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Basic Drug Info
Drug Name:Solu-Cortef
Manufacturer:Pharmacia and Upjohn Company
Other Info:Rx onlyLAB-0121-5.0May 2008



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, SOLU-CORTEF Sterile Powder is indicated for intravenous or intramuscular use in the following conditions:1.Endocrine DisordersPrimary 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 doubtfulShock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspectedCongenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis2.Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Post-traumatic osteoarthritisSynovitis of osteoarthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Acute and subacute bursitisEpicondylitisAcute nonspecific tenosynovitisAcute gouty arthritisPsoriatic arthritisAnkylosing spondylitis3.Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis4.Dermatologic DiseasesPemphigusSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisBullous dermatitis herpetiformisSevere seborrheic dermatitisSevere psoriasisMycosis fungoides5.Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:Bronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessSeasonal or perennial allergic rhinitisDrug hypersensitivity reactionsUrticarial transfusion reactionsAcute noninfectious laryngeal edema (epinephrine is the drug of first choice)6.Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye, such as:Herpes zoster ophthalmicusIritis, iridocyclitisChorioretinitisDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmiaAnterior segment inflammationAllergic conjunctivitisAllergic corneal marginal ulcersKeratitis7.Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitis (systemic therapy)Regional enteritis (systemic therapy)8.Respiratory DiseasesSymptomatic sarcoidosisBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyLoeffler's syndrome not manageable by other meansAspiration pneumonitis9.Hematologic DisordersAcquired (autoimmune) hemolytic anemiaIdiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)Secondary thrombocytopenia in adultsErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia10.Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood11.Edematous StatesTo induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus12.Nervous SystemAcute exacerbations of multiple sclerosis13.MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement
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.

Arthritis -- inflammation of the joints; tends to be chronic.

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.

Herpes zoster disease -- An acute infectious, usually self-limited, disease believed to represent activation of latent varicella-zoster virus (HERPESVIRUS 3, HUMAN) in those who have been rendered partially immune after a previous attack of CHICKENPOX. It involves the SENSORY GANGLIA and their areas of innervation and is characterized by severe neuralgic pain along the distribution of the affected nerve and crops of clustered vesicles over the area. (From Dorland, 27th ed)

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.

Ulcerative Colitis -- Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.

Regional enteritis -- Inflammation of the intestines, but usually only of the small intestine. Regional enteritis increases the risk for developing colon cancer. Also called Crohn's disease.

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

TUBERCULOSIS DISSEMINATED --

Syndrome -- A symptom complex of unknown etiology, that is characteristic of a particular abnormality.

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.

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)

Contraindications

The use of SOLU-CORTEF Sterile Powder is contraindicated in premature infants because the 100 mg, 250 mg, 500 mg and 1000 mg ACT-O-VIAL System contain benzyl alcohol.

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

SOLU-CORTEF 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

Exposure to excessive amounts of benzyl alcohol has been associated with increased toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants.

There have been rare reports of deaths, primarily in pre-term infants, associated with exposure to excessive amounts of benzyl alcohol.

The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol.

Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered.

The amount of benzyl alcohol at which toxicity may occur is unknown.

If the patient requires more than the recommended dosages of other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see PRECAUTIONS, Pediatric Use).In patients on corticosteroid therapy subjected to 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 of 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.1These 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.2Prolonged 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.Results from one multicenter, randomized, placebo controlled study with methylprednisolone hemisuccinate, an IV corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment.

High doses of systemic corticosteroids, including SOLU-CORTEF, should not be used for the treatment of traumatic brain injury.

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