Methylprednisolone sodium succinate parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Powder for solution for injection containing methylprednisolone sodium succinate
Drugs List
Therapeutic Indications
Uses
Anaphylaxis
Cerebral oedema secondary to cerebral tumour
Inflammatory or allergic conditions
Rapidly evolving severe relapsing remitting multiple sclerosis
Severe erythema multiforme (Stevens-Johnson syndrome)
Status asthmaticus
Transplant rejection - treatment
Anti-inflammatory agent for use in conditions where a rapid and intense corticosteroid effect is required e.g.:
Severe erythema multiforme (Stevens-Johnson syndrome)
Bronchial asthma
Severe seasonal and perennial allergic rhinitis
Angioneurotic oedema
Anaphylaxis
Ulcerative colitis
Crohn's disease
Aspiration of gastric contents
Fulminating or disseminated tuberculosis (in conjunction with antituberculosis chemotherapy)
Cerebral oedema secondary to cerebral tumour
Acute exacerbations of multiple sclerosis superimposed on a relapsing/remitting background
Tuberculosis meningitis (with appropriate TB chemotherapy)
Transplantation (graft rejection following transplantation)
Acute spinal cord injury
Cerebral oedema
Dosage
Initial doses of up to 250 mg should be given intravenously over a period of at least 5 minutes.
When administering methylprednisolone sodium succinate intravenously in high doses (above 250 mg) it should be given over a period of at least 30 minutes.
The preferred route for emergency use is by intravenous injection.
Frequent patient review is required to titrate dose against disease activity.
Undesirable effects can be minimised by use of lowest effective dose for the minimum period.
In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilised; usually not beyond 48 to 72 hours.
Adults
Dosage is dependant on the condition being treated and initial dosage will vary from 10 to 500 mg.
Larger doses may be required for treatment short-medium term treatment of severe, acute conditions.
Graft rejection reactions following transplantation:
500 mg to 1g daily continued only until the patient's condition has stabilised, usually not beyond 48 to 72 hours.
Anaphylactic reactions:
Adrenaline or noradrenaline should be administered initially for a haemodynamic effect.
Intravenous methylprednisolone may then be used for a prolonged effect and to prevent recurrence.
Sensitivity reactions:
Treatment of status asthmaticus:
40 mg intravenously repeated as indicated by patient response. Some patients may benefit by use of a slow intravenous drip given over a period of hours.
Acute spinal cord injury:
The treatment should begin within 8 hours of injury. Initially give 30 mg/kg methylprednisolone as a bolus over 15 minutes. This is to be followed by a 45 minute pause. Then give a continuous infusion of 5.4 mg/kg/hour for 23 hours. There should be a separate intravenous site for the infusion pump.
Acute exacerbations of multiple sclerosis:
500mg or 1g daily for 3 days. Methylprednisolone should be given as an intravenous infusion over at least 30 minutes.
Cerebral oedema associated with brain tumours:
Tapering the dose of corticosteroid appears to be important in order to avoid a rebound increase in intracranial pressure. If brain swelling (not attributable to bleeding) does occur as the dose is reduced, restart larger and more frequent doses parenterally. Patients with certain malignancies should remain on oral corticosteroids for months or even life. Similar doses may be used to control oedema during radiation therapy.
Suggested dosage scheduling:
Schedule A:
Pre-operative: 20 mg intramuscularly for 3 to 6 hours
During surgery: 20 to 40 mg intravenously every hour
Post-operative:
-20 mg intramuscularly every 3 hours for 24 hours THEN
-16 mg intramuscularly every 3 hours for 24 hours THEN
-12 mg intramuscularly every 3 hours for 24 hours THEN
- 8 mg intramuscularly every 3 hours for 24 hours THEN
- 4 mg intramuscularly every 3 hours for 24 hours THEN
- 4 mg intramuscularly every 6 hours for 24 hours THEN
- 4 mg intramuscularly every 12 hours for 24 hours
Schedule B:
Pre-operative: 40 mg intramuscularly every 6 hours for 2 to 3 days
Post-operatively: 40 mg intramuscularly every 6 hours for 3 to 5 days and then change to oral formulation.
