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  • Solu Medrol
    / Pfizer


    Active Ingredient
    Methylprednisolone 40, 125, 500, 1000 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 1 ml X 40 mg

    full basket chart 2019 9700

    Vial

    1 X 2 ml X 125 mg

    full basket chart 2021 19109

    Vial

    1 X 8 ml X 500 mg

    full basket chart 75594 19719

    Vial

    1 X 16 ml X 1000 mg

    full basket chart 75593 19720

    Related information


    Dosage

    Methylprednisolone sodium succinate may be administered by intravenous (IV) injection or infusion, or by intramuscular (IM) injection. The preferred method for initial emergency use is IV injection. Dosage may be reduced for infants and children but should be selected based on the severity of the condition and the response of the patient rather than on the age or weight of the patient. The paediatric dosage should not be less than 0.5 mg/kg every 24 hours.
    Adjunctive therapy in life-threatening conditions: Administer 30 mg/kg IV over a period of at least 30 minutes. Dose may be repeated every 4 to 6 hours for up to 48 hours.
    Rheumatic disorders unresponsive to standard therapy (or during exacerbation episodes): Administer either regimen as IV pulse dosing over at least 30 minutes. The regimen may be repeated if improvement has not occurred within a week after therapy, or as the patient’s condition dictates. 1 g/day for 1 to 4 days, or 1 g/month for 6 months.
    Systemic lupus erythematosus unresponsive to standard therapy (or during exacerbation episodes): Administer 1 g/day for 3 days as IV pulse dosing over at least 30 minutes. The regimen may be repeated if improvement has not occurred within a week after therapy, or as the patient’s condition dictates.
    Multiple sclerosis unresponsive to standard therapy (or during exacerbation episodes): Administer 1 g/day for 3 or 5 days as IV pulse dosing over at least 30 minutes.  The regimen may be repeated if improvement has not occurred within a week after therapy, or as the patient’s condition dictates.
    Edematous states, such as glomerulonephritis or lupus nephritis, unresponsive to standard therapy (or during exacerbation episodes): Administer either regimen as IV pulse dosing over at least 30 minutes.  The regimen may be repeated if improvement has not occurred within 1 week after therapy, or as the patient’s condition dictates. 30 mg/kg every other day for 4 days, or 1 g/day for 3, 5 or 7 days.
    Terminal cancer (to improve quality of life): Administer 125 mg /day IV for up to 8 weeks.
    Prevention of nausea and vomiting associated with cancer chemotherapy: For mild to moderately emetogenic chemotherapy: Administer 250 mg IV over at least 5 minutes 1 hour before start of chemotherapy.  Repeat dose of methylprednisolone at the initiation of chemotherapy and at the time of discharge.  A chlorinated phenothiazine may also be used with the first dose of methylprednisolone for increased effect. For severely emetogenic chemotherapy: Administer 250 mg IV over at least 5 minutes with appropriate doses of metoclopramide or a butyrophenone 1 hour before start of chemotherapy. Repeat dose of methylprednisolone at the initiation of chemotherapy and at the time of discharge.
    Acute spinal cord injury: Treatment should begin within 8 hours of injury. For patients initiated on treatment within 3 hours of injury: Administer 30 mg/kg as an IV bolus over a 15-minute period, followed by a 45-minute pause, and then a continuous IV infusion of 5.4 mg/kg/h for 23 hours. For patients initiated on treatment within 3 to 8 hours of injury: Administer 30 mg/kg as an IV bolus over a 15-minute period, followed by a 45-minute pause, and then a continuous IV infusion of 5.4 mg/kg/h for 47 hours. There should be a separate intravenous site for the infusion pump.
    Pneumocystis jiroveci pneumonia in patients with AIDS: Therapy should begin within 72 hours of initial anti-pneumocystis treatment. One possible regimen is to administer 40 mg IV every 6 to 12 hours with gradual tapering over a maximum of 21 days or until the end of pneumocystis therapy. Due to the increased rate of reactivation of tuberculosis in AIDS patients, consideration should be given to the administration of antimycobacteria therapy if corticosteroids are used in this high risk group.  The patient should also be observed for activation of other latent infections.
    Exacerbation of chronic obstructive pulmonary disease (COPD): Two dose regimens have been studied: 0.5 mg/kg IV every 6 hours for 72 hours, or 125 mg IV every 6 hours for 72 hours, switch to an oral corticosteroid and taper dose.  Total treatment period should be at least 2 weeks.
    As adjunctive therapy in other indications: Initial dose will vary from 10 to 500 mg IV, depending on the clinical condition.  Larger doses may be required for short-term management of severe, acute conditions.  Initial doses up to 250 mg should be administered IV over a period of at least 5 minutes, while larger doses should be administered over at least 30 minutes.  Subsequent doses may be administered IV or IM at intervals dictated by the patient’s response and clinical condition.
    To avoid compatibility and stability problems, it is recommended that methylprednisolone sodium succinate be administered separately from other drugs whenever possible, as either IV push, through an IV medication chamber, or as an IV “piggy-back” solution.
    NOTE: Some of the Methylprednisolone sodium succinate formulations contain benzyl alcohol.
    Undesirable effects may be minimised by using the lowest effective dose for the minimum period.
    Parenteral drug products should wherever possible be visually inspected for particulate matter and discoloration prior to administration.
    Paediatric population: In the treatment of high dose indications, such as haematological, rheumatic, renal and dermatological conditions, a dosage of 30 mg/kg/day to a maximum of 1 g/day is recommended. This dosage may be repeated for three pulses either daily or on alternate days. In the treatment of graft rejection reactions following transplantation, a dosage of 10 to 20 mg/kg/day for up to 3 days, to a maximum of 1 g/day, is recommended. In the treatment of status asthmaticus, a dosage of 1 to 4 mg/kg/day for 1‑3 days is recommended.
    Elderly patients: Solu-Medrol is primarily used in acute short‑term conditions. There is no information to suggest that a change in dosage is warranted in the elderly. However, treatment of elderly patients should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age and close clinical supervision is required.
    For full details see prescribing information.


