Professional Documents
Culture Documents
Introductory Information
Synthetic glucocorticoid; minimal mineralocorticoid activity.b, c, d
Class: 68:04 Adrenals; hs051 (VA primary)
Brands*: A-methaPred, Depo-Medrol, Medrol, Medrol Dosepak, Meprolone Unipak,
Solu-Medrol
*
Uses
Treatment of a wide variety of diseases and conditions principally for glucocorticoid effects
as an anti-inflammatory and immunosuppressant agent and for its effects on blood and
lymphatic systems in the palliative treatment of various diseases.c, d
Usually, inadequate alone for adrenocortical insufficiency because of minimal
mineralocorticoid activity.c
Adrenocortical Insufficiency
Corticosteroids are administered in physiologic dosages to replace deficient endogenous
hormones in patients with adrenocortical insufficiency.a, c
Because production of both mineralocorticoids and glucocorticoids is deficient in
adrenocortical insufficiency, hydrocortisone or cortisone (in conjunction with liberal salt
intake) usually is the corticosteroid of choice for replacement therapy.a, c, d, m
If methylprednisolone is used, must also administer a mineralocorticoid (fludrocortisone),
particularly in infants.a, c, d
.c
.c
.c
Thyroiditis
Treatment of granulomatous (subacute, nonsuppurative) thyroiditis.a, c, d, m
Anti-inflammatory actions relieves fever, acute thyroid pain, and swelling.c
May reduce orbital edema in endocrine exophthalmos (thyroid ophthalmopathy).c
Usually reserved for palliative therapy in severely ill patients unresponsive to salicylates and
thyroid hormones.c
, rheumatic fever
[especially with carditis]) and collagen diseases (e.g., acute rheumatic carditis,
, vasculitis
, but
polyarteritis nodosa
, relapsing polychondritis
syndrome
and polymyositis
, polymyalgia rheumatica
.a, c High dosage may be required for acute situations; after a response has
been obtained, drug must often be continued for long periods at low dosage.c
Polymyositis
respond well.c
Rarely indicated in psoriatic arthritis, diffuse scleroderma
(progressive systemic
In osteoarthritis
eczema
, cutaneous sarcoidosis
For control of severe or incapacitating allergic conditions (e.g., contact dermatitis, atopic
dermatitis) intractable to adequate trials of conventional treatment.a, d, e, f, m
Chronic skin disorders seldom an indication for systemic glucocorticoids.c
Intralesional or sublesional injections occasionally indicated for localized chronic skin
disorders, keloids, psoriatic plaques, alopecia areata, discoid lupus erythematosus,
necrobiosis lipoidica diabeticorum, granuloma annulared, m unresponsive to topical therapy.c
;c if used, exacerbation may occur when the drug is
Rarely indicated systemically for alopecia (areata, totalis, or universalis).c May stimulate hair
growth, but hair loss returns when the drug is discontinued.c
Allergic Conditions
For control of severe or incapacitating allergic conditions intractable to adequate trials of
conventional treatment and control of acute manifestations, including anaphylactic and
anaphylactoid reactions
, angioedema
Ocular Disorders
To suppress a variety of allergic and nonpyogenic ocular inflammations.c
To reduce scarring in ocular injuries
.c
For the treatment of severe acute and chronic allergic and inflammatory processes involving
the eye and adnexa (e.g., allergic conjunctivitis, keratitis, allergic corneal marginal ulcers,
herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, diffuse posterior uveitis
and choroiditis, anterior segment inflammation, optic neuritis, sympathetic ophthalmia,
temporal arteritis).a, c d, e, f, m
Acute optic neuritis optimally treated with initial high-dose IV therapy followed by chronic
oral therapy. Assists in recovery of vision and slows progression to clinically definite multiple
sclerosis.
Less severe allergic and inflammatory allergic conditions of the eye are treated with topical
(to the eye) corticosteroids.g
Topically applied glucocorticoids appear to be as effective as systemic steroids for the
treatment of most anterior ocular inflammations.c
Systemically in stubborn cases of anterior segment eye disease and when deeper ocular
structures are involved.c
Asthma
Adjunctively for moderate to severe exacerbations of asthma and for maintenance in
persistent asthma.c, g
Systemically (oral or IV) for treatment of moderate to severe acute exacerbations of asthma
(oral prednisone usually preferred); speeds resolution of airflow obstruction and reduces rate
of relapse.g
Because onset of effects is delayed, do not use alone for emergency treatment.c
Early systemic glucocorticoid therapy particularly important for asthma exacerbations in
infants and children.g
In hospital management of an acute asthma exacerbation, may give systemic adjunctive
glucocorticoids if response to oral inhalation therapy is not immediate, if oral corticosteroids
were used as self-medication prior to hospitalization, or if the episode is severe.c
For severe persistent asthma once initial control is achieved, high dosages of inhaled
corticosteroids are preferable to oral glucocorticoids for maintenance because inhaled
corticosteroids have fewer systemic effects.
Maintenance therapy with low doses of an orally inhaled corticosteroid is preferred treatment
for adults and children with mild persistent asthmac (i.e., patients with daytime symptoms of
asthma more than twice weekly but less than once daily, and nocturnal symptoms of asthma
more than twice per month).b
Orally as an adjunct to other therapy to speed resolution of all but the mildest exacerbations
of asthma when response to a short-acting inhaled 2-agonist is not prompt or sustained after
1 hour or in those who have a history of severe exacerbations.c
Oral glucocorticoids with minimal mineralocorticoid activity and relatively short half-life
(e.g., prednisone, prednisolone, methylprednisolone) are preferred.
COPD
For severe exacerbations of COPD
in pediatric patients.g
tuberculosis and also may reduce mortality associated with certain forms of extrapulmonary
disease (e.g., meningitis, pericarditis).
Systemic adjunctive glucocorticoids may reduce sequelae (e.g., intellectual impairment)
and/or improve survival in moderate to severe tuberculous meningitis; used in the treatment
of tuberculous meningitis with subarachnoid block or impending block concurrently with
appropriate antituberculous chemotherapy.a, d, e, f, m
Systemic adjunctive glucocorticoid therapy rapidly reduces the size of pericardial effusions
and the need for drainage procedures and decreases mortality (probably through control of
hemodynamically threatening effusion) in acute tuberculous pericarditis.
