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  • Depo-Medrol with Lidocaine
    / Pfizer


    Active Ingredient *
    Lidocaine HCl 10 mg/ml
    Methylprednisolone (as acetate) 40 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    2 ml

    not in the basket chart 619 4054

    Dosage

    Because of possible physical incompatibilities, methylprednisolone acetate with lidocaine should not be diluted or mixed with other solutions: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Therapy with methylprednisolone acetate with lidocaine 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. 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, injections may be repeated at intervals ranging from one to five or more weeks depending upon the degree of relief obtained from the initial injection.
    For full details see prescribing information.


    Indications

    Depo-Medrol may be used by any of the following routes: Periarticular, Intrabursal, Intrasynovial and Intra/Sub-lesional. It Umust notU be used by the intrathecal or intravenous routes The following routes of administrationU are not recommended;U epidural, intranasal, intraocular and any other unapproved route of administration Methylprednisolone acetate with lidocaine is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Synovitis of osteoarthritis, Rheumatoid arthritis, Acute and subacute bursitis, Acute gouty arthritis, Epicondylitis, Acute nonspecific tenosynovitis, Post-traumatic osteoarthritis.


    Contra-Indications

    In patients who have systemic fungal infections, In patients with known hypersensitivity to methylprednisolone or any component of the formulation, In patients with known hypersensitivity to Lidocaine or other local anesthetics of the amide type, For use by the intrathecal route of administration, For use by the intravenous route of administration Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.


    Special Precautions

    This product contains benzyl alcohol which is potentially toxic when administered locally to neural tissue. Multidose use of methylprednisolone acetate 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 reaction, 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 intra-articular injection should include precautions against injection or leakage into the dermis. Methylprednisolone acetate with lidocaine should not be administered by any route other than those listed in Therapeutic Indications. It is critical that, during administration of methylprednisolone acetate with lidocaine, 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. 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.
    The following additional precautions apply for parenteral corticosteroids: Intra-synovial injection of a corticosteroid may produce systemic, as well as local effects. No additional benefit derives from the intramuscular administration of methylprednisolone acetate with lidocaine. Where parenteral corticosteroid therapy for sustained systemic effect is desired, plain methylprednisolone acetate 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.
    Immunosuppressant Effects/increased Susceptibility to Infections: Corticosteroids may increase susceptibility to infection, 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 organisms, 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 complications increases. Do not use intra-synovial, intrabursal or intratendinous administration for local effect in the presence of acute infection. Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. Administration of live or live, attenuated vaccines is 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. Indicated immunization procedures may be undertaken in patients receiving non-immunosuppressive doses of corticosteroids. 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. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
    Immune System Effects: Allergic reactions may occur. Because rare instances of skin reactions and anaphylactic/anaphylactoid reactions have occurred in patients receiving corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
    Endocrine Effects: In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamicpituitary-adrenal (HPA) suppression (secondary adrenocortical insufficiency). The degree and duration of adrenocortical insufficiency produced is variable among patients and depends on the dose, frequency, time of administration, and duration of glucocorticoid therapy. Because glucocorticoids can produce or aggravate Cushing’s syndrome, glucocorticoids should be avoided in patients with Cushing’s disease. There is an enhanced effect of corticosteroids on patients with hypothyroidism.
    For full details see prescribing information.


    Side Effects

    Adverse reactions related to lidocaine hydrochloride: Lightheadedness, nervousness, apprehension, euphoria, confusion, drowsiness, tinnitus, blurred or double vision, vomiting, sensation of heat, cold, numbness, twitching, tremors, convulsions, loss of consciousness, respiratory depression, respiratory arrest. Bradycardia, hypotension, cardiovascular collapse, cardiac arrest. Allergic reactions. Vertebral compression fractures. Peptic ulceration with possible perforation and hemorrhage, gastric hemorrhage, pancreatitis, esophagitis, perforation of the bowel. Impaired wound healing, thin fragile skin, petechiae and ecchymosis. Increased intracranial pressure, pseudotumor cerebri, seizures. Endocrinological changes. Prolonged use may produce posterior subcapsular cataracts, glaucoma, infections due to fungi. Patients with ocular herpes simplex. Masking of infections.
    Adverse reactions relatedto methylprednisolone acetate: Side effects rarely occurring in very short-term therapy, which should always be carefully traced. This is part of the follow-up of any corticotherapy, and does not specifically pertain to any particular product: Sodium retention, fluid retention, congestive heart failure, potassium loss, hypokalemic alkalosis, hypertension, musculoskeletal, muscle weakness, steroid myopathy, osteoporosis.
    For full details see prescribing information.


    Drug interactions

    Other antiarrhythmics, cimetidine, propranolol, thaizides and loop diuretics. Phenytoin, barbiturates, carbamazepine, aminoglutethimide, rifampicin. Thiazide and loop diuretics, cardiac glycosides, acetazolamide. Oral hypoglycemics, insulin, antihypertensives, anabolic steroids, ophthalmic idoxuridine. NSAIDs, aspirin, other salicylates, coumarin anticoagulants, vaccines, estrogens.


    Pregnancy and Lactation

    Fertility: No evidence exists showing that corticosteroids are carcinogenic, mutagenic or impair fertility.
    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 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. Corticosteroids and Lidocaine readily cross the placenta. One retrospective study found an increased incidence of low birth weights in infants born of mothers receiving corticosteroids. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy must be carefully observed and evaluated for signs of adrenal insufficiency. Although neonatal adrenal insufficiency appears to be rare in infants who were exposed in utero to corticosteroids, those exposed to substantial doses of corticosteroids must be carefully observed and evaluated for signs of adrenal insufficiency. The use of local anesthetics such as Lidocaine during labor and delivery may be associated with adverse effects on mother and fetus. There are no known effects of corticosteroids on labor and delivery. Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy.
    Lactation: Corticosteroids are excreted in breast milk. It is not known whether Lidocaine is excreted in human breast milk.
    Corticosteroids distributed into breast milk may suppress growth and interfere with endogenous glucocorticoid production in nursing infants. Since adequate reproductive studies have not been performed in humans with glucocorticoids, these drugs should be administered to nursing mothers only if the benefits of therapy are judged to outweigh the potential risks to the infant.


    Overdose

    Reports of acute toxicity and/or death following overdose of corticosteroids are rare. In the event of overdose, no specific antidote is available; treatment is supportive and symptomatic. Methylprednisolone is dialyzable.


    Manufacturer
    PFIZER Manufacturing Belgium NV, Belgium
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