Halobetasol 0.05% Ointment 50gm
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Corticosteroid, Potent
Pregnancy Category
Category C
FDA Approved
Mar 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Halobetasol is a very strong (potent) corticosteroid medicine applied to the skin to reduce inflammation, redness, and itching caused by certain skin conditions like psoriasis and eczema. It works by calming down the immune response in the skin.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.
Applying the Medication
This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vagina.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
Do not apply the medication to your face, underarms, or groin area unless your doctor has specifically instructed you to do so. Additionally, do not cover the treated area with bandages or dressings unless your doctor has told you to do so.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing. 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 you have been instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in drug take-back programs in your area.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.
Applying the Medication
This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vagina.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
Do not apply the medication to your face, underarms, or groin area unless your doctor has specifically instructed you to do so. Additionally, do not cover the treated area with bandages or dressings unless your doctor has told you to do so.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing. 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 you have been instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in drug take-back programs in your area.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Apply a thin layer to the affected skin areas as directed by your doctor, usually once or twice a day.
- Do not use more than 50 grams per week.
- Do not use for longer than 2 consecutive weeks unless specifically instructed by your doctor.
- Wash your hands before and after applying the ointment.
- Do not cover the treated area with bandages or other dressings unless your doctor tells you to, as this can increase absorption and side effects.
- Avoid contact with eyes, mouth, and other mucous membranes.
- Do not use on the face, groin, or armpits unless specifically directed by your doctor, as these areas are more susceptible to side effects.
- Keep out of reach of children.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected skin areas once or twice daily.
Condition-Specific Dosing:
psoriasis:
Apply a thin layer to affected areas once or twice daily for up to 2 weeks. Treatment should be limited to 50 grams per week.
eczema:
Apply a thin layer to affected areas once or twice daily for up to 2 weeks. Treatment should be limited to 50 grams per week.
Pediatric Dosing
Neonatal:
Not established. Use is generally not recommended due to increased risk of systemic absorption and HPA axis suppression.
Infant:
Not established. Use is generally not recommended due to increased risk of systemic absorption and HPA axis suppression.
Child:
Not established. Use is generally not recommended due to increased risk of systemic absorption and HPA axis suppression. If used, limit to smallest amount for shortest duration.
Adolescent:
Not established. Use with caution, similar to adults but with increased monitoring for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical application.
Moderate:
No specific adjustment needed for topical application.
Severe:
No specific adjustment needed for topical application.
Dialysis:
No specific adjustment needed for topical application, as systemic absorption is minimal.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical application.
Moderate:
No specific adjustment needed for topical application.
Severe:
No specific adjustment needed for topical application.
Pharmacology
Mechanism of Action
Halobetasol propionate is a synthetic corticosteroid. Corticosteroids exert their effects by binding to glucocorticoid receptors in the cytoplasm, forming a complex that translocates to the nucleus. This complex then binds to specific DNA sequences (glucocorticoid response elements), modulating gene transcription. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines). This results in anti-inflammatory, antipruritic, and vasoconstrictive actions.
Pharmacokinetics
Absorption:
Bioavailability:
Variable; depends on vehicle, skin integrity, site of application, duration of exposure, and use of occlusive dressings. Systemic absorption can occur.
Tmax:
Not applicable for topical application; systemic levels are generally low.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not specifically quantified for topical application; systemically absorbed corticosteroids distribute widely.
ProteinBinding:
High (typically >90% for corticosteroids) to plasma proteins, primarily albumin and corticosteroid-binding globulin.
CnssPenetration:
Limited for topical application; significant CNS penetration is not expected with typical use.
Elimination:
HalfLife:
Not specifically quantified for topical application; systemically absorbed corticosteroids have variable half-lives (e.g., 18-36 hours for betamethasone, a related compound).
Clearance:
Not specifically quantified for topical application.
ExcretionRoute:
Primarily renal excretion of inactive metabolites.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days to weeks of consistent application.
DurationOfAction:
Localized effect persists for several hours after application; systemic effects are minimal with appropriate use.
Safety & Warnings
Side Effects
Urgent 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 where the medication was applied
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 unusual symptoms, contact your doctor or seek medical help:
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.
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 where the medication was applied
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 unusual symptoms, contact your doctor or seek medical help:
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:
- Severe burning, itching, or irritation of the treated skin.
- Skin thinning, easy bruising, or stretch marks (striae) in the treated area.
- Changes in skin color (lightening or darkening).
- New or worsening skin infections.
