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Depo-medrol + Lidocaine

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Indications:

Musculoskeletal and joint disorders.

Contraindications:

Not for i.v. use or intrathecal administration. Contraindicated in systemic fungal infections and patients with known hypersensitivity to components of the product, lidocaine or other local anesthetics of the amide type.

Adverse reactions:

Depo-Medrol: Note: The following are typical for all systemic corticosteroids. Their inclusion in this list does not necessarily indicate the specific event has been observed with this particular formulation. 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 compresssion fractures, aseptic necrosis of femoral and humeral heads, pathologic fractures, tendon rupture - particularly of the Achilles tendon. Gastrointestinal: peptic ulcer with possible subsequent perforation and hemorrhage, pancreatitis, gastrointestinal 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, suppression of pituitary-adrenal axis, 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, glaucoma, exophthalmos. Metabolic: negative nitrogen balance due to protein catabolism. Immune System: masking of infections, latent infections becoming active, opportunistic infections, hypersensitivity reactions including anaphylaxis, may suppress reactions to skin tests. Lidocaine: CNS: lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensation of heat or cold, numbness, twitching, tremors, convulsions, loss of consciousness, respiratory depression, respiratory arrest. Cardiovascular: bradycardia, hypotension, cardiovascular collapse, cardiac arrest. Allergic Reactions: cutaneous lesions, urticaria, edema, anaphylactic reactions.

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.

Warnings:

This product contains benzyl alcohol which is potentially toxic when administered locally to neural tissue. Multidose use of Depo-Medrol with Lidocaine 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. 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 intra-articular injection should include precautions against injection or leakage into the dermis. Depo-Medrol with Lidocaine should not be administered by any route other than those listed under Indications. It is critical that, during administration of this drug 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. Appropriate measures must be taken to avoid intravascular injection. 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 sub-capsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. 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 percautionary measures should be taken prior to administration, especially when the patients have 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. Pregnancy: Some animal studies have shown that corticosteroids, when administered to the mother at high doses, may cause fetal malformations. Adequate human reproductive studies have not been done with corticosteroids or with Lidocaine. Therefore the use of this drug in pregnancy, nursing mothers, or women of child bearing 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. Labor and Delivery: Corticosteroids and lidocaine 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. The use of local anesthetics such as lidocaine during labor and delivery may be associated with adverse effects on mother and fetus. Lactation: Corticosteroids are excreted in breast milk. It is not known whether lidocaine is excreted in breast milk. 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. 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. When multidose vials are used, special care to prevent contamination of the contents is essential. There is some evidence that benzalkonium chloride 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. Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear 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. The following additional precautions apply for parenteral corticosteroids: Intrasynovial injection of a corticosteroid may produce systemic as well as local effects. No additional benefit derives from the i.m. administration of Depo-Medrol with Lidocaine. Where parenteral corticosteroid therapy for sustained systemic effect is desired, plain Depo-Medrol should be used. 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. 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. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants. 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.

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SOLUTION FOR INJECTION

Dosage and Administration

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