DEXAMETHASONE elixir

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Dexamethasone (UNII: 7S5I7G3JQL) (Dexamethasone - UNII:7S5I7G3JQL)

Available from:

Rising Pharma Holdings, Inc.

INN (International Name):

Dexamethasone

Composition:

Dexamethasone 0.5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer - Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis - Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lup

Product summary:

Dexamethasone Elixir, USP 0.5 mg/5 mL is supplied as a clear, red, raspberry-flavored liquid in the following size:    8 fl oz (237 mL) bottle (NDC 64980-509-24) RECOMMENDED STORAGE Store at 20˚-25˚C (68˚-77˚F) [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED AVOID FREEZING Dispense in a tight container as defined in the USP. Rx Only Manufactured for: Rising Pharmaceuticals, Inc. East Brunswick, NJ 08816 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R8-11/22

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXAMETHASONE- DEXAMETHASONE ELIXIR
RISING PHARMA HOLDINGS, INC.
----------
DEXAMETHASONE ELIXIR, USP
DESCRIPTION
EACH 5 ML (TEASPOONFUL) CONTAINS:
Dexamethasone, USP . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . 0.5 mg
ALSO CONTAINS:
Benzoic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . 0.1%
(as preservative)
Alcohol (% v/v) . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . 5.1%
INACTIVE INGREDIENTS: artificial raspberry flavor; citric acid; FD&C
red no. 40; sucrose;
propylene glycol and purified water. IT MAY ALSO CONTAIN sodium
citrate dihydrate.
Glucocorticoids are adrenocortical steroids, both naturally occurring
and synthetic,
which are readily absorbed from the gastrointestinal tract.
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 weight is 392.47. It is designated chemically as
9-fluoro-11β,17,21-trihydroxy-
16α-methylpregna-1,4-diene-3,20-dione. The molecular formula is C
H
FO and the
structural formula is:
CLINICAL PHARMACOLOGY
Naturally occurring glucocorticoids, (hydrocortisone and cortisone),
which also have
salt-retaining properties, are used as replacement therapy in
adrenocortical deficiency
states. Their synthetic analogs, including dexamethasone, are
primarily used for their
potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify
the body’s immune responses to diverse stimuli.
At equipotent anti-inflammatory doses, dexamethasone almost completely
lacks the
sodium-retaining property of hydrocortisone and closely related
derivatives of
hydrocortisone.
INDICATIONS AND USAGE
1. _ Endocrine Disorders:_ Primary or secondary adrenocortical
insufficiency
(hydrocortisone or cortisone is the first choice; synthetic analogs
may be used in
conjunction with mineralocorticoids where applicable; in infancy
mine