise risks and details of the prescriber, drug, dosage and duration of treatment.
Patients should be advised to avoid exposure to measles, chickenpox and herpes zoster. If exposure occurs, patients should be advised to seek urgent medical attention.
Growth retardation (children)
Peptic ulceration with perforation and haemorrhage
Altered liver function tests
Suppression of clinical signs of infection
Increased susceptibility and severity of infections
Vertebral and long bone fractures
Congestive cardiac failure
Thinning of skin
Suppression of the hypothalamic-pituitary-adrenal axis
Decreased glucose tolerance
Increased I.C.P. with papilloedema in children (pseudotumour cerebri)
Increased intra-ocular pressure
Optic nerve damage
Depression of hypothalamus, pituitary and adrenal function on withdrawal
Suppression of reactions to skin tests
Aggravation of schizophrenia
Recurrence of dormant tuberculosis
Exacerbation of ophthalmic viral disease
Exacerbation of ophthalmic fungal disease
Myocardial rupture following recent myocardial infarction
Withdrawal syndrome - see product information
Mental status changes
Withdrawal Symptoms and Signs
A withdrawal syndrome may occur symptoms may present as:
Painful itchy skin nodules
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Shelf Life and Storage
Store below 25 degrees C
Last Full Review Date: April 2012
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Summary of product characteristics: Medrone tablets 2mg, 4mg. Pharmacia Ltd. August 2011.
Summary of product characteristics: Medrone tablets 16mg. Pharmacia Ltd. September 2011.
Summary of product characteristics: Medrone tablets 100mg. Pharmacia Ltd. August 2011.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 August 2017
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