DEXABLISS- dexamethasone tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Levins Pharmaceuticals, LLC

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 Disease: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia,

Přehled produktů:

Dexabliss Tablets USP, 1.5 mg are supplied as white, round shaped tablets debossed “702” on one side and bisected on the opposite side the bisect on the tablet provides for a functional scoring of the tablets to ensure accurate breaking. They are supplied in packages of 39 tablets, with child-resistant closure, 11-day Dose Pack, (NDC# 71905-400-11).

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

DEXABLISS- DEXAMETHASONE TABLET
LEVINS PHARMACEUTICALS, LLC
----------
DEXABLISS (DEXAMETHASONE TABLETS USP), 1.5 MG
RX ONLY
DES CRIPTION
Dexamethasone Tablets USP, 1.5 mg
Each Tablet contains: Dexamethasone USP, 1.5 mg
For oral administration
INACTIVE INGREDIENTS
Dexamethasone Tablets USP, 1.5 mg contain lactose monohydrate,
magnesium stearate, starch and
compressible sugar.
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. The
molecular formula is C22N29FO5.
The molecular weight is 392.47. It is designated chemically as
9-fluoro-11B,17,21 -trihydroxy-16 a –
methylpregna-1,4-diene-3,20-dione and the structural formula
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 adr