The aim is to discontinue therapy within 10 days.
Elderly
(See Dosage; Adult)
It should be noted that the common side effects may have more serious consequences and therefore, close clinical supervision is recommended.
Children
Treatment of high dose indications such as haematological, rheumatic, renal and dermatological conditions:
30 mg/kg/day to a maximum of 1 gram per day, repeated for 3 pulses either daily or on alternate days.
Treatment of graft rejection reactions:
10 to 20 mg/kg/day for up to 3 days. Maximum of 1 gram daily.
Treatment of status asthmaticus:
1 to 4 mg/kg/day for 1 to 3 days.
Not recommended in children for treatment of acute spinal cord injury.
Additional Dosage Information
Patients subjected to severe stress following corticoid therapy should be observed closely for signs and symptoms of adrenocortical insufficiency.
Withdrawal:
Withdrawal should not be abrupt in patients who have been administered more than physiological doses of systemic corticosteroids (approximately 6 mg methylprednisolone) for more than 3 weeks.
Dose reduction should be carried out according to whether the disease is likely to relapse during dose reduction. This will require clinical assessment of disease activity during the withdrawal period. If the disease is unlikely to relapse on withdrawal, but there is uncertainty about hypothalamic�pituitary�adrenal axis (HPA) suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses. Once a daily dose of 6 mg methylprednisolone is reached, dose reduction should be slowed to allow the HPA-axis to recover.
Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3 weeks is appropriate if it is considered that the disease is unlikely to relapse. Abrupt withdrawal of doses up to 32 mg daily of methylprednisolone for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less:
In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less:
a) patients who have had repeated courses of systemic corticosteroids, especially if taken for greater than 3 weeks.
b) when a short course has been prescribed within one year of cessation of long term therapy.
c) patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy.
d) patients receiving doses greater than 32 mg daily.
e) patients repeatedly taking doses in the evening.
Administration
For intravenous or intramuscular injection.
Contraindications
Live virus immunisation
Septic shock
Uncontrolled systemic infection
Cushing's disease
Precautions and Warnings
Abscess
Children under 18 years
Elderly
Family history of diabetes mellitus
Family history of glaucoma
Infection
Predisposition to thromboembolic disease
Predisposition to thrombophlebitis
Breastfeeding
Congestive cardiac failure
Diabetes mellitus
Diverticulitis
Epileptic disorder
Glaucoma
History of severe affective disorders
History of steroid-induced psychosis
History of tuberculosis
Hypertension
Hypothyroidism
Latent or healed tuberculosis
Myasthenia gravis
Myocardial infarction
Ocular herpes simplex infection
Osteoporosis
Peptic ulcer
Pregnancy
Recent gastrointestinal anastomosis
Recent myocardial infarction
Renal impairment
Seizures
Severe affective disorders
Ulcerative colitis
Disease reactivation may occur in patients with latent TB
May mask symptoms of peptic ulcer
May mask symptoms or signs of infections
Temporary increase in dose may be needed during illness, trauma or surgery
Premature infants: Perform cardiac evaluation and monitoring
Avoid rapid infusion rates
Resuscitation facilities must be immediately available
Bradycardia may follow administration of large doses
Clinical presentations of infections may be atypical
Frequent review needed to titrate dose to disease activity
If visual disturbances occur, perform ophthalmic evaluation
Monitor and discontinue if appropriate if psychiatric or CNS problems occur
Monitor regularly the height of children receiving prolonged treatment
Possible mineralocorticoid secretion suppression & need for supplementation
Advise patient to report new visual problems and symptoms
Advise patients/carers to seek medical advice if changes in behaviour/mood
Antibody response to non-live vaccines may be diminished
Breastfeeding: Risk of adrenal suppression in breastfed infant
Corticosteroids may cause growth retardation in children under 18 years
Potassium supplements may be required
Do not withdraw this drug suddenly
Advise patient not to take NSAIDs unless advised by clinician
Advise patient not to take St John's wort concurrently
Dietary salt restriction may be necessary
Advise patient to avoid exposure to measles
Ensure patient receives Steroid Treatment/Steroid Emergency Card
If exposed to chickenpox or Herpes zoster seek urgent medical attention
Chickenpox is of serious concern as it may be fatal in immunosuppressed patients. Passive immunization with varicella/zoster immunoglobin (VZIG) within 10 days of exposure to chickenpox is needed by exposed non-immune patients who are receiving systemic corticosteroids (or have used them in the past 3 months). If a diagnosis of chickenpox is confirmed, corticosteroids should not be stopped and the dose may need to be increased. Specialist care is required.