    Indications

    Methylprednisolone sodium succinate is indicated in the following conditions:
    Endocrine Disorders:
    – primary or secondary adrenocortical insufficiency (in conjunction with mineralocorticoids, where applicable)
    – acute adrenocortical insufficiency (mineralocorticoid supplementation may be necessary)
    – shock secondary to adrenocortical insufficiency, or shock unresponsive to conventional therapy when adrenal cortical insufficiency may be present (when mineralocorticoid activity is undesirable)
    – preoperatively, or in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful
    – congenital adrenal hyperplasia
    – nonsuppurative thyroiditis
    – hypercalcemia associated with cancer.
    Rheumatic Disorders: (as adjunctive therapy for short-term administration in the management of an acute episode or exacerbation)
    – post-traumatic osteoarthritis
    – synovitis of osteoarthritis
    – rheumatoid arthritis, including juvenile rheumatoid arthritis
    – acute and subacute bursitis
    – epicondylitis
    – acute nonspecific tenosynovitis
    – acute gouty arthritis
    – psoriatic arthritis
    – ankylosing spondylitis.
    Collagen Diseases and Immune Complex Diseases: (during an exacerbation or as maintenance therapy in selected cases)
    – systemic lupus erythematosus (and lupus nephritis)
    – acute rheumatic carditis
    – systemic dermatomyositis (polymyositis)
    – polyarteritis nodosa
    – Goodpasture’s syndrome.
    Dermatologic Diseases:
    – pemphigus
    – severe erythema multiforme (Stevens-Johnson syndrome)
    – exfoliative dermatitis
    – severe psoriasis
    – bullous dermatitis herpetiformis
    – severe seborrheic dermatitis
    – mycosis fungoides.
    Allergic States: (to control severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment)
    – bronchial asthma
    – contact dermatitis
    – atopic dermatitis
    – serum sickness
    – seasonal or perennial allergic rhinitis
    – drug hypersensitivity reactions
    – urticarial transfusion reactions
    – acute non-infectious laryngeal oedema (epinephrine is the drug of first choice).
    Ophthalmic Diseases: (severe acute and chronic allergic and inflammatory processes involving the eye)
    – herpes zoster ophthalmicus
    – iritis, iridocyclitis
    – chorioretinitis
    – diffuse posterior uveitis and choroiditis
    – optic neuritis
    – sympathetic ophthalmia
    – anterior segment inflammation
    – allergic conjunctivitis
    – allergic corneal marginal ulcers
    Gastrointestinal Diseases: (to manage critical periods of the disease)
    – ulcerative colitis
    – regional enteritis
    Respiratory Diseases:
    – symptomatic sarcoidosis
    – berylliosis
    – fulminating or disseminated tuberculosis (when used concurrently with appropriate antituberculous chemotherapy)
    – Loeffler’s syndrome not manageable by other means
    – aspiration pneumonitis
    – moderate to severe Pneumocystis jiroveci pneumonia in AIDS patients (as adjunctive therapy when given within the first 72 hours of initial anti-pneumocystis treatment)
    – exacerbations of chronic obstructive pulmonary disease (COPD).
    Hematologic Disorders:
    – acquired (autoimmune) hemolytic anemia
    – idiopathic thrombocytopenic purpura in adults
    – secondary thrombocytopenia in adults
    – erythroblastopenia (RBC anemia)
    – congenital (erythroid) hypoplastic anemia.
    Neoplastic Diseases: (palliative management)
    – leukemias and lymphomas in adults
    – acute leukemia of childhood
    – to improve quality of life in patients with terminal cancer.
    Edematous States:
    – To induce diuresis or remission of proteinuria in the nephrotic syndrome without uremia.
    Nervous System:
    – cerebral oedema from primary or metastatic tumors, or surgical or radiation therapy
    – acute exacerbations of multiple sclerosis
    – acute spinal cord injury. The treatment should begin within 8 hours of injury.
    Other Indications:
    – tuberculous meningitis with subarachnoid block or impending block (when used concurrently with appropriate antituberculous chemotherapy)
    – trichinosis with neurologic or myocardial involvement
    – organ transplantation
    – prevention of nausea and vomiting associated with cancer chemotherapy.


