METHYLPREDNISOLONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

METHYLPREDNISOLONE

Composition:

METHYLPREDNISOLONE 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methylprednisolone 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:

Methylprednisolone tablets USP, are available in the following strengths and package sizes: Methylprednisolone tablets USP, 4 mg are white to off-white, oval-shaped, flat-faced, beveled-edge tablets, debossed with '916' on one side and quadrisect on other side and are supplied as follows: NDC 68382-916-01 in bottle of 100 tablets NDC 68382-916-05 in bottle of 500 tablets NDC 68382-916-34 in unit-of-use cartons of 21 tablets Methylprednisolone tablets USP, 8 mg are white to off-white, oval-shaped, biconvex tablets, debossed with '917' on one side and bisect on other side and are supplied as follows: NDC 68382-917-11 in bottle of 25 tablets with child-resistant closure NDC 68382-917-01 in bottle of 100 tablets NDC 68382-917-05 in bottle of 500 tablets NDC 68382-917-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Methylprednisolone tablets USP, 16 mg are white to off-white, oval-shaped, biconvex tablets, debossed with '918' on one side and quadrisect on other side and are supplied as follows: NDC 68382-918-18 in bottle of 50 tablets with child-resistant closure NDC 68382-918-01 in bottle of 100 tablets NDC 68382-918-05 in bottle of 500 tablets NDC 68382-918-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Methylprednisolone tablets USP, 32 mg are white to off-white, oval-shaped, biconvex tablets, debossed with '919' on one side and bisect on other side and are supplied as follows: NDC 68382-919-11 in bottle of 25 tablets with child-resistant closure NDC 68382-919-01 in bottle of 100 tablets NDC 68382-919-05 in bottle of 500 tablets NDC 68382-919-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Store at 20°C to 25° C (68°F to 77° F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPREDNISOLONE- METHYLPREDNISOLONE TABLET
ZYDUS PHARMACEUTICALS USA INC.
----------
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, USP
occurs as a white to practically white, odorless, crystalline powder.
It melts at about
240°C, with some decomposition. It is practically insoluble in water,
sparingly soluble in
ethanol (96 %), in dioxane, in methanol and slightly soluble in
acetone, in methylene
chloride and in chloroform, very slightly soluble in ether.
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:
C
H
O
Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32
mg of
methylprednisolone. In addition each tablet contains the following
inactive ingredients:
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinized
starch, and sodium starch glycolate.
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
22
30
5
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 hy