Depo-Medrol (Methylprednisolone Acetate)

DEPO-MEDROL®

Pharmacia & Upjohn

Methylprednisolone Acetate

Glucocorticoid

Action And Clinical Pharmacology: Depo-Medrol is a sterile aqueous suspension of the synthetic glucocorticoid methylprednisolone acetate. It has a strong and prolonged anti-inflammatory, immunosuppressive and antiallergic activity. Depo-Medrol can be administered i.m. for a prolonged systemic activity as well as in situ for a local treatment. The prolonged activity of Depo-Medrol is explained by the slow release of the active substance.

Indications And Clinical Uses: I.M.: When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the i.m. use of methylprednisolone is indicated as follows:

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). Congenital adrenal hyperplasia, hypercalcemia associated with cancer, 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 non-specific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis.

Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.

Dermatologic Diseases: Pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, 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, acute noninfectious laryngeal edema (epinephrine is the drug of first choice).

Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus, iritis, iridocyclitis, chorioretinitis, diffuse posterior uveitis, optic neuritis, drug hypersensitivity reactions, anterior segment inflammation, allergic conjunctivitis, allergic corneal marginal ulcers, keratitis.

Gastrointestinal Diseases: To tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy), regional enteritis (systemic therapy).

Respiratory Diseases: Symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherap, aspiration pneumonitis.

Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, secondary thrombocytopenia in adults, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia.

Neoplastic Diseases: For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.

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.

CNS: Acute exacerbations of multiple sclerosis.

Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.

Intra-Synovial or Soft Tissue Administration (including periarticular and intrabursal): See Warnings. Indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: synovitis of osteo-arthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, post traumatic osteoarthritis.

Intralesional Administration: Indicated for intralesional use in the following conditions: keloids, localized hypertrophic infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis), discoid lupus erythematosus, necrobiosis lipoidica diabeticorum, alopecia areata.

May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).

Contra-Indications: Intrathecal administration.

I.V. administration.

Systemic fungal infections.

Known hypersensitivity to the product and its constituents.

Manufacturers’ Warnings In Clinical States: Benzyl Alcohol Formulation (20 mg/mL-5 mL vial, 40 mg/mL-2 and 5 mL vial, 80 mg/mL-5 mL vial): Multidose use of methylprednisolone from a single vial requires special care to avoid contamination. Although initially sterile, any multidose use of vials may lead to contamination unless strict aseptic technique is observed. Particular care, such as use of disposable sterile syringes and needles is necessary. Multidose use of methylprednisolone from vials is not recommended for intrasynovial injection.

This product contains benzyl alcohol which is potentially toxic when administered locally to neural tissue.

Depo-Medrol should not be used in premature infants, because the formulation contains benzyl alcohol. Benzyl alcohol has been reported to be associated with fatal “gasping syndrome” in premature infants.

Myristyl Gamma Picolinium Chloride Formulation (40 mg/mL-1 mL vial, 80 mg/mL-1 mL vial): This product is not suitable for multidose use. Following administration of the desired dose, any remaining suspension should be discarded.

General Warnings: While crystals of adrenal steroids in the dermis suppress inflammatory reactions, their presence may cause disintegration of the cellular elements and physiochemical changes in the ground substance of the connective tissue. The resultant infrequently occurring dermal and/or subdermal changes may form depressions in the skin at the injection site. The degree to which this reaction occurs will vary with the amount of adrenal steroid injected. Regeneration is usually complete within a few months or after all crystals of the adrenal steroid have been absorbed.

In order to minimize the incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections. Multiple small injections into the area of the lesion should be made whenever possible. The technique of intrasynovial and i.m. injections should include precautions against injection or leakage into the dermis. Injection into the deltoid muscle should be avoided because of a high incidence of s.c. atrophy.

Methylprednisolone should not be administered by any route other than those listed under Indications. It is critical that, during administration of methylprednisolone, appropriate technique be used and care taken to assure proper placement of drug.

Administration by other than indicated routes has been associated with reports of serious medical events including: arachnoiditis, meningitis, paraparesis/paraplegia, sensory disturbances, bowel/bladder dysfunction, seizures, visual impairment including blindness, ocular and periocular inflammation, and residue or slough at injection site.