Hastens the resolution of pain, dyspnea, and fever associated with tuberculous pleurisy.c
Lipid Pneumonitis
Promotes the breakdown or dissolution of pulmonary lesions and eliminates sputum lipids in
lipid pneumonitis.c
Pneumocystis jiroveci Pneumonia
Systemic adjunctive glucocorticoids decrease the likelihood of deterioration of oxygenation,
respiratory failure, and/or death in moderate to severe Pneumocystis jiroveci (formerly
Pneumocystis carinii) pneumonia in AIDS
in an attempt to
that occurs as the result of exposure to anthrax spores in the context of biologic
warfare or bioterrorism if extensive edema, respiratory compromise, or meningitis is present.
Hematologic Disorders
Management of acquired (autoimmune) hemolytic anemia, pure red cell aplasia, idiopathic
thrombocytopenic purpura (ITP), secondary thrombocytopenia, erythroblastopenia, or
congenital (erythroid) hypoplastic anemia.a, d, e, f, m
High or even massive dosages decrease bleeding tendencies and normalize blood counts;
does not affect the course or duration of hematologic disorders.c
Glucocorticoids, immune globulin IV (IGIV), or splenectomy are first-line therapies for
moderate to severe ITP, depending on the extent of bleeding involved.
May not affect or prevent renal complications in Henoch-Schoenlein purpura.c
Insufficient evidence of effectiveness in aplastic anemia in children, but widely used.c
Shock
Although IV glucocorticoids may be life-saving in shock secondary to adrenocortical
insufficiency (see Adrenocortical Insufficiency under Uses), the value of the drugs in the
treatment of shock resulting from other causes
is controversial.c
Management of shock should be based on specific treatment of the primary cause and
secondary abnormalities, and glucocorticoids, if used, should be regarded only as adjunctive
supportive treatment.c
Value in adjunctive treatment of septic shock
is particularly controversial.
syndrome and septic shock, and may increase the risk of mortality in certain patients (i.e.,
patients with increased Scr or those who develop secondary infections after treatment).e
Pericarditis
To reduce the pain, fever, and inflammation of pericarditis
with MI.c
Glucocorticoids can provide effective symptomatic relief, but aspirin considered the
treatment of choice for post-MI pericarditis because of greater evidence establishing benefit.
Important to distinguish between pain caused by pericarditis and that caused by ischemia
since management will differ.
Consider possibility that cardiac rupture may account for recurrent pain since use of
glucocorticoids may be a risk factor in its development.
Glucocorticoids may cause thinning of developing scar and myocardial rupture.
Management of tuberculous pericarditis. (See Advanced Pulmonary and Extrapulmonary
Tuberculosis under Uses.)
GI Diseases
Short-term palliative therapy for acute exacerbations and systemic complications of
ulcerative colitis, regional enteritis (Crohn's disease), and celiac disease
.a, c, d, e, f, m
Glucocorticoids should not be used for maintenance therapy of chronic GI diseases (e.g.,
ulcerative colitis, Crohn's disease) because they usually do not prevent relapses and the drugs
may produce severe adverse effects with long-term administration.a, c
Glucocorticoids have been used in the management of moderately to severely active Crohn's
disease and in mild esophageal or gastroduodenal Crohn's disease in pediatric patients.
Neoplastic Diseases
Alone or as a component of various chemotherapeutic regimens in the palliative treatment of
neoplastic diseases of the lymphatic system (e.g., leukemias and lymphomas in adults and
acute leukemias in children).a d, e, f, m
Treatment of breast cancer
(e.g., cytotoxic agents, hormones, antiestrogens) and should be reserved for unresponsive
disease.c
Glucocorticoids alone or as a component of various combination chemotherapeutic regimens
for palliative treatment of advanced, symptomatic (i.e., painful) hormone-refractory prostate
cancer
to improve outcome or reduce intracranial pressure not recommended in patients with head
injury.
Cerebral Malaria
Glucocorticoids are not effective and can have detrimental effects in the management of
cerebral malaria caused by Plasmodium falciparum; no longer recommended for this
condition.c
Acute Spinal Cord Injury
Some evidence indicates that large IV doses of glucocorticoids (i.e., methylprednisolone) can
improve motor and sensory function in patients with acute spinal cord injury
when
treatment is initiated promptly following injury (within 8 hours). It is not known whether
improvement in neurologic function with such therapy will routinely lead to specific
improvements in disability.
Low Back Pain
Has been used epidurally (alone or combined with a local anesthetic and/or an opiate
analgesic) for symptomatic relief of low back pain
controversial and convincing evidence of efficacy is lacking, most experts consider such
therapy an option for short-term relief of acute, subacute, or chronic radicular pain in patients
with low back pain and radiculopathy associated with disk disease or herniation or spinal
stenosis when more conservative therapies (e.g., rest, analgesics, physical therapy) fail and as
a means of potentially avoiding surgery.
Limited evidence suggests that therapeutic facet joint
injections
although facet joint injections may be useful in some patients with facet arthropathy.
Inclusion of a glucocorticoid in trigger point injections does not appear to be beneficial.
Sacroiliac joint injections performed using fluoroscopic guidance may provide temporary
pain relief in some patients when the principal source of spinal pain is the sacroiliac joint.
Oral glucocorticoids
a, d, m
more rapid onset of action, more consistent effects, and fewer adverse effects.
Anti-inflammatory and immunomodulating effects accelerate neurologic recovery by
restoring the blood-brain barrier, reducing edema, and possibly improving axonal conduction.
Shortens the duration of relapse and accelerates recovery; remains to be established whether
the overall degree of recovery improves or the long-term course is altered.
Myasthenia Gravis
Management of myasthenia gravis
anticholinesterase therapy.
Parenterally for the treatment of myasthenic crisis.
