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MEDROL is a brand name for Methylprednisolone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). Symptoms typically emerge within a few days or weeks of starting treatment. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Psychological effects have been reported upon withdrawal of corticosteroids; the frequency MEDROL (methylprednisolone) Page 13 of 34 is unknown.
Patients/caregivers should be encouraged to seek medical attention if psychological symptoms develop in the patient, especially if depressed mood or suicidal ideation is suspected. Patients/caregivers should be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids.
Renal Caution is required in patients with systemic sclerosis because an increased incidence of scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone. Corticosteroids should be used with caution in patients with renal insufficiency.
Reproductive Health:
Female and Male Potential Steroids may increase or decrease motility and number of spermatozoa in some patients. , angioedema) may occur. Because rare instances of skin reactions and anaphylactic/anaphylactoid reactions have occurred in patients receiving corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
This medicine contains lactose produced from cow’s milk. Caution should be exercised in patients with a known or suspected hypersensitivity to cow’s milk or its components or other dairy products because it may contain trace amounts of milk ingredients.
1 Pregnant Women Pregnant Women: Corticosteroids readily cross the placenta. Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, rabbits have yielded an increase incidence of cleft palate in the offspring (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
One retrospective study found an increased incidence of low birth weights in infants born of mothers receiving corticosteroids. Cataracts have been observed in infants born to mothers undergoing long- term treatment with corticosteroids during pregnancy.
Since adequate human reproductive studies have not been done with methylprednisolone, this drug should be used during pregnancy at the lowest possible dose, only if clearly needed, where the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Infants born to mothers who have received substantial doses of corticosteroids during pregnancy must be carefully observed and evaluated for signs of adrenal insufficiency. There are no known effects of corticosteroids on labour and delivery.
, Immune 01/2025 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 06/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1. INDICATIONS ............................................................................................................. 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 5 2. CONTRAINDICATIONS ................................................................................................
5 4. DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ......................................................
5 Missed Dose ........................................................................................................... 7 5. OVERDOSAGE............................................................................................................
7 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 7 7. WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations ..............................................................................................
; 9 DRUG INTERACTIONS). Special pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma.
It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation.
In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
Corticosteroids should not be used in cerebral malaria. There is currently no evidence of benefit from steroids in this condition. Tuberculosis The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculosis regimen.
If corticosteroids are indicated in patients with latent tuberculosis reactivity, close observation is necessary as reactivation of the disease may MEDROL (methylprednisolone) Page 11 of 34 occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Vaccinations Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids (see 2 CONTRAINDICATIONS). Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 Breast-feeding Nursing Women: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a careful benefit-risk assessment should be conducted and a decision should be made whether to discontinue nursing, or discontinue the drug, taking into account the importance of the drug to the mother.
3 Pediatrics Pediatrics: Growth may be suppressed in children receiving long-term daily, divided dose glucocorticoid therapy and use of such regimen should be restricted to the most urgent indication. 2 Recommended Dose and Dosage Adjustment, Alternate Day Therapy).
Pediatric patients may experience a decrease in their growth velocity at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary- adrenal (HPA) axis suppression. Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.
In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.
Infants and children on prolonged corticosteroid therapy are at special risk from raised intracranial pressure. High doses of corticosteroids may produce pancreatitis in children. 4 Geriatrics Geriatric populations are associated with different efficacy responses and safety.
Treatment of elderly patients with corticoids should be cautious starting with a low dose because the existence of concomitant conditions in elderly patients such as decreased hepatic, renal and cardiac function and the presence of diabetes or osteoporosis.
8. 1 Adverse Reaction Overview Note: The following are typical for all systemic corticosteroids. Their inclusion in this list does not necessarily indicate that the specific event has been observed with this particular formulation.
Allergic reactions:
Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, angioedema.
MEDROL (methylprednisolone) Page 15 of 34 Blood and lymphatic system disorders:
Leukocytosis Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, flushing, hypertension, hypotension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent […]
1 Pregnant Women ............................................................................................. 2 Breast-feeding .................................................................................................. 3 Pediatrics..........................................................................................................
4 Geriatrics .......................................................................................................... 14 8. ADVERSE REACTIONS...............................................................................................
1 Adverse Reaction Overview ................................................................................. 14 9. DRUG INTERACTIONS .............................................................................................. 2 Drug Interactions Overview .................................................................................
3 Drug-Behavioral Interactions ............................................................................... 4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions ........................................................................................
6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions....................................................................... 20 10. CLINICAL PHARMACOLOGY ......................................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics .................................................................................................
20 11. STORAGE, STABILITY AND DISPOSAL ........................................................................ 21 12. SPECIAL HANDLING INSTRUCTIONS.......................................................................... 21 PART II: SCIENTIFIC INFORMATION .....................................................................................
22 13. PHARMACEUTICAL INFORMATION .......................................................................... 22 14. CLINICAL TRIALS ......................................................................................................
22 15. MICROBIOLOGY ...................................................................................................... 22 16. NON-CLINICAL TOXICOLOGY ....................................................................................
22 Patient Medication Information ......................................................................................... 24 MEDROL (methylprednisolone) Page 4 of 34 PART I: HEALTH PROFESSIONAL INFORMATION 1. INDICATIONS Medrol (methylprednisolone) is indicated for: 1.
Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; post-traumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis.
3. Collagen Diseases During an exacerbation or as […]
Indicated immunization procedures may be undertaken in patients receiving non immunosuppressive doses of corticosteroids. While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially in high doses, because of possible hazards of neurological complications and lack of antibody response.
Viral Infections Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure.
The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated.
) If chicken pox develops, treatment with antiviral agents should be considered. 0 mg/dL or secondary infections). Monitoring and Laboratory Tests Corticosteroids may suppress reactions to skin tests. Since methylprednisolone suppresses endogenous adrenocortical activity, it is highly important that the patient receiving MEDROL be under careful observation, not only during the course of treatment but for some time after treatment is terminated.
Monitoring for signs and symptoms of drug-induced secondary adrenocortical insufficiency may be necessary for up to one year following cessation of long- term or high-dose corticosteroid therapy. , pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis.
Elevations of creatine kinase may occur. Cases of rhabdomyolysis have been reported. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. , decreasing absorption and increasing excretion) and inhibition of osteoblast function.
This, together with a decrease in protein matrix of the bone secondary to an increase in MEDROL (methylprednisolone) Page 12 of 34 protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age.
, postmenopausal women) before initiating corticosteroid therapy. Osteoporosis is a common but infrequently recognized adverse effect associated with a long- term use of glucocorticoids. Neurologic Corticosteroids should be used with caution in patients with seizure disorders.
Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine. Since concurrent administration of these agents results in a mutual inhibition of metabolism, it is possible that convulsions and other adverse events associated with the individual use of either drug may be more apt to occur.
Systemic corticosteroids are not indicated for, and therefore should not be used to treat traumatic brain injury, a multicenter study revealed an increased mortality at 2 weeks and 6 months after injury in patients administered methylprednisolone sodium succinate compared to placebo.
A causal association with methylprednisolone sodium succinate treatment has not been established. There have been reports of epidural lipomatosis in […]