Methylprednisolone acetate parenteral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Suspension for injection containing methylprednisolone acetate
Inflammatory or allergic conditions
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.
Intramuscular administration - for sustained systemic effect:
Frequency should be determined by duration of clinical response, on average an 80mg injection may be expected to last 2 weeks.
Allergic conditions (severe seasonal and perennial allergic rhinitis, asthma, drug reactions): 80 to 120 mg.
For seasonal allergic rhinitis a single injection is usually sufficient, a second may be used after 2-3 weeks.
Dermatological conditions: 40 to 120 mg
Rheumatic disorders and collagen diseases (rheumatoid arthritis, systemic lupus erythematosus): 40 to 120 mg per week.
Rheumatoid arthritis, osteo-arthritis:
Injections may be repeated at intervals of 1 to 5 weeks depending on the degree of relief obtained from the initial injection.
Large joint: (knee, ankle, shoulder) 20 to 80 mg
Medium joint: (elbow, wrist) 10 to 40 mg
Small joint: (metacarpophalangeal, interphalangeal, sternoclavicular, acromioclavicular) 4 to 10 mg
Subdeltoid bursitis, prepatellar bursitis, olecranon bursitis:
Administered directly into bursae 4 to 30 mg.
In most cases repeated injection is not necessary.
Administer directly in to the tendon sheath 4 to 30 mg. In chronic or recurrent conditions repeat injections may be necessary.
Keloids, localised lichen planus, localised lichen simplex, granuloma annulare, alopecia areata, discoid lupus erythematosus:
Administered directly into the lesion for local effect in dermatological conditions 20 to 60 mg.
For large lesions, the dose may be distributed by repeated local injections of 20 to 40 mg. One to four injections are commonly used.
Infiltrate 4 to 30 mg in to the affected area.
There is no information to warrant a change in dosage, however, the more serious consequences of the common side effects should be borne in mind, particularly for long term treatment.
Close clinical supervision is required.
Dosage may be reduced for infants and children but should be governed more by the severity of the condition and patient response rather than age or size.
May be used by any of the following routes: Intramuscular, intra-articular, periarticular, intrabursal, intralesional and in to the tendon sheath.
The slower rate of absorption by the intramuscular route should be recognised. In conditions where a prompt response is desirable, an alternative route should be considered.
Due to the absence of a true tendon sheath, the Achilles tendon should not be injected with methylprednisolone acetate.
Injection into the deltoid muscle should be avoided because of a high incidence of subcutaneous atrophy.
Uncontrolled systemic infection
Precautions and Warnings
Children under 18 years
Family history of diabetes mellitus
Family history of glaucoma
Predisposition to thromboembolic disease
Predisposition to thrombophlebitis
Congestive cardiac failure
History of severe affective disorders
History of steroid myopathy
History of steroid-induced psychosis
History of tuberculosis
Latent or healed tuberculosis
Ocular herpes simplex infection
Recent gastrointestinal anastomosis
Severe affective disorders
Administration of live vaccines is not recommended
Disease reactivation may occur in patients with latent TB
May mask symptoms of peptic ulcer
May mask symptoms or signs of infections
Exclude joint infection before injection
Passive immunisation of chicken pox / herpes zoster may be required
Aseptic technique should be used throughout
Aspirate prior to injection to avoid intravascular administration
Do not inject into unstable joints
Do not mix with other drugs or substances
For intralesional administration, if possible use multiple injection sites
For single use only
Resuscitation facilities must be immediately available
Avoid injection into deltoid muscle-high incidence of subcutaneous atrophy
Avoid local injection into previously infected joints
Frequent review needed to titrate dose to disease activity
Monitor and discontinue if appropriate if psychiatric or CNS problems occur
Possible mineralocorticoid secretion suppression & need for supplementation
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
Consider septic arthritis post joint inj if pain,fever,swelling occur
Corticosteroids may cause growth retardation in children under 18 years
May exacerbate diabetes mellitus
May precipitate diabetes mellitus
Patient should report worrying psychological changes esp. suicidal thoughts
Potassium supplements may be required
Reduces response of pituitary-adrenal axis to stress
Sudden withdrawal may be inadvisable -see product information/SPC
Advise patient not to take NSAIDs unless advised by clinician
Advise patient not to take St John's wort concurrently
Advise patient to avoid grapefruit products
Dietary salt restriction may be necessary
Advise patient to rest treated joint after intra-articular injection
Advise those on systemic corticosteroids to avoid chickenpox/H zoster
Ensure patient receives Steroid Treatment/Steroid Emergency Card
If exposed to chickenpox or Herpes zoster seek urgent medical attention
Undesirable effects may be minimised by using the lowest effective dose for the minimum period.
