Halcinonide

Halcinonide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Halcinonide is a topical corticosteroid that is FDA approved for the treatment of corticosteroid-responsive dermatoses. Common adverse reactions include Dry skin, Pruritus, Burning sensation, Irritation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• HALOG (Halcinonide Cream, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage

Apply the 0.1% HALOG (Halcinonide Cream, USP) to the affected area two to three times daily. Rub in gently.

Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply HALOG under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

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

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Halcinonide in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Halcinonide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Halcinonide in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Halcinonide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Halcinonide in pediatric patients.

Contraindications

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

Warnings

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 steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of any 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, and for impairment of thermal homeostasis. If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or use a sequential approach when utilizing the occlusive technique.

Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Occasionally, a patient may develop a sensitivity reaction to a particular occlusive dressing material or adhesive and a substitute material may be necessary.

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.

This preparation is not for ophthalmic, oral, or intravaginal use.

Laboratory Tests A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression.

Adverse Reactions

Clinical Trials Experience

• The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (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.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Halcinonide in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): 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.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Halcinonide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Halcinonide during labor and delivery.

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 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.

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

Geriatic Use

• Of approximately 3000 patients included in clinical studies of 0.1% HALOG CREAM, 14% were 60 years or older, while 4% were 70 years or older. No overall differences in safety were observed between these patients and younger patients. Efficacy data have not been evaluated for differences between elderly and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Gender

There is no FDA guidance on the use of Halcinonide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Halcinonide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Halcinonide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Halcinonide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Halcinonide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Halcinonide in patients who are immunocompromised.

Administration and Monitoring

Administration

• topical

Monitoring

• patients receiving a large dose of any 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, and for impairment of thermal homeostasis.

IV Compatibility

There is limited information regarding IV Compatibility of Halcinonide in the drug label.

Overdosage

• Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects

Pharmacology

There is limited information regarding Halcinonide Pharmacology in the drug label.

Mechanism of Action

Structure

File:Halcinonide01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Halcinonide in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Halcinonide in the drug label.

Nonclinical Toxicology

Carcinogenesis and Mutagenesis and 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 showed negative results.

Clinical Studies

There is limited information regarding Clinical Studies of Halcinonide in the drug label.

How Supplied

Storage

There is limited information regarding Halcinonide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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 dermatologic 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.

Precautions with Alcohol

• Alcohol-Halcinonide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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