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Basic Drug Info
Drug Name:A-METHAPRED
Manufacturer:HOSPIRA, INC.
Other Info:Rx onlyFor Intravenous or Intramuscular Administration



Clinical Trials:


Indications and Usage
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, A-Methapred sterile powder is indicated for intravenous or intramuscular use in the following conditions: Endocrine Disorders• Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance)• Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used)• Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful• Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected• Congenital adrenal hyperplasia• Hypercalcemia associated with cancer• Nonsuppurative thyroiditisRheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:• Post-traumatic osteoarthritis• Synovitis of osteoarthritis• Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)• Acute and subacute bursitis• Epicondylitis• Acute nonspecific tenosynovitis• Acute gouty arthritis• Psoriatic arthritis• Ankylosing spondylitisCollagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:• Systemic lupus erythematosus• Systemic dermatomyositis (polymyositis)• Acute rheumatic carditisDermatologic Diseases• Pemphigus• Severe erythema multi-forme (Stevens-Johnson syndrome)• Exfoliative dermatitis• Bullous dermatitis herpetiformis• Severe seborrheic dermatitis• Severe psoriasis• Mycosis fungoidesAllergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: • Bronchial asthma• Contact dermatitis• Atopic dermatitis• Serum sickness• Seasonal or perennial allergic rhinitis• Drug hypersensitivity reactions• Urticarial transfusion reactions• Acute noninfectious laryngeal edema (epinephrine is the drug of first choice)Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye, such as: • Herpes zoster ophthalmicus• Iritis, iridocyclitis• Chorioretinitis• Diffuse posterior uveitis and choroiditis• Optic neuritis• Sympathetic ophthalmia• Anterior segment inflammation• Allergic conjunctivitis• Allergic corneal marginal ulcers• KeratitisGastrointestinal DiseasesTo tide the patient over a critical period of the disease in:• Ulcerative colitis (systemic therapy)• Regional enteritis (systemic therapy)Respiratory Diseases• Symptomatic sarcoidosis• Berylliosis• Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy• Loeffler’s syndrome not manageable by other means • Aspiration pneumonitisHematologic Disorders• Acquired (autoimmune) hemolytic anemia• Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)• Secondary thrombocytopenia in adults• Erythroblastopenia (RBC anemia)• Congenital (erythroid) hypoplastic anemiaNeoplastic DiseasesFor palliative management of: • Leukemias and lymphomas in adults• Acute leukemia of childhoodEdematous States• To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosusNervous System• Acute exacerbations of multiple sclerosisMiscellaneous• Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy• Trichinosis with neurologic or myocardial involvement
Endocrine System Diseases -- impairment of health or a condition of abnormal functioning of the system of glands that release their secretions (hormones) directly into the circulatory system.

Adrenal cortical hypofunction -- The inability of the adrenal gland to produce adequate amounts of cortisol.

Adrenal gland hypofunction -- abnormally diminished activity of the adrenal gland.

Shock -- A pathological condition that can suddenly affect the hemodynamic equilibrium, usually manifested by failure to perfuse or oxygenate vital organs.

Hypercalcemia -- Abnormally high level of calcium in the blood.

Rheumatoid Arthritis -- A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.

Chronic Childhood Arthritis -- Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

Rheumatism -- Disorders of connective tissue, especially the joints and related structures, characterized by inflammation, degeneration, or metabolic derangement.

acute disease/disorder -- Disease having a short and relatively severe course.

Pemphigus -- Group of chronic blistering diseases characterized histologically by ACANTHOLYSIS and blister formation within the EPIDERMIS.

Serum sickness (disorder) -- Immune complex disease caused by the administration of foreign serum or serum proteins and characterized by fever, lymphadenopathy, arthralgia, and urticaria. When they are complexed to protein carriers, some drugs can also cause serum sickness when they act as haptens inducing antibody responses.

Iritis -- Inflammation of the iris characterized by circumcorneal injection, aqueous flare, keratotic precipitates, and constricted and sluggish pupil along with discoloration of the iris.

Chorioretinitis -- Inflammation of the choroid in which the sensory retina becomes edematous and opaque. The inflammatory cells and exudate may burst through the sensory retina to cloud the vitreous body.

Posterior Uveitis -- Inflammation of the choroid as well as the retina and vitreous body. Some form of visual disturbance is usually present. The most important characteristics of posterior uveitis are vitreous opacities, choroiditis, and chorioretinitis.

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Unspecified pulmonary tuberculosis, unspecified examination -- MYCOBACTERIUM infections of the lung.

