Locoid Lipocream Information
Locoid lipocream (Hydrocortisone butyrate)
Locoid lipocream (Hydrocortisone butyrate) Description
Locoid lipocream (Hydrocortisone butyrate) ® Cream contains the topical corticosteroid hydrocortisone butyrate, a hydrocortisone ester.
It has the chemical name: (11ß)-11,21-dihydroxy-17-[(1-oxobutyl)oxy]-pregn-4-ene-3,20-dione;
the molecular formula: CHO;
the molecular weight: 432.54;
and the CAS registry number: 13609-67-1.
The structural formula is:
Each gram of Locoid lipocream (Hydrocortisone butyrate) ® Cream contains 1 mg of hydrocortisone butyrate in a hydrophilic base consisting of cetostearyl alcohol, ceteth-20, mineral oil, white petrolatum, citric acid, sodium citrate, propylparaben and butylparaben (preservatives) and purified water.
Locoid lipocream (Hydrocortisone butyrate) Clinical Pharmacology
Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Locoid lipocream (Hydrocortisone butyrate) 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 other disease processes in the skin increase percutaneous absorption. Occlusive dressings or widespread application may increase the possibility of hypothalamic-pituitary-adrenal (HPA) axis suppression.
The vasoconstrictor assay showed that Locoid lipocream (Hydrocortisone butyrate) ® Cream had a more pronounced skin blanching effect than Locoid® Cream, suggesting greater percutaneous absorption from the former. At the present time, no adequate HPA axis suppresion studies have been conducted for Locoid lipocream (Hydrocortisone butyrate) ® Cream.
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees.
Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Locoid lipocream (Hydrocortisone butyrate) Indications And Usage
Locoid lipocream (Hydrocortisone butyrate) ® (hydrocortisone butyrate 0.1%) Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Locoid lipocream (Hydrocortisone butyrate) Contraindications
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Locoid lipocream (Hydrocortisone butyrate) Precautions
Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which increase the risk of systemic toxicity include the application of more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See )
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.
Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Chronic corticosteroid therapy may interfere with the growth and development of children.
Locoid lipocream (Hydrocortisone butyrate) Adverse Reactions
The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Locoid lipocream (Hydrocortisone butyrate) Overdosage
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See )
Locoid lipocream (Hydrocortisone butyrate) Dosage And Administration
Locoid lipocream (Hydrocortisone butyrate) ® (hydrocortisone butyrate 0.1%) Cream should be applied to the affected areas as a thin film two or three times daily (depending on the severity of the condition) and for no longer than two weeks. If an infection develops, appropriate antimicrobial therapy should be instituted.
Locoid lipocream (Hydrocortisone butyrate) How Supplied
Locoid lipocream (Hydrocortisone butyrate) ® (hydrocortisone butyrate 0.1%) Cream is supplied in tubes containing:
15 g NDC 0496-0821-15
45 g NDC 0496-0821-45
60 g NDC 0496-0821-25
Store at controlled temperature between 59º - 77ºF (15º - 25ºC).
Protected Under U.S. Patent