Medical advice should be sought immediately if exposure to measles occurs. Prophylaxis with normal intramuscular immunoglobulin may be needed.
Corticosteroids should be used with great care in patients with known/suspected parasitic infections such as Strongyloides (threadworm) infestation, which may lead to Strongyloides hyperinfection and dissemination with widespread larval migration. This is often accompanied by severe enterocolitis and potentially fatal gram negative septicaemia. The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis where the corticosteroid is used in conjunction with an appropriate anti-tuberculous regimen.
In patients with latent tuberculosis or tuberculin reactivity undergoing prolonged corticosteroid therapy, chemoprophylaxis should be considered to avoid disease reactivation. Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
In patients subjected to unusual stress, it is recommended to increase the dosage of rapidly acting corticosteroids before, during and after the stressful situation. Pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamic-pituitary-adrenal (HPA) suppression. The degree and duration of adrenocortical insufficiency produced is variable among patients and depends on the dose, frequency, time of administration, and duration of glucocorticoid therapy. Alternate day therapy may help to minimise this HPA suppression. In addition, acute adrenal insufficiency leading to a fatal outcome may occur if glucocorticoids are withdrawn abruptly.
A steroid withdrawal syndrome may also occur following abrupt withdrawal of glucocorticoids. This includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, weight loss, and/or hypotension. These effects are thought to be due to the sudden change in glucocorticoid concentration (rather than to low corticosteroid levels).
The potential for psychiatric adverse reactions typically emerge within a few days to weeks of starting treatment. The risk is dose dependant, although dose levels do not allow prediction of the onset, type, severity or duration of reactions. The psychiatric adverse reactions usually recover after dose reduction/ withdrawal. Particular caution is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or first degree relatives.
There have been a few reports of cardiac arrhythmias/circulatory collapse/cardiac arrest associated with the rapid intravenous administration of large doses of methylprednisolone (greater than 500 mg given over a period of less than 10 minutes). Bradycardia has been reported with the administration of large doses of methylprednisolone sodium succinate which may be unrelated to the duration and speed of infusion. Low doses and alternate-day therapy may reduce the incidence of cardiac adverse reactions.
Symptoms of peptic ulcer may be masked in patients taking glucocorticoid therapy, so that perforation or haemorrhage may occur without significant pain. When taken in combination with NSAIDs, the risk of developing gastrointestinal ulcers is increased.
Average and large doses of hydrocortisone or cortisone can cause an increase in blood pressure, salt and water retention, and an increase in potassium excretion. These effects are less likely to occur with the synthetic derivatives except when used in large doses. An increase calcium excretion is common with all corticosteroids.
Infants and children on prolonged corticosteroid therapy should be carefully observed with regards to their growth and development. Growth may be suppressed in children receiving long-term, daily, divided-dose glucocorticoid therapy. Alternate-day glucocorticoid therapy usually minimises this side effect. There is also an increased risk from raised intracranial pressure and pancreatitis in children and infants receiving long-term regimes
Premature infants may develop hypertrophic cardiomyopathy following administration of methylprednisolone sodium succinate.
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.
Pregnancy and Lactation
Pregnancy
Use methylprednisolone sodium succinate with caution 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. There is limited evidence in humans that corticosteroids result in an increased incidence of congenital abnormalities. However, when corticosteroids are administered for long periods or repeatedly during pregnancy, there is an increased risk of intra-uterine growth retardation. Additionally, pre-natal exposure to corticosteroids may lead to hypoadrenalism in the neonate but this usually resolves following birth. Infants should be carefully observed for signs of adrenal insufficiency. When corticosteroids are considered essential, patients with normal pregnancies may be treated as though they were in the non-gravid state.