The presence of crystals of adrenal steroids in the dermis may cause disintegration of the cellular elements and physiochemical changes in the connective tissue. These changes may result in depressions in the skin at the injection site. The degree to which this reaction occurs will vary with the amount of adrenal steroid administered. It usually takes a few months to complete the regeneration process (until all of the crystals of the adrenal steroid have been absorbed). Multiple smaller injections into the area of the lesion should be made if possible. The technique of intra-articular and intramuscular injection should include precautions against injection or leakage into the dermis.
Intralesional doses should be injected deeply, particularly in visible sites in patients with pigmented skins, as there have been reports of subcutaneous depigmentation and atrophy. Systemic as well as local effects should be expected as systemic absorption of methylprednisolone occurs following intra-articular injections.
There is an increased risk of inflammatory response in the joint when corticosteroids are injected intra-articularly, particularly bacterial infection introduced with the injection. Charcot-like arthropathies have been reported particularly after repeated injections. To exclude any bacterial infection prior to injection, examination of any joint fluid present is recommended.
Chickenpox and measles can have a more serious (or fatal) course in non-immune children or adults on corticosteroids. Passive immunization with varicella/zoster immunoglobin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months. This should be given within 10 days of exposure to chickenpox. The illness warrants specialist care and urgent treatment if a diagnosis of chickenpox is confirmed. It is important to note that corticosteroids should not be stopped and the dose may need to be increased.
Supplemental corticosteroids have been suggested to be beneficial in patients with septic shock who exhibit adrenal insufficiency. However, the routine use of corticosteroids in septic shock is not recommended. A systematic review of short course high dose corticosteroids did not support their use. Conversely, meta-analyses and a review suggest that longer courses (5 to 11 days) of low-dose corticosteroids might reduce mortality, especially in patients with vasopressor dependent septic shock.
When corticosteroids are administered for prolonged periods at pharmacologic doses, hypothalamic-pituitary-adrenal (HPA) suppression may occur. The duration and degree of adrenocortical insufficiency produced is variable and depends on the dose, frequency, time of administration, and duration of glucocorticoid therapy. This effect may be minimized by use of alternate-day therapy. In addition, if glucocorticoids are withdrawn abruptly, acute adrenal insufficiency leading to a fatal outcome may occur. Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy. Thus, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Salt/mineralocorticoid should only required if mineralocorticoid secretion is impaired.
Epidural lipomatosis has been reported in patients taking corticosteroids, typically with long-term use at high doses.
Posterior subcapsular cataracts and nuclear cataracts (particularly in children), exophthalmos, or increased intraocular pressure, which may result in glaucoma with possible damage to the optic nerves, and enhanced establishment of secondary ocular infections due to fungi or viruses may occur with prolonged use of corticosteroids.
Cyclical pulsed IV methylprednisolone (usually at initial doses of more than 1 g per day) may cause drug induced liver injury including acute hepatitis or liver enzyme increase. The time to onset of symptoms may be several weeks or longer. Resolution of the adverse events has been observed after treatment was discontinued in most cases. Appropriate monitoring is required.
