DEXAMETHASONE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Physicians Total Care, Inc

INN (שם בינלאומי):

DEXAMETHASONE

הרכב:

DEXAMETHASONE 0.5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

0.5 mg yellow, scored tablets (Identified 54 299). NDC 54868-0927-0: Bottles of 30 tablets. 0.75 mg pale blue, scored tablet (Identified 54 960). NDC 54868-0916-0: Bottles of 30 tablets. 1.5 mg pink, scored tablets (Identified 54 943). NDC 54868-1744-0: Bottles of 100 tablets. 2 mg white, scored tablets (Identified 54 662). NDC 54868-3157-0 Bottles of 10 tablets. NDC 54868-3157-1 Bottles of 48 tablets. 4 mg green, scored tablets (Identified 54 892). NDC 54868-0218-3 Bottles of 03 tablets. NDC 54868-0218-9 Bottles of 05 tablets. NDC 54868-0218-1 Bottles of 10 tablets. NDC 54868-0218-5 Bottles of 16 tablets. NDC 54868-0218-0 Bottles of 20 tablets. NDC 54868-0218-4 Bottles of 30 tablets. NDC 54868-0218-7 Bottles of 40 tablets. NDC 54868-0218-8 Bottles of 50 tablets. NDC 54868-0218-6 Bottles of 100 tablets. NDC 54868-0218-2 Bottles of 120 tablets. 6 mg aqua, scored tablets (Identified 54 769). NDC 54868-5903-0: Bottles of 06 tablets. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a well-closed, light-resistant container as defined in the USP/NF. 4047401//04 Revised September 2007 © RLI, 2007

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DEXAMETHASONE - DEXAMETHASONE TABLET
PHYSICIANS TOTAL CARE, INC
----------
RX ONLY
DESCRIPTION
Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP,
Dexamethasone Oral Solution, 0.5 mg per 5
mL and Dexamethasone _Intensol_™ Oral Solution (Concentrate), 1 mg
per mL are for oral administration.
Each tablet contains:
Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg
Each 5 mL of Oral Solution contains:
Dexamethasone.......................................................
0.5 mg
Each mL of _Intensol_ ™ Oral Solution (Concentrate) contains:
Dexamethasone....................................................... 1
mg
Alcohol 30%
Inactive Ingredients
The tablets contain lactose monohydrate, magnesium stearate, starch,
sucrose, cosmetic ochre (1 mg),
D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C
Green No. 3 (4, 6 mg),
FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No.
6 (0.5, 4 mg).
The oral solution contains citric acid, disodium edetate, flavoring,
glycerin, methylparaben, propylene
glycol, propylparaben, sorbitol and water.
The _Intensol_™ oral solution contains alcohol, benzoic acid, citric
acid, disodium edetate, propylene
glycol, and water.
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 C
H FO .
The molecular weight is 392.47. It is designated chemically as
9-fluoro-11β,17,21-trihydroxy-16α-
methylpregna-1,4-diene,3,20-dione and the structural formula is:
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 sy