Depo-Medrol

Depo-Medrol

methylprednisolone

Manufacturer:

Pfizer
Full Prescribing Info
Contents
Methylprednisolone acetate.
Description
Depo-Medrol is the 6-methyl derivative of prednisolone.
Methylprednisolone acetate is pregna-1,4-diene-3,20-dione,21-(acetyloxy-11,17-dihydroxy-6-methyl-,(6α,11β) with a molecular weight of 416.51. It is a white or practically white, odorless, crystalline powder which melts at 215°C with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform and methanol, and slightly soluble in ether. It is practically insoluble in water.
Action
Depo-Medrol is an anti-inflammatory glucocorticoid for IM, intrasynovial, soft tissue or intralesional injection.
Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used in replacement therapy in adrenocortical deficiency states. Their synthetic analogues are used primarily for their potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune response to diverse stimuli.
Indications/Uses
IM Administration: 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 IM use of Depo-Medrol 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 analogues 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); epicondylitis; acute nonspecific tenosynovitis; acute gouty arthritis; psoriatic arthritis; ankylosing spondylitis; acute and subacute bursitis.
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 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; optic neuritis; drug hypersensitivity reactions; anterior segment inflammation; allergic conjunctivitis; allergic corneal, marginal ulcers; and keratitis.
Gastrointestinal Diseases: To tide the patient over a critical period of the diseases in ulcerative colitis (systemic therapy); regional enteritis (systemic therapy).
Respiratory Diseases: Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; Loeffler's syndrome not manageable by other means; symptomatic sarcoidosis; berylliosis; aspiration pneumonitis.
Haematologic Disorders: Acquired (autoimmune) hemolytic anemia; secondary thrombocytopenia in adults; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia.
Neoplastic Diseases: For palliative management of leukaemias and lymphomas; acute leukaemia 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.
Nervous System: 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.
Intrasynovial or Soft Tissue Administration (Including Periarticular and Intrabursal) (see Warnings): Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Synovitis of osteoarthritis, rheumatoid arthritis, post-traumatic osteoarthritis, epicondylitis, acute nonspecific tenosynovitis, acute and subacute bursitis, acute gouty arthritis.
Intralesional Administration: Depo-Medrol is indicated for intralesional use in the following conditions: Keloids; localized hypertrophic, infiltrated, inflammatory lesions of lichen planus, psoriatic plaques; granuloma annulare; lichen simplex chronicus (neurodermatitis); discoid lupus erythematosus; necrobiosis lipodica diabeticorum; alopecia areata. Depo-Medrol may also be useful in cystic tumors or an aponeurosis of tendon (ganglia).
Dosage/Direction for Use
Because of possible physical incompatibilities, Depo-Medrol should not be diluted or mixed with other solutions. Parenteral suspensions should be inspected visually for any foreign particulate matter and discoloration prior to administration, whenever solution and container permit.
Administration for Local Effect: Therapy with Depo-Medrol 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 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 individual patients. In chronic cases, injections may be repeated at intervals ranging from 1-5 or more weeks depending upon the degree of relief obtained from the initial injection. The doses in the following table are given as a general guide: See table.