In patients on corticosteroid therapy subjected to any 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, protozoan 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 complication increases. Do not use intra-articularly, intrabursally, or for intratendinous administration for local effect in the presence of acute infection.

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.

Growth may be suppressed in children receiving long-term, daily-divided dose glucocorticoid therapy. The use of such a regimen should be restricted to those most serious indications.

Administration of live or live, attenuated vaccines is contra-indicated 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 nonimmunosuppressive doses of corticosteroids. While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be under taken in patients who are on corticosteroids especially in high doses, because of the possible hazards of neurological complications and lack of antibody response.

The use of methylprednisolone 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 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.

Allergic skin reactions have been reported apparently related to the excipients in the formulation. Rarely has skin testing demonstrated a reaction to methylprednisolone acetate, per se.

Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Pregnancy and Lactation: Some animal studies have shown that corticosteroids, when administered to the mother at high doses, may cause fetal malformations. Adequate human reproduction 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, this drug 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. Corticosteroids are excreted in breast milk.

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 occurring during that period, hormone therapy should be reinstituted. 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.

ASA should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed.

When multidose vials are used, special care to prevent contamination of the contents is essential. There is some evidence that benzalkonium is not an adequate antiseptic for sterilizing multidose vials. A povidone-iodine solution or similar product is recommended to cleanse the vial top prior to aspiration of contents (see Warnings).

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, the reduction must 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.

Corticosteroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection. Caution must also be used in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis, when steroids are used as direct or adjunctive therapy.

The following additional precautions apply for parenteral corticosteroids: Intra-articular injection of a corticosteroid may produce systemic as well as local effects.

Appropriate examination of any joint fluid present is necessary to exclude a septic process.

A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.

Local injection of a steroid into a previously infected joint is to be avoided.

Corticosteroids should not be injected into unstable joints.

Sterile technique is necessary to prevent infections or contamination.

The slower rate of absorption by i.m. administration should be recognized.

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 do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect (see Dosage).

Since 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.

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No evidence exists showing that corticosteroids are carcinogenic, mutagenic or impair fertility.

Drug Interactions: The pharmacokinetic interactions listed below are potentially clinically important. Mutual inhibition of metabolism occurs with concurrent use of cyclosporine and methylprednisolone, therefore it is possible that adverse events associated with the individual use of either drug may be more apt to occur. Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine.

Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of methylprednisolone and may require increase in methylprednisolone dose to achieve the desired response.

Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of methylprednisolone and thus decrease its clearance. Therefore the dose of methylprednisolone should be titrated to avoid steroid toxicity.

Methylprednisolone may increase the clearance of chronic high dose ASA. This could lead to a decrease in salicylate serum levels or increase the risk of salicylate toxicity when methylprednisolone is withdrawn. ASA should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia.

The effect of methylprednisolone on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulant when given concurrently with corticosteroids. Therefore coagulation indices should be monitored to maintain the desired anticoagulant effect.

Adverse Reactions: Fluid and Electrolyte Disturbances: sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension.

Musculoskeletal: muscle weakness, steroid myopathy, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, tendon rupture – particularly of the Achilles tendon.

Gastrointestinal: peptic ulcer with possible subsequent perforation and hemorrhage, pancreatitis, gastric hemorrhage, esophagitis, perforation of the bowel.

Increases in ALT, AST and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

Dermatologic: impaired wound healing, thin fragile skin, petechiae and ecchymoses.

Neurological: increased intracranial pressure (pseudotumor cerebri), psychic derangements, seizures.

Endocrine: menstrual irregularities, development of Cushingoid state, suppression of growth in children, decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetes, suppression of pituitary-adrenal axis.

Ophthalmic: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.

Metabolic: negative nitrogen balance due to protein catabolism.

Immune System: masking infections, latent infections becoming active, opportunistic infections, hypersensitivity reactions including anaphylaxis, suppressed reactions to skin tests.