Organ Transplants
In massive dosage, used concomitantly with other immunosuppressive drugs to prevent
rejection of transplanted organs
.c
A steroid withdrawal syndrome consisting of lethargy, fever, and myalgia can develop
following abrupt discontinuance.c Symptoms often occur without evidence of adrenal
insufficiency (while plasma glucocorticoid concentrations were still high but were falling
rapidly).c
If used for only brief periods (a few days) in emergency situations, may reduce and discontinue
dosage quite rapidly.c
Very gradually withdraw systemic glucocorticoids until recovery of HPA-axis function occurs
following long-term therapy with pharmacologic dosages.c, d, e, m (See Adrenocortical
Insufficiency under Warnings.)
Exercise caution when transferring from systemic glucocorticoid to oral or nasal inhalation
corticosteroid therapy.c
Many methods of slow withdrawal or "tapering" have been described.c
In one suggested regimen, decrease by 2-4 mg every 3-7 days of until the physiologic dose (4
mg) is reached.c
Other recommendations state that decrements usually should not exceed 2 mg every 1-2
weeks.c
When a physiologic dosage has been reached, single 20-mg oral morning doses of
hydrocortisone can be substituted for whatever glucocorticoid the patient has been receiving.c
After 2-4 weeks, may decrease hydrocortisone dosage by 2.5 mg every week until a single
morning dosage of 10 mg daily is reached.c
For certain acute allergic conditions (e.g., contact dermatitis such as poison ivy) or acute
exacerbations of chronic allergic conditions, glucocorticoids may be administered short term
(e.g., for 6 days).c Administer an initially high dose on the first day of therapy, and then
withdraw therapy by tapering the dose over several days.c
Administration
Administer orally, by IV injection or infusion, or IM injection.a, d, e, f, m
Administer for local effect by intra-articular, intralesional, intrasynovial, soft-tissue, or
epidural injection.c, d, m
Generally reserve IM or IV therapy for patients who are not able to take the drug orally or for
use in an emergency situation.d, e After the initial emergency period, a longer-acting injectable
corticosteroid preparation or oral administration of a corticosteroid should be considered.b
Methylprednisolone acetate injections (in multiple-dose vials) contain benzyl alcohol; do not
administer intrathecally because of reports of severe adverse events with such use.m
Oral Administration
Methylprednisolone
Administer orally as tablets.a
IV Administration
Methylprednisolone Sodium Succinate
Administer by IV injection or infusion.e
Reconstitution of Methylprednisolone Sodium Succinate
Reconstitute by pressing on a plastic activator to force the diluent provided from the
manufacturer from an upper compartment of a 2-compartment vial to a lower compartment
containing sterile powder.e Alternately, use bacteriostatic water for injection with benzyl
alcohol for reconstitution.e
Dilution of Methylprednisolone Sodium Succinate
When administered by IV infusion, the drug can be added to 5% dextrose, or 0.9% sodium
chloride, or 5% dextrose in sodium chloride injection.e
Rate of Administration of Methylprednisolone Sodium Succinate
Direct IV injection: Administer over a period of several minutes.e
IM Administration
Do not administer IM for conditions prone to bleeding (e.g., idiopathic thrombocytopenic
purpura [ITP]).e
Methylprednisolone Acetate
Administer by IM injection.d, m
Because it is slowly absorbed, IM administration is not indicated when an immediate effect of
short duration is required.d
Commercially available single-dose vials are for single use only.d, m Although initially sterile,
multiple use of a single-dose vial may result in contamination, unless strict aseptic technique
is observed.m
Methylprednisolone Sodium Succinate
Administer by IM injection.e
Absorption from IM injection sites is rapid.b
Intra-articular, Intralesional, and Soft Tissue Administration
Methylprednisolone Acetate
Administer by intra-articular, intralesional, intrasynovial, or soft tissue injection.b, d, m (See
Dermatologic Effects under Cautions.)
May infiltrate the tissue surrounding the joint with a local anesthetic (e.g., procaine
hydrochloride) before administration of methylprednisolone acetate.b, d
Examine joint fluid to exclude sepsis and avoid injection into an infected site; if joint sepsis is
evident, institute appropriate antibacterial therapy.c, d, m Symptoms of septic arthritis include
local swelling, further restriction of joint motion, fever, or malaise.c, d, m Do not inject
glucocorticoids into unstable joints and caution patients not to overuse joints in which the
inflammatory process still is active despite symptomatic improvement.c
Epidural Administration
Long-acting injectable suspension has been administered by epidural injection, although
safety of epidural injections using preserved formulations is controversial and epidural
administration of these formulations is not recommended by the manufacturer.c Limited
evidence suggests that large particles in glucocorticoid suspensions may cause embolic
vascular occlusion following inadvertent intra-arterial injection.
Inject into the epidural space near the site where the nerve roots pass before entering the
intervertebral foramen.
Epidural injections may be performed by caudal, interlaminar, or transforaminal approaches;
the transforaminal approach requires the smallest injection volume and appears to be the most
specific and possibly most effective route.
Because of the potential for complications related to improper needle placement or drug
administration, many experts state that epidural injections should be performed by an
experienced clinician using fluoroscopic guidance and contrast control to ensure that the
needle is correctly positioned and that the injection is not performed intravascularly,
intrathecally, or into tissues other than the epidural space.
Optimal technique, dosage, timing of initial injection, injection frequency, and maximum
number of injections remain to be established.
