METHYLPREDNISOLONE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Lupin Pharmaceuticals, Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 cardit

Produktu pārskats:

Methylprednisolone Tablets USP are available in the following strengths and package sizes:   2 mg (White to off white, elliptical shaped tablets debossed with 'L10' on one side and crossed score line on the other side)   Bottles of 100 Tablets             NDC 688180-685-01   4 mg (White to off white, elliptical shaped tablets debossed with 'L11' on one side and crossed score line on the other side)   Bottles of 100 Tablets             NDC 688180-686-01 Unit of Use blister package of 21 (21 tablets blister in one carton)           NDC 688180-686-11   8 mg (White to off white, elliptical shaped tablets debossed with 'L12' on one side and single score line on the other side)          Bottles of 25 Tablets                                       NDC 688180-687-55   16 mg (White to off white, elliptical shaped tablets debossed with 'L13' on one side and crossed score line on the other side)          Bottles of 50 Tablets                            NDC 688180-688-08   32 mg (White to off white, elliptical shaped tablets debossed with 'L14' on one side and single score line on the other side.)          Bottles of 25 Tablets                           NDC 688180-689-55   Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].   REFERENCES 1.      Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WBSaunders Company 1992:1050–1. 2.      Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954–63.   Rx only   Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States   Manufactured by: Lupin Limited Nagpur 441 108 INDIA   Revised August 2018

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

METHYLPREDNISOLONE - METHYLPREDNISOLONE TABLET
LUPIN PHARMACEUTICALS, INC.
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METHYLPREDNISOLONE TABLETS USP
DESCRIPTION
Methylprednisolone tablets USP 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 374.5.
The structural
formula is represented below:
Each methylprednisolone tablets USP for oral administration contains 2
mg, 4 mg, 8 mg,
16 mg, or 32 mg of methylprednisolone. In addition, each tablet
contains the inactive
ingredients colloidal silicon dioxide, hypromellose, lactose
monohydrate, magnesium
stearate, microcrystalline cellulose, 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
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 as