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SOLU-MEDROL is a brand name for Methylprednisolone, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Intravenous administration of SOLU-MEDROL (methylprednisolone sodium succinate) is indicated in situations in which a rapid and intense hormonal effect is required. SOLU-MEDROL (methylprednisolone sodium succinate) is indicated for: • Hypersensitivity and dermatologic conditions - Status asthmaticus - Anaphylactic…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Because complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.
• The lowest possible dose of corticosteroid should be used to control the condition under treatment. • Patients should be advised to inform subsequent health professionals of the prior use of SOLU- MEDROL. • The existence of diabetes, osteoporosis, renal insufficiency, chronic psychosis, cardiovascular disease, myasthenia gravis or predisposition to thrombophlebitis requires that SOLU-MEDROL be administered with extreme caution.
• Dosage adjustments may be required based on the following: - during remission - exacerbation of the disease process - the patient’s individual response to therapy - upon exposure of the patient to emotional or physical stress such as serious infection, surgery or injury.
SOLU-MEDROL dosage may need to be increased during and after the stressful situation. • Geriatrics: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
• Caution is recommended with prolonged corticosteroid treatment in the elderly due to a potential increased risk for osteoporosis, as well as increased risk for fluid retention with possible resultant hypertension. 3 Pediatrics). 2 Recommended Dose and Dosage Adjustment • Corticosteroid therapy is an adjunct to, and not replacement for, conventional therapy.
, shock states), the recommended dose of SOLU-MEDROL is 30 mg per kg, given intravenously over a period of at least 30 minutes. This large dose may be repeated every 4- 6 hours for up to 48 hours. • In other indications, initial dosage will vary from 10 to 500 mg depending on the clinical problem being treated.
Larger doses may be required for short-term management of severe, acute conditions. , doses greater than 250 mg). Subsequent doses may be given intravenously or intramuscularly at intervals dictated by the patient's response and clinical condition.
• SOLU-MEDROL in doses of 40 to 120 mg administered as retention enemas or by continuous drip three to seven times weekly for periods of two or more weeks have been shown to be a useful adjunct in the treatment of some patients with ulcerative colitis.
1 Adverse Reaction Overview The following Adverse Reactions have been reported with the systemic use of SOLU-MEDROL and other corticosteroid preparations. MedDRA (v15) System Organ Class Undesirable Effect Blood and lymphatic system disorders Leukocytosis Infections and infestations Infection; opportunistic infection; injection site infections following non-sterile administration; decreased resistance to infection Immune system disorders Drug hypersensitivity; (anaphylactoid reaction; anaphylactic reaction (with or without circulatory collapse)) SOLU-MEDROL (methylprednisolone sodium succinate) Page 20 of 44 MedDRA (v15) System Organ Class Undesirable Effect Endocrine disorders Cushingoid; hypothalamic pituitary adrenal axis suppression; steroid withdrawal syndrome; moon face; abnormal fat deposits; glycosuria; hypertrichosis; secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) A steroid “withdrawal syndrome,” seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of glucocorticoids.
This syndrome 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.
Metabolism and nutrition disorders Lipomatosis; sodium retention; sodium excretion; fluid retention; alkalosis hypokalemic; dyslipidaemia; metabolic acidosis; glucose tolerance impaired; increased requirement for insulin (or oral hypoglycemic agents in diabetics); nitrogen balance negative (due to protein catabolism); blood urea increased; increased appetite (which may result in weight increased); diuresis Psychiatric disorders Affective disorder (including affect lability, depressed mood, euphoric mood, drug dependence, suicidal ideation); psychotic disorder (including mania, delusion, hallucination, schizophrenia [aggravation of]); mental disorder; insomnia; mood swings; personality change; confusional state; abnormal behavior; anxiety; irritability; emotional instability Nervous system disorders Epidural lipomatosis; intracranial pressure increased (with papilledema [idiopathic intracranial hypertension] usually following discontinuation of treatment); convulsion; amnesia; cognitive disorder; dizziness; headache; seizures; neuritis; neuropathy; paresthesia Eye disorders Central serous chorioretinopathy; cataract; glaucoma; exophthalmos; rare instances of blindness associated with periocular injections.
