Halobetasol 0.05% Cream 50gm
It is used to treat skin rashes and other skin irritation.
Drug Class
Corticosteroid, Topical
Pharmacologic Class
Adrenocorticoid, Halogenated
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) corticosteroid cream used on the skin to reduce redness, swelling, and itching caused by skin conditions like psoriasis and eczema. It works by calming down the body's immune response in the skin.
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 vaginal area.
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.
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
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 make up for a missed dose.
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 vaginal area.
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.
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
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 make up for a missed dose.
Lifestyle & Tips
- Wash hands before and after applying the cream.
- Apply a thin layer only to the affected skin area, as directed by your doctor.
- Do not use more than 50 grams per week.
- Do not use for longer than 2 consecutive weeks unless specifically instructed by your doctor.
- Avoid applying to the face, groin, or armpits unless specifically directed by your doctor, as these areas are more prone to side effects.
- Do not use with occlusive dressings (e.g., bandages, plastic wrap) unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use for diaper rash.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected skin area once or twice daily.
Condition-Specific Dosing:
Psoriasis:
Apply a thin layer to the affected skin area once or twice daily for up to 2 weeks. Treatment should not exceed 50 grams per week.
Eczema/Dermatitis:
Apply a thin layer to the affected skin area once or twice daily for up to 2 weeks. Treatment 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, apply a thin layer once daily for shortest duration possible, under strict medical supervision.
Adolescent:
For adolescents 12 years and older, apply a thin layer to the affected skin area once or twice daily for up to 2 weeks. Treatment should not exceed 50 grams per week. Use with caution due to potential for HPA axis suppression.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Dialysis:
No specific considerations for topical use.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Pharmacology
Mechanism of Action
Halobetasol propionate is a super-high potency corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing phospholipase A2 inhibitory proteins, collectively called lipocortins. 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.
Pharmacokinetics
Absorption:
Bioavailability:
Variable; depends on integrity of skin barrier, vehicle, duration of exposure, and use of occlusive dressings. Systemic absorption can occur.
Tmax:
Not precisely quantified for topical application; peak systemic levels are generally low and variable.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical application.
ProteinBinding:
Not precisely quantified for topical application, but generally binds to plasma proteins like other corticosteroids.
CnssPenetration:
Limited (systemic absorption is low, but can occur with extensive use).
Elimination:
HalfLife:
Not precisely quantified for topical application; systemic half-life of absorbed drug is similar to other corticosteroids.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Primarily renal excretion of metabolites.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory effects.
PeakEffect:
Within days to 2 weeks of continuous use.
DurationOfAction:
Effects persist as long as applied; local effects can last for hours after application.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 where the medication was applied
Thinning of the skin
Changes in eyesight
Other Possible Side Effects
Most people do not experience severe side effects, and many have no side effects or only minor ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 where the medication was applied
Thinning of the skin
Changes in eyesight
Other Possible Side Effects
Most people do not experience severe side effects, and many have no side effects or only minor ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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:
- Worsening of your skin condition or new skin problems (e.g., thinning skin, stretch marks, acne, increased hair growth).
- Signs of skin infection (redness, swelling, pus, fever).
- Unusual tiredness, weakness, nausea, vomiting, dizziness, or weight gain (signs of too much medicine absorbed into the body).
- Blurred vision or other eye problems (if used near eyes).
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.
To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:
A comprehensive list of your current medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems or conditions.
Your doctor and pharmacist will assess potential interactions between this medication and your other medications or health conditions to determine safe usage. Never start, stop, or adjust the dosage of any medication without first consulting 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.
To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:
A comprehensive list of your current medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems or conditions.
Your doctor and pharmacist will assess potential interactions between this medication and your other medications or health conditions to determine safe usage. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 a large area of skin or near open wounds, and discuss this with your doctor.
Do not use this medication for a longer period than prescribed by your doctor. Additionally, do not use it to treat acne, rosacea, or a rash around the mouth, as it is not intended for these conditions.