TUBERCULOSIS DISSEMINATED --

Loeffler's Pneumonia --

Purpura, Thrombocytopenic, Idiopathic -- Thrombocytopenia occurring in the absence of toxic exposure or a disease associated with decreased platelets. It is mediated by immune mechanisms, in most cases IMMUNOGLOBULIN G autoantibodies which attach to platelets and subsequently undergo destruction by macrophages. The disease is seen in acute (affecting children) and chronic (adult) forms.

Secondary thrombocytopenia --

leukemia -- A progressive, malignant disease of the blood-forming organs, characterized by distorted proliferation and development of leukocytes and their precursors in the blood and bone marrow. Leukemias were originally termed acute or chronic based on life expectancy but now are classified according to cellular maturity. Acute leukemias consist of predominately immature cells; chronic leukemias are composed of more mature cells. (From The Merck Manual, 2006)

Lymphoma -- A general term for various neoplastic diseases of the lymphoid tissue.

Leukemia, Adult Acute --

Proteinuria -- The presence of proteins in the urine, an indicator of KIDNEY DISEASES.

Nephrotic Syndrome -- A condition characterized by severe PROTEINURIA, greater than 3.5 g/day in an average adult. The substantial loss of protein in the urine results in complications such as HYPOPROTEINEMIA; generalized EDEMA; HYPERTENSION; and HYPERLIPIDEMIAS. Diseases associated with nephrotic syndrome generally cause chronic kidney dysfunction.

Uremia -- A clinical syndrome associated with the retention of renal waste products or uremic toxins in the blood. It is usually the result of RENAL INSUFFICIENCY. Most uremic toxins are end products of protein or nitrogen CATABOLISM, such as UREA or CREATININE. Severe uremia can lead to multiple organ dysfunctions with a constellation of symptoms.

SPONDYLOMETAEPIPHYSEAL DYSPLASIA, SHORT LIMB-HAND TYPE --

Meningitis -- Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)

TUBERCULOUS MENINGITIS -- A form of bacterial meningitis caused by MYCOBACTERIUM TUBERCULOSIS or rarely MYCOBACTERIUM BOVIS. The organism seeds the meninges and forms microtuberculomas which subsequently rupture. The clinical course tends to be subacute, with progressions occurring over a period of several days or longer. Headache and meningeal irritation may be followed by SEIZURES, cranial neuropathies, focal neurologic deficits, somnolence, and eventually COMA. The illness may occur in immunocompetent individuals or as an OPPORTUNISTIC INFECTION in the ACQUIRED IMMUNODEFICIENCY SYNDROME and other immunodeficiency syndromes. (From Adams et al., Principles of Neurology, 6th ed, pp717-9)

Trichinosis -- A disease due to infection with TRICHINELLA SPIRALIS. It is caused by eating undercooked meat, usually pork.

Contraindications

The use of A-Methapred sterile powder is contraindicated in premature infants because the reconstitution diluent contains benzyl alcohol.

Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.

A-Methapred sterile powder is also contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents.
Syndrome -- A symptom complex of unknown etiology, that is characteristic of a particular abnormality.

Systemic mycosis --

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

While on corticosteroid therapy patients should not be vaccinated against smallpox.

Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.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.

  A study has failed to establish the efficacy of Methylprednisolone Sodium Succinate for Injection, USP in the treatment of sepsis syndrome and septic shock. The study also suggests that treatment of these conditions with Methylprednisolone Sodium Succinate for Injection, USP may increase the risk of mortality in certain patients (ie, patients with elevated serum creatinine levels or patients who develop secondary infections after Methylprednisolone Sodium Succinate for Injection, USP.

  Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.  Usage in pregnancy.

Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers, or women of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.

Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

   Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.

These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

  While on corticosteroid therapy patients should not be vaccinated against smallpox.

Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.The use of Methylprednisolone Sodium Succinate for Injection, USP sterile powder in active tuberculosis should be restricted to those cases of fulminatingor disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with appropriate antituberculous regimen.

  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 anaphylactic (eg, bronchospasm) 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.

There are reports of cardiac arrhythmias and/or circulatory collapse and/or cardiac arrest following the rapid administration of large IV doses of Methylprednisolone Sodium Succinate for Injection, USP (greater than 0.5 gram administered over a period of less than 10 minutes).

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.

   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.

In such children or adults who have not had these diseases, particular care should be taken to avoid exposure.

How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known.

The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known.

If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated.

If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated.

(See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents may be considered.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.