DEXAMETHASONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

DEXAMETHASONE

Composition:

DEXAMETHASONE 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

4 mg green, scored tablets (Identified 54 892). NDC# 49999-059-06 6 tab/btl NDC# 49999-059-12 12 TAB/BTL NDC# 49999-059-30 30 tab/btl NDC# 49999-059-60 60 tab/btl NDC# 49999-059-90 90 tab/btl 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE- DEXAMETHASONE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
DEXAMETHASONE TABLETS USP,
RX ONLY
DES CRIPTION
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%
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 (hydrocortisone or
cortisone is the drug of choice;
may