Dosage
Available as methylprednisolone, methylprednisolone acetate, and methylprednisolone
sodium succinate.a, b, d, e, m Dosage of methylprednisolone sodium succinate or
methylprednisolone acetate is expressed in terms of methylprednisolone or
methylprednisolone acetate, respectively.d, e, m
After a satisfactory response is obtained, decrease dosage in small decrements to the lowest
level that maintains an adequate clinical response, and discontinue the drug as soon as
possible.a, b, e
Monitor patients continually for signs that indicate dosage adjustment is necessary, such as
remissions or exacerbations of the disease and stress (surgery, infection, trauma).b
High dosages may be required for acute situations of certain rheumatic disorders and collagen
diseases; after a response has been obtained, drug often must be continued for long periods at
low dosage.c
High or massive dosages may be required in the treatment of pemphigus, exfoliative
dermatitis, bullous dermatitis herpetiformis, severe erythema multiforme, or mycosis
fungoides.c Early initiation of systemic glucocorticoid therapy may be life-saving in
pemphigus vulgaris.c Reduce dosage gradually to the lowest effective level, but
discontinuance may not be possible.c, d, m
Massive dosages may be required for treatment of shock.b
Increase dosage of rapidly acting corticosteroids in patients subjected to any unusual stress
before, during, and after the stressful situation.a, d, e, m
Pediatric Patients
Base pediatric dosage on severity of the disease and patient response rather than on strict
adherence to dosage indicated by age, body weight, or body surface area.b, e
Usual Dosage
Oral: 0.117-1.66 mg/kg daily or 3.3-50 mg/m2 daily, administered in 3 or 4 divided doses.b
>IM
Methylprednisolone sodium succinate: 0.03-0.2 mg/kg or 1-6.25 mg/m2 IM 1-2 times daily
has been used.b
Asthma
Oral: To gain prompt control of asthma in infants and children 4 years of age with very
poorly controlled, moderate-to-severe asthma (i.e., >3 exacerbations per year requiring oral
corticosteroids) and in children 5-11 years of age with asthma of comparable control and
severity (i.e., 2 exacerbations per year requiring oral corticosteroids): Methylprednisolone
1-2 mg/kg daily (maximum 60 mg daily) may be added to existing asthma therapy.
In children 11 years of age undergoing emergency department treatment for moderate-tosevere acute asthma exacerbations not controlled with an inhaled 2-adrenergic agonist: May
add methylprednisolone 1-2 mg/kg daily in 2 divided doses (maximum 60 mg daily).
Continue treatment until patient achieves a PEF of 70% of predicted or personal best.
Allergic Conditions
>IM
and
moderate to severe Pneumocystis jiroveci pneumonia: 30 mg twice daily for 5 days, followed
by 30 mg once daily for 5 days, and then 15 mg once daily for 11 days (or until completion of
the anti-infective regimen). Initiate within 24-72 hours of initial antipneumocystis therapy.
Acute Spinal Cord Injury
>IV
Methylprednisolone sodium succinate: 30 mg/kg IV (administered over 15 minutes),
followed after 45 minutes by a continuous IV infusion of 5.4 mg/kg per hour for 23 hours.
Lupus Nephritis
>IV
Methylprednisolone sodium succinate: 30 mg/kg IV every other day for 6 doses.b
Adults
Usual Dosage
Oral: Initially, 2-60 mg daily, depending on disease being treated, and is usually divided into
4 doses.b
>IV or IM
Methylprednisolone sodium succinate: Usually, 10-250 mg; may repeat up to 6 times daily.b
>IV then IV or IM
Methylprednisolone sodium succinate: For high-dose therapy, administer 30 mg/kg over at
least 30 minutes.e May repeat every 4-6 hours for 48 hours.e Continue high-dose therapy only
until the condition stabilizes, usually 48-72 hours.e
For other conditions, 10-40 mg over several minutes.e Administer subsequent doses IV or IM
depending on response and clinical condition.e
>IM
Methylprednisolone acetate: 10-80 mg.b
Methylprednisolone acetate for maintenance of patients with rheumatoid arthritis: 40-120 mg
weekly.
When methylprednisolone acetate suspension is given as a temporary substitute for oral
therapy, dose of the suspension should be equal to the total daily oral dose of
methylprednisolone; administer IM once daily.d, m If a prolonged effect is desired, may
administer an IM dose of methylprednisolone acetate equal to 7 times the daily oral dose of
methylprednisolone once weekly.d, m
Intrarticular, Intrasynovial, Intralesional, or Soft-tissue Injection
Varies depending on location, size, and degree of inflammation.b, d, m In chronic cases, repeat
injections at intervals ranging from 1-5 weeks or more, depending on degree of relief
resulting from initial injection.d, m
Large Joints (e.g., knee): 20-80 mg of methylprednisolone acetate.d, m
Smaller Joints: 4-40 mg of methylprednisolone acetate repeated.d, m
Bursae, Ganglia, Tendinitis, Epicondylitis: 4-30 mg of methylprednisolone acetate; repeat if
necessary for recurrent or chronic conditions.d, m
Soft Tissue: 4-30 mg of methylprednisolone acetate for soft tissue infiltration; repeat if
necessary for recurrent or chronic conditions.d.
Asthma
Oral: In adults and adolescents with very poorly controlled, moderate-to-severe asthma (i.e.,
2 exacerbations per year requiring oral corticosteroids): May add methylprednisolone 40-60
mg daily as a single dose or in 2 divided doses to low-to-high maintenance dosages of the
inhaled corticosteroid and a long-acting inhaled 2-agonist bronchodilator. Continue with a
short course (usually 3-10 days) of oral corticosteroid therapy until patient achieves a PEF of
80% of his or her personal best and until symptoms resolve. May need a longer duration of
treatment in some patients. There is no evidence that tapering the dosage after improvement
will prevent a relapse.
In adults and adolescents with severe asthma who are inadequately controlled with a highdose inhaled corticosteroid, intermittent oral corticosteroid therapy, and a long-acting inhaled
2-agonist bronchodilator (based on consensus and clinical experience): May use
methylprednisolone 7.5-60 mg daily in the morning or every other day. May consider a short
course (2 weeks) of oral corticosteroids to confirm clinical response prior to implementing
long-term therapy with these agents. Once long-term oral corticosteroid therapy is initiated,
use the lowest possible effective dosage (i.e., alternate-day or once-daily administration);
monitor the patient carefully for adverse effects. Once asthma is well controlled, make
repeated attempts to reduce the oral corticosteroid dosage.
In adults and adolescents undergoing emergency department treatment for moderate-to-severe
acute asthma exacerbations not controlled with an inhaled 2-adrenergic agonist: May add
methylprednisolone 40-80 mg daily as a single dose or in 2 divided doses to an inhaled 2adrenergic agonist. Continue treatment until patient achieves a PEF of 70% of predicted or
personal best.
