DEXAMETHASONE 1.5 MG tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Larken Laboratories, Inc.

INN (International Name):

DEXAMETHASONE

Composition:

DEXAMETHASONE 1.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Dexamethasone 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 tablet to ensure accurate breaking. They are available in bottles of 100 tablets, NDC 68047-702-01. 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Distributed by: Larken Laboratories, Inc. Canton, MS 39046 www.larkenlabs.com 500393-08 Rev. 12/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE 1.5 MG- DEXAMETHASONE 1.5 MG TABLET
LARKEN LABORATORIES, INC.
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DEXAMETHASONE TABLETS USP, 1.5 MG
RX ONLY
DESCRIPTION
Dexamethasone Tablets USP, 1.5 mg
Each tablet contains: Dexamethasone USP … 1.5 mg.
For oral administration.
INACTIVE INGREDIENT
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 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 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 se