MEDROL- methylprednisolone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pharmacia & Upjohn Company LLC

INN (International Name):

METHYLPREDNISOLONE

Composition:

METHYLPREDNISOLONE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

MEDROL Tablets are indicated in the following conditions: 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 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 During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Severe seborrheic dermatitis Exfoliative dermatitis Mycosis fungoides Pemphigus Severe psoriasis 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 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 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 Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Acute exacerbations of multiple sclerosis 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.

Product summary:

MEDROL Tablets are available in the following strengths and package sizes: 2 mg (white, elliptical, scored, imprinted MEDROL 2)   Bottles of 100                                                   NDC 0009-0020-01 4 mg (white, elliptical, scored, imprinted MEDROL 4)   Bottles of 100                                                   NDC 0009-0056-02   DOSEPAK™ Unit of Use (21 tablets)           NDC 0009-0056-04 8 mg (white, elliptical, scored, imprinted MEDROL 8)   Bottles of 25                                                     NDC 0009-0022-01 16 mg (white, elliptical, scored, imprinted MEDROL 16)   Bottles of 50                                                     NDC 0009-0073-01 32 mg (white, elliptical, scored, imprinted MEDROL 32)   Bottles of 25                                                     NDC 0009-0176-01 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Authorization status:

New Drug Application

Summary of Product characteristics

MEDROL- METHYLPREDNISOLONE TABLET
PHARMACIA & UPJOHN COMPANY LLC
----------
MEDROL
METHYLPREDNISOLONE
TABLETS, USP
DESCRIPTION
MEDROL 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 MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg,
16 mg or 32
mg of methylprednisolone.
Inactive ingredients:
2 MG
4 MG AND 8 MG
Calcium Stearate
Calcium Stearate
Corn Starch
Corn Starch
Erythrosine Sodium
Lactose
Lactose
Sucrose
Mineral Oil
Sorbic Acid
®
Sucrose
16 MG AND 32 MG
Calcium Stearate
Corn Starch
Lactose
Mineral Oil
Sucrose
ACTIONS
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
MEDROL 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
Hypercal