- Signs of systemic absorption, such as unusual weight gain, swelling in the face or ankles, increased thirst or urination, or muscle weakness (especially if used over large areas or for prolonged periods).
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. Be sure to describe the symptoms you experienced.
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. This medication is not recommended for children younger than 12 years old.
Additional Interactions and Precautions:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues. 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. Be sure to describe the symptoms you experienced.
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. This medication is not recommended for children younger than 12 years old.
Additional Interactions and Precautions:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues. 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, such as soaps, consult with your doctor to ensure safe use.
To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss the application with your doctor.
Adhere to your doctor's prescribed treatment duration and avoid using this medication for longer than recommended. Additionally, do not use this medication to treat acne, rosacea, or perioral dermatitis (a rash around the mouth).
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 pediatric patients, use this medication with caution, as children may be at a higher risk of experiencing certain side effects. 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.
To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss the application with your doctor.
Adhere to your doctor's prescribed treatment duration and avoid using this medication for longer than recommended. Additionally, do not use this medication to treat acne, rosacea, or perioral dermatitis (a rash around the mouth).
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 pediatric patients, use this medication with caution, as children may be at a higher risk of experiencing certain side effects. 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:
- Prolonged or excessive use can lead to systemic absorption, potentially causing symptoms of Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension, hyperglycemia), adrenal insufficiency upon withdrawal, and growth retardation in children.
What to Do:
Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. In case of accidental ingestion or significant systemic absorption, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify areas for application.
Timing: Prior to initiation of therapy.
Adrenal function (HPA axis suppression)
Rationale: Consider if large body surface area is treated, prolonged use, or occlusive dressings are used, especially in children, due to risk of systemic absorption.
Timing: Before starting therapy if risk factors are present.
Routine Monitoring
Local skin reactions (atrophy, striae, telangiectasias, burning, itching)
Frequency: Regularly during treatment, especially after 2 weeks of continuous use.
Target: Absence of new or worsening reactions.
Action Threshold: Discontinue use if severe reactions occur; consider alternative therapy.
Signs of systemic corticosteroid effects (Cushing's syndrome, hyperglycemia, glucosuria)
Frequency: Periodically, especially with prolonged use, large surface area application, or in pediatric patients.
Target: Absence of signs/symptoms.
Action Threshold: If suspected, perform appropriate diagnostic tests (e.g., plasma cortisol, ACTH stimulation test) and gradually withdraw medication.
Efficacy of treatment
Frequency: Weekly or bi-weekly during the initial treatment period.
Target: Improvement in dermatological symptoms.
Action Threshold: If no improvement after 2 weeks, re-evaluate diagnosis and treatment plan.
Symptom Monitoring
- Burning
- Itching
- Irritation
- Erythema
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Maceration of the skin
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
- Weight gain (systemic)
- Moon face (systemic)
- Fatigue (systemic)
- Weakness (systemic)
Special Patient Groups
Pregnancy
Category C. 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 teratogenic effects, though systemic absorption from topical use is generally low.
Second Trimester:
Risk of fetal growth restriction and other adverse effects with high systemic exposure.
Third Trimester:
Risk of fetal growth restriction and other adverse effects with high systemic exposure; potential for adrenal suppression in the neonate if used extensively near term.
Lactation
Use with caution. It is not known whether topical halobetasol is excreted in human milk. Systemically administered corticosteroids appear in human milk. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with appropriate use (minimal systemic absorption), but potential for adverse effects if significant absorption occurs or if applied to areas where infant may ingest.
Pediatric Use
Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Risk of HPA axis suppression and Cushing's syndrome is higher. Use the smallest amount for the shortest duration necessary, and avoid occlusive dressings. Not recommended for children under 12 years of age.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could increase the risk of local side effects (e.g., atrophy, purpura) and potentially systemic absorption. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Halobetasol propionate is a super-high potency topical corticosteroid; use should be limited to 2 consecutive weeks and no more than 50 grams per week to minimize the risk of HPA axis suppression.
- Avoid use on the face, groin, or axillae due to increased risk of skin atrophy, telangiectasias, and striae in these sensitive areas.
- Occlusive dressings significantly increase systemic absorption and local side effects; generally avoid unless specifically directed by a physician.
- Patients should be advised to report any signs of local irritation or systemic effects.
- Not for ophthalmic, oral, or intravaginal use.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol, betamethasone, triamcinolone, fluocinonide, hydrocortisone) of varying potencies.
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Topical retinoids for psoriasis.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe dermatoses.
Cost & Coverage
Average Cost:
Varies widely, typically $50 - $200+ per 50gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic; Tier 3 or higher for brand.
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.