Solu-Medrol

Solu-Medrol

methylprednisolone

Manufacturer:

Pfizer
Full Prescribing Info
Contents
Methylprednisolone sodium succinate.
Description
Methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-,monosodium salt, (6α, 11β) and the molecular weight is 496.53.
Methylprednisolone sodium succinate USP occurs as a white or nearly white, odorless, hygroscopic, amorphous solid. It is very soluble in water and alcohol, insoluble in chloroform and very slightly soluble in acetone.
Methylprednisolone sodium succinate is extremely soluble in water that it may be administered with a small volume of diluent and is especially well-suited for IV use in situations in which high blood levels of methylprednisolone are required rapidly.
Action
Pharmacology: Methylprednisolone is a potent anti-inflammatory steroid. It has a greater anti-inflammatory potency and even less tendency to induce sodium and water retention than prednisolone. Methylprednisolone sodium succinate has the same metabolic and anti-inflammatory actions as methylprednisolone. When given parenterally and in equimolar quantities, the 2 compounds are equivalent in biologic activity. The relative potency of Solu-Medrol and hydrocortisone sodium succinate, as indicated by depression of eosinophil count, following IV administration, is at least 4:1. This is in agreement with the relative oral potency of methylprednisolone and hydrocortisone.
Indications/Uses
When oral therapy is not feasible and the strength, dosage form and route of administration reasonably lend Solu-Medrol to the treatment of the condition, it is indicated for IV or IM use in the following conditions:
Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis.
Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Post-traumatic osteoarthritis; synovitis of osteoarthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); acute and subacute bursitis; epicondylitis; acute nonspecific tenosynovitis; acute gouty arthritis; psoriatic arthritis; and ankylosing spondylitis.
Collagen Diseases (Immune Complex Diseases): During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus (and lupus nephritis); systemic dermatomyositis (polymyositis); and acute rheumatic carditis.
Dermatologic Diseases: Pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis and mycosis fungoides.
Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: Bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, seasonal or perennial allergic rhinitis, drug hypersensitivity reactions, urticarial transfusion reactions and acute non-infectious laryngeal edema (epinephrine is the drug of choice).
Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye eg, herpes zoster ophthalmicus; iritis, iridocyclitis; chorioretinitis; diffuse posterior uveitis and choroiditis; keratitis; sympathetic ophthalmia; allergic conjunctivitis; allergic corneal marginal ulcers and optic neuritis.
Gastrointestinal Diseases: To tide the patient over a critical period of the disease in: Ulcerative colitis (systemic therapy) and regional enteritis (systemic therapy).
Respiratory Diseases: Symptomatic sarcoidosis, berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; Loeffler's syndrome not manageable by other means; and aspiration pneumonitis.
Hematologic Disorders: Acquired (autoimmune) hemolytic anemia; idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated), erythroblastopenia (RBC anemia); secondary thrombocytopenia in adults; and congenital (erythroid) hypoplastic anemia.
Neoplastic Diseases: For palliative management of: Leukemias and lymphomas in adults and acute leukemia of childhood.
Terminal Cancer: To improve the quality of life in patients with terminal cancer.
Edematous States: To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
Nervous System: Cerebral Edema from Tumor: Primary or metastatic and/or associated with surgical or radiation therapy.
Acute exacerbations of multiple sclerosis. Acute spinal cord injury. The treatment should begin within 8 hrs of injury.
Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.
Dosage/Direction for Use
When high-dose therapy is desired, the recommended dose of Solu-Medrol is 30 mg/kg administered IV over at least 30 min. This dose may be repeated every 4-6 hrs for 48 hrs.
In general, high-dose corticosteroid therapy should be continued only until the patient's condition has stabilized, usually not beyond 48-72 hrs.
Although adverse effects associated with high-dose, short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.
In other indications, initial dosage will vary from 10-40 mg of methylprednisolone depending on the clinical problem being treated. Larger doses may be required for short-term management of severe, acute conditions. The initial dose usually should be given IV or IM at intervals dictated by the patient's responses and clinical condition. Corticoid therapy is an adjunct to, and not replacement for conventional therapy.
Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size. It should not be <0.5 mg/kg every 24 hrs.
Dosage must be decreased or discontinued gradually when Solu-Medrol has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies eg, urinalysis, 2-hr postprandial blood sugar, determination of blood pressure and body weight and a chest x-ray, should be made at regular intervals during prolonged therapy. Upper GI x-rays are desirable in patients with an ulcer history or significant dyspepsia.
Solu-Medrol may be administered by IV or IM injection or by IV infusion, the preferred method for initial emergency use being IV injection. To administer by IV (or IM) injection, prepare solution as directed.
The desired dose may be administered IV over a period of several minutes. If desired, the medication may be administered in diluted solutions by adding water for injection or other suitable diluent to the Act-O-Vial and withdrawing the indicated dose.
To prepare solutions for IV infusion, first prepare the solution for injection as directed. This solution may then be added to indicated amounts of 5% dextrose in water, isotonic saline solution or 5% dextrose in isotonic saline solution.
Overdosage
There is no clinical syndrome of acute overdosage with Solu-Medrol. Methylprednisolone is dialyzable.
Contraindications
Systemic fungal infections and known hypersensitivity to the components of Solu-Medrol. Premature infants: Because vials contain benzyl alcohol which has been reported to be associated with a fatal gasping syndrome in premature infants.
Warnings
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly-acting corticosteroids before, during and after the stressful situation is indicated.
Corticosteroids may mask some signs of infection and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infections with any pathogen including viral, bacterial, fungal, protozoal or helminthic infections, in any location in the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity or neutrophil function. These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.
A study has failed to establish the efficacy of Solu-Medrol in the treatment of sepsis syndrome and septic shock. The study also suggests that treatment of these conditions with Solu-Medrol may increase the risk of mortality in certain patients (ie, patients with elevated serum creatinine levels or patients who develop secondary infections after Solu-Medrol).
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. 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 on high doses, because of the possible hazards of neurological complications and a lack of antibody response.
