Convulsions have been reported with this concurrent use. Digitalis glycosides : Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, including oral contraceptives : Estrogens may decrease to hepatic metabolism of certain corticosteroids, thereby increasing their effect.
Hepatic Enzyme Inducers e. Hepatic Enzyme Inhibitors e. Nonsteroidal anti-inflammatory agents NSAIDS : Concomitant use of aspirin or other nonsteroidal anti-inflammatory agents and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.
Vaccines : Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines.
No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose.
Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used furing pregnancy only if the potential benefit justifies the potential risk to the fetus.
Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypadrenalism. This product contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to continue nursing, or discontinue the drug, taking into account the importance of the drug to the mother.
Carefully examine vials to determine formulation that is being used. Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.
The risk of benzyl alcohol toxicity depends on the quantity administered and the hepatic capacity to detoxify the chemical. Premature and low-birth-weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity.
Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic lead of benzyl alcohol from all sources. The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. Other indications for pediatric use of corticosteroids, e.
Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.
Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression i.
Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives.
In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautions, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Allergic reactions : Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular : Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction see WARNINGS , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.
Dermatologic : Acne, allergic dermatitis, burning or tingling especially in the perineal area after intravenous injection , cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired would dealing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticarial.
Endocrine : Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin for oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness particularly in time so f stress, as in trauma, surgery, or illness , suppression of growth in pediatric patients.
Fluid and electrolyte disturbances : Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention. Musculoskeletal : Aseptic necrosis of femoral and humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare following intra-articular use , steroid myopathy, tendon rupture, vertebral compression fractures.
Ophthalmic : Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections. Other : Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motitliy and number of spermafozoa, injection site infections following nonsterile administration see WARNINGS , malaise, moon face, weight gain.
Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced. Use within 48 hours after mixing. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
This preparation may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection.
Following the initial emergency period, consideration should be given to employing a longer acting injectable preparation or an oral preparation. Bradycardia has been reported during or after the administration of large doses of methylprednisolone sodium succinate, and may be unrelated to the speed or duration of infusion.
This does may be repeated every 4 to 6 hours for 48 hours. In other indications, initial dosage will vary from 10 to 40 mg of methylprednisolone depending on the specific disease entity being treated. However, in certain overwhelming, acute, life-threatening situations, administrations in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.
If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. SOLU-MEDROL may be administered by intravenous or intramuscular injection or by intravenous infusion, the preferred method for initial emergency use being intravenous injection. To administer by intravenous or intramuscular injection, prepare solution as directed. The desired dose may be administered intravenously over a period of several minutes.
If desired, the medication may be administered in diluted solutions by adding Water for Injection or other suitable diluent see below to the Act-O-Vial and withdrawing the indicated dose.
To prepare solutions for intravenous infusion, first prepare the solution for injection as directed. In pediatric patients, the initial dose of methylprednisolone may vary depending on the specific disease entity being treated. The range of initial doses is 0.
This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.
Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size. It should not be less than 0. Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. 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 GI X-rays are desirable in patients with an ulcer history or significant dyspepsia. Press down on the plastic activator to force diluent into the lower compartment. Gently agitate to effect solution.
Remove plastic tab covering center of stopper. Sterilize top of stopper with a suitable germicide. Insert needle squarely through center of stopper until tip is just visible. Invert vial and withdraw dose.
This product's label may have been updated. For current full prescribing information, please visit www. Description The formulations containing benzyl alcohol should not be used in neonates.
The structural formula is represented below: Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly SOLU-MEDROL is available in preservative and preservative-free formulations: When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8 and the tonicities are, for the 40 mg per mL solution, 0.
Clinical Pharmacology Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract.
Indications When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows: Allergic states : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.
Side effects that can occur during or shortly after an infusion include blood-pressure changes, heart rate changes, irregular heart rate, electrolyte imbalances, elevated blood sugar, flushing of the skin, sweating, metallic taste, difficulty sleeping, mood or behavior changes, psychosis, seizures, increased susceptibility to infection, and anaphylaxis serious allergic reaction. If you need to take IV methylprednisolone or oral prednisone on an ongoing basis, the long-term side effects of corticosteroids include but are not limited to weight gain, acne, thinning of skin, stretch marks, elevated blood sugar, elevated cholesterol, peptic ulcers, cataracts, glaucoma, weight gain, decreased bone density, increased risk of osteonecrosis of the bone, growth suppression, muscle wasting, and increased susceptibility to infection.
Tell your rheumatology provider if you are concerned you may be experiencing any side effects, or if you develop a fever or any new symptoms after starting this medication, as it may cause an increased risk for infection. If you miss a scheduled infusion, notify your rheumatology provider. Talk to your rheumatology provider about which vaccines are appropriate for you.
If you are pregnant or are considering pregnancy, discuss this with your rheumatology provider before starting medication. May increase risk and mask signs of infection. May cause electrolyte imbalances, adrenocortical insufficiency, psychotic derangements.
Alternate, intermittent, or single-daily doses at 8 AM minimize adrenal suppression. Monitor weight, growth, fluid and electrolyte balance. IV: drug-induced liver injury; discontinue if toxic hepatitis occurs. Intrasynovial: avoid previously infected or unstable joints. Solu-Medrol 40mg: consider allergy to cow's milk if new or worsening allergic symptoms occur; use alternatives.
Avoid abrupt cessation. Use lowest effective dose. Pregnancy Cat. Nursing mothers: not recommended. Potentiated by CYP3A4 inhibitors eg, ketoconazole, macrolides , cyclosporine, estrogens. Antagonized by CYP3A4 inducers eg, barbiturates, phenytoin, carbamazepine, rifampin , cholestyramine.
May potentiate cyclosporine seizure risk. May antagonize oral anticoagulants monitor , isoniazid. Increased risk of arrhythmias with digitalis. May need to adjust dose of antidiabetic agents.
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