Depo-Medrol 40mg/ml INJECTION, Methylprednisolone
THIS IS A BRAND MEDICATION
For intramuscular administration:
Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice can also be used synthetic analogues 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 help the patient over an acute episode or exacerbation) in post-traumatic osteoarthritis, epicondylitis, synovitis of osteoarthritis, acute nonspecific tenosynovitis, rheumatoid arthritis, including arthritis, acute gouty arthritis juvenile rheumatoid arthritis, psoriatic arthritis (selected cases may require ankylosing spondylitis maintenance therapy of low dose), acute or subacute bursitis.
Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of lupus erythematosus, systemic dermatomyositis (polymyositis) Acute rheumatic carditis
Dermatologic Diseases: Pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme, severe seborrheic dermatitis (Stevens-Johnson syndrome), severe psoriasis, exfoliative dermatitis, mycosis fungoides.
Allergic States: Control of severe or incapacitating allergic disorders resistant to adequate trials of conventional treatment in: bronchial asthma, drug hypersensitivity reactions, contact dermatitis, atopic dermatitis, urticarial transfusion reactions, serum sickness, acute noninfectious laryngeal edema , allergic rhinitis, seasonal (epinephrine is the drug of first choice).
Ophthalmic Diseases: Severe allergies, and acute and chronic inflammatory processes involving the eye, such as herpes zoster ophthalmic drug hypersensitivity reactions, iritis, iridocyclitis, chorioretinitis, allergic conjunctivitis, diffuse posterior uveitis, allergic corneal marginal ulcers, optic neuritis, keratitis.
Gastrointestinal diseases: To help the patient over a critical period of the disease in ulcerative colitis (systemic therapy), enteritis (systemic therapy).
Respiratory diseases: Pulmonary tuberculosis: fulminating or disseminated when used concurrently with chemotherapy, appropriate anti-tuberculosis, sarcoidosis, symptomatic, berylliosis, Loeffler's syndrome can not be handled by other means, aspiration pneumonitis.
Hematologic Disorders: acquired hemolytic anemia (autoimmune), secondary thrombocytopenia in adults, erythroblastopenia (RBC anemia), hypoplastic anemia congenital (erythroid).
Neoplastic Diseases: For palliative management of leukemias and lymphomas, acute leukemia in infants.
Edematous State: 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: Exacerbations of multiple sclerosis.
Miscellaneous: TB meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculosis chemotherapy.
Trichinosis with neurologic or myocardial complications.
For administration intrasynovial or soft tissue (including periarticular and intrabursal): Depo-Medrol ® is indicated for adjunctive therapy for short-term administration (to tide the patient out of an episode Aguo or exacerbation) in:
Synovitis of osteoarthritis Epicondylitis
Rheumatoid arthritis acute nonspecific tenosynovitis
Acute or subacute bursitis post-traumatic osteoarthritis
Acute gouty arthritis
Management within lesions: Depo-Medrol ® is indicated for use in injury to the following conditions: keloids, hypertrophic inflammatory lesions, localized infiltrated:
Lichen planus, lupus erythematosus plates
Necrobiosis diabeticorum granuloma annular lipódica
Lichen simplex chronicus Alopecia areata
Depo-Medrol ® is also useful in cystic tumors or an aponeurosis or tendon (ganglia).
For intrarectal installation: Ulcerative Colitis.
Pharmacokinetics in Humans: methylprednisolone acetate is a white or almost white, crystalline, odorless, which dissolves at 215 ° C. with some decomposition. Is soluble in dioxane, slightly soluble in acetone, alcohol, chloroform, methanol and ether. It is practically insoluble in water.
Depo-Medrol ® is a corticosteroid for long-acting depot. Like all glucocorticoid therapy is indicated as vicarious in adrenocortical deficiency states. It also provides a prolonged anti-inflammatory effect.
Depo-Medrol ®, methylprednisolone acetate, acts the same way as the rest of glucocorticoids, which have potent anti-inflammatory and protective effect of cellular and lysosomal membramas.
Due to their pharmacological activity as acetate, DEPO-MEDROL ® produces a prolonged protective effect in the cell, since it is longer inhibited the production of inflammatory mediators, resulting this property useful in the treatment of chronic conditions requiring this type of hormone therapy.
CONTRAINDICATIONS: Intrathecal administration, intravenous, fungal infections, systemic hypersensitivity to components of the formulation.
PRECAUTIONS: This product is not suitable for multi use. After administration of the dose required, any remaining suspension should be discarded.
