Halobetasol 0.05% Ointment 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
Mar 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Halobetasol 0.05% Ointment is a very strong steroid medicine applied to the skin. It helps reduce redness, swelling, and itching caused by severe skin conditions like eczema or psoriasis. It should be used exactly as prescribed and for a short time only.
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 area being treated. 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 continue with your regular 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 vaginal area.
Wash your hands before and after applying the medication, unless your hand is the area being treated. 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 continue with your regular schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply a thin layer to the affected skin area(s) as directed by your doctor, usually once or twice daily.
- Wash your hands before and after applying the ointment.
- Do not use more than the prescribed amount or for longer than 2 consecutive weeks, unless specifically instructed by your doctor.
- Do not use more than 50 grams of ointment per week.
- Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless your doctor tells you to.
- Avoid applying the ointment to your face, groin, or armpits unless specifically directed by your doctor, as these areas are more sensitive to side effects.
- Avoid getting the ointment in your eyes, mouth, or nose. If it gets into these areas, rinse thoroughly with water.
- Do not use this medicine for diaper rash.
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:
maximumDuration:
Do not use for more than 2 consecutive weeks.
maximumAmount:
Do 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.
Adolescent:
For adolescents 12 years and older, use with caution and for limited duration, similar to adult dosing but with close monitoring for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Halobetasol propionate is a synthetic corticosteroid. It induces 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. Thus, halobetasol propionate exerts anti-inflammatory, antipruritic, and vasoconstrictive actions.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <6%) through intact skin; increased by inflammation, skin folds, occlusive dressings, prolonged use, and in pediatric patients.
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application.
ProteinBinding:
Not well-defined for topical application.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined for topical application due to minimal systemic absorption.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Primarily renal (for systemically absorbed drug), but minimal.
Unchanged:
Not well-defined for topical application.
Pharmacodynamics
OnsetOfAction:
Local anti-inflammatory and antipruritic effects typically observed within days.
PeakEffect:
Local effects peak within days to a week of consistent application.
DurationOfAction:
Effects persist as long as applied; local duration not precisely quantified.
Confidence:
Medium
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 symptoms that bother you or do not go away, contact your doctor or seek medical help:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of all 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 symptoms that bother you or do not go away, contact your doctor or seek medical help:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of all 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 no improvement after 2 weeks.
- Signs of a skin infection (e.g., pus, fever, increased pain or redness).
- Severe burning, stinging, or irritation at the application site.
- Skin thinning, stretch marks (striae), or unusual hair growth in the treated area.
- Changes in skin color (lightening or darkening).
- Systemic side effects such as unusual weight gain, swelling in your ankles or feet, increased thirst or urination, or muscle weakness (signs of too much steroid absorption).
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.
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. Verify that it is safe to take this medication with your existing treatments and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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.
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. Verify that it is safe to take this medication with your existing treatments and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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 use this medication safely, avoid applying it to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss with your doctor beforehand.
Do not exceed the prescribed treatment duration, as specified by your doctor. Additionally, this medication is not intended to treat acne, rosacea, or rashes around the mouth.
Be aware that this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to weigh the benefits and risks of using this medication during these situations. When breastfeeding, avoid applying the medication directly to the nipple or the surrounding area.
For children using this medication, it is essential to exercise caution, as the risk of certain side effects may be higher. In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so consult with your doctor to discuss the potential risks and benefits.
To use this medication safely, avoid applying it to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss with your doctor beforehand.
Do not exceed the prescribed treatment duration, as specified by your doctor. Additionally, this medication is not intended to treat acne, rosacea, or rashes around the mouth.
Be aware that this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to weigh the benefits and risks of using this medication during these situations. When breastfeeding, avoid applying the medication directly to the nipple or the surrounding area.
For children using this medication, it is essential to exercise caution, as the risk of certain side effects may be higher. In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so consult with your doctor to discuss the potential risks and benefits.
Overdose Information
Overdose Symptoms:
- Signs of Cushing's syndrome (e.g., moon face, central obesity, buffalo hump)
- Adrenal insufficiency (HPA axis suppression) upon withdrawal
- Hyperglycemia (high blood sugar)
- Glucosuria (sugar in urine)
What to Do:
If you suspect an overdose or excessive systemic absorption, contact your poison control center (1-800-222-1222) or seek immediate medical attention. Management is supportive and may involve gradual withdrawal of the corticosteroid.
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.
Routine Monitoring
Local skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis, burning, itching)
Frequency: Regularly during treatment, especially with prolonged use.
Target: Absence of new or worsening reactions.
Action Threshold: If severe or persistent reactions occur, discontinue use and reassess.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight gain, moon face)
Frequency: Periodically, especially with extensive body surface area application, prolonged use, or in pediatric patients.
Target: Normal adrenal function.
Action Threshold: If suspected, perform appropriate tests (e.g., ACTH stimulation test) and consider gradual withdrawal or alternative therapy.
Blood glucose (in susceptible patients)
Frequency: Periodically, especially in diabetic patients or those at risk for hyperglycemia with extensive or prolonged use.
Target: Within normal limits or patient's target range.
Action Threshold: If hyperglycemia occurs, adjust diabetes management or consider discontinuing halobetasol.
Symptom Monitoring
- Burning
- itching
- irritation
- dryness
- folliculitis
- hypertrichosis
- acneiform eruptions
- hypopigmentation
- perioral dermatitis
- allergic contact dermatitis
- maceration of the skin
- secondary infection
- skin atrophy
- striae
- miliaria
- unusual weight gain
- fatigue
- muscle weakness
- swelling in ankles/feet
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption of topical corticosteroids can occur.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical corticosteroids are limited.
Second Trimester:
Potential for fetal growth restriction or other systemic effects with extensive or prolonged use.
Third Trimester:
Potential for fetal growth restriction or other systemic effects with extensive or prolonged use.
Lactation
Use with caution. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use; higher risk with extensive application or prolonged use due to potential for systemic absorption and excretion into breast milk.
Pediatric Use
Children are more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio and immature skin barrier. Not recommended for children under 12 years of age. If used in adolescents, monitor closely for signs of HPA axis suppression, Cushing's syndrome, and growth retardation.
Geriatric Use
Generally safe for use in geriatric patients. However, elderly patients may have thinner skin, which could increase the risk of local side effects like skin atrophy and purpura. Monitor for skin fragility.
Clinical Information
Clinical Pearls
- Halobetasol propionate is one of the most potent (super-high potency) topical corticosteroids available. It should be reserved for severe, recalcitrant dermatoses.
- Due to its high potency, limit the duration of use to 2 consecutive weeks to minimize the risk of local adverse effects (e.g., skin atrophy, striae) and systemic absorption (e.g., HPA axis suppression).
- Avoid use on the face, groin, or axillae unless specifically directed by a physician, as these areas are more prone to atrophy, telangiectasias, and other side effects.
- Not indicated for the treatment of rosacea or perioral dermatitis, as it can exacerbate these conditions.
- Patients should be instructed on proper application technique: apply a thin layer, rub in gently, and do not use occlusive dressings unless advised by a healthcare professional.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol propionate, betamethasone dipropionate, fluocinonide, triamcinolone acetonide)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for certain inflammatory skin conditions, especially on sensitive areas.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread, or recalcitrant dermatoses.
Cost & Coverage
Average Cost:
Varies, typically $100 - $300+ per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for generic), Tier 3 or higher (for 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 information about the medication taken, the amount, and the time it happened.