The following additional adverse reactions are related to parenteral corticosteroid therapy: rare instances of blindness associated with intralesional therapy around the face and head, anaphylactic reaction or allergic reactions, hyperpigmentation or hypopigmentation, s.c. and cutaneous atrophy, sterile abscess, postinjection flare – following intra-synovial use, Charcot-like arthropathy. Injection site infections can occur following nonsterile technique.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: There is no clinical syndrome of acute overdosage with methylprednisolone. Repeated frequent doses (daily or several times/week) over a protracted period may result in a Cushingoid state.

Dosage And Administration: Because of possible physical incompatibilities, methylprednisolone should not be diluted or mixed with other solutions. Parenteral suspensions should be inspected visually for foreign particulate matter and discoloration prior to administration whenever drug product and container permit.

Administration for Local Effect: Therapy with methylprednisolone does not obviate the need for the conventional measures usually employed. Although this method of treatment will ameliorate symptoms, it is in no sense a cure and the hormone has no effect on the cause of the inflammation.

Rheumatoid and Osteoarthritis: The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. In chronic cases, injections may be repeated at intervals ranging from 1 to 5 or more weeks depending upon the degree of relief obtained from the initial injection. The doses in Table I are given as a general guide.

Procedure: It is recommended that the anatomy of the joint involved be reviewed before attempting intra-articular injection. In order to obtain the full anti-inflammatory effect it is important that the injection be made into the synovial space. Employing the same sterile technique as for a lumbar puncture, a sterile 20 to 24 gauge needle (on a dry syringe) is quickly inserted into the synovial cavity. Procaine infiltration is elective. The aspiration of only a few drops of joint fluid proves the joint space has been entered by the needle. The injection site for each joint is determined by that location where the synovial cavity is most superficial and most free of large vessels and nerves. With the needle in place, the aspirating syringe is removed and replaced by a second syringe containing the desired amount of methylprednisolone. The plunger is then pulled outward slightly to aspirate synovial fluid and to make sure the needle is still in the synovial space. After the injection, the joint is moved gently a few times to aid mixing of the synovial fluid and the suspension. The site is covered with a small sterile dressing.

Suitable sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal, and hip joints. Since difficulty is occasionally encountered in entering the hip joint, precautions should be taken to avoid any large blood vessels in the area. Joints not suitable for injection are those that are anatomically inaccessible such as the spinal joints and those like the sacroiliac joints that are devoid of synovial space. Treatment failures are most frequently the result of failure to enter the joint space. Little or no benefit follows injection into surrounding tissue. If failures occur when injections into the synovial spaces are certain, as determined by aspiration of fluid, repeated injections are usually futile. Local therapy does not alter the underlying disease process, and whenever possible comprehensive therapy including physiotherapy and orthopedic correction should be employed.

Following intra-articular steroid therapy, care should be taken to avoid overuse of joints in which symptomatic benefit has been obtained. Negligence in this matter may permit an increase in joint deterioration that will more than offset the beneficial effects of the steroid.

Unstable joints should not be injected. Repeated intra-articular injection may in some cases result in instability of the joint. X-ray follow-up is suggested in selected cases to detect deterioration.

If a local anesthetic is used prior to the injection of methylprednisolone, the anesthetic package insert should be read carefully and all the precautions observed.

Bursitis: The area around the injection site is prepared in a sterile way and a wheal at the site made with 1% procaine HCl solution. A 20 to 24 gauge needle attached to a dry syringe is inserted into the bursa and the fluid aspirated. The needle is left in place and the aspirating syringe changed for a small syringe containing the desired dose. After injection, the needle is withdrawn and a small dressing applied.

Miscellaneous: Ganglion, Tendinitis, Epicondylitis: In the treatment of conditions such as tendinitis or tenosynovitis, care should be taken, following application of a suitable antiseptic to the overlying skin, to inject the suspension into the tendon sheath rather than into the substance of the tendon. The tendon may be readily palpated when placed on a stretch. When treating conditions such as epicondylitis, the area of greatest tenderness should be outlined carefully and the suspension infiltrated into the area. For ganglia of the tendon sheaths, the suspension is injected directly into the cyst. In many cases, a single injection causes a marked decrease in the size of the cystic tumor and may effect disappearance.

The usual sterile precautions should be observed, of course, with each injection.