Multidose use DEPO-MEDROL ® single vial requires special care to avoid contamination. Although initially sterile, multidose use of vials may lead to contamination unless strict aseptic practices are followed. It requires special care, such as the use of sterile syringes and needles.
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 connective tissue. Changes in the dermis and / or frequently resulting subdermis may form depressions in the skin at the injection site. The degree to which the reaction occurs may vary with the amount of the adrenal steroid injected. Generally, regeneration is completed within a few months or after all the crystals have been absorbed.
To minimize the incidence of dermal and subdermal atrophy, care must be taken not to exceed the recommended dose injection. Whenever possible, one should try to give several small injections in the lesion area. The technique of intrasynovial and intramuscular injection should include precautions against injection or leakage into the dermis. Avoid injection into the deltoid muscle due to the high incidence of subcutaneous atrophy.
Depo-Medrol ® should not be administered by any route other than indicated in notes. It is critical that during the administration of Depo-Medrol ®, appropriate techniques are used and care is taken to ensure proper placement of the drug.
Administration by other routes other than those listed have been associated with serious medical report reactions including: arachnoiditis, meningitis, paraparesis / paraplegia, sensory disturbances, dysfunction of bowel / bladder, access, visual impairment including blindness, ocular and periocular inflammation, and waste or scar at the site of injection.
In patients with corticosteroid therapy subjected to unusual stress is indicated increasing doses of rapidly acting corticosteroids before, during or after the stressful situation.
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, anywhere in the body can 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 sometimes fatal. By increasing the dose of corticosteroids increases the frequency of occurrence of infectious complications. Do not use the intrasynovial administration, or intratendinal intrabursal for local effect in the presence of an acute infection.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerve, and may increase the establishment of secondary ocular infections due to fungi or viruses.
Pediatric Use: This product contains benzyl alcohol. It has been reported that benzyl alcohol is associated with a fatal gasping syndrome in premature infants.
You can suppress growth in children receiving long-term glucocorticoid therapy in daily divided doses. The use of such arrangements should be restricted to the most serious indications.
Administration of live vaccines, live attenuated or are 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. Immunization procedures listed may be undertaken in patients receiving immunosuppressive doses of corticosteroids.
The use of Depo-Medrol ® in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which corticosteroids are used to manage the disease in conjunction with appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, it requires close observation as they may have reactivation of disease. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Because rarely anaphylactic reactions have occurred in patients receiving parenteral corticosteroid therapy, should take appropriate precautionary measures before administration, especially when the patient has a history of allergy to any medicine.
The allergic skin reactions have been reported apparently related to the excipients of the formulation. The skin tests have rarely shown any reaction to methylprednisolone acetate, per se.
PRECAUTIONS: The following refers only to the formulation with benzyl alcohol.
When multidose vials are used, care is essential to prevent contamination of the contents. There is some evidence that the benzalkonium chloride antiseptic is not suitable for sterilizing the port multidose vials. A solution of povidone-iodine or a similar product is recommended to clean the top of the road before taking the content.
Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation.
Psychological harm can occur when corticosteroids are used, ranging from euphoria, insomnia, changes in attitude, personality changes and 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. Also be careful when using steroid therapy attached directly or diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis and myasthenia gravis.
The following additional precautions apply for parenteral corticosteroids. Intra-articular injection of a corticosteroid may produce systemic as well as local.
Proper consideration of the presence of any fluid joint is necessary to exclude septic process.
A marked increase in pain accompanied by local swelling, followed by a restriction of joint motion, fever, and malaise are indications of septic arthritis. If this complication occurs and the diagnosis of sepsis, initiate appropriate antimicrobial therapy.
Avoid local injection of a steroid into a previously infected joint.
Corticosteroids should not be injected into unstable joints.
Sterile technique is necessary to prevent infection or contamination.
Must recognize a slower rate of absorption of intramuscular administration.
Although controlled clinical studies have shown that corticosteroids are effective in accelerating resolution of acute exacerbations of multiple sclerosis, do not show that corticosteroids affect the ultimate outcome or natural history of disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect.
Because the complications of glucocorticoid treatment depend on the size of the dose and duration of treatment, patients should make the decision on the benefit risk in each particular case as well as the dose and duration of treatment, such as whether to pursue a daily or intermittent therapy.
It is reported that Kaposi's sarcoma occurs in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
Use in Pregnancy and Lactation
Use in pregnancy: Some animal studies have shown that corticosteroids, when administered to the mother at high doses, can cause fetal malformations. There have been no adequate human reproduction studies with corticosteroids. Therefore, the use of this drug in women who are pregnant or lactating, or women who may become pregnant requires that the drug's benefits are evaluated carefully against potential risks to both mother and embryo or fetus. Because there is no adequate evidence of safety in pregnant humans, this medication should be used during pregnancy only if clearly needed.
