Depo-Medrol

Depo-Medrol Special Precautions

methylprednisolone

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

DKSH
Full Prescribing Info
Special Precautions
SPECIAL RISK GROUPS: Patients belonging to the following special risk groups should be under strict medical surveillance and should be treated during an as short as possible period: Children: 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.
Diabetics: manifestations of latent diabetes mellitus or increased requirements for insulin or oral hypoglycemic agents.
Hypertensive patients: aggravation of arterial hypertension.
Patients with psychiatric antecedents: existing emotional instability or psychotic tendencies may be aggravated by glucocorticoids.
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.
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 GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.
Medical surveillance is recommended in case of discontinuation of a chronic treatment. The possibility of a drug-induced secondary adrenocortical insufficiency can be minimized by a gradual reduction or discontinuation of the dosage. The adrenocortical function should be evaluated after discontinuation of a chronic treatment. The most important symptoms of adrenocortical insufficiency are asthenia, orthostatic hypotension and depression.
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 intra-articular and intramuscular 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 subcutaneous atrophy.
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting glucocorticoids before, during and after the stressful situation is indicated.
Glucocorticoids 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 glucocorticoids are used. Do not use intra-articularly, intrabursally or intratendinous administration in the presence of acute infection; I.M. administration can only be considered after institution of an appropriate antimicrobial treatment.
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 glucocorticoids 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.
Allergic skin reactions have been reported apparently related to the excipients. Rarely has skin testing demonstrated a reaction to methylprednisolone 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.
Allergic skin reactions have been reported apparently related to the excipients. Rarely has skin testing demonstrated a reaction to methylprednisolone acetate, per se.
Glucocorticoids should be used with caution in non specific 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.
No evidence exists showing that glucocorticoids are carcinogenic, mutagenic or impair fertility.
Corticotherapy has to be considered when interpreting a whole series of biological tests and parameters (e.g. skin tests, thyroid hormone levels).
INTRA-ARTICULAR USE: In case of intra-articular use and/or other local administration a strict sterile technique is needed to avoid iatrogen infections. 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, the anesthetic package insert should be read carefully and all the precautions observed.
THE FOLLOWING ADDITIONAL PRECAUTIONS APPLY FOR PARENTERAL GLUCOCORTICOIDS: 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, local injections of glucocorticoids should be discontinued and appropriate antimicrobial therapy should be instituted.
Local injection of a steroid into a previously infected joint is to be avoided.
Glucocorticoids should not be injected into unstable joints. Sterile technique is necessary to prevent infections or contamination.
Although controlled clinical trials have shown glucocorticoids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that glucocorticoids affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of glucocorticoids are necessary to demonstrate a significant effect.
Ability to drive and to operate machinery: Although visual disorders belong to the rare adverse reactions, caution is recommended by patients driving cars and/or using machines.
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