Loading...
Loading...
Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Halobetasol Propionate
Generic Name
Halobetasol Propionate
Active Ingredient
HalobetasolCategory
Retinoid [EPC]
Salt Form
Propionate
Variants
13
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| .5 mg/g | OINTMENT | TOPICAL | 72162-2067 |
| .5 mg/g | OINTMENT | TOPICAL | 70752-119 |
| .5 mg/g | OINTMENT | TOPICAL | 72162-1396 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Halobetasol Propionate, you must consult a qualified healthcare professional.
| .5 mg/g | OINTMENT | TOPICAL | 72162-2258 |
| .5 mg/g | OINTMENT | TOPICAL | 0713-0339 |
| .5 mg/g | OINTMENT | TOPICAL | 63629-8664 |
| .5 mg/g | AEROSOL, FOAM | TOPICAL | 68308-769 |
| .5 mg/g | OINTMENT | TOPICAL | 63629-8665 |
| .5 mg/g | CREAM | TOPICAL | 63629-8735 |
| .5 mg/g | CREAM | TOPICAL | 45802-129 |
| .5 mg/g | CREAM | TOPICAL | 0713-0640 |
| .5 mg/g | OINTMENT | TOPICAL | 45802-131 |
+ 1 more variants
Detailed information about Halobetasol Propionate
Halobetasol propionate is a super-high potency (Class I) topical corticosteroid used to treat inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, such as plaque psoriasis.
For the treatment of corticosteroid-responsive dermatoses and plaque psoriasis, the standard adult dosage involves applying a thin layer of halobetasol propionate (0.05%) to the affected skin areas once or twice daily.
Halobetasol propionate is generally not recommended for use in children under the age of 12. Some specific formulations (like certain lotions or foams) may have FDA approval for adolescents aged 12 to 17, but this must be confirmed with the specific product labeling.
Children have a larger skin surface area-to-body weight ratio compared to adults, which significantly increases the risk of systemic absorption and hypothalamic-pituitary-adrenal (HPA) axis suppression. If used in pediatric patients, the lowest effective dose should be used for the shortest possible duration.
Systemic absorption of topical halobetasol is generally low. Therefore, formal dosage adjustments for renal impairment are typically not required. However, monitoring for systemic corticosteroid effects is advised in patients with end-stage renal disease.
Because halobetasol is metabolized in the liver, patients with severe hepatic impairment may have reduced clearance of the drug if significant systemic absorption occurs. While no specific dose adjustments are mandated, healthcare providers should monitor these patients closely for signs of Cushing's syndrome or HPA axis suppression.
Clinical trials of halobetasol did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of skin atrophy and concomitant diseases.
If you miss a dose of halobetasol, apply it as soon as you remember. However, if it is almost time for your next scheduled application, skip the missed dose and return to your regular dosing schedule. Do not 'double up' or apply extra medication to make up for a missed dose.
Topically applied halobetasol can be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is unlikely; however, chronic overdosage (using too much or for too long) can lead to HPA axis suppression and Cushing's syndrome.
Signs of chronic overdose include:
If an overdose is suspected or if the medication is accidentally swallowed, contact a Poison Control Center or seek emergency medical attention immediately.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or extend the duration of use without medical guidance.
Because halobetasol is a super-high potency steroid, local skin reactions are relatively common. These usually occur at the site of application and may include:
These side effects may occur with regular use over several days or weeks:
Halobetasol is a 'Class I' corticosteroid, meaning it is among the most powerful topical anti-inflammatory agents known. It must be used with extreme caution. It is not a general-purpose 'itch cream' and should never be shared with others or used for skin conditions for which it was not specifically prescribed.
No FDA black box warnings for Halobetasol. However, the potential for systemic toxicity is a primary concern for regulatory bodies.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. This is more likely to occur if the drug is applied to large surface areas, used for a long time, or used under occlusion. 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.
There are no specific drugs that are absolutely contraindicated for use with topical halobetasol. However, the use of other high-potency topical corticosteroids (e.g., clobetasol, betamethasone) at the same time is strongly discouraged. This increases the risk of systemic absorption and HPA axis suppression without providing additional therapeutic benefit.
Halobetasol must NEVER be used in the following circumstances:
Pregnancy Category C: According to the FDA, there are no adequate and well-controlled studies of the teratogenic potential of halobetasol propionate in pregnant women. However, corticosteroids have been shown to be teratogenic (causing birth defects) in laboratory animals when administered systemically at relatively low dosage levels. Some topical corticosteroids have also been shown to be teratogenic in animals.