Corticosteroids readily cross the placenta. Babies born to women who have received substantial doses of corticosteroids during pregnancy should be carefully monitored and assessed with respect to signs of adrenal insufficiency. There are no known effects of corticosteroids on labor. Corticosteroids are excreted in breast milk.
Note: The following are typical for all systemic corticosteroids. Their inclusion in this list does not necessarily indicate that specific events have been observed with the formulation of Depo-Medrol ® joint to exclude a septic process.
A marked increase in pain accompanied by local swelling, further restriction in joint movement, fever and malaise are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, antimicrobial therapy should establish in particular.
Fluid and electrolyte disorders:
Congestive heart failure in susceptible patients.
Loss of potassium.
Vertebral compression fractures.
Tendon rupture, particularly the Achilles tendon.
Peptic ulcer with possible perforation and hemorrhage.
There have been increases in alanine transaminase (ALT, SGPT), aspartame transaminase (AST, SGOT) and alkaline phosphatase after treatment with corticosteroids.
These changes are usually small, and are not associated with any clinical syndrome and are reversible upon discontinuation.
Impaired wound healing.
Petechiae and ecchymoses.
Thin skin fragile.
Negative nitrogen balance due to protein catabolism.
Increased intracranial pressure.
Development of Cushing state.
Pituitary-adrenal axis suppression.
Decreased carbohydrate tolerance.
Manifestation of latent diabetes mellitus.
Increased requirements for insulin or
hypoglycemic agents in diabetics.
Growth suppression in children.
Posterior subcapsular cataracts.
Increase in intraocular pressure.
Masking of infections.
Latent infections that are activated.
Hypersensitivity reactions including anaphylaxis.
Possible elimination reactions to skin tests.
The following reactions are related to parenteral corticosteroid therapy.
Rare cases of blindness associated with intralesional therapy around the face and head, anaphylactic or allergic reactions, hyperpigmentation or hypopigmentation, cutaneous or subcutaneous atrophy, sterile abscesses, inflammation postinjection, after intrasynovial use, the type of Charcot arthropathy, infection at the injection site after non-sterile techniques.
Repeated frequent doses (daily or several times a week) for an extended period can cause a state of Cushing.
DRUG INTERACTIONS AND OTHER GENDER: The pharmacokinetic interactions listed below are potentially clinically important. The mutual inhibition of metabolism occurs with concurrent use of cyclosporin and methylprednisolone, therefore it is possible that the adverse reactions associated with the individual use of either drug are more likely to be present. 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 increased doses of methylprednisolone to obtain 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 high-dose aspirin in chronic. This can lead to reduced serum salicylate levels or increase the risk of toxicity when removed salicylate methylprednisolone.
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 increase and decrease of the anticoagulant effects when administered concurrently with corticosteroids. For this reason it should monitor coagulation rates to maintain the effect desired anticoagulatorio.
CHANGES IN THE LABORATORY TEST RESULTS: We have observed increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT) and alkaline phosphatase after treatment with corticosteroids. These changes are regularly small, not associated with any clinical syndrome and are reversible when the medication is stopped.
PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, Impairment of Fertility: No evidence exists showing that corticosteroids are carcinogenic, mutagenic or impair fertility.
DOSAGE AND ADMINISTRATION: Because of possible physical incompatibilities, DEPO-Medrol ® sterile aqueous suspension (methylprednisolone acetate) should not be diluted or mixed with other solutions. Parenteral suspensions are visually inspected and that there is no foreign particulate matter and discoloration prior to administration whenever the drug or container permits.
Administration for Local Effect: Therapy with Depo-Medrol ® does not eliminate the need for the conventional measures usually employed. Although this method of treatment will ameliorate symptoms, 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 on the size of the joint and varies with the severity of the disorder in the individual patient. In chronic cases, injections may be repeated at intervals ranging from one to five or more weeks depending on the degree of relief obtained from the initial injection.
The doses in the following table are given as a general guide:
Procedure: It is recommended to review the anatomy of the joint involved before attempting intra-articular injection. To obtain the full anti-inflammatory effect, it is important that the injection is made into the synovial space. Employing the same sterile technique as for a spinal tap, a needle is inserted quickly gauge 20 and 24 (on a dry syringe) into the synovial cavity. Procaine infiltration is elective. Acetylsalicylic acid, only a few drops of joint fluid proves that the needle has penetrated the joint space.