, 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 ......................................................
3 Reconstitution ........................................................................................................ 4 Administration .......................................................................................................
9 5 OVERDOSAGE............................................................................................................ 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 10 7 WARNINGS AND PRECAUTIONS ...............................................................................
SOLU-MEDROL is contraindicated: • in patients with known hypersensitivity to the ingredients. SOLU-MEDROL ACT-O-VIALS, 40 mg, include lactose produced from cow’s milk. This dosage form is therefore contraindicated 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.
• for systemic fungal infections • in patients administered with live or live, attenuated vaccines while receiving immunosuppressive doses of corticosteroids. • for intrathecal or epidural administration. Reports of serious medical events have been associated with these routes of administration.
• for use in premature infants, as the Bacteriostatic Water for Injection that is indicated for reconstituting SOLU-MEDROL Plain Vials products contains benzyl alcohol. 3 Pediatrics. • for intramuscular administration in idiopathic thrombocytopenic purpura.
Except for short-term emergency therapy, SOLU-MEDROL is contraindicated in patients with: • arrested tuberculosis • herpes simplex keratitis • acute psychoses SOLU-MEDROL (methylprednisolone sodium succinate) Page 6 of 44 • Cushing's syndrome • peptic ulcer • markedly elevated serum creatinine • vaccinia and varicella
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Methylprednisolone in Canada.
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Many patients can be controlled with 40 mg of SOLU-MEDROL administered in from 1 to 10 fluid ounces of water depending on the degree of involvement of the inflamed colonic mucosa. Other accepted therapeutic measures should, of course, be instituted.
3 Reconstitution Parenteral Products: DIRECTIONS FOR USING THE PLAIN VIAL SYSTEM SOLU-MEDROL 500 mg Vial: reconstitute with 8 mL Bacteriostatic Water for Injection USP (benzyl alcohol as preservative). SOLU-MEDROL 1 g Vial: reconstitute with 16 mL Bacteriostatic Water for Injection USP (benzyl alcohol as preservative).
5 mg/mL DIRECTIONS FOR USING THE ACT-O-VIAL SYSTEM 1. Press down on plastic activator to force diluent into the lower compartment. 2. Gently shake to mix the solution. SOLU-MEDROL (methylprednisolone sodium succinate) Page 8 of 44 3. Remove plastic tab covering centre of stopper.
4. Sterilize top of stopper with an antiseptic (ex. alcohol wipe). 5. Insert needle squarely through centre of stopper until tip is just visible. 6. Invert vial and withdraw dose. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
5 mg/mL 500 mg ACT-O-VIAL Entire contents supplied 125 mg/mL 1 g ACT-O-VIAL Entire contents supplied 125 mg/mL Compatibility The compatibility and stability of SOLU-MEDROL, in solutions and with other drugs in intravenous admixtures is dependent on admixture pH, concentration, time, temperature, and the ability of methylprednisolone to solubilize itself.
V. V. V. "piggy-back" solution. 9% sodium chloride. The resulting solutions are physically and chemically stable for 48 hours. 4 Administration SOLU-MEDROL may be administered by intravenous or intramuscular injection or by intravenous infusion, the preferred method for initial emergency use being intravenous injection.
To administer SOLU-MEDROL, reconstitute the Plain Vial or ACT-O-VIAL as per instructions. Store reconstituted solution at room temperature (between 15 and 30°C). Use reconstituted solution within 48 hours. SOLU-MEDROL Plain Vials and ACT-O-VIALS are single dose vials.