The use of Solu-Medrol 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 appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Because rare instances of anaphylactoid reactions (eg, bronchospasm) reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
There are reports of cardiac arrhythmias and/or circulatory collapse and/or cardiac arrest following the rapid administration of large IV doses of methylprednisolone sodium succinate (>0.5 g administered over a period of <10 min). Bradycardia has been reported during or after administration of large doses of methylprednisolone succinate and may be unrelated to the speed or duration of infusion.
Use in pregnancy: Some animal studies have shown that corticosteroids, when administered to the mother at high doses, may cause fetal malformations. Adequate human reproductive studies have not been done with corticosteroids. Therefore, the use of this drug in pregnancy, nursing mothers or women of childbearing potential requires that the benefits of the drug be carefully weighed against the potential risk to the mother and embryo or fetus. Since there is inadequate evidence of safety in human pregnancy, Solu-Medrol should be used in pregnancy only if clearly needed.
Corticosteroids readily cross the placenta. Infants born of 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 labor and delivery.
Use in children: Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. In such children, or in adults who have not had these disease, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled IV immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.
Benzyl alcohol is contained in the accompanying diluent. Benzyl alcohol has been reported to be associated with a fatal 'gasping syndrome' in premature infants.
Special Precautions
Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress during that period, hormone therapy should be re-instituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation.
The lowest possible dose of corticosteroid should be used to control the condition under treatment and when reduction in dosage is possible, it should be gradual.
Psychic derangements may appear when corticosteroids are used ranging from euphoria, insomnia, mood swings, personality changes and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Aspirin should be used cautiously in conjunction with corticosteroid in hypoprothrombinemia.
Corticosteroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection, also in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis and myasthenia gravis.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See Dosage & Administration.)
Since complications of treatment with glucocorticoids are dependent on the size of the dose and duration of treatment, a risk/benefit decision must be made in each case as well as to whether daily or intermittent therapy should be used.
Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. 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.
An acute myopathy has been described with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (eg, myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular-blocking drugs (eg, pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevations of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.
Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
Information for the Patient: Patients who are on immunosuppressive doses of corticosteroids should be warned to avoid exposure to chickenpox or measles, and if exposed, to obtain medical advice.
Carcinogenicity, Mutagenicity & Impairment of Fertility: There is no evidence that corticosteroids are carcinogenic, mutagenic or can impair fertility.
Because prednisolone is excreted in breast milk, it is reasonable to assume that all corticosteroids are. No specific data is known for methylprednisolone succinate.
Use In Pregnancy & Lactation
Use in pregnancy: Some animal studies have shown that corticosteroids, when administered to the mother at high doses, may cause fetal malformations. Adequate human reproductive studies have not been done with corticosteroids. Therefore, the use of this drug in pregnancy, nursing mothers or women of childbearing potential requires that the benefits of the drug be carefully weighed against the potential risk to the mother and embryo or fetus. Since there is inadequate evidence of safety in human pregnancy, Solu-Medrol should be used in pregnancy only if clearly needed.
Corticosteroids readily cross the placenta. Infants born of 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 labor and delivery.
Adverse Reactions
Fluid and Electrolyte Disturbances: Sodium and fluid retention, potassium loss and hypokalemic alkalosis.
Musculoskeletal: Muscle weakness, steroid myopathy, vertebral compression fractures, aseptic necrosis, pathologic fractures, osteoporosis and tendon rupture, particularly of the Achilles tendon.
Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage; pancreatitis; esophagitis; gastric hemorrhage; and perforation of the bowel. Increases in alanine transaminase (ALT, SGPT) and aspartate transaminase (AST, SGOT) have been observed. These changes are not associated with any chemical syndromes and are reversible upon discontinuation.
Dermatologic: Impaired wound healing; thin, fragile skin; petechiae and ecchymoses; facial erythema; increased sweating and may suppress reactions to skin tests.
Neurological: Increased intracranial pressure, pseudotumor cerebri, psychic derangements, seizures, convulsions, vertigo and headache.
Endocrine: Menstrual irregularities; development of Cushingoid state; suppression of pituitary-adrenal axis; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness particularly in times of stress as in trauma, surgery or illness; decreased carbohydrate tolerance; manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic agents in diabetics.
Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma and exophthalmos.
Immune System: Masking of infections; latent infections becoming active; opportunistic infections; may suppress reactions to skin tests; hypersensitivity reactions including anaphylaxis.
Metabolic: Negative nitrogen balance due to protein catabolism.
The following additional reactions are related to parenteral corticosteroid therapy: Hyperpigmentation or hypopigmentation; SC and cutaneous atrophy; sterile abscess and anaphylactic reaction with or without circulatory collapse, cardiac arrest, bronchospasm, urticaria, nausea and vomiting, cardiac arrhythmias; hypotension or hypertension.
Drug Interactions
Methylprednisolone has a wide spectrum of clinical use and is, therefore, used with numerous concurrent drugs. The interactions summarized in the table below are of known or likely clinical significance. The need for dosage adjustment of either medication will depend on the clinical situation, the dose regimen prescribed and the observed clinical response. The interactions listed have either pharmacokinetic or pharmacodynamic basis. (See table.)


Click on icon to see table/diagram/image

Caution For Usage
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Storage
Store unreconstituted product and solution at controlled room temperature maximum 30°C. Store solution at controlled room temperature maximum 30°C. Use solution within 48 hrs after mixing.
ATC Classification
H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Act-O-Vial 125 mg/2 mL x 1's. 500 mg/8 mL x 1's.
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