Ultravate 0.05% Oint 50gm
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Synthetic Glucocorticoid; Super-High Potency Corticosteroid
Pregnancy Category
Category C
FDA Approved
Mar 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ultravate Ointment contains halobetasol, a strong medicine called a corticosteroid. It is used on the skin to reduce redness, itching, and swelling caused by certain skin conditions like eczema or psoriasis. It works by calming down the skin's immune response.
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 your 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. Also, 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 your medication, and consider participating in a drug take-back program 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 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 your 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. Also, 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 your medication, and consider participating in a drug take-back program 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 extra doses to make up for a missed one.
Lifestyle & Tips
- Wash your hands before and after applying the ointment.
- Apply a thin layer of the ointment to the affected skin area. Do not use more than directed.
- Do not cover the treated area with bandages or other dressings unless specifically told to by your doctor, as this can increase absorption and side effects.
- Avoid using this medicine on your face, groin, or armpits unless your doctor tells you to.
- Do not use this medicine for longer than 2 weeks unless directed by your doctor.
- Do not use more than 50 grams (one 50gm tube) per week.
- 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
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected skin area once or twice daily.
Condition-Specific Dosing:
duration:
Treatment should be limited to 2 consecutive weeks, and the 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.
Adolescent:
For adolescents 12 years and older, apply a thin layer to the affected skin area once or twice daily for up to 2 consecutive weeks. Total dosage should not exceed 50 grams per week.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended due to minimal systemic absorption.
Moderate:
No specific dose adjustment recommended due to minimal systemic absorption.
Severe:
No specific dose adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended due to minimal systemic absorption.
Moderate:
No specific dose adjustment recommended due to minimal systemic absorption.
Severe:
No specific dose adjustment recommended due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Halobetasol propionate is a synthetic corticosteroid that exerts its therapeutic effects primarily through its anti-inflammatory, antipruritic, and vasoconstrictive properties. It induces 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. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1%) through intact skin; however, absorption can increase significantly with inflammation, skin barrier damage, occlusive dressings, and in pediatric patients.
Tmax:
Not applicable for topical application with minimal systemic absorption.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not precisely quantified for topical application; systemically absorbed corticosteroids are widely distributed throughout the body.
ProteinBinding:
Systemically absorbed corticosteroids are highly protein-bound (primarily to albumin and transcortin).
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not precisely quantified for topical application; systemically absorbed corticosteroids have varying half-lives.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Metabolites are primarily excreted by the kidneys, with some excretion in the bile.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Effects persist as long as treatment continues; varies based on skin condition and individual response.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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 unusual symptoms, contact your doctor for advice:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 attention 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 unusual symptoms, contact your doctor for advice:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 where the medicine is applied.
- Signs of skin infection (e.g., pus, spreading redness, fever).
- Skin thinning, easy bruising, or stretch marks where the medicine is applied.
- Unusual tiredness or weakness.
- Swelling in your face or ankles.
- Blurred vision or other eye problems (rare, with prolonged or extensive use).
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 allergic reaction you experienced, including any symptoms.
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.
Other Important Interactions:
This medication may interact with other drugs or health conditions. To ensure safe use, tell your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your overall health and any existing medical conditions
Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so 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 allergic reaction you experienced, including any symptoms.
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.
Other Important Interactions:
This medication may interact with other drugs or health conditions. To ensure safe use, tell your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your overall health and any existing medical conditions
Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so 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, plan to become pregnant, or are 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 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, plan to become pregnant, or are 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 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:
- Symptoms of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, high blood pressure, high blood sugar).
- Adrenal insufficiency (e.g., fatigue, weakness, nausea, vomiting, low blood pressure) upon abrupt withdrawal after prolonged, extensive use.
- Local skin atrophy.
What to Do:
If you suspect an overdose due to excessive or prolonged use, contact your doctor or a poison control center immediately (Call 1-800-222-1222). Management is supportive and may involve gradual withdrawal of the corticosteroid if systemic effects are present.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any contraindications (e.g., skin infections).
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: Regularly during treatment, especially with prolonged use or on sensitive areas.
Target: Absence or minimal severity of reactions.
Action Threshold: Discontinue use if severe irritation or sensitization occurs. Re-evaluate if skin atrophy or other significant local side effects develop.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension)
Frequency: Consider if used extensively, for prolonged periods, with occlusive dressings, or in pediatric patients.
Target: Normal cortisol levels (if tested).
Action Threshold: Perform ACTH stimulation test if HPA axis suppression is suspected. Discontinue or gradually withdraw the drug if suppression is confirmed.
Signs of secondary infection
Frequency: Regularly during treatment.
Target: Absence of signs of infection (e.g., pus, increased redness, warmth).
Action Threshold: Initiate appropriate antimicrobial therapy if infection develops. Discontinue halobetasol if infection is not controlled.
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
- Signs of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity)
- Hyperglycemia
- Glucosuria
Special Patient Groups
Pregnancy
Halobetasol propionate 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. Animal studies have shown teratogenic effects with systemically administered corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects, though systemic absorption from topical use is minimal.
Second Trimester:
Potential for fetal growth restriction or other systemic effects if significant absorption occurs.
Third Trimester:
Potential for fetal growth restriction or other systemic effects if significant absorption occurs.
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 ointment is administered to a nursing woman. If used, avoid application to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with proper use due to minimal systemic absorption, but potential for adverse effects if significant amounts are ingested by the infant.
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. Use in children under 12 years is not recommended. If used in adolescents, monitor closely for signs of HPA axis suppression, Cushing's syndrome, and growth retardation.
Geriatric Use
No specific dose adjustments are necessary. However, elderly patients may have thinner skin, which could increase the risk of local side effects such as skin atrophy and purpura. Monitor for these effects.
Clinical Information
Clinical Pearls
- Ultravate (halobetasol propionate) is a super-high potency topical corticosteroid. It should be used with caution and for limited durations (typically no more than 2 weeks) to minimize the risk of local and systemic side effects.
- Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy and other side effects.
- Occlusive dressings significantly increase systemic absorption and should generally be avoided unless prescribed by a physician for specific conditions.
- Patients should be educated on the proper application technique (thin layer, gentle rub) and the importance of not exceeding the recommended duration or amount (50 grams per week).
- Consider the potential for HPA axis suppression, especially in pediatric patients or with extensive/prolonged use, and monitor accordingly.
Alternative Therapies
- Other super-high potency corticosteroids (e.g., Clobetasol propionate, Betamethasone dipropionate augmented)
- High potency corticosteroids (e.g., Fluocinonide, Mometasone furoate)
- Medium potency corticosteroids (e.g., Triamcinolone acetonide)
- Low potency corticosteroids (e.g., Hydrocortisone)
- Non-steroidal topical agents for inflammatory dermatoses (e.g., calcineurin inhibitors like tacrolimus or pimecrolimus, vitamin D analogs like calcipotriene for psoriasis).
Cost & Coverage
Average Cost:
$100 - $300 per 50gm tube (brand)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 for brand, Tier 1 for generic. Generally covered by most prescription plans.
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, 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 taken, the amount, and the time it occurred.