METHYLPREDNISOLONE- methylprednisolone tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

Methylprednisolone (UNII: X4W7ZR7023) (Methylprednisolone - UNII:X4W7ZR7023)

Fáanlegur frá:

JUBILANT CADISTA PHARMACEUTICALS INC.

INN (Alþjóðlegt nafn):

Methylprednisolone

Samsetning:

Methylprednisolone 4 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Methylprednisolone Tablets, USP are available in the following strengths and package sizes:   4mg (White, oval shaped tablets, debossed with "TL 001" on one side and quadrisected on the other side.) Bottles of 100: NDC 59746-001-06 Unit of use pack (21 tablets): NDC 59746-001-03 8mg (White, oval shaped tablets, debossed with "TL 002", scored on one side and plain on the other side.) Bottles of 25:NDC 59746-002-04 Bottles of 100:NDC 59746-002-06 16mg (White, oval shaped tablets, debossed with "TL 003" on one side and quadrisected on the other side.) Bottles of 50:NDC 59746-003-14 32 mg (White, oval shaped tablets, debossed with "TL 015" on one side and bisected on the other side.) Bottles of 25:NDC 59746-015-04 Store at 20 to 25° C (68 to 77° F) [see USP Controlled Room Temperature]. Rx only Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised: 08/2018

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

METHYLPREDNISOLONE - METHYLPREDNISOLONE TABLET
JUBILANT CADISTA PHARMACEUTICALS INC.
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METHYLPREDNISOLONE TABLETS, USP RX ONLY
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 374.48. The structural
formula is represented below:
C
H O
Methylprednisolone Tablets, USP, for oral administration, are
available as scored tablets in the
following strengths: 4 mg, 8 mg, 16 mg, and 32 mg. In addition each
tablet contains the following
inactive ingredients: colloidal silicon dioxide, lactose anhydrous (4
mg and 8 mg), lactose monohydrate
(16 mg and 32 mg), magnesium stearate, microcrystalline cellulose,
pregelatinized starch, sodium lauryl
sulfate, and sodium starch glycolate.
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