DEXAMETHASONE- dexamethasone tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)

זמין מ:

ECR Pharmaceuticals

INN (שם בינלאומי):

DEXAMETHASONE

הרכב:

DEXAMETHASONE 1.5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Allergic states Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders Acquired (autoimmune) h

leaflet_short:

Dexamethasone tablets, USP 1.5 mg are scored, pink, pentagonal-shaped tablets debossed “ECR” score “86” on one side and plain on the other side. These are available in compliance packages of 21 tablets (DexPak® 6 Day TaperPak® , NDC 0095-0089-21), 35 tablets (DexPak® 10 Day TaperPak® , NDC 0095-0087-35) and 51 tablets (DexPak® 13 Day TaperPak® , NDC 0095-0088-51). Store at controlled room temperature 20º to 25ºC (68º to 77ºF), [see USP Controlled Room Temperature]. Dispense in tight, light resistant container as defined in the USP/NF. Rx Only Keep This and All Medications Out of the Reach of Children. Manufactured for: ECR Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA Manufactured by: Mikart, Inc. Atlanta, GA 30318 ®/™ are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates. © Valeant Pharmaceuticals North America LLC Rev. 11/2017 update p/n update p/n

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DEXAMETHASONE- DEXAMETHASONE TABLET
ECR PHARMACEUTICALS
----------
DEXPAK
13 DAY TAPER PACK
DEXAMETHASONE TABLETS, USP, 1.5 MG
RX ONLY
UPDATE P/N
DESCRIPTION
Dexamethasone tablets, USP, 1.5 mg, are for oral administration. Each
tablet contains 1.5 mg of
dexamethasone. Inactive ingredients are microcrystalline cellulose NF,
anhydrous lactose NF, FD&C
Red #40 aluminum lake, croscarmellose sodium NF, and magnesium
stearate NF. The molecular weight
for dexamethasone is 392.47. It is designated chemically as
9-fluoro-11β,17,21-trihydroxy-16α-
methylpregna-1,4-diene-3,20-dione. The empirical formula is C
H FO and the structural formula is:
Dexamethasone, a synthetic adrenocortical steroid, is a white to
practically white, odorless, crystalline
powder. It is stable in air. It is practically insoluble in water.
CLINICAL PHARMACOLOGY
Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are readily absorbed
from the gastrointestinal tract. Glucocorticoids cause varied
metabolic effects. In addition, they modify
the body’s immune responses to diverse stimuli. Naturally occurring
glucocorticoids (hydrocortisone
and cortisone), which also have sodium-retaining properties, are used
as replacement therapy in
adrenocortical deficiency states. Their synthetic analogs including
dexamethasone are primarily used
for their anti-inflammatory effects in disorders of many organ
systems. At equipotent anti-inflammatory
doses, dexamethasone almost completely lacks the sodium-retaining
property of hydrocortisone and
closely related derivatives of hydrocortisone.
INDICATIONS AND USAGE
_ALLERGIC STATES_
Control of severe or incapacitating allergic conditions intractable to
adequate trials of conventional
treatment in asthma, atopic dermatitis, contact dermatitis, drug
hypersensitivity reactions, perennial or
seasonal allergic rhinitis, and serum sickness.
_DERMATOLOGIC DISEASES_
Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis
fungoides, pemphigus, and severe
erythema multiforme (Stevens