DEXAMETHASONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ANI Pharmaceuticals, Inc.

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 anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases For the palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low- dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. Systemic fungal infections (see WARNINGS, Fungal Infections). Dexamethasone tablets are contraindicated in patients who are hypersensitive to any components of this product.

Product summary:

Dexamethasone Tablets, USP are available as follows: 0.5 mg tablets are supplied as a light yellow, round, shallow, biconvex tablet, scored on one side and debossed with “N 398” on the other side. NDC 70954-398-10: Bottle of 100 Tablets 0.75 mg tablets are supplied as a pale blue, round, shallow, biconvex tablet, scored on one side and debossed with “N 399” on the other side. NDC 70954-399-10: Bottle of 100 Tablets 1.5 mg tablets are supplied as a pink, round, shallow, biconvex tablet, scored on one side and debossed with “N 401” on the other side. NDC 70954-401-10: Bottle of 100 Tablets 2 mg tablets are supplied as a white to off white, round, shallow, biconvex tablet, scored on one side and debossed with “N 402” on the other side. NDC 70954-402-10: Bottle of 100 Tablets 4 mg tablets are supplied as a green, round, shallow, biconvex tablet, scored on one side and debossed with “N 403” on the other side. NDC 70954-403-10: Bottle of 100 Tablets NDC 70954-403-30: Unit dose blister packages of 100 (10 cards of 10 Tablets each) 6 mg tablets are supplied as an aqua, round, shallow, biconvex tablet, scored on one side and debossed with “N 404” on the other side. NDC 70954-404-10: Bottle of 100 Tablets   Store and Dispense Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight light-resistant, child-resistant container as defined in the USP/NF. All trademarks are the property of their respective owners. Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Issued: 02/2024 LB4336-02

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE - DEXAMETHASONE TABLET
ANI PHARMACEUTICALS, INC.
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DEXAMETHASONE TABLETS, USP
RX ONLY
DESCRIPTION
Dexamethasone Tablets, USP for oral administration, are supplied in
the following
potencies, 0.5 mg, 0.75 mg, 1.5 mg, 2 mg, 4 mg and 6 mg. Inactive
ingredients are
Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium,
Magnesium
Stearate, FD&C Blue #1 Aluminum Lake (0.75 mg, 4 mg, 6 mg), D&C Red
#27 Aluminum
Lake (1.5 mg), FD&C Red #40 Aluminum Lake (1.5 mg), FD&C Yellow #6
Aluminum Lake
(0.5 mg), D&C Yellow #10 Aluminum Lake (0.5 mg, 0.75 mg, 1.5 mg, 4 mg,
6 mg).
The molecular weight for dexamethasone is 392.47. It is designated
chemically as 9-
fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione.
The empirical
formula is C22H29FO5 and the structural formula is
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.
FDA approved dissolution test specifications differ from USP.
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 & USAGE
ALLERGIC STATES
Control of severe or incapacitating allergic conditions intractable to
adequate trials of
conventional treatment in asthma, atopic dermatitis, contact
dermatitis, drug
hyperse