Dermatologic Diseases
>Intralesional Injection
Methylprednisolone acetate: 20-60 mg into the lesion.d For large lesions, it may be necessary
to administer 20-40 mg doses by repeated local injections spaced across the affected area.d
Usually, 1-4 injections are employed, with interval between injections varying with the type
of lesion treated and the duration of improvement observed with each injection.d
>IM
Methylprednisolone acetate: In patients with dermatologic lesions, usually, 40-120 mg of
methylprednisolone acetate once weekly for 1-4 weeks.d
mg twice daily for 5 days, followed by 30 mg once daily for 5 days, and then 15 mg once
daily for 11 days (or until completion of the anti-infective regimen). Initiate within 24-72
hours of initial antipneumocystis therapy.
Shock
>IV
Life-threatening shock: massive doses of methylprednisolone as the sodium succinate such as
30 mg/kg by direct IV injection (over 3-15 minutes) initially and repeated every 4-6 hours if
needed or 100-250 mg by direct IV injection (over 3-15 minutes) initially and repeated at 2to 6-hour intervals as required.b
Alternatively, following the initial dose by direct IV injection, additional doses of 30 mg/kg
may be administered by slow continuous IV infusion every 12 hours for 24-48 hours.b
Continue high-dose therapy only until the patient's condition has stabilized and usually not
beyond 48-72 hours.b
Acute Spinal Cord Injury
>IV
Warnings/Precautions
Warnings
Adrenocortical Insufficiency
When given in supraphysiologic doses for prolonged periods, glucocorticoids may cause
decreased secretion of endogenous corticosteroids by suppressing pituitary release of
corticotropin (secondary adrenocortical insufficiency).c
The degree and duration of adrenocortical insufficiency is highly variable among patients and
depends on the dose, frequency and time of administration, and duration of glucocorticoid
therapy.c
Acute adrenal insufficiency (even death) may occur if the drugs are withdrawn abruptly or if
patients are transferred from systemic glucocorticoid therapy to local (e.g., inhalation)
therapy.c
Withdraw methylprednisolone very gradually following long-term therapy with
pharmacologic dosages.c, d, e, m (See Discontinuance of Therapy under Dosage and
Administration.)
Adrenal suppression may persist up to 12 months in patients who receive large dosages for
prolonged periods.c
Until recovery occurs, signs and symptoms of adrenal insufficiency may develop if subjected
to stress (e.g., infection, surgery, trauma) and replacement therapy may be required.c, d, e, f, m
Since mineralocorticoid secretion may be impaired, sodium chloride and/or a
mineralocorticoid should also be administered.c, e, f, m
If the disease flares up during withdrawal, dosage may need to be increased and followed by
a more gradual withdrawal.c
Immunosuppression
Increased susceptibility to infections secondary to glucocorticoid-induced
immunosuppression.d, e, m Certain infections (e.g., varicella [chickenpox], measles) can have a
more serious or even fatal outcome in such patients.d, e, m (See Increased Susceptibility to
Infection under Warnings.)
Administration of live virus vaccines, including smallpox, is contraindicated in patients
receiving immunosuppressive dosages of glucocorticoids.a, d, e, m If inactivated viral or
bacterial vaccines are administered to such patients, the expected serum antibody response
may not be obtained.e May undertake indicated immunization procedures in patients
receiving glucocorticoids as replacement therapy (e.g., Addison's disease).a, d, e, f, m
Use with caution in patients with active ocular herpes simplex infections for fear of corneal
perforation.c, m
Transient blindness, amblyopia, acute retinal necrosis syndrome, and intraocular hemorrhage
have occurred following epidural glucocorticoid injection.
Endocrine and Metabolic Effects
Administration over a prolonged period may produce various endocrine disorders including
hypercorticism (cushingoid state) and amenorrhea or other menstrual difficulties.c
Increased or decreased motility and number of sperm in some men.c
May decrease glucose tolerance, produce hyperglycemia, and aggravate or precipitate
diabetes mellitus, especially in patients predisposed to diabetes mellitus.c If glucocorticoid
therapy is required in patients with diabetes mellitus, changes in insulin or oral antidiabetic
agent dosage or diet may be necessary.c
Administer by epidural injection with caution in patients with diabetes mellitus.
Exaggerated response to the glucocorticoids in hypothyroidism; use with caution.a, c, d, e, m
Changes in thyroid status may require dosage adjustment.d, m
Cardiovascular Effects
Use with extreme caution in recent MI since an association between use of glucocorticoids
and left ventricular free-wall rupture has been suggested.c, d, m
Use with caution in patients with CHF and hypertension.a, d, m
Bradycardia has occurred during or after IV administration of large doses of
methylprednisolone sodium succinate; may be unrelated to rate or duration of infusion.c, e
Cardiac arrhythmias, circulatory collapse, and/or cardiac arrest reported following rapid (<10
minutes) administration of large IV doses of methylprednisolone sodium succinate.e
Administer by epidural injection with caution in patients with CHF.
Dermatologic Effects
Dermal and/or subdermal changes forming depressions in the skin at the injection site
reported with methylprednisolone acetate injectable suspension (Depo-Medrol).m Exercise
care to minimize the incidence of dermal and subdermal atrophy; do not exceed
recommended doses of the injections.m
For intralesional use, administer multiple small injections into the area of the lesion,
whenever possible.d, m
Avoid injection or leakage into the dermis; avoid injection into the deltoid muscle, because of
high incidence of sub-Q atrophy.d, m
Kaposi's sarcoma has been reported in patients receiving glucocorticoid therapy;
discontinuance of such therapy may result in clinical improvement of the disease.a, d, m
Sensitivity Reactions
Anaphylactic or anaphylactoid reactions with or without circulatory collapse, cardiac arrest,
or bronchospasm.c, d, e, m Take appropriate precautionary measures prior to administration,
especially in patients with a history of allergy to any drug.d, e
Urticaria and other allergic or hypersensitivity reactions reported.a, d, e, f, m
General Precautions
Monitoring
Prior to initiation of long-term glucocorticoid therapy, perform baseline ECGs, blood
pressures, chest and spinal radiographs, glucose tolerance tests, and evaluations of HPA-axis
function in all patients.c, d, e
Perform upper GI radiographs in patients predisposed to GI disorders, including those with
known or suspected peptic ulcer disease.c, d
During long-term therapy, perform periodic height, weight, chest and spinal radiographs,
hematopoietic, electrolyte, glucose tolerance, and ocular and blood pressure evaluations.