It is not known whether topical administration of halobetasol propionate 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.
Halobetasol propionate is a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. Its molecular mechanism involves the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Common questions about Halobetasol Propionate
Halobetasol is a super-high potency topical corticosteroid used primarily to treat moderate to severe plaque psoriasis and other inflammatory skin conditions like severe eczema. It works by reducing the swelling, redness, and itching associated with these conditions. Because of its strength, it is usually reserved for cases that have not responded to milder steroid treatments. It is only intended for short-term use on specific areas of the body. Your healthcare provider will determine the appropriate formulation, such as a cream, ointment, or foam, based on your specific skin needs.
The most common side effects of halobetasol are local skin reactions at the site of application, including stinging, burning, and itching. Some patients may also notice dryness or redness of the skin shortly after applying the medication. These symptoms are often temporary and may resolve as your skin becomes accustomed to the treatment. However, if these reactions persist or worsen, you should contact your doctor. Because it is so potent, even common side effects should be monitored to ensure the skin is not being damaged.
There is no known direct drug interaction between topical halobetasol and alcohol consumption. However, alcohol can be a trigger for certain skin conditions like psoriasis, potentially making the medication seem less effective. Additionally, heavy alcohol use can affect liver function, which is where any systemically absorbed halobetasol is processed. It is generally best to consume alcohol in moderation while treating a flare-up of a skin condition. Always consult your healthcare provider about your lifestyle habits during treatment.
Halobetasol is classified as Pregnancy Category C, meaning there are no definitive studies in humans, but animal studies have shown potential risks to the fetus. It should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the unborn baby. If prescribed, it should be used for the shortest time possible and on the smallest skin area necessary. You must inform your doctor if you are pregnant or planning to become pregnant before using this medication. They may suggest a lower-potency steroid as a safer alternative.
Many patients begin to see an improvement in their skin symptoms, such as reduced itching and redness, within a few days of starting halobetasol. For conditions like plaque psoriasis, it may take up to a week to see a significant reduction in the thickness and scaling of the plaques. However, the medication is strictly limited to two weeks of continuous use for most formulations to prevent serious side effects. If you do not see any improvement after two weeks, you must consult your doctor for a re-evaluation. Do not continue using it beyond the prescribed timeframe.
If you have used halobetasol for the recommended short duration (two weeks or less), you can usually stop using it without issues. However, if you have been using it for longer or over a large area, stopping suddenly can cause a 'rebound' effect where your skin condition returns worse than before. This is known as topical steroid withdrawal. To avoid this, your doctor may instruct you to gradually reduce the frequency of application. Always follow the specific discontinuation plan provided by your healthcare professional.
If you miss a dose of halobetasol, apply it as soon as you remember, unless it is nearly time for your next scheduled application. In that case, skip the missed dose and continue with your regular schedule. Do not apply a double amount of the medication to make up for the missed application, as this increases the risk of skin thinning and systemic absorption. Consistency is important for managing skin inflammation, but safety is the priority. If you frequently miss doses, discuss a reminder system with your pharmacist.
When used correctly as a topical treatment for a short period, halobetasol is unlikely to cause weight gain. However, if the medication is used excessively, for a long time, or over very large areas, enough can be absorbed into the bloodstream to cause systemic side effects. One of these effects is Cushing's syndrome, which can cause weight gain, particularly in the face and trunk. This is a sign of serious toxicity and requires immediate medical attention. Always stick to the 50-gram-per-week limit to avoid these systemic risks.
Halobetasol can interact with other medications, particularly other steroids taken by mouth or injection, which can increase the risk of adrenal suppression. You should also be cautious when using other topical products on the same area of skin, as they may change how much halobetasol is absorbed. For example, using it with a retinoid like tazarotene is a common combination but requires careful monitoring for irritation. Always provide your doctor with a full list of all prescriptions, over-the-counter drugs, and herbal supplements you are using. This ensures your treatment plan is safe and effective.
Yes, halobetasol propionate is available as a generic medication in several forms, including cream and ointment. Generic versions are typically more cost-effective than brand-name products like Ultravate while containing the same active ingredient and providing the same potency. However, some newer formulations, such as specific lotions or aerosol foams, may still be protected by patents and only available as brand-name products. Your pharmacist can help you determine if a generic version is available for the specific formulation your doctor has prescribed.