    Contra-Indications

    Solu-Medrol is contraindicated:
    – in patients who have systemic fungal infections unless specific anti-infective therapy is employed and in cerebral oedema in malaria.
    – in patients with known hypersensitivity to methylprednisolone or to any of the excipients.
    – Solu-Medrol 40mg/ml: in patients with a known or suspected allergy to cow’s milk or its components, or other dairy products, because it contains -trace amounts of milk ingredients.
    – for use by the intrathecal route of administration.
    Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.


    Special Precautions

    Immunosuppressant Effects/Increased Susceptibility to Infections: Corticosteroids may increase susceptibility to infection, may mask some signs of infection, and new infections may appear during their use.
    Immune System Effects: Allergic reactions may occur. Rarely skin reactions and anaphylactic/anaphylactoid reactions have been reported following parenteral Solu-Medrol therapy.
    Cow’s milk allergy – Solu-Medrol 40mg/ml: Solu-Medrol 40mg/ml contains lactose monohydrate produced from bovine origin as an excipient and may therefore contain trace amounts of cow’s milk proteins (the allergens of cow’s milk). Serious allergic reactions, including bronchospasm and anaphylaxis, were reported in patients allergic to cow’s milk proteins who were treated for acute allergic conditions. Patients with known or suspected allergy to cow’s milk must not be administered Solu-Medrol 40mg/ml.
    Endocrine Effects: In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.
    Metabolism and Nutrition: Frequent patient monitoring is necessary in patients with diabetes mellitus (or a family history of diabetes).
    Psychiatric Effects: Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids.
    Nervous System Effects: Corticosteroids should be used with caution in patients with seizure disorders. Frequent patient monitoring is necessary in patients with epilepsy.
    Ocular Effects: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. Central serous chorioretinopathy, may lead to retinal detachment.
    Frequent patient monitoring is necessary in patients with glaucoma (or a family history of glaucoma) and in patients with ocular herpes simplex, for fear of corneal perforation.
    Cardiac Effects: Adverse effects of glucocorticoids on the cardiovascular system, such as dyslipidemia and hypertension, may predispose treated patients with existing cardiovascular risk factors to additional cardiovascular effects, if high doses and prolonged courses are used. Accordingly, corticosteroids should be employed judiciously in such patients and attention should be paid to risk modification and additional cardiac monitoring if needed. Low dose and alternate day therapy may reduce the incidence of complications in corticosteroid therapy.
    Vascular Effects: Steroids should be used with caution in patients with hypertension. Frequent patient monitoring is necessary.
    Gastrointestinal Effects: High doses of corticosteroids may produce acute pancreatitis. In combination with NSAIDs, the risk of developing gastrointestinal ulcers is increased.
    Hepatobiliary Effects: Drug induced liver injury including acute hepatitis or liver enzyme increase can result from cyclical pulsed IV methylprednisolone (usually at initial dose ≥ 1 g/day).
    Musculoskeletal Effects: Particular care is required when considering the use of systemic corticosteroids in patients with myasthenia gravis or osteoporosis (post-menopausal females are particularly at risk) and frequent patient monitoring is necessary.
    Renal and urinary disorders: Caution is required in patients with systemic sclerosis because an increased incidence of scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone. Blood pressure and renal function (s-creatinine) should therefore be routinely checked. When renal crisis is suspected, blood pressure should be carefully controlled. Particular care is required when considering the use of systemic corticosteroids in patients with renal insufficiency and frequent patient monitoring is necessary.
    Investigations: Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
    Paediatric population: Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. 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 indications. Infants and children on prolonged corticosteroid therapy are at special risk from raised intracranial pressure. High doses of corticosteroids may produce pancreatitis in children.
    For full details see prescribing information.