Genitourinary Effects
Increased or decreased motility and number of sperm in some men.c
Nervous System Effects
May precipitate mental disturbances ranging from euphoria, insomnia, mood swings,
depression and anxiety, and personality changes to frank psychoses.a, d, e, m Use may aggravate
emotional instability or psychotic tendencies.a, d, e, m
Use with caution in patients with myasthenia gravis.a
Aseptic meningitis, arachnoiditis, exacerbation of pain, spinal cord trauma, subdural
injection, intracranial air injection, increased intracranial pressure, nerve injury, seizures,
bladder or bowel dysfunction, paraparesis or paralysis, sensory disturbances, and brain
damage reported following epidural and/or intrathecal glucocorticoid injection. Unclear
whether these effects involved improper needle placement or were related to administration
of the drug and/or preservatives.
Results from a multicenter, randomized, placebo controlled study with methylprednisolone
hemisuccinate (an IV corticosteroid) showed an increase in early (at 2 weeks) and late (at 6
months) mortality in patients with cranial trauma who were determined not to have other
clear indications for corticosteroid treatment.d, m Do not use high doses of systemic
corticosteroids, including methylprednisolone acetate (Depo-Medrol), for treatment of
traumatic brain injury.d, m
GI Effects
Corticosteroids should be used with caution in patients with diverticulitis, nonspecific
ulcerative colitis (if there is a probability of impending perforation, abscess, or other
pyogenic infection), or those with recent intestinal anastomoses.a, d, m
Use with caution in patients with active or latent peptic ulcer.a, d, m Manifestations of
peritoneal irritation following GI perforation may be minimal or absent in patients receiving
corticosteroids.c, d, m Suggest concurrent administration of antacids between meals to prevent
peptic ulcer formation in patients receiving high dosages of corticosteroids.c, d, e
Specific Populations
Pregnancy
Category C.d, f, m
If substantial dosage received during pregnancy, carefully observe infant for signs of
hypoadrenalism.a
Fluoroscopy (recommended for ensuring proper needle placement for epidural injections) is
contraindicated in pregnant women.
Lactation
Glucocorticoids are distributed into milk and could suppress growth, interfere with
endogenous glucocorticoid production, or cause other adverse effects in nursing infants.c, d, m
Discontinue nursing or the drug.m
Pediatric Use
The effects of glucocorticoids on the pathophysiology and course of diseases are considered
to be similar in adults and children.c, d, m Evidence of safety and efficacy of corticosteroids in
pediatric patients is based on treatment of nephrotic syndrome (in patients >2 years of age)
and aggressive leukemias and lymphomas (in patients >1 month of age).c, d, m Evidence of
safety and efficacy in other pediatric indications (e.g., severe asthma and wheezing) is based
on controlled trials in adults.c, d
Adverse effects in pediatric patients are similar to those in adults.c, d, m As in adults, perform
periodic evaluations of height, weight, IOP, and BP.c, d Children, like adults, also should
undergo clinical evaluation for the presence of infection, psychosocial disturbances,
thromboembolism, peptic ulcers, cataracts, and osteoporosis.c, d, m
With long-term use, may delay growth and maturation in children and adolescents.c, d, m
Monitor carefully the growth and development of pediatric patients receiving prolonged
corticosteroid therapy.a, c, d, m Titrate dosage to the lowest effective level.c Alternate-day
therapy with glucocorticoids that cause shorter HPA-axis suppression than does
dexamethasone (e.g., prednisone, prednisolone, methylprednisolone) may minimize growth
suppression and should be instituted if growth suppression occurs.c
Glucocorticoid-induced osteoporosis and associated fractures are common in children and
adolescents receiving long-term systemic therapy. In addition, may prevent achievement of
peak bone mass during adolescence by inhibiting bone formation. Methods for monitoring
bone mineralization (e.g., dual-energy x-ray absorptiometry [DEXA]) in children and
adolescents are similar to those in adults.
Ensure children and adolescents consistently ingest either through diet or supplementation
adequate calcium and vitamin D.
Methylprednisolone sodium succinate (in single-dose vials) and methylprednisolone acetate
(in multiple-dose vials) injection preparations containing benzyl alcohol are contraindicated
in premature infants.e, m Administration of injections preserved with benzyl alcohol has been
associated with toxicity in neonates (gasping syndrome).c, d, e, m (See Contraindications under
Cautions.)
Geriatric Use
Interaction
Comments
May result in a loss of corticoidinduced adrenal suppressiond, m
Analgesics, opiate
opiate analgesics
glucocorticoid injections
Epidural injection: Potential for Improve patient safety by excluding
Anesthetics, local
opiate analgesics
glucocorticoid injections
Conflicting reports of alterations Monitor coagulation indices to
Anticoagulants, oral
effecta, c, d, e
myasthenia gravis
Increased blood glucose
Antidiabetic therapy
Barbiturates
Carbamazepine
Cholestyramine
Withdraw anticholinesterases at
least 24 hours before initiating
corticosteroid therapyd, m
May require dosage adjustment of
concentrations in diabetes
mellitusm
May enhance metabolism of
hypoglycemic agentsm
corticosteroidsm
Increase dosage of
methylprednisolonea, c, d, m
methylprednisolonea, c, e
May enhance metabolism of
corticosteroidsm
Increased clearance of oral
corticosteroidsm
May decrease hepatic
Cyclosporine
their effectsd, m
Plasma concentrations of
Digitalis glycosides
Isoniazid
Ketoconazole
Macrolide antibiotics
(e.g., erythromycin,
troleandomycin)
methylprednisolone.c Mutual
concomitant usea, c, e
concomitant usea, e
Increased risk of arrhythmias
associated with hypokalemiad, m
Serum isoniazid concentration
may be decreasedd, m
Decreased metabolism of certain
corticosteroids c, d, m
methylprednisolone to avoid
potential adverse effectsc, d, e
Titrate dosage of
a, c, d, e
Titrate dosage of
methylprednisolone to avoid
potential adverse effectsa, d, e
Use concurrently with cautiona, c, d, m
Observe patients receiving both
NSAIAs
effectsa, c, d, m
either drugc
concentrations;c, d when
Phenytoin
corticosteroidsc, d, m
methylprednisolonec, d, e, m
Enhance the potassium-wasting
Potassium-depleting
effects of glucocorticoidsc
drugs (diuretics,
amphotericin B)
Rifampin
caution in hypoprothrombinemiad
Increase dosage of
methylprednisolonec, d, e
Skin tests
necessaryb
(supraphysiologic dosages) c
Pharmacokinetics
Absorption
Bioavailability
Absorption from IM injection of methylprednisolone sodium succinate is rapid.b
Systemic absorption of methylprednisolone acetate occurs slowly following intra-articular,
intrabursal, intrasynovial, intradermal, or soft tissue injection; c, d, m Absorption from intraarticular injection sites is usually very slow and continues for about 7 days.b
Onset
Following IM administration (80-120 mg) in patients with severe poison ivy, relief onset
within 8-12 hours.d
Following oral administration in patients with asthma, effects may not be evident for several
hours.
