DEXAMETHASONE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
03-01-2023

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Cardinal Health 107, LLC

INN (Jina la Kimataifa):

DEXAMETHASONE

Tungo:

DEXAMETHASONE 2 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 a

Bidhaa muhtasari:

Dexamethasone Tablets USP 2 mg tablets are supplied as a white, flat tablet with beveled edges, scored on one side and product identification “54 662” debossed on the other side. Overbagged with 10 tablets per bag, NDC 55154-4914-0 4 mg tablets are supplied as a green, flat tablet with beveled edges, scored on one side and product identification “54 892” debossed on the other side. Overbagged with 10 tablets per bag, NDC 55154-4901-0 Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight light-resistant, child-resistant container as defined in the USP/NF. Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 Distributed By: Cardinal Health Dublin, OH 43017 L29829241118 L29066001118 4047401//07 Revised December 2019

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

                                DEXAMETHASONE- DEXAMETHASONE TABLET
CARDINAL HEALTH 107, LLC
----------
DEXAMETHASONE TABLETS USP, DEXAMETHASONE ORAL SOLUTION USP AND
DEXAMETHASONE ORAL SOLUTION USP _INTENSOL_™ (CONCENTRATE)
DESCRIPTION
Dexamethasone Tablets USP are available for oral administration
containing either 0.5
mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone USP.
Each tablet
contains the following inactive ingredients: lactose monohydrate,
magnesium stearate,
starch, sugar, D&C Yellow #10 (0.5 mg and 4 mg), FD&C Blue #1 (0.75 mg
and 1.5
mg), FD&C Green #3 (4 mg and 6 mg), FD&C Red #3 (1.5 mg), FD&C Red #40
(1.5
mg), FD&C Yellow #6 (0.5 mg and 4 mg) and Yellow Iron Oxide (1 mg).
Dexamethasone Oral Solution USP is formulated for oral administration
containing 0.5
mg per 5 mL of dexamethasone USP. The cherry brandy flavored oral
solution contains
the following inactive ingredients: anhydrous citric acid, cherry
brandy flavor, disodium
edetate, glycerin, methylparaben, propylene glycol, propylparaben,
sorbitol solution and
water.
Dexamethasone Oral Solution USP Intensol™ (Concentrate) is
formulated for oral
administration containing 1 mg per mL of dexamethasone USP. In
addition, the oral
solution contains the following inactive ingredients: alcohol 30% v/v,
anhydrous citric
acid, benzoic 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
empirical 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
22
29
5
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 glucocorticoi
                                
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