CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. skin rash that becomes thick and discolored from rubbing it. Hemorrhoids should be evaluated by a colo-rectal or general surgeon you will require dietary, bathroom habit modifications and sometimes . The medication should not be used for any disorder other than that for which it was prescribed. if you are having surgery, including dental surgery, tell the doctor or dentist that you are using halobetasol topical. Consult your pharmacist or local waste disposal company. Halobetasol Propionate Cream 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. 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. If the victim has collapsed or is not breathing, call local emergency services at 911. During pregnancy, this medication should be used only when clearly needed. Studies in the rat following oral administration at dose levels up to 50 mcg/kg/day indicated no impairment of fertility or general reproductive performance. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Halobetasol Propionate Cream should not be used with occlusive dressings. Stay away from open fire, flames, and do not smoke while you are applying halobetasol foam, and for a short time afterwards. Copyright, 2023. It is for external use only. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Halobetasol may cause other side effects. Before using halobetasol, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as hydrocortisone, prednisone); or if you have any other allergies. It is for external use only. HALOBETASOL is a corticosteroid. Halobetasol Propionate Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Do not use if there is an infection or sore present in the area to be treated. Corticosteroids, like Halobetasol Propionate, prevent the body from producing chemicals that cause swelling. Halobetasol reduces the swelling, itching, and redness that can occur in these types of conditions. skin inflammation. Positive mutagenicity effects were observed in two genotoxicity assays. Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. E. FOUGERA & CO. In controlled clinical trials, the most frequent adverse events reported for Halobetasol Propionate Ointment included stinging or burning in 1.6% of the patients. This medication may be harmful if swallowed. Halobetasol foam is flammable. Apply a thin layer of this medicine to the affected area of the skin. Safety and effectiveness of Halobetasol Propionate Ointment in pediatric patients have not been established and use in pediatric patients under 12 is not recommended. Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. Halobetasol is a highly potent steroid that helps reduce inflammation in the body. If you miss a dose, use it as soon as you remember. Halobetasol Propionate Ointment should not be used with occlusive dressings. Halobetasol Propionate Ointment, 0.05% is supplied in the following tube sizes: Store at 20-25C (68-77F) [see USP Controlled Room Temperature]. 4971 Southridge Blvd., Suite 101 If a favorable response does not occur promptly, use of Halobetasol Propionate Cream should be discontinued until the infection has been adequately controlled. 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. Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using halobetasol foam and each time you get a refill. Keep this medication in the container it came in, tightly closed, and out of reach of children. 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. Find patient medical information for halobetasol propionate topical on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Many people using this medication do not have serious side effects. . 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. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not wrap or bandage the treated area unless your doctor tells you that you should. skin rash that becomes thick and discolored from rubbing it. These doses are approximately 13, 33 and 3 times, respectively, the human topical dose of Halobetasol Propionate Cream. itching of the genital area. Teratogenic effects: Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. In controlled clinical trials, the most frequent adverse events reported for Halobetasol Propionate Cream included stinging, burning or itching in 4.4% of the patients. Your doctor may order certain lab tests to check your body's response to halobetasol. Instead, the best way to dispose of your medication is through a medicine take-back program. If you miss a dose, use it as soon as you remember. Do not use if there is an infection or sore in the area to be treated. Dr. Jarrod Kaufman answered. Do not start, stop, or change the dosage of any medicines without your doctor's approval. This can lead to side effects of too much corticosteroid. Do not wash your hands after use if putting this on your hand. If no improvement is seen within 2 weeks, reassessment of diagnosis may . Keep all medical and lab appointments. Burning, stinging, itching, dryness or redness may occur when first applied to the skin. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Use in children under 12 years of age is not recommended. Chemically halobetasol propionate is 21-chloro-6,9-difluoro-11,17-dihydroxy-16-methylpregna-1,4-diene-3-20-dione,17-propionate, C25H31ClF2O5 . Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Mayo Clinic does not endorse companies or products. The lowest GoodRx price for the most common version of halobetasol is around $34.80, 83% off the average retail price of $205.44. WebMD does not provide medical advice, diagnosis or treatment. NOT FOR OPHTHALMIC USE. Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: Laboratory Tests: The following tests may be helpful in evaluating patients for HPA axis suppression: Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. 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. You may report side effects to Health Canada at 1-866-234-2345. Distributed by: If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088). Before using this medication, tell your doctor or pharmacist your medical history. 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. Halobetasol Propionate Cream 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. Pediatric Use: Safety and effectiveness of Halobetasol Propionate Cream in pediatric patients have not been established and use in pediatric patients under 12 is not recommended. This product may contain inactive ingredients, which can cause allergic reactions or other problems. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). A division of Fougera Pharmaceuticals Inc.Melville, New York 11747. In Canada - Call your doctor for medical advice about side effects. Halobetasol propionate has the molecular weight of 485. 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 corticosteroid. FREE delivery. Tell your doctor if your condition does not get better or if it gets worse. It is in the topical corticosteroid class of drugs. Topically applied Halobetasol Propionate Ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS). Review/update the 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. Use this medication only on the skin. 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. Halobetasol Cream Prescribing Information, Teratogenic effects: Pregnancy Category C, To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or. The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH-stimulation test; A.M. plasma cortisol test; Urinary free-cortisol test. No overall differences in safety or effectiveness were observed between these patients and younger patients; and 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. 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. Such an observation should be corroborated with appropriate diagnostic patch testing. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. See the doctor regularly so your child's height can be checked. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Tell your doctor right away if you have any serious side effects, including: stretch marks, skin thinning/discoloration, acne, excessive hair growth, small red bumps on the skin (folliculitis). What should I know about storage and disposal of this medication? This activity will highlight the mechanism of action, adverse event profile, and other key . However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. 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. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. 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). skin inflammation. McKesson Corporation Things to remember when you fill your prescription. 2) The medication should not be used for any disorderother than that for which it was prescribed. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Chemically halobetasol propionate is 21-chloro-6 . If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. All rights reserved. Halobetasol Propionate Ointment 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. What side effects can this medication cause? The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Last updated on Feb 20, 2023. Rx Only. URL of this page: https://medlineplus.gov/druginfo/meds/a601060.html. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Do not double the dose to catch up. Skin infections can become worse when using this medication. Halobetasol Propionate Ointment produced HPA axis suppression when used in divided doses at 7 grams per day for one week in patients with psoriasis. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. plaque psoriasis. Ask your pharmacist any questions you have about refilling your prescription. 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