The dose in the treatment of the various conditions of the tendinous or bursal structures listed above varies with the condition being treated and ranges from 4 to 30 mg. In recurrent or chronic conditions, repeated injections may be necessary.

Injections for Local Effect in Dermatologic Conditions: Following cleansing with an appropriate antiseptic such as 70% alcohol, 20 to 60 mg of the suspension is injected into the lesion. It may be necessary to distribute doses ranging from 20 to 40 mg by repeated local injections in the case of large lesions. Care should be taken to avoid injection of sufficient material to cause blanching since this may be followed by a small slough. One to four injections are usually employed, the intervals between injections varying with the type of lesion being treated and the duration of improvement produced by the initial injection.

When multidose vials are used, special care to prevent contamination of the contents is essential (see Warnings).

Administration for Systemic Effect: The i.m. dosage will vary with the condition being treated. When a prolonged effect is desired, the weekly dose may be calculated by multiplying the daily oral dose by 7 and given as a single i.m. injection.

Dosage must be individualized according to the severity of the disease and response of the patient. For infants and children, the recommended dosage will have to be reduced, but dosage should be governed by the severity of the condition rather than by strict adherence to the ratio indicated by age or body weight.

Hormone therapy is an adjunct to, and not a replacement for, conventional therapy. Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. The severity, prognosis and expected duration of the disease and the reaction of the patient to medication are primary factors in determining dosage. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, 2-hour 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 gastrointestinal x-rays are desirable in patients with an ulcer history or significant dyspepsia.

In patients with the adrenogenital syndrome, a single i.m. injection of 40 mg every 2 weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly i.m. dose will vary from 40 to 120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticoid therapy is 40 to 120 mg methylprednisolone administered i.m. at weekly intervals for 1 to 4 weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following i.m. administration of a single dose of 80 to 120 mg. In chronic contact dermatitis, repeated injections at 5 to 10 day intervals may be necessary. In seborrheic dermatitis, a weekly dose of 80 mg may be adequate to control the condition.

Following i.m. administration of 80 to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to 2 weeks. Similarly in patients with allergic rhinitis (hay fever) an i.m. dose of 80 to 120 mg may be followed by relief of coryzal symptoms within 6 hours persisting for several days to 3 weeks.

If signs of stress are associated with the condition being treated, the dosage of the suspension should be increased. If a rapid hormonal effect of maximum intensity is required, the i.v. administration of highly soluble methylprednisolone sodium succinate is indicated.

Multiple Sclerosis: In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).

Availability And Storage: Multidose Vials: 20 mg: Each mL of sterile suspension contains: methylprednisolone acetate 20 mg. Nonmedicinal ingredients: dibasic sodium phosphate, monobasic sodium phosphate, polyethylene glycol, polysorbate 80, sodium chloride to adjust tonicity and benzyl alcohol as a preservative. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Vials of 5 mL.

40 mg: Each mL of sterile suspension contains: methylprednisolone acetate 40 mg. Nonmedicinal ingredients: dibasic sodium phosphate, monobasic sodium phosphate, polyethylene glycol, polysorbate 80, sodium chloride to adjust tonicity and benzyl alcohol as a preservative. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Vials of 2 and 5 mL.

80 mg: Each mL of sterile suspension contains: methylprednisolone acetate 80 mg. Nonmedicinal ingredients: dibasic sodium phosphate, monobasic sodium phosphate, polyethylene glycol, polysorbate 80, sodium chloride to adjust tonicity and benzyl alcohol as a preservative. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Vials of 5 mL.

Single Use Vials: 40 mg: Each mL of sterile suspension contains: methylprednisolone acetate 40 mg. Nonmedicinal ingredients: myristyl gamma picolinium chloride (MGPC), polyethylene glycol and sodium chloride to adjust the tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Vials of 1 mL.

80 mg: Each mL of sterile suspension contains: methylprednisolone acetate 80 mg. Nonmedicinal ingredients: myristyl gamma picolinium chloride (MGPC), polyethylene glycol and sodium chloride to adjust the tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Vials of 1 mL.

Store at room temperature between 15 and 30°C.

DEPO-MEDROL® Pharmacia & Upjohn Methylprednisolone Acetate Glucocorticoid

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