dexamethasone- Dexamethasone tablet dexamethasone- Dexamethasone solution, concentrate dexamethasone- Dexamethasone solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

INN (International Name):

Dexamethasone

Pharmaceutical form:

TABLET

Composition:

0.5 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:

0.5 mg yellow, scored tablets (Identified 54 299). NDC 0054-8179-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4179-25: Bottles of 100 tablets. 0.75 mg pale blue, scored tablet (Identified 54 960). NDC 0054-8180-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4180-25: Bottles of 100 tablets. 1 mg yellow, scored tablets (Identified 54 489). NDC 0054-8174-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4181-25: Bottles of 100 tablets. 1.5 mg pink, scored tablets (Identified 54 943). NDC 0054-8181-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4182-25: Bottles of 100 tablets. NDC 0054-4182-31: Bottles of 1000 tablets. 2 mg white, scored tablets (Identified 54 662). NDC 0054-8176-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4183-25 Bottles of 100 tablets. 4 mg green, scored tablets (Identified 54 892). NDC 0054-8175-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4184-25: Bottles of 100 tablets. 6 mg aqua, scored tablets (Identified 54 769). NDC 0054-8183-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4186-25: Bottles of 100 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. NDC 0054-3177-57: Bottles of 240 mL. NDC 0054-3177-63: Bottles of 500 mL. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF. NDC 0054-3176-44: Bottles of 30 mL with calibrated dropper [graduations of 0.25 mL (0.25 mg), 0.5 mL (0.5 mg), 0.75 mL (0.75 mg), and 1 mL (1 mg), on the dropper]. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Do not use if solution contains a precipitate. Dispense only in this bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days. 4047401//04 Revised September 2007 © RLI, 2007

Summary of Product characteristics

DEXAMETHASONE- DEXAMETHASONE TABLET
DEXAMETHASONE- DEXAMETHASONE SOLUTION, CONCENTRATE
DEXAMETHASONE- DEXAMETHASONE SOLUTION
----------
DEXAMETHASONE TABLETS USP,
DEXAMETHASONE ORAL SOLUTION,
AND DEXAMETHASONE INTENSOL ™ ORAL SOLUTION (CONCENTRATE)
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:
[ENTER IMAG E CAPTION HERE]
CLINICAL PHARMACOLOGY
Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are readily absorbed
22
29
5
from the gastrointestinal tract. Glucocorticoids cause varied
metabolic effects. In addition, they modify
the body's immune response