Discard unused portion. Reconstituted SOLU-MEDROL products can be used directly for intravenous or […]
Ear and labyrinth disorders Vertigo Cardiac disorders Cardiac failure congestive (in susceptible patients); arrhythmia; cardiac arrest; bradycardia; tachycardia; cardiac enlargement; circulatory collapse; hypertrophic cardiomyopathy in premature infants; myocardial rupture following recent myocardial infarction; pulmonary oedema; syncope SOLU-MEDROL (methylprednisolone sodium succinate) Page 21 of 44 MedDRA (v15) System Organ Class Undesirable Effect Vascular disorders Hypertension; hypotension; flushing; thromboembolism; thrombophlebitis, thrombosis, vasculitis Respiratory, thoracic and mediastinal disorders Hiccups; bronchospasm, pulmonary embolism Gastrointestinal disorders Peptic ulcer (with possible peptic ulcer perforation and peptic ulcer haemorrhage); intestinal perforation; gastric haemorrhage; pancreatitis; esophagitis ulcerative; oesophagitis; abdominal distension; abdominal pain; diarrhoea; dyspepsia; nausea; vomiting; dysgeusia; peritonitis (peritonitis may be the primary presenting sign or symptom of a gastrointestinal disorder such as perforation, obstruction or pancreatitis) Hepatic disorders Hepatomegaly, hepatitis, drug-induced liver injury, liver failure Skin and subcutaneous disorders Angioedema; hirsutism; petechiae; ecchymoses; skin atrophy; erythema; hyperhidrosis; skin striae; rash; pruritus; urticaria; acne; panniculitis; skin hypopigmentation; skin hyperpigmentation; allergic dermatitis; burning or tingling (especially in the perineal area after intravenous injection); cutaneous and subcutaneous atrophy; dry scaly skin; sterile abscess; thinning scalp hair; Kaposi’s sarcoma Musculoskeletal and connective tissue disorders Muscular weakness; myalgia; myopathy; rhabdomyolysis; muscle atrophy; osteoporosis; osteonecrosis; pathological; post-injection flare (following intra-articular use); fracture; neuropathic arthropathy; arthralgia; growth retardation Reproductive system and breast disorders Menstruation irregular; increased or decreased motility and number of spermatozoa.
General disorders and administration site conditions Impaired healing; fatigue; malaise; injection site reaction; oedema peripheral Investigations Urine calcium increased; blood potassium decreased; Carbohydrate tolerance decreased; intraocular pressure increased; aminotransferase increased; aspartate aminotransferase increased; blood alkaline phosphatase increased; suppression of reactions to skin tests; blood urea increased Injury, poisoning and procedural complications Spinal compression fracture; tendon rupture (particularly of the Achilles tendon)
1 Special Populations .............................................................................................. 1 Pregnant Women ............................................................................................. 2 Breast-feeding ..................................................................................................
3 Pediatrics.......................................................................................................... 4 Geriatrics ..........................................................................................................
19 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview ................................................................................. 19 9 DRUG INTERACTIONS ..............................................................................................
2 Drug Interactions Overview ................................................................................. 4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions ........................................................................................
6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions....................................................................... 26 10 CLINICAL PHARMACOLOGY ......................................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics .................................................................................................
28 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 29 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 29 PART II: SCIENTIFIC INFORMATION .....................................................................................
30 13 PHARMACEUTICAL INFORMATION .......................................................................... 30 14 CLINICAL TRIALS ......................................................................................................
30 15 MICROBIOLOGY ...................................................................................................... 31 16 NON-CLINICAL TOXICOLOGY ....................................................................................
32 SOLU-MEDROL (methylprednisolone sodium succinate) Page 4 of 44 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Intravenous administration of SOLU-MEDROL (methylprednisolone sodium succinate) is indicated in situations in which a rapid and intense hormonal effect is required.
SOLU-MEDROL (methylprednisolone sodium succinate) is indicated for: • Hypersensitivity and dermatologic conditions - Status asthmaticus - Anaphylactic reactions - Drug reactions - Contact dermatitis - Urticaria - Generalized neurodermatitis - Reactions to insect bites - Pemphigus foliaceous and vulgaris - Exfoliative dermatitis - Erythema multiforme • In anaphylactic reactions epinephrine or norepinephrine should be administered first for an immediate hemodynamic effect followed by intravenous injection of SOLU-MEDROL and other accepted procedures.
There is evidence that the corticoids through their prolonged hemodynamic effect are of value in preventing recurrent attacks of acute anaphylactic reactions. • In sensitivity reactions such as in serum sickness, allergic dermatosis (urticaria) and reactions to insect bites, SOLU-MEDROL is capable of providing […]