NUCORT- hydrocortisone acetate lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Gentex Pharma

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE: NuCort lotion is a topical corticosteroid and is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. CONTRAINDICATIONS: Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Geriatric Use: Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious using the least amount compatible with an effective therapeutic regimen and reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Product summary:

NuCort® is supplied in 2oz. bottles (NDC 15014-0185-01, NDC 15014-0185-02) Store upright at controlled room temperature 15° – 30°C (59° – 86°F).

Authorization status:

unapproved drug other

Summary of Product characteristics

NUCORT- HYDROCORTISONE ACETATE LOTION
GENTEX PHARMA
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
NUCORT LOTION
(HYDROCORTISONE ACETATE 2%)
RX ONLY
DESCRIPTION: NuCort
(hydrocortisone acetate 2%) is a low potency topical lotion
containing:
Hydrocortisone Acetate 2% in a base containing: Acrylates/C10-30 Alkyl
Acrylate Crosspolymer,
Aloe Barbadensis Leaf Juice, Benzyl Alcohol, C12-15 Alkyl Bensoate,
Camphor, Cetyl Alcohol, Cetyl
Palmitate, Dimethicone, Glycerin, Glyceryl Stearate, Menthol, PEG-7
Glyceryl Cocoate, Polysorbate
60, Purified Water, Sorbitan Stearate, Squalane and Triethanolamine
NuCort® contains a synthetic
corticosteroid used as an anti-inflammatory Hydrocortisone acetate
Molecular weight: 404.50.
Solubility of hydrocortisone acetate in water: 1mg/100mL. Chemical
name: Pregn-4-ene-3, 20-dione,
21-(acetyloxy)-11, 17-dihydroxy-(11β)-.The structural formula of
hydrocortisone acetate is:
CLINICAL PHARMACOLOGY: Topical corticosteroids share
anti-inflammatory, antipruritic and
vasoconstrictive actions. The mechanism of anti-inflammatory activity
of the topical corticosteroids is
unclear. Various laboratory methods, including vasoconstrictor assays,
are used to compare and predict
potencies and/or clinical efficacies of the topical corticosteroids.
There is some evidence to suggest
that a recognizable correlation exists between vasoconstrictor potency
and therapeutic efficacy in man.
_PHARMACOKINETICS:_ The extent of percutaneous absorption of topical
corticosteroids is determined by
many factors including the vehicle, the integrity of the epidermal
barrier, and the use of occlusive
dressings. Topical corticosteroids can be absorbed from normal intact
skin. Inflammation and/or disease
processes in the skin increase the percutaneous absorption of topical
corticosteroids. Occlusive
dressings substantially increase the percutaneous absorption of
topical cortic