DEXAMETHASONE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
22-12-2010

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Physicians Total Care, Inc.

INN (Jina la Kimataifa):

DEXAMETHASONE

Tungo:

DEXAMETHASONE 1.5 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome) 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. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in ad

Bidhaa muhtasari:

Dexamethasone tablets USP 1.5mg are scored, pink, pentagonal-shaped tablets debossed “ECR 86”. These are available in compliance packages of Store at controlled room temperature 20º to 25ºC (68º to 77ºF), see USP. 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 Richmond, Virginia 23255 Manufactured by: Mikart, Inc. Atlanta, GA 30318 MI 0087/88/89 Rev. 11/08 Code 970A00 Rev. 06/08 Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK      74146

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

                                DEXAMETHASONE - DEXAMETHASONE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
DEXAMETHASONE 13 DAY PACK
DESCRIPTION
Dexamethasone tablets USP, 1.5mg for oral administration. 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
C22H29F05 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-Johnson syndrome)
_ENDOCRINE DISORDERS_
Primary or secondary adrenocortical insufficiency (hyd
                                
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