Duration
The duration of anti-inflammatory activity of methylprednisolone approximately equals the
duration of HPA-axis suppression, about 1.25-1.5 days for a single 40-mg oral dose.c
Distribution
Extent
Most glucocorticoids are removed rapidly from the blood and distributed to muscles, liver,
skin, intestines, and kidneys.c
Glucocorticoids appear in breast milk and the placenta.c
Elimination
Metabolism
Metabolized in most tissues, but mainly in the liver, to inactive compounds.c
Half-life
Approximately 2.5-3.5 hours following oral administration of methylprednisolone or IV or
IM administration of methylprednisolone sodium succinate.h
Special Populations
The metabolic clearance of corticosteroids may be decreased in patients with hypothyroidism
and increased in those with hyperthyroidism.d, m
Stability
Storage
Oral
Tablets
20-25C.a
Tight, light-resistant containers at 15-30C (methylprednisolone tablets).f
Parenteral
Powder for Injection
Store unreconstituted at 20-25C.e Store reconstituted solution at 20-25C; use reconstituted
solution within 48 hourse
Suspension for Injection
20-25C.d, m
Single-dose vials of methylprednisolone acetate injectable suspension (Depo-Medrol) are
not intended for multiple-dose withdrawal; discard any remaining suspension.d
Avoid contamination of multiple-dose vials of methylprednisolone acetate injectable
suspension by using strict aseptic technique.m Use povidone-iodine solution or similar
product to cleanse the vial top prior to aspiration of contents.m Although initially sterile, such
vials may become contaminated; use of disposable sterile syringes and needles is necessary.m
Similar to other corticosteroids, methylprednisolone acetate suspension is heat labile; do not
autoclave when it is desirable to sterilize the outside of the vial.d, m
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Parenteral
Methylprednisolone Acetate
The manufacturer states that methylprednisolone acetate should not be diluted or mixed with
other solutions because of possible physical incompatibilities.d
Methylprednisolone Sodium Succinate
Must reconstitute only with diluent provided by the manufacturer or bacteriostatic water for
injection with benzyl alcohol.e The manufacturers state that reconstituted solution may be
diluted with 5% dextrose, or 0.9% sodium chloride, or 5% dextrose in sodium chloride
injection.e
Solution Compatibility (Methylprednisolone Sodium Succinate)k
Compatible
Amino acids 4.25%, dextrose 25%
Dextrose 5% in sodium chloride 0.45 or 0.9%
Ringer's injection, lactated
Sodium chloride 0.9%
Variable
Dextrose 5% in water (compatibility concentration dependent)
Drug Compatibility (Methylprednisolone Sodium Succinate)
>Admixture Compatibilityk
Compatible
Chloramphenicol sodium succinate
Cimetidine HCl
Clindamycin phosphate
Dopamine HCl
Granisetron HCl
Heparin sodium
Norepinephrine bitartrate
Penicillin G potassium
Ranitidine HCl
Theophylline
Verapamil HCl
Incompatible
Calcium gluconate
Glycopyrrolate
Metaraminol bitartrate
Nafcillin sodium
Penicillin G sodium
Variable
Aminophylline
Cytarabine
>Y-Site Compatibilityk
Compatible
Acyclovir sodium
Amifostine
Amiodarone HCl
Amphotericin B cholesteryl sulfate complex
Aztreonam
Bivalirudin
Cefepime HCl
Cisplatin
Cladribine
Cyclophosphamide
Cytarabine
Dexmedetomidine HCl
Dopamine HCl
Doxorubicin HCl
Doxorubicin HCl liposome injection
Enalaprilat
Famotidine
Fludarabine phosphate
Gatifloxacin
Granisetron HCl
Heparin sodium
Hetastarch in lactated electrolyte injection (Hextend)
Inamrinone lactate
Linezolid
Melphalan HCl
Meperidine HCl
Methotrexate sodium
Metronidazole
Midazolam HCl
Milrinone lactate
Morphine sulfate
Nicardipine HCl
Piperacillin sodium-tazobactam sodium
Remifentanil HCl
Sodium bicarbonate
Tacrolimus
Teniposide
Theophylline
Thiotepa
Topotecan HCl
Incompatible
Allopurinol sodium
Amsacrine
Ciprofloxacin
Docetaxel
Etoposide phosphate
Fenoldopam mesylate
Filgrastim
Gemcitabine HCl
Ondansetron HCl
Paclitaxel
Propofol
Sargramostim
Vinorelbine tartrate
Variable
Diltiazem HCl
Heparin sodium with hydrocortisone sodium succinate
Potassium chloride
Vitamin B complex with C
Actions
Principally an anti-inflammatory or immunosuppressant agent.d
Exhibits potent anti-inflammatory activity and minimal mineralocorticoid properties.c
Decreases inflammation by stabilizing leukocyte lysosomal membranes, preventing release of
destructive acid hydrolases from leukocytes; or reducing leukocyte adhesion to capillary
endothelium.c
Inhibits macrophage accumulation in inflamed areas.c
Reduces capillary wall permeability and edema formation.c
Antagonizes histamine activity and release of kinin from substrates.c
Reduces fibroblast proliferation, collagen deposition, and subsequent scar tissue formation.c
Stimulates erythroid cells of bone marrow, prolongs survival time of erythrocytes and platelets,
and produces neutrophilia and eosinopenia.c
Promotes gluconeogenesis, redistribution of fat from peripheral to central areas of the body,
and protein catabolism, which results in negative nitrogen balance.c
Reduces intestinal absorption and increase renal excretion of calcium.c, e
Suppresses the immune response by reducing activity and volume of the lymphatic system,
producing lymphocytopenia.c
Advice to Patients
In patients receiving long-term therapy, importance of not discontinuing the drug abruptly or
without supervision of a clinician.b, d, m
Importance of notifying a clinician of any infections, signs of infections (e.g., fever, sore
throat, pain during urination, muscle aches), or injuries that develop during therapy or within
12 months after therapy is discontinued.c, d, m
Importance of carrying identification cards listing the diseases being treated, the glucocorticoid
regimen, and the name and telephone number of the clinician.c
When surgery is required, importance of informing the attending physician, dentist, or
anesthesiologist of recent (within 12 months) glucocorticoid therapy.c
In immunosuppressed patients, importance of avoiding exposure to certain infections (e.g.,
chickenpox, measles) and of the importance of obtaining medical advice if such exposure
occurs.a, d, e, m
Importance of informing clinicians of existing or contemplated concomitant therapy, including
prescription and OTC drugs.a, c
Importance of women informing clinicians if they are or plan to become pregnant or plan to
breast-feed.a
Importance of informing patients of other important precautionary information.a, c (See
Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects
in some individuals; consult specific product labeling for details.