It should be noted that cataracts have been observed in infants born to mothers undergoing long-term corticosteroid treatment 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 methylprednisolone sodium succinate with caution during breastfeeding.
Corticosteroids are excreted in small amounts in breast milk, however doses up to 40 mg 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.
Methylprednisolone is one of the corticoids of choice for systemic treatment. High doses of 1 gram daily for a few days does not require any change to the breastfeeding schedule. If high doses are given repeatedly, it is advisable to wait 3 to 4 hours before the next feed (Schaefer, 2015). LactMed notes that local injections (such as for tendinitis) should not be expected to cause adverse effects in breastfed infants, but may occasionally cause loss of milk supply temporarily.
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
Amenorrhoea
Amnesia
Anaphylactic reaction
Anaphylactoid reaction
Anxiety
Avascular osteonecrosis
Behavioural disturbances
Blood pressure changes
Blood urea increased
Blurred vision
Bradycardia
Bronchospasm
Chorioretinopathy
Confusion
Congestive cardiac failure
Convulsions
Corneal thinning
Cushingoid facies
Decreased glucose tolerance
Delusions
Dependence
Depression
Diarrhoea
Dizziness
Dyslipidaemia
Dyspepsia
Ecchymosis
Epidural lipomatosis
Euphoria
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Exacerbation of psychoses
Exophthalmos
Gastro-intestinal haemorrhage
Gastro-intestinal perforation
Glaucoma
Growth suppression in infancy, childhood and adolescence
Hallucinations
Headache
Hepatitis
Hiccups
Hirsutism
Hypersensitivity reactions
Hypokalaemic alkalosis
Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
Impaired healing
Increased appetite
Increased calcium excretion
Increased intra-ocular pressure
Increased susceptibility to infection
Increases in hepatic enzymes
Irritability
Kaposi's Sarcoma
Lability of affect
Leucocytosis
Malaise
Mania
Menstrual disturbances
Nausea
Negative nitrogen balance
Oedema
Oesophageal candidiasis
Opportunistic infections
Osteoporosis
Papilloedema
Peptic ulceration with perforation and haemorrhage
Petechiae
Posterior subcapsular cataracts
Potassium loss
Psychosis
Pulmonary embolism
Raised intracranial pressure
Recurrence of dormant tuberculosis
Reduced plasma potassium levels
Scleral thinning
Skin atrophy
Skin pigmentation changes
Sleep disturbances
Sodium/water retention
Spinal fracture
Striae
Suppression of clinical signs of infection
Suppression of reactions to skin tests
Suppression of the hypothalamic-pituitary-adrenal axis
Telangiectasia
Tendon rupture
Thromboembolism
Transient cognitive dysfunction
Unpleasant taste
Vertigo
Vomiting
Withdrawal symptoms
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: February 2017
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Summary of product characteristics: Methylprednisolone 500 mg powder and solvent for solution for injection/infusion .Beacon Pharmaceuticals. Revised January 2017.
Summary of product characteristics: Methylprednisolone 1000 mg powder and solvent for solution for injection/infusion. Beacon Pharmaceuticals. Revised January 2017.
Summary of product characteristics: Solu-Medrone 40 mg. Pfizer Ltd. Revised February 2021.
Summary of product characteristics: Solu-Medrone 125 mg. Pfizer Ltd. Revised February 2021.
Summary of product characteristics: Solu-Medrone 500 mg. Pfizer Ltd. Revised February 2021.
Summary of product characteristics: Solu-Medrone 1 gram. Pfizer Ltd. Revised February 2021.
Summary of product characteristics: Solu-Medrone 2 gram. Pfizer Ltd. Revised February 2021.
HPRA Drug Safety Notice August 2017
Available at: https://www.hpra.ie
Last accessed: 24 October 2017
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 24 October 2017
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
Methylprednisolone. Last revised: 27 January 2017
Last accessed: 13 February 2017
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