Halobetasol 0.05% Cream 15gm
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Corticosteroid, Super-High Potency
Pregnancy Category
Category C
FDA Approved
Sep 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Halobetasol is a very strong (super-high potency) steroid cream used to treat severe skin conditions like eczema and psoriasis. It works by reducing redness, swelling, and itching. It should only be used for short periods and exactly as prescribed by your doctor.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Precautions
Unless directed by your doctor, do not apply the medication to your face, underarms, or groin area.
Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.
Storage and Disposal
Store the medication at room temperature and do not freeze it.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Precautions
Unless directed by your doctor, do not apply the medication to your face, underarms, or groin area.
Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.
Storage and Disposal
Store the medication at room temperature and do not freeze it.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply a thin layer to the affected area, usually once or twice a day, as directed by your doctor.
- Wash your hands before and after applying the cream.
- Do not use more than the prescribed amount or for longer than 2 weeks unless specifically instructed by your doctor.
- Do not use on the face, groin, or armpits unless specifically directed by your doctor, as these areas are more sensitive to side effects.
- Do not cover the treated area with bandages or other occlusive dressings unless instructed by your doctor, as this can increase absorption and side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Inform your doctor if your condition worsens or does not improve after 2 weeks of treatment.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected skin area once or twice daily.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
duration:
Treatment should be limited to 2 consecutive weeks. Total dosage should not exceed 50 grams per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age due to increased risk of systemic absorption and HPA axis suppression. If used, limit to the smallest amount for the shortest duration.
Adolescent:
Apply a thin layer to the affected skin area once or twice daily. Limit treatment to 2 consecutive weeks. Total dosage should not exceed 50 grams per week.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Halobetasol propionate is a synthetic corticosteroid. Like other topical corticosteroids, it possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. These effects are thought to be mediated by the induction of phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 6% or less) through intact skin. Absorption is increased by occlusive dressings, inflammation, and other diseases of the skin.
Tmax:
Not typically applicable for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not well-characterized due to minimal systemic absorption.
ProteinBinding:
Not well-characterized due to minimal systemic absorption.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-characterized due to minimal systemic absorption.
Clearance:
Not well-characterized due to minimal systemic absorption.
ExcretionRoute:
Primarily renal, if systemically absorbed.
Unchanged:
Not well-characterized due to minimal systemic absorption.
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Effects persist as long as applied, with residual effects for a short period after discontinuation.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation at the site of application
Thinning of the skin
Changes in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation at the site of application
Thinning of the skin
Changes in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased irritation, burning, itching, or redness at the application site
- Development of new skin problems like thinning skin, stretch marks, acne, or hair growth
- Signs of skin infection (e.g., pus, fever, spreading redness)
- Unusual fatigue, weakness, dizziness, or nausea (signs of systemic absorption)
- Swelling in the face or ankles, or unexplained weight gain
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the symptoms you experienced during an allergic reaction.
The presence of an infection at the site where this medication will be administered.
Special Considerations for Children:
If the patient is under 12 years of age, do not administer this medication. It is not approved for use in children younger than 12 years old.
Interactions with Other Medications and Health Conditions:
This medication may interact with other drugs or health problems. To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or diseases
Do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the symptoms you experienced during an allergic reaction.
The presence of an infection at the site where this medication will be administered.
Special Considerations for Children:
If the patient is under 12 years of age, do not administer this medication. It is not approved for use in children younger than 12 years old.
Interactions with Other Medications and Health Conditions:
This medication may interact with other drugs or health problems. To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or diseases
Do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before using any other medications or skin products, including soaps, consult with your doctor to ensure safe use.
When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. Exercise caution when applying it to large areas of skin or near open wounds, and discuss this with your doctor.
Do not use this medication for longer than prescribed by your doctor, and do not use it to treat acne, rosacea, or rashes around the mouth. Prolonged use may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to weigh the benefits and risks to you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
For children, this medication should be used with caution, as the risk of certain side effects may be higher. In some cases, it may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss the potential risks and benefits.
When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. Exercise caution when applying it to large areas of skin or near open wounds, and discuss this with your doctor.
Do not use this medication for longer than prescribed by your doctor, and do not use it to treat acne, rosacea, or rashes around the mouth. Prolonged use may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to weigh the benefits and risks to you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
For children, this medication should be used with caution, as the risk of certain side effects may be higher. In some cases, it may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss the potential risks and benefits.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects due to absorption, including Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, thin skin, easy bruising), hyperglycemia, glucosuria, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment should be initiated. HPA axis function should be assessed. Call 1-800-222-1222 for poison control advice.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin infections or atrophy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response of dermatosis
Frequency: Weekly or as clinically indicated
Target: Reduction in erythema, pruritus, scaling
Action Threshold: Lack of improvement or worsening of condition after 1-2 weeks; development of local adverse reactions.
Signs of HPA axis suppression (e.g., fatigue, weight loss, hypotension)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings.
Target: Normal adrenal function
Action Threshold: Any signs or symptoms suggestive of systemic absorption or HPA axis suppression; consider laboratory testing (e.g., ACTH stimulation test, plasma cortisol).
Local skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis)
Frequency: At each follow-up visit
Target: Absence of new or worsening local adverse effects
Action Threshold: Development of significant local adverse effects; consider reducing frequency, potency, or discontinuing therapy.
Symptom Monitoring
- Worsening of skin condition
- Increased redness, itching, burning, or stinging at application site
- Development of new skin lesions (e.g., pimples, thinning skin, stretch marks)
- Signs of skin infection (e.g., pus, fever, increased pain)
- Unusual fatigue or weakness
- Weight gain, especially in the face or trunk
- Increased thirst or urination
Special Patient Groups
Pregnancy
Halobetasol is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies with high doses of corticosteroids. Risk in humans is uncertain.
Second Trimester:
Risk of HPA axis suppression in the fetus with prolonged or extensive use of potent topical corticosteroids.
Third Trimester:
Risk of HPA axis suppression in the fetus with prolonged or extensive use of potent topical corticosteroids.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when halobetasol propionate cream is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use due to minimal systemic absorption. Monitor infant for signs of systemic corticosteroid effects (e.g., poor weight gain).
Pediatric Use
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects, including HPA axis suppression and Cushing's syndrome. Use in children under 12 years is generally not recommended. If used, limit to the smallest amount for the shortest duration. Monitor for growth retardation.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to local adverse effects such as skin atrophy and purpura. Monitor closely for skin integrity and systemic effects.
Clinical Information
Clinical Pearls
- Halobetasol is a super-high potency topical corticosteroid; use with caution and for short durations (typically ⤠2 weeks) to minimize risk of local and systemic side effects.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more susceptible to atrophy and other side effects.
- Educate patients on proper application technique (thin layer, gentle rub) and the importance of not exceeding the prescribed duration or amount (e.g., 50g/week).
- Be vigilant for signs of HPA axis suppression, especially in pediatric patients or those using the cream on large body surface areas or under occlusion.
- Consider tapering off if used for longer periods to prevent rebound flares of the dermatosis.
Alternative Therapies
- Other super-high potency topical corticosteroids (e.g., Clobetasol propionate, Betamethasone dipropionate augmented)
- High potency topical corticosteroids (e.g., Fluocinonide, Mometasone furoate)
- Medium potency topical corticosteroids (e.g., Triamcinolone acetonide)
- Calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for steroid-sparing therapy, especially on sensitive areas.
- Vitamin D analogs (e.g., Calcipotriene) for psoriasis.
- Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread dermatoses not controlled by topical agents.
Cost & Coverage
Average Cost:
$50 - $250+ per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2-3 (often requires prior authorization for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it was taken.