Click on icon to see table/diagram/image


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 2nd syringe containing the desired amount of Depo-Medrol. The plunger is then pulled outward slightly to aspirate synovial fluid and to make sure the needle is still in the synovial space. After 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, eg 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 injections 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 corticosteroid 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 injection of Depo-Medrol, all the precautions should be 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 is 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 is applied.
Miscellaneous: Ganglion, Tendinitis, Epicondylitis: In the treatment of conditions eg, 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 eg, 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 with each injection.
The dose in the treatment of the various conditions of the tendinous or bursal structures listed varies with the condition being treated and ranges from 4-30 mg. In recurrent or chronic conditions, repeated injections may be necessary.
Injections for Local Effect in Dermatologic Conditions: Following cleansing with an appropriate antiseptic eg, 70% alcohol, 20-60 mg of the suspension is injected into the lesion. It may be necessary to distribute doses ranging from 20-40 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 vary with the type of lesion being treated and the duration of improvement produced by the initial injection.
Administration for Systemic Effect: The IM 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 IM 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 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 eg, urinalysis, 2-hr postprandial blood sugar, determination of blood pressure and body weight, and 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.
In patients with the androgenital syndrome, a single IM injection of 40 mg every 2 weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly IM dose will vary from 40-120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticoid therapy is 40-120 mg of methylprednisolone acetate administered IM at weekly intervals for 1-4 weeks. In acute severe dermatitis due to poison ivy, relief may result within 8-12 hrs following IM administration of a single dose of 80-120 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 IM administration of 80-120 mg to asthmatic patients, relief may result within 6-48 hrs and persist for several days to 2 weeks. Similarly, in patients with allergic rhinitis (hay fever), an IM dose of 80-120 mg may be followed by relief of coryzal symptoms within 6 hrs persisting for several days to 3 weeks.
If signs of stress are associated with the condition being treated, the dose should be increased. If a rapid hormonal effect of maximum intensity is required, the IV administration of highly soluble methylprednisolone sodium succinate is indicated.
Overdosage
There is no clinical syndrome of acute overdosage with Depo-Medrol.
Repeated frequent doses (daily or several times/week) over a protracted period may result in a Cushingoid state.
Contraindications
Intrathecal and IV administration, systemic fungal infections and known hypersensitivity to the components of Depo-Medrol.
Warnings
Multidose use of Depo-Medrol 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 eg, use of disposable sterile syringes and needles, is necessary.
While crystals of adrenal steroids in the dermis suppress inflammatory reactions, their presence may cause disintegration of the cellular elements and physicochemical 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 IM injection should include precautions against injection or leakage into the dermis. Injection into the deltoid muscle should be avoided because of a high incidence of SC atrophy.
Depo-Medrol should not be administered by any route other than listed under Indications. It is critical that during administration of Depo-Medrol, appropriate technique should be used and care taken to assure proper placement of the drug.
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. Do not use intrasynovially, intrabursally or 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.
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.
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 possible hazards of neurological complications and lack of antibody response.
The use of Depo-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 antituberculosis 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 anaphylactic 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.
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 occurring during that period, hormone therapy should be reinstituted.
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of corneal perforation.
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.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed.
The following additional precautions apply for parenteral corticosteroids: Intrasynovial 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 IM 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 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 the duration of treatment, a risk/benefit decision must be made in each individual and as to whether daily or intermittent therapy should be used.
Carcinogenicity, Mutagenicity & Impairment of Fertility: No evidence exists showing that corticosteroids are carcinogenic, mutagenic or impair fertility.
Use in pregnancy & lactation: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
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 diseases, 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.
Use In Pregnancy & Lactation
Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Adverse Reactions
Fluid and Electrolyte Disturbances: Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis and hypertension.
Musculoskeletal: Muscle weakness, steroid myopathy, osteoporosis, vertebral compression fractures, aseptic necrosis and pathologic fractures.
Gastrointestinal: Peptic ulceration with possible subsequent perforation and hemorrhage; gastric hemorrhage; perforation of the bowel; and esophagitis, pancreatitis.
Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT) 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, petechiae and ecchymosis, and thin fragile skin.
Metabolic: Negative nitrogen balance due to protein catabolism.
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; decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics.
Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, exophthalmos and glaucoma.
Immune System: Masking of infections, latent infections becoming active, opportunistic infections, hypersensitivity reactions including anaphylaxis, and may suppress reactions to skin tests.
The following additional reactions are related to parenteral corticosteroid therapy: Rare instances of blindness associated with intralesional therapy around the face and head, anaphylactic or allergic reactions, hyperpigmentation or hypopigmentation, SC and cutaneous atrophy, sterile abscess, post-injection flare following intrasynovial use, Charcot-like arthropathy, injection site infections following nonsterile technique.
Adverse Reactions Reported with the Following Routes of Administration: Intrathecal/Epidural: Arachnoiditis, meningitis, paraparesis/paraplegia, bowel/bladder dysfunction, seizures.
Intranasal: Allergic reactions and rhinitis.
Ophthalmic: Temporary/permanent visual impairment including blindness; increased intraocular pressure; ocular and periocular inflammation including allergic reactions; infection; and residue or slough at injection site.
Miscellaneous injection site (scalp, tonsillar fauces, sphenopalatine ganglion): Blindness.
Drug Interactions
The pharmacokinetic interactions listed are potentially clinically important. Mutual inhibition of metabolism occurs with concurrent use of cyclosporin 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 cyclosporin. Drugs that induce hepatic enzymes eg, phenobarbital, phenytoin and rifampin may increase the clearance of methylprednisolone and may require increase in methylprednisolone dose to achieve the desired response. Drugs eg, 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 aspirin. This could lead to a decrease in salicylate serum levels or increase the risk of salicylate toxicity when methylprednisolone is withdrawn. Aspirin 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.
Storage
Store at maximum temperature 30°C.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Form
Depo-Medrol powd for inj 40 mg/mL
Packing/Price
(vial) 1 mL x 1's (Rp123,054/boks)
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