Be aware that this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to weigh the benefits and risks of using this medication. When breastfeeding, avoid applying the medication directly to the nipple or the surrounding area.
For children using this medication, it is crucial to exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication 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 a large area of skin or near open wounds, and discuss this with your doctor.
Do not use this medication for a longer period than prescribed by your doctor. Additionally, do not use it to treat acne, rosacea, or a rash around the mouth, as it is not intended for these conditions.
Be aware that this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to weigh the benefits and risks of using this medication. When breastfeeding, avoid applying the medication directly to the nipple or the surrounding area.
For children using this medication, it is crucial to exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication 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:
- Symptoms of Cushing's syndrome (e.g., moon face, central obesity, buffalo hump, striae, hypertension, hyperglycemia)
- Adrenal insufficiency (e.g., fatigue, weakness, nausea, vomiting, hypotension, hypoglycemia) upon abrupt withdrawal after prolonged, extensive use.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (type, severity, location of lesion)
Rationale: To assess baseline disease state and guide treatment.
Timing: Prior to initiation of therapy.
Area of body surface area (BSA) affected
Rationale: To estimate potential for systemic absorption and guide quantity of cream dispensed.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response of skin lesion
Frequency: Weekly or as clinically indicated
Target: Reduction in erythema, scaling, pruritus
Action Threshold: Lack of improvement after 2 weeks, worsening condition, or signs of adverse effects (e.g., skin atrophy, infection).
Signs of local adverse reactions (e.g., atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)
Frequency: At each follow-up visit
Target: Absence of new or worsening local adverse effects
Action Threshold: Presence of significant local adverse effects warrants discontinuation or change in therapy.
Signs/symptoms of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension, hypoglycemia)
Frequency: Periodically, especially with extensive use, prolonged therapy, or in children
Target: Absence of symptoms
Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels.
Symptom Monitoring
- Worsening of skin condition
- New skin irritation, burning, itching, or redness
- Thinning of skin
- Stretch marks (striae)
- Easy bruising
- Increased hair growth at application site
- Acne-like eruptions
- Signs of skin infection (pus, fever, increased pain)
- Unusual fatigue or weakness
- Weight gain, especially in the face and trunk (Cushingoid features)
- Blurred vision (if used near eyes)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester:
Potential for fetal growth restriction or other adverse effects with high systemic exposure.
Third Trimester:
Potential for fetal growth restriction or other adverse effects with high systemic exposure; risk of HPA axis suppression in the neonate if used extensively near term.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution. If used, avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, appropriate use. Potential for adverse effects if significant systemic absorption occurs in mother and drug passes into milk.
Pediatric Use
Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio. Not recommended for children under 12 years of age. Use in adolescents 12 years and older should be limited to the shortest duration and smallest amount possible.
Geriatric Use
No specific dosage adjustments are required. Use with caution in patients with thin or fragile skin, as they may be more susceptible to local adverse effects (e.g., skin atrophy, purpura).
Clinical Information
Clinical Pearls
- Halobetasol is a super-high potency topical corticosteroid; use should be limited to 2 consecutive weeks and not exceed 50 grams per week to minimize risk of HPA axis suppression.
- Avoid use on the face, groin, or axillae due to increased risk of skin atrophy, telangiectasias, and other local side effects.
- Occlusive dressings significantly increase systemic absorption and should be avoided unless specifically directed by a physician.
- Patients should be advised to report any signs of local irritation, skin thinning, or systemic symptoms (e.g., fatigue, weight gain).
- Not for ophthalmic, oral, or intravaginal use.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol, betamethasone, fluocinonide, triamcinolone, hydrocortisone) of varying potencies.
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for certain inflammatory skin conditions.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions.
Cost & Coverage
Average Cost:
Varies widely, typically $50-$300+ per 50gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1-3, depending on insurance plan and generic vs. brand
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 medication taken, the amount, and the time it occurred.