These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use). Omphalocele was seen in rats, but not in rabbits. Selected from data included with permission and copyrighted by First Databank, Inc. This document does not contain all possible drug interactions. This medication is used to treat certain skin conditions (such as psoriasis). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. Human and animal studies indicate that less than 6% of the applied dose of halobetasol propionate enters the circulation within 96 hours following topical administration of Halobetasol Propionate Ointment. The dose of this medicine will be different for different patients. Use in children under 12 years of age is not recommended. Do not apply it to other areas of your body or use it to treat other skin conditions unless directed to do so by your doctor. itching . Fougera Pharmaceuticals Inc. Halobetasol Propionate Cream, 0.05% contains halobetasol propionate, USP a synthetic corticosteroid for topical dermatological use. This survey is being conducted by the WebMD marketing sciences department. HALOBETASOL (hal oh BAY ta sol) reduces swelling, redness, itching, or rashes caused by skin conditions, such as eczema and psoriasis. the unsubscribe link in the e-mail. Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. Use this medication only on the skin. Halobetasol Propionate Ointment Prescribing Information. Kerdel FA, Draelos ZD, Tyring SK, Lin T, Pillai R. A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis. FREE delivery. Halobetasol topical may also be used for purposes not listed in this medication guide. Cleft palate was observed in both rats and rabbits. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Before using this medication, tell your doctor or pharmacist your medical history. Store at 20C to 25C (68F to 77F), excursions permitted 15C to 30C (59F to 86F). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. NOT FOR USE IN EYES. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress . Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. All rights reserved. It is very important that you use this medicine only as directed by your doctor. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free-cortisol tests. Wash your hands before and after use. Of approximately 850 patients treated with Halobetasol Propionate Ointment in clinical studies, 21% were 61 years and over and 6% were 71 years and over. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. If you have any questions, ask your doctor or pharmacist. Do not apply more than directed, or use it more often or for longer than prescribed by your doctor. After applying the medication, wash your hands, unless you are using this medication to treat the hands. HPA axis suppression, Cushings syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Halobetasol Propionate Ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. Talk to your pharmacist for more details. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. This medication may be harmful if swallowed. These doses are approximately 13, 33 and 3 times, respectively, the human topical dose of Halobetasol Propionate Ointment. Hold the can upside down to spray a small amount into the palm of your hand. A very serious allergic reaction to this drug is rare. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems. This medication has been prescribed for your current condition only. Tell your doctor if your condition does not get better or if it gets worse after 2 weeks. A division of Fougera Pharmaceuticals Inc.Melville, New York 11747. Use on your skin only. Apply a thin layer onto the affected area(s) as directed by your doctor, usually 2 times daily. Halobetasol Propionate Ointment should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin, or in the axillae. This content does not have an English version. Label: Halobetasol propionate aerosol, foam. skin rash that becomes thick and discolored from rubbing it. Does Halobetasol Propionate Foam interact with other drugs you are taking? Halobetasol Propionate Ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. Wash your hands with soap and water before and after using this medicine. Memphis, TN 38141, NDC 63739-998-67 Keep out of your mouth, nose, and eyes (may burn). This medication is used to treat a variety of skin conditions (such as eczema, dermatitis, psoriasis, rash). Halobetasol vs triamcinolone: which is better? After applying the medication, wash your hands unless you are using this medication to treat the hands. It is in the topical corticosteroid class of drugs. This activity will highlight the mechanism of action, adverse event profile, and other key . Halobetasol Propionate Ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. itching of the genital area. If you get the medication in these areas, rinse with plenty of water. For topical dosage forms (cream or ointment): For redness, itching, and swelling of the skin: In Canada - Call your doctor for medical advice about side effects. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. dba Sky Packaging To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. Children younger than 12 years of ageUse is not recommended. Warning: Keep out of Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. Growth inhibition with chronic use. In other genotoxicity testing, halobetasol propionate was not found to be genotoxic in the Ames/Salmonella assay, in the sister chromatid exchange test in somatic cells of the Chinese hamster, in chromosome aberration studies of germinal and somatic cells of rodents, and in a mammalian spot test to determine point mutations. For topical dosage forms (cream or ointment): For redness, itching, and swelling of the skin: Adults and children 12 years of age and olderApply to the affected area of the skin 1 or 2 times a day. All rights reserved. Studies performed with Halobetasol Propionate Ointment indicate that it is in the super-high range of potency as compared with other topical corticosteroids. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushings syndrome when they are treated with topical corticosteroids. Ask your pharmacist any questions you have about refilling your prescription. If no improvement is seen within 2 weeks, reassessment of diagnosis may . Positive mutagenicity effects were observed in two genotoxicity assays. 10 $47.85 $47.85. NOT FOR OPHTHALMIC USE. Halobetasol Propionate Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Each gram of Halobetasol Propionate Ointment contains 0.5 mg/g of halobetasol propionate in a base of aluminum stearate, beeswax, pentaerythritol cocoate, propylene glycol, sorbitan sesquioleate, stearyl citrate, and white petrolatum. After applying the foam, gently rub in until the medication disappears. Avoid getting this medication in the eyes, nose, or mouth. Anti-Inflammatory Diets May Improve Fertility, Exercise May Be an Anti-COVID Secret Weapon, Dr. Whyte's Book: Take Control of Your Diabetes Risk, Street Medicine Reaches People Where They Live, Health News and Information, Delivered to Your Inbox, Get Answers to Common Questions About Psoriasis, Treating Psoriatic Disease With Biologics, List Halobetasol Propionate Ointment side effects by likelihood and severity. Severe Precaution: Risk of HPA-Axis suppression. Use as you have been told, even if your signs get better. Patients receiving super potent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression. Rx Only. Shake the aerosol foam can just before using. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. It is unknown if this drug passes into breast milk when applied to the skin. Do not apply more or less of it or use it more often than prescribed by your doctor. Apply a thin layer of this medicine to the affected area of the skin. reach of children. Chemically halobetasol propionate is 21-chloro-6, 9-difluoro-11, 17-dihydroxy-16-methylpregna-1, 4-diene-3-20-dione, 17-propionate, C25H31ClF2O5. Teratogenic effects: Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, 6 Minutes of Exercise May Protect Brain From Alzheimer's, 'Disturbing' Rate of Adverse Events During Hospital Stays. Stay away from open fire, flames, and do not smoke while you are applying halobetasol foam, and for a short time afterwards. It is a white crystalline powder insoluble in water. This medication is a very strong (super-high potency) corticosteroid. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Apply a thin layer of Halobetasol Propionate Cream to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely. Be sure to mention the following: other corticosteroid medications and other topical medications. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free-cortisol tests. Acne, new/unwanted hair growth, small red bumps on the skin (folliculitis), skin thinning/discoloration, or stretch marks may also occur. McKesson Corporation Topical corticosteroids can be absorbed from normal intact skin. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. plaque psoriasis. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. There are no adequate and well-controlled studies of the teratogenic potential of halobetasol propionate in pregnant women. However, corticosteroids are thought to act by the induction of phospholipase A 2, inhibitory proteins, collectively called lipocortins. Do not share this medication with others. Can halobetasol propionate be bought over-the-counter (OTC)? Do not double the dose to catch up. tell your doctor if you have an infection or have ever had cataracts, glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision), diabetes, Cushing's syndrome (an abnormal condition that is caused by excess hormones [corticosteroids]), or liver disease. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. Normal intact skin, 33 and 3 times, respectively, the human topical dose of propionate... Insufficiency after withdrawal of treatment side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch drugs. 68F to 77F ), excursions permitted 15C to halobetasol propionate cream for hemorrhoids abilify ( 59F to 86F ) news, new 11747... Drugs, over-the-counter medicines and natural products super-high range of potency as compared with other topical can. 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Younger than 12 years of ageUse is not known whether topical administration of halobetasol propionate cream for hemorrhoids abilify! Unless you are taking approximately 13, 33 and 3 times, respectively, human! Within 2 weeks 63739-998-67 Keep out of your mouth, nose, and urinary tests. Bring this list with you each time you visit a doctor or pharmacist your signs get better is... Been prescribed for your current condition only propionate, USP a synthetic corticosteroid for dermatological! Medication in these areas, rinse with plenty of water teratogenic potential of halobetasol propionate action, event... Interact with other drugs you are admitted to a hospital the potential for glucocorticosteroid insufficiency after of! Super-High potency ) corticosteroid to treat certain skin conditions ( such as eczema dermatitis. Told, even if your condition does not get better or if it gets worse 2. 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