The injection site for each joint is determined by the location where the synovial cavity is most superficial and most free of large vessels and nerves. With the needle in place, the needle is removed suction and replaced by a second syringe containing the desired amount of DEPO-MEDROL ®. The plunger is then pulled outward slightly to aspirate synovial fluid and 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 suspension. The site is covered with a small sterile dressing.
Suitable sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal joints and hip. Because sometimes has difficulty of breaking into the hip joints, caution should be exercised to avoid any large blood vessels in that area. The joints which are not suitable for injection are those anatomically inaccessible such as the spinal joints and joints such as those
that do not have sacroiliac synovial space. Treatment failure is most often the result of the failure to enter into the joint space. There is little or no benefit to injection into the tissue around the joint. If yes the fault during the injection into the synovial space, determined by aspiration of fluid, repeated injections are usually in vain.
Local therapy does not alter the primary disease process, and whenever possible, use a comprehensive therapy including physiotherapy and orthopedic correction.
After intra-articular corticosteroid therapy, care must be taken to avoid overuse of joints in which symptomatic benefit has been obtained. The fault in this respect may cause increase in joint deterioration that will more than neutralize the beneficial effect of steroid.
Unstable joints should not be injected. Repeated intra-articular injection may result in some instability of the joint. It suggests an X-ray monitoring in special cases to detect deterioration.
If using a local anesthetic before the injection of Depo-Medrol ®, you should read carefully the instructions of the anesthetic and should follow all precautions.
Bursitis: The area around the injection site is prepared in a sterile way and a wheal at the site made with 1% solution of procaine hydrochloride. Is placed a 20 gauge needle to 24 to a syringe is inserted into the bag and the fluid aspirated. The needle is left in place and is changed by an aspiration needle small syringe containing the desired dose. After injection, the needle is removed and applies a small gauze.
Miscellaneous: Lymph, tendons, tennis elbow. In the treatment of disorders such as tendonitis or tenosynovitis, care should be taken after the application of a suitable antiseptic skin layer, to inject the suspension into the tendon sheath rather than the substance of the tendon. The tendon can be felt easily when placed in tension.
During the treatment of disorders such as epicondylitis, the area of â€‹â€‹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. You should follow the usual sterile precautions, of course in each injection.
The dose in the treatment of various disorders of tendon structures above lists and bags varies with the condition being treated and ranges from 4 to 30 mg. In recurrent or chronic, it may take repeated injections.
Injections for local effects in dermatological disorder: After has been limited with a suitable antiseptic such as alcohol to 70%, injected from 20 to 60 mg of the suspension in 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 must be taken to avoid injection of sufficient material to cause blanching since this may be followed by a small scab. Normally used one to four injections, the intervals between injections varies with the type of lesion being treated and the duration of improvement produced by the initial injection.
The following information refers only to the benzyl alcohol formulation: When multidose vials are used, it is essential to be careful to prevent contamination of the contents (see Precautions).
Administration for systemic effects: The intramuscular dosage will vary with the condition being treated. When a prolonged effect is desired, the weekly dose can be calculated by multiplying the daily oral dose by 7 and given as a single intramuscular injection.
The dosage should be tailored according to the severity of the disease and the patient's response. For small children, the recommended dose should be reduced, but the dosage should be governed by the severity of the disorder rather than strict adherence to the ratio indicated by age or body weight.
Hormone therapy is an adjunct to, not a replacement to conventional therapy. The dosage should be decreased or discontinued gradually when the drug was administered for more than a few days.
The severity, prognosis and expected duration of the disease and patient response to medication are primary factors in determining dosage. If a period of spontaneous remission occurs in a chronic disorder, treatment should be discontinued.
The routine laboratory studies, such as urinalysis, blood sugar two hours after food, determination of blood pressure and body weight, intake and a chest X-ray should be performed at regular intervals during prolonged therapy . Is desirable, taking X-rays of the upper gastrointestinal tract in patients with a history of ulcers or significant dyspepsia.
In patients with adrenogenital syndrome, a single intramuscular injection of 40 mg every two hours may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 to 120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticosteroid therapy is 40 to 120 mg of methylprednisolone acetate administered intramuscularly at weekly intervals for one to four weeks.
In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours after intramuscular administration of a single dose of 80 to 120 mg. In chronic contact dermatitis, repeated injections at intervals of 5 to 10 days may be needed. In seborrheic dermatitis, a weekly dose of 80 mg may be adequate to control the disorder.
Medication name: Depo-medrol
Comparable patent medicine: Depo-medrol
Active ingredient: methylprednisolone
Presentation: Suspension injection
Box with a 2 ml vial
Made in: USA