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Basic Drug Info
Drug Name:Prednisolone
Manufacturer:Watson Laboratories, Inc.
Other Info:



Clinical Trials:


Indications and Usage

1.

Endocrine disorders.

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer2.

Rheumatic disorders.

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis; including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis3.

Collagen diseases.

During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditisSystemic dermatomyositis (polymyositis)4.

Dermatologic diseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis5.

Allergic states.

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisSerum sicknessBronchial asthmaContact dermatitisAtopic dermatitisDrug hypersensitivity reactions6.

Ophthalmic diseases.

Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia7.

Respiratory diseases Symptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis8.

Hematologic disordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia9.

Neoplastic diseases.

For palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood10.

Edematous states.

To induce a diuresis or remission of proteinuria in the nephritic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.11.

Gastrointestinal diseases.

To tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis12.

Nervous system.

Acute exacerbations of multiple sclerosis13.

MiscellaneousTuberculous meningitis with sub-arachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis 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.

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.

PSORIATIC ARTHRITIS -- A type of inflammatory arthritis associated with PSORIASIS, often involving the axial joints and the peripheral terminal interphalangeal joints. It is characterized by the presence of HLA-B27-associated SPONDYLOARTHROPATHY, and the absence of rheumatoid factor.

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.

Collagen Diseases -- Historically, a heterogeneous group of acute and chronic diseases, including rheumatoid arthritis, systemic lupus erythematosus, progressive systemic sclerosis, dermatomyositis, etc. This classification was based on the notion that "collagen" was equivalent to "connective tissue", but with the present recognition of the different types of collagen and the aggregates derived from them as distinct entities, the term "collagen diseases" now pertains exclusively to those inherited conditions in which the primary defect is at the gene level and affects collagen biosynthesis, post-translational modification, or extracellular processing directly. (From Cecil Textbook of Medicine, 19th ed, p1494)

Lupus Erythematosus -- A chronic inflammatory connective tissue disease marked by skin rashes, joint pain and swelling, inflammation of the kidneys, inflammation of the fibrous tissue surrounding the heart (i.e., the pericardium), as well as other problems. Not all affected individuals display all of these problems. Also called systemic lupus erythematosus.

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

Dermatomyositis -- A subacute or chronic inflammatory disease of muscle and skin, marked by proximal muscle weakness and a characteristic skin rash. The illness occurs with approximately equal frequency in children and adults. The skin lesions usually take the form of a purplish rash (or less often an exfoliative dermatitis) involving the nose, cheeks, forehead, upper trunk, and arms. The disease is associated with a complement mediated intramuscular microangiopathy, leading to loss of capillaries, muscle ischemia, muscle-fiber necrosis, and perifascicular atrophy. The childhood form of this disease tends to evolve into a systemic vasculitis. Dermatomyositis may occur in association with malignant neoplasms. (From Adams et al., Principles of Neurology, 6th ed, pp1405-6)

Polymyositis -- Diseases characterized by inflammation involving multiple muscles. This may occur as an acute or chronic condition associated with medication toxicity (DRUG TOXICITY); CONNECTIVE TISSUE DISEASES; infections; malignant NEOPLASMS; and other disorders. The term polymyositis is frequently used to refer to a specific clinical entity characterized by subacute or slowly progressing symmetrical weakness primarily affecting the proximal limb and trunk muscles. The illness may occur at any age, but is most frequent in the fourth to sixth decade of life. Weakness of pharyngeal and laryngeal muscles, interstitial lung disease, and inflammation of the myocardium may also occur. Muscle biopsy reveals widespread destruction of segments of muscle fibers and an inflammatory cellular response. (Adams et al., Principles of Neurology, 6th ed, pp1404-9)

Lupus Vulgaris -- A form of cutaneous tuberculosis. It is seen predominantly in women and typically involves the NASAL MUCOSA; BUCCAL MUCOSA; and conjunctival mucosa.

Seborrheic dermatitis -- A chronic inflammatory disease of the skin with unknown etiology. It is characterized by moderate ERYTHEMA, dry, moist, or greasy (SEBACEOUS GLAND) scaling and yellow crusted patches on various areas, especially the scalp, that exfoliate as dandruff. Seborrheic dermatitis is common in children and adolescents with HIV INFECTIONS.

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

Disorder of eye -- impairment of health or a condition of abnormal functioning of the organ of sight.

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.

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

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

TUBERCULOSIS DISSEMINATED --

Thrombocytopenic purpura -- Any form of purpura in which the PLATELET COUNT is decreased. Many forms are thought to be caused by immunological mechanisms.

Thrombocytopenia -- A subnormal level of BLOOD PLATELETS.

Neoplasms -- New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.

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.

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 --

Gastrointestinal Diseases -- Diseases in any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM.

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
Systemic fungal infections
Systemic mycosis --

Warnings

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals.

Chickenpox 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 chickenpox, 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 chickenpox develops, treatment with antiviral agents may be considered.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.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.
Branded Drugs
The following US Branded drugs contain Prednisolone


CHLOROPTIC-P S.O.P. -- ALLERGAN PHARMACEUTICAL

METI-DERM -- SCHERING CORP SUB SCHERING PLOUGH CORP

PRELONE -- MURO PHARMACEUTICAL INC

PRELONE -- TEVA PHARMACEUTICALS USA INC

CORTALONE -- HALSEY DRUG CO INC

DELTA-CORTEF -- PHARMACIA AND UPJOHN CO

FERNISOLONE-P -- FERNDALE LABORATORIES INC

STERANE -- PFIZER LABORATORIES DIV PFIZER INC


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