Other drugs with the same active ingredient (Halobetasol)
Rare but significant local reactions include:
While rare with topical use, systemic absorption can lead to serious complications.
> Warning: Stop taking Halobetasol and call your doctor immediately if you experience any of these.
Prolonged use of halobetasol (beyond the recommended 2-week limit) significantly increases the risk of irreversible skin damage. Long-term effects include:
There are currently no FDA black box warnings for halobetasol propionate. However, the FDA mandates strict 'Precautions' regarding HPA axis suppression and the 50g/week limit, which serve as the primary safety guardrails for this medication.
Report any unusual symptoms to your healthcare provider. If you notice signs of skin infection (pus, swelling, warmth), do not apply halobetasol to that area and consult a professional.
Patients may develop allergic contact dermatitis to the active ingredient or any of the components in the vehicle (such as propylene glycol). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. Allergic contact dermatitis is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation.
Topical corticosteroid use may increase the risk of posterior subcapsular cataracts and glaucoma. Patients should be instructed to avoid contact with the eyes. If visual symptoms like blurred vision occur, the patient should be referred to an ophthalmologist for evaluation.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, the use of halobetasol should be discontinued until the infection has been adequately controlled.
Patients using large doses of a potent topical steroid or applying it to a large surface area should be evaluated periodically for evidence of HPA axis suppression. This may include:
Halobetasol is a topical medication and is not expected to affect the ability to drive or operate machinery. However, if systemic absorption occurs and causes significant malaise or vision changes, caution is advised.
There are no known direct interactions between topical halobetasol and alcohol. However, alcohol consumption can sometimes trigger psoriasis flares or dehydrate the skin, potentially complicating the treatment process. Discuss your alcohol intake with your doctor.
Do not stop using halobetasol abruptly if you have been using it for an extended period or on a large area of the body. While it is usually limited to 2 weeks, longer use requires a 'tapering' period where the frequency of application is gradually reduced. Sudden discontinuation can lead to a 'rebound' effect, where the skin condition returns more severely than before.
> Important: Discuss all your medical conditions with your healthcare provider before starting Halobetasol, especially if you have a history of skin infections, thin skin, or adrenal gland problems.
Halobetasol may interfere with the following laboratory tests:
For each major interaction, the mechanism usually involves pharmacodynamic synergism (combined effects on the HPA axis) or altered percutaneous absorption (if used with other skin products). The management strategy involves spacing out applications, avoiding overlapping products on the same skin site, and regular clinical monitoring.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including other creams or ointments used for skin conditions.
Conditions requiring careful risk-benefit analysis include:
Patients who have reacted poorly to other halogenated corticosteroids (those containing fluorine or chlorine in their chemical structure, like clobetasol or fluocinonide) are at a higher risk of cross-sensitivity to halobetasol. If you have ever had a 'rash from a rash cream,' inform your dermatologist before starting this medication.
> Important: Your healthcare provider will evaluate your complete medical history, including any previous reactions to topical products, before prescribing Halobetasol.
Safety and effectiveness in pediatric patients under 12 years of age have not been established.
Clinical studies did not identify specific differences in safety between elderly and younger patients. However, the elderly often have thinner skin and more fragile blood vessels.
While renal clearance is the primary route of elimination for absorbed halobetasol, the amount absorbed is typically too low to require dose adjustments in patients with kidney disease. However, these patients should be monitored for systemic effects if they have compromised skin barriers.
Patients with liver failure may have a reduced ability to metabolize absorbed halobetasol. Since the drug is a super-potent steroid, even small increases in systemic levels can lead to HPA axis suppression. Use with caution and monitor for signs of systemic steroid excess.
> Important: Special populations require individualized medical assessment. Always inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
| Parameter | Value |
|---|---|
| Bioavailability | ~3% (highly variable based on skin integrity) |
| Protein Binding | ~60-90% (when systemically absorbed) |
| Half-life | Approximately 2-4 hours (plasma half-life) |
| Tmax | Not applicable for topical (local effect is immediate) |
| Metabolism | Hepatic (reduction and conjugation) |
| Excretion | Renal (primary) and Fecal |
Halobetasol is classified as a Super-High Potency Topical Corticosteroid (Group I). It is related to other potent steroids such as clobetasol propionate and diflorasone diacetate. It is distinct from lower-potency steroids like hydrocortisone (Class VII) or triamcinolone acetonide (Class IV).