Methylprednisolone
Routes
Oral
Dosage Forms
Tablets
Strengths
2 mg
4 mg*
Brand Names
Medrol (scored)
Medrol (scored)
Medrol Dosepak
Meprolone Unipak
Manufacturer
Pfizer
Pfizer
Pfizer
Major
Methylprednisolone Tablets
Medrol (scored)
Pfizer
Methylprednisolone Tablets
16 mg
Medrol (scored)
Pfizer
32 mg
Medrol (scored)
Pfizer
* available from one or more manufacturer, distributor, and/or repackager by generic
8 mg
(nonproprietary) name
Methylprednisolone Acetate
Routes
Parenteral
Dosage Forms
Injectable
suspension
Depo-Medrol
Pfizer
Dosage
Forms
For
injection
Strengths
40 mg (of
methylprednisolone)*
Brand Names
Manufacturer
A-methaPred
Hospira
Methylprednisolone Sodium
125 mg (of
methylprednisolone)*
Succinate Injection
Solu-Medrol
Pfizer
A-methaPred
Hospira
Methylprednisolone Sodium
500 mg (of
methylprednisolone)*
Succinate Injection
Solu-Medrol
Pfizer
A-methaPred
Hospira
1 g (of
methylprednisolone)
Succinate Injection
Solu-Medrol
Pfizer
A-methaPred
Hospira
Pfizer
Solu-Medrol
Pfizer
methylprednisolone)
* available from one or more manufacturer, distributor, and/or repackager by generic
(nonproprietary) name
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This
pricing information was updated 03/2011. For the most current and up-to-date pricing
information, please visit www.drugstore.com. Actual costs to patients will vary depending on
the use of specific retail or mail-order locations and health insurance copays.
Depo-Medrol 20MG/ML Suspension (PFIZER U.S.): 5/$28.64 or 10/$46.26
Medrol 16MG Tablets (PFIZER U.S.): 30/$102.99 or 90/$299.96
Medrol 32MG Tablets (PFIZER U.S.): 25/$127.99 or 75/$367.97
Medrol 4MG Tablets (PFIZER U.S.): 25/$44.7 or 75/$122.64
Medrol 8MG Tablets (PFIZER U.S.): 30/$70.97 or 90/$198.35
MethylPREDNISolone 16MG Tablets (CADISTA): 50/$147 or 150/$419.98
MethylPREDNISolone 4MG Tablets (TEVA PHARMACEUTICALS USA): 30/$17.99 or
90/$29.97
MethylPREDNISolone 8MG Tablets (PRASCO LABORATORIES): 25/$45.99 or
75/$125.97
Use is not currently included in the labeling approved by the US Food and Drug
Administration.
References
a. Pfizer. Medrol (methylprednisolone) tablets prescribing information. New York, NY; 2006
Nov.
b. AHFS drug information 2004. McEvoy GK, ed. Methylprednisolone. Bethesda, MD:
American Society of Health-System Pharmacists; 2004:2914-5.
c. AHFS drug information 2005. McEvoy GK, ed. Corticosteroids general statement. Bethesda,
MD: American Society of Health-System Pharmacists; 2005:2908-21.
d. Pfizer. Depo-Medrol (methylprednisolone acetate) injectable suspension (single-dose vials)
prescribing information. New York, NY; 2009 Apr.
e. Pfizer. Solu-Medrol (methylprednisolone sodium succinate) sterile powder for injection
prescribing information. New York, NY; 2009 May.
f. BarrLaboratories. Methylprednisolone tablets prescribing information. Pomona, NY; 2001
Nov.
g. Behrman RE, Kliegman RM, Jenson HB, eds. Nelson textbook of pediatrics. 17th ed.
Philadelphia: Saunders; 2004:1407-8.
h. Woodward HM. Upjohn Company unpublished data (personal communication), 1976.
i. Walsh LJ, Wong CA, Oborne J et al. Adverse effects of oral corticosteroids in relation to dose
in patients with lung disease. Thorax. 2001; 56:279-84. [PubMed 11254818] [Free Fulltext
PMC]
j. Bello CE, Garrett SD. Therapeutic issues in oral glucocorticoid use. Lippincotts Prim Care
Pract. 1999; 3:333-41. [PubMed 10711134]
k. Trissel LA. Handbook on injectable drugs. 13th ed. Bethesda, MD: American Society of
Health-System Pharmacists; 2005:1001-1010.
l. USP DI: drug information for the health care provider. 24th ed. Greenwood Village, CO:
Thomson Micromedex; 2004;1:940-6.