    Side Effects

    The following adverse reactions have been reported with the following routes of administration: Intrathecal/Epidural: Arachnoiditis, functional gastrointestinal disorder/bladder dysfunction, headache, meningitis, paraparesis/paraplegia, seizure and sensory disturbances.
    Under normal circumstances Solu-Medrol therapy would be considered as short‑term. However, the possibility of side‑effects attributable to corticosteroid therapy should be recognised, particularly when high‑dose therapy is being used. Such side-effects include:
    Infections and infestations: Infection (including increased susceptibility and severity of infections with suppression of clinical symptoms and signs); Opportunistic infection; Recurrence of dormant tuberculosis, Peritonitis.
    Neoplasms benign, malignant and unspecified: Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy.  Discontinuation of corticosteroids may result in clinical remission.
    Blood and lymphatic system disorders: Leukocytosis
    Immune system disorders: Drug hypersensitivity (Anaphylactic reaction Anaphylactoid reaction)
    Metabolism and nutrition disorders: Metabolic acidosis; Sodium retention; Fluid retention; Glucose tolerance impaired; Alkalosis hypokalaemic; Dyslipidemia, Increased insulin requirements (or oral hypoglycemic agents in diabetics); Lipomatosis, Increased appetite (which may result in weight increased); Epidural lipomatosisץ
    Psychiatric disorders: A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood drug dependence and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported for all corticosteroids. Reactions may occur in both adults and children. In adults, the frequency of severe reactions was estimated to be 5%-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.
    Gastrointestinal disorders: Peptic ulcer (with possible peptic ulcer perforation and peptic ulcer haemorrhage); Gastric haemorrhage; Intestinal perforation; Pancreatitis; Ulcerative oesophagitis; Oesophagitis; Oesophageal candidiasis; Abdominal pain; Abdominal distension; Diarrhoea; Dyspepsia; Nausea; Vomiting; Bad taste in mouth may occur especially with rapid administration.
    For full details see prescribing information.


    Drug interactions

    Methylprednisolone is a cytochrome P450 enzyme (CYP) substrate and is mainly metabolized by the CYP3A4 enzyme.
    CYP3A4 INHIBITORS: Drugs that inhibit CYP3A4 activity generally decrease hepatic clearance and increase the plasma concentration of CYP3A4 substrate medications, such as methylprednisolone. In the presence of a CYP3A4 inhibitor, the dose of methylprednisolone may need to be titrated to avoid steroid toxicity.
    CYP3A4 INDUCERS: Drugs that induce CYP3A4 activity generally increase hepatic clearance, resulting in decreased plasma concentration of medications that are substrates for CYP3A4. Co-administration may require an increase in methylprednisolone dosage to achieve the desired result.
    CYP3A4 SUBSTRATES: In the presence of another CYP3A4 substrate, the hepatic clearance of methylprednisolone may be affected, with corresponding dosage adjustments required. It is possible that adverse events associated with the use of either drug alone may be more likely to occur with co-administration.
    Incompatibilities: To avoid compatibility and stability problems, it is recommended that methylprednisolone sodium succinate be administered separately from other compounds that are administered via the IV route of administration. Drugs that are physically incompatible in solution with methylprednisolone sodium succinate include allopurinol sodium, doxapram hydrochloride, tigecycline, diltiazem hydrochloride, calcium gluconate, vecuronium bromide, rocuronium bromide, cisatracurium besylate, glycopyrrolate and propofol.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: The ability of corticosteroids to cross the placenta varies between individual drugs, however, methylprednisolone does cross the placenta. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate in man, however, when administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following pre-natal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. Infants born to mothers, who have received substantial doses of corticosteroids during pregnancy must be carefully observed and evaluated for signs of adrenal insufficiency. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with normal pregnancies may be treated as though they were in the non-gravid state. Since adequate human reproductive studies have not been done with methylprednisolone sodium succinate, this medicinal product should be used during pregnancy only after a careful assessment of the benefit‑risk ratio to the mother and fetus. In humans, the risk of low birth weight appears to be dose related and may be minimized by administering lower corticosteroid doses. Cataracts have been observed in infants born to mothers undergoing long-term treatment with corticosteroids during pregnancy.
    Lactation: Corticosteroids are excreted in small amounts in breast milk, however, doses of up to 40 mg daily of methylprednisolone are unlikely to cause systemic effects in the infant. This medicinal product should be used during breast feeding only after a careful assessment of the benefit‑risk ratio to the mother and infant.


    Overdose

    There is no clinical syndrome of acute overdosage with corticosteroids. Reports of acute toxicity and/or death following overdosage of corticosteroids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic. Methylprednisolone is dialysable. Following chronic overdosage the possibility of adrenal suppression should be guarded against by gradual diminution of dose levels over a period of time. In such event the patient may require to be supported during any further stressful episode.


    Important notes

    Storage: Store below 25°C.


    Manufacturer
    PFIZER Manufacturing Belgium NV, Belgium
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