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Hydrocortisone Lotion

Pronunciation

Dosage Form: topical lotion

Rx only
FOR EXTERNAL USE ONLY
AVOID CONTACT WITH EYES

DESCRIPTION:

Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of hydrocortisone in a vehicle consisting of carbomer 980, propylene glycol, polysorbate 40, propylene glycol stearate, cholesterol and related sterols, isopropyl myristate, sorbitan palmitate, cetyl alcohol, triethanolamine, sorbic acid, simethicone, and purified water.

Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β)- and is represented by the following structural formula:

Hydrocortisone has the molecular formula C21H30O5 and a molecular weight of 362.47. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

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 other disease processes in the skin increase the percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION.)

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.

INDICATIONS AND USAGE:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS:

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS:

General - Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS - Pediatric Use).

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.

Information for the Patient - Patients using topical corticosteroids should receive the following information and instructions:

1.
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2.
Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
3.
The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
4.
Patients should report any signs of local adverse reactions, especially under occlusive dressing.
5.
Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests - The following tests may be helpful in evaluating the HPA axis suppression:

 
Urinary free cortisol test
 
ACTH stimulation test

Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy: Teratogenic effects- Pregnancy Category C. - Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers - 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.

Pediatric Use - 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 to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients 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.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

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

Perioral dermatitis

Itching

Allergic contact dermatitis

Irritation

Maceration of the skin

Dryness

Secondary infection

Folliculitis

Skin atrophy

Hypertrichosis

Striae

Acneiform eruptions

Miliaria

Hypopigmentation

OVERDOSAGE:

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION:

Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED:

Hydrocortisone Lotion USP, 2.5% is supplied in a 59 mL (2 Fl Oz) bottle.

 
NDC 0168-0288-02

Shake well before using. Store at controlled room temperature 15°- 30°C (59°- 86°F).

Keep out of the reach of children.

E. FOUGERA & CO.
A division of Fougera
PHARMACEUTICALS INC.
Melville, New York 11747

I2288C/IF2288C
R10/15
#278

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 59 ML (2Fl Oz) LABEL

 
NDC 0168-0288-02

Fougera®

Hydrocortisone Lotion USP, 2.5%

Rx only

FOR EXTERNAL USE ONLY
AVOID CONTACT WITH EYES
SHAKE WELL BEFORE USING

59 mL (2 Fl Oz)

E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, New York 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 59 ML (2Fl Oz) CARTON

 
NDC 0168-0288-02

Fougera®

HYDROCORTISONE
LOTION USP, 2.5%

Rx only

FOR EXTERNAL USE ONLY
AVOID CONTACT WITH EYES
SHAKE WELL BEFORE USING

59 mL (2 Fl Oz)

E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, New York 11747

HYDROCORTISONE 
Hydrocortisone Lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0168-0288
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 25 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)  
PROPYLENE GLYCOL  
POLYSORBATE 40  
PROPYLENE GLYCOL STEARATE  
CHOLESTEROL  
ISOPROPYL MYRISTATE  
SORBITAN MONOPALMITATE  
CETYL ALCOHOL  
TROLAMINE  
SORBIC ACID  
DIMETHICONE  
SILICON DIOXIDE  
WATER  
Packaging
# Item Code Package Description
1 NDC:0168-0288-02 59 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040351 07/25/2000
Labeler - E.FOUGERA & COMPANY A division of Fougera Pharmaceuticals Inc. (043838424)
Revised: 10/2015
 
E.FOUGERA & COMPANY A division of Fougera Pharmaceuticals Inc.



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