Quest for the right Drug
דפו מדרול 40 מ"ג/מ"ל DEPO MEDROL 40 MG/ML (METHYLPREDNISOLONE ACETATE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
זריקה ליד המפרק, תוך-שרירי, תוך מפרקי, לתוך פצע, לתוך נוזל העצם, להחדרה רקטלית, לרקמות רכות : PERIARTICULAR, I.M, INTRA-ARTICULAR, INTRA-LESIONAL, INTRABURSAL, INTRARECTAL INSTILLATION, SOFT TISSUES
צורת מינון:
תרחיף להזרקה : SUSPENSION FOR INJECTION
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Posology : מינונים
4.2 Posology and Method of Administration Depo-Medrol may be used by any of the following routes: - Intramuscular - Intra-articular, periarticular, intrabursal or soft tissues - Intralesional - Intrarectal instillation Depo-Medrol is contra-indicated for I.V administration. Depo-Medrol is contra-indicated for intrathecal route of administration Depo-Medrol is not recommended for epidural, intranasal, intra-ocular or any other unapproved route of administration (see Undesirable effects reported from non recommended routes of administration). A. I.M. ADMINISTRATION FOR SYSTEMIC EFFECT The intramuscular 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 singular intramuscular injection. Dosage must be individualized according to the severity of the disease and response of the patient. In general, the duration of the treatment should be kept as short as possible. Medical surveillance is necessary. 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. Strict medical surveillance is recommended when a chronic treatment is discontinued. The severity, prognosis and expected duration of the disease and the reaction of the patient to medication are primary factors in determining the dosage. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-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 Gl X-rays are desirable in patients with an ulcer history or significant dyspepsia. In patients with the adrenogenital syndrome, a single intramuscular injection of 40 mg every two weeks 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 corticoid 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 following intramuscular administration of a single dose of 80 to 120 mg. In chronic contact dermatitis repeated injections at 5 to 10 day 2024-0093542 Page 4 of 21 intervals may be necessary. In seborrheic dermatitis, a weekly dose of 80 mg may be adequate to control the condition. Following intramuscular administration of 80 to 120 mg to asthmatic patients. relief may result within 6 to 48 hours and persist for several days to two 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 intravenous administration of highly soluble methylprednisolone sodium succinate is indicated. B. IN SITU 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 the inflammation. 1. 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, repeated injections, if needed, may be given at intervals of 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: Table 1.General guide for dosage Size of Joint Example Range of Dosage Large Knees 20-80 mg Ankles Shoulders Medium Elbows 10-40 mg Wrists Small Metacarpophalangeal 4-10 mg Interphalangeal Sternoclavicular Acromioclavicular 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 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 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 2024-0093542 Page 5 of 21 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. 2. Bursitis The area around the injection site is prepared in a sterile way and a wheal at the site made with 1% procaine hydrochloride 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. 3. Miscellaneous: ganglion, tendinitis, epicondylitis In the treatment of conditions such as tendinitis or tenosynovitis, care should be taken 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 (application of a suitable antiseptic to the skin). 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. 4. 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. C. INTRARECTAL ADMINISTRATION Depo-Medrol in doses of 40 to 120 mg administered as retention enemas or by continuous drip three to seven times weekly for periods of two or more weeks, have been shown to be a useful adjunct in the treatment of some patients with ulcerative colitis. Many patients can be controlled with 40 mg of methylprednislone acetate administered in from 30-300 ml of water depending upon the degree of involvement of the inflamed colonic mucosa. Other accepted therapeutic measures should, of course, be instituted.
שימוש לפי פנקס קופ''ח כללית 1994
Rheumatoid arthritis, osteoarthritis, other arthritic conditions by intra-articular injection, inflammatory, allergic & rheumatic conditions requiring a glucocorticoid effect, in patients for whom treatment with oral corticosteroid is not feasible
תאריך הכללה מקורי בסל
01/01/1995
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דפו מדרול 40 מ"ג/מ"ל