METHYLPREDNISOLONE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)

Prieinama:

Tianjin Tianyao Pharmaceuticals Co., Ltd.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Methylprednisolone Tablets are indicated in the following conditions: 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 hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Severe seborrheic dermatitis Exfoliative dermatitis Mycosis fungoides Pemphigus Severe psoriasis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Serum sickness Contact dermatitis Bronchial asthma Atopic dermatitis 6 . Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Keratitis Optic neuritis Allergic conjunctivitis Chorioretinitis Iritis and iridocyclitis 7 . Respiratory Diseases Symptomatic sarcoidosis Berylliosis Loeffler's syndrome not manageable by other means Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic 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 colitis Regional enteritis 12. Nervous System Acute exacerbations of multiple sclerosis 13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement. Systemic fungal infections and known hypersensitivity to components.

Produkto santrauka:

Methylprednisolone Tablets, oval and scored, are available in the following strength and package size: 4 mg are white oval tablets with “MP” debossed on one side and quadrisect scored on the other side. Bottles of 100                    NDC 57582-101-01 Unit-of–use cartons of 21 tablets    NDC 57582-101-02 Store at controlled room temperature 20° to 25°C (68° to 77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature] Protect from light.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
TIANJIN TIANYAO PHARMACEUTICALS CO., LTD.
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METHYLPREDNISOLONE TABLETS, USP
DESCRIPTION
Methylprednisolone Tablets contain methylprednisolone which is a
glucocorticoid.
Glucocorticoids are adrenocortical steroids, both naturally occurring
and synthetic,
which are readily absorbed from the gastrointestinal tract.
Methylprednisolone occurs as
a white to practically white, odorless, crystalline powder. It is
sparingly soluble in alcohol,
in dioxane, and in methanol, slightly soluble in acetone, and in
chloroform, and very
slightly soluble in ether. It is practically insoluble in water.
The chemical name for methylprednisolone is pregna-1, 4-diene-3,
20-dione, 11, 17, 21-
trihydroxy-6-methyl-, (6α, 11β)-and the molecular weight is 374.48.
The structural
formula is represented below:
Each Methylprednisolone tablet for oral
administration contains 4mg of methylprednisolone.
Inactive ingredients: Colloidal Silicon Dioxide, Lactose
Monohydrate-Cellulose
Microcrystalline, Magnesium Stearate, Croscarmellose Sodium.
CLINICAL PHARMACOLOGY
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-
retaining properties, are used as replacement therapy in
adrenocortical deficiency
states. Their synthetic analogs are primarily used for their potent
anti-inflammatory
effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify
the body’s immune responses to diverse stimuli.
INDICATIONS AND USAGE
Methylprednisolone Tablets are indicated in the following conditions:
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 hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. RHEUMATIC DISORDERS
As adjunctive