Pregnancy and Lactation
Use methylprednisolone acetate with caution during pregnancy.
Methylprednisolone acetate crosses the placenta. There have been reports of an increased incidence of low birth weights in infants born of mothers receiving corticosteroids.
Corticosteroids may increase the risk of intrauterine growth retardation when administered for long periods or repeatedly during pregnancy. Hypoadrenalism may occur in the neonate following prenatal exposure to corticosteroids but usually resolves after birth. Infants should be evaluated for signs of adrenal insufficiency if they have been exposed to corticosteroids in utero, although neonatal adrenal insufficiency appears to be rare. Patients with normal pregnancies may be treated as though they were in the non-gravid state if corticosteroids are essential. Cataracts have been observed in infants born to mothers treated with long term corticosteroids 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 ).
Use methylprednisolone acetate with caution during breastfeeding.
Corticosteroids are excreted in small amounts in breast milk. 40 mg methylprednisolone daily are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this have a potential risk of adrenal suppression. However, the benefits of breastfeeding are likely to outweigh any possible risk.
LactMed suggests that no adverse effect have been reported in breastfed infants whose mothers have used corticosteroids during breastfeeding. A temporary reduction in milk supply may occur after local injections, such as for tendinitis, have been administered. These local injections would not be expected to cause any adverse effects in breastfed infants.
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
Acute adrenal insufficiency
Altered glucose tolerance
Blood pressure changes
Congestive cardiac failure
Exacerbation of ophthalmic fungal disease
Exacerbation of ophthalmic viral disease
Growth suppression in infancy, childhood and adolescence
Hyperpigmentation of skin
Impaired carbohydrate tolerance, increased need for anti-diabetic therapy
Increased intra-ocular pressure
Increased susceptibility and severity of infections
Lability of affect
Local infection at injection site
Raised intracranial pressure
Rare instances of blindness with intralesional therapy around face and head
Recurrence of dormant tuberculosis
Reversible elevations in liver enzymes
Suppression of clinical signs of infection
Suppression of the hypothalamic-pituitary-adrenal axis
Thinning of skin
Vertebral and long bone fractures
Vertebral compression fractures
Withdrawal Symptoms and Signs
Following abrupt discontinuance of glucocorticoids, a steroid â€œwithdrawal syndromeâ€? (seemingly unrelated to adrenocortical insufficiency) may also occur. This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, weight loss, and/or hypotension. These adverse effects are thought to be related to the sudden change in glucocorticoid concentration.
During prolonged therapy, adrenal cortical atrophy develops and may persist for months after stopping treatment. In patients who have received more than physiological doses of systemic corticosteroids (approximately 6 mg methylprednisolone) for greater than 3 weeks, withdrawal should not be abrupt. Dose reduction should be carried out with regards to whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced. If the disease is unlikely to relapse on withdrawal, but there is uncertainty about 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 slower in order to allow the HPA-axis to recover. If it considered that the disease is unlikely to relapse, abrupt withdrawal of systemic corticosteroid treatment which has continued up to 3 weeks is considered appropriate. This is because 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 following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even if corticosteriod treatment has lasted for 3 weeks or less: â€¢ Individuals who have received repeated courses of systemic corticosteroids, particularly if taken for greater than 3 weeks. â€¢ When a short course has been prescribed within one year of cessation of long term therapy (months or years). â€¢ Patients who are predisposed to adrenocortical insufficiency other than exogenous corticosteroid therapy. â€¢ Patients receiving doses of systemic corticosteroid greater than 32 mg daily of methylprednisolone. â€¢ Patients repeatedly taking doses in the evening.
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 ).
Last Full Review Date: May 2017
Joint Formulary Committee. British National Formulary. 72nd ed. London: BMJ Group and Pharmaceutical Press; 2016.
Summary of Product Characteristics: Depo-Medrone 40mg/ml. Pfizer Limited. Revised January 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: 22 March 2017
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