Ultravate 0.05% Oint 15gm
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Synthetic Adrenocorticosteroid
Pregnancy Category
Category C
FDA Approved
Sep 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ultravate Ointment contains halobetasol, a strong medicine that reduces redness, swelling, and itching caused by certain skin conditions like psoriasis and eczema. It's a type of steroid that works on your 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 vagina.
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 disposing of medications, 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 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 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 disposing of medications, 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.
Lifestyle & Tips
- Apply a very thin layer only to the affected skin areas as directed by your doctor.
- Do not use more than the prescribed amount or for longer than 2 weeks, unless specifically instructed by your doctor.
- Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless your doctor tells you to, as this can increase absorption and side effects.
- Avoid applying to the face, groin, or armpits unless specifically directed by your doctor, as these areas are more susceptible to side effects.
- Wash your hands before and after applying the ointment.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- Do not use for diaper rash.
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:
Psoriasis and Eczema:
Apply a thin layer to the affected skin area once or twice daily. Treatment should be limited to 2 weeks, and total dosage should not exceed 50 g 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 adverse effects (e.g., HPA axis suppression).
Adolescent:
For adolescents 12 years and older, use with caution and limit treatment to 2 weeks, not exceeding 50 g per week.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
No specific adjustment recommended due to minimal systemic absorption.
Severe:
No specific adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
No specific adjustment recommended due to minimal systemic absorption.
Severe:
No specific adjustment recommended due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Halobetasol propionate is a high-potency synthetic corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing phospholipase A2 inhibitory proteins, 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; approximately 6% systemic absorption reported in one study with 0.05% cream under occlusive conditions. Absorption is increased by inflammation, skin barrier defects, and occlusive dressings.
Tmax:
Not well-defined for topical application due to variable absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not specifically quantified for topical application; systemically absorbed corticosteroids are widely distributed.
ProteinBinding:
Not specifically quantified for topical application; systemically absorbed corticosteroids are highly protein bound.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined for topical application; systemic corticosteroids generally have half-lives in hours.
Clearance:
Not specifically quantified for topical application.
ExcretionRoute:
Primarily renal (metabolites), some biliary.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Depends on application frequency; effects persist for several 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
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice 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 possible side effects. If you have questions or concerns about side effects, contact 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
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice 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 possible side effects. If you have questions or concerns about side effects, contact 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 redness, swelling, or irritation of the skin where the ointment is applied.
- Thinning of the skin, easy bruising, or stretch marks (striae) in the treated area.
- Acne-like breakouts or increased hair growth in the treated area.
- Signs of infection (pus, fever) in the treated area.
- Signs of systemic absorption, especially with prolonged or extensive use: unusual tiredness, weight loss, headache, swelling in ankles/feet, vision problems, increased thirst/urination (signs of high blood sugar).
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 approved for use in children younger than 12 years old.
Other Important Interactions:
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 conditions. 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 approved for use in children younger than 12 years old.
Other Important Interactions:
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 conditions. 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 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 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 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:
- Chronic overdose or misuse can lead to systemic effects such as Cushing's syndrome (moon face, buffalo hump, central obesity), 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. Call a poison control center immediately (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition and extent of dermatosis
Rationale: To establish baseline severity and guide treatment duration.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response and adverse skin reactions (e.g., atrophy, striae, telangiectasias)
Frequency: Regularly during treatment, especially if prolonged.
Target: Improvement in dermatosis without significant adverse effects.
Action Threshold: Discontinue if adverse reactions occur or if no improvement after 2 weeks.
Signs of HPA axis suppression (e.g., fatigue, weight loss, hypotension)
Frequency: Consider if used on large surface areas, under occlusion, or for prolonged periods, especially in children.
Target: Normal cortisol levels.
Action Threshold: Perform ACTH stimulation test if suppression is suspected; taper or discontinue therapy.
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
- Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria)
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 teratogenicity, though systemic absorption from topical use is low.
Second Trimester:
Risk of fetal growth restriction or other systemic effects if significant absorption occurs.
Third Trimester:
Risk of fetal growth restriction or other systemic effects if significant absorption occurs.
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 proper use, but potential for systemic effects in infant if significant absorption occurs and passes into milk.
Pediatric Use
Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio. Not recommended for children under 12 years of age. If used, limit to the smallest effective amount for the shortest duration possible, and monitor closely for HPA axis suppression.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy or purpura. Monitor skin integrity closely.
Clinical Information
Clinical Pearls
- Halobetasol propionate is a super-high potency topical corticosteroid; use with extreme caution and for short durations (typically ⤠2 weeks).
- Avoid use on the face, groin, or axillae due to increased risk of skin atrophy, telangiectasias, and other local side effects.
- Do not use occlusive dressings unless specifically instructed by a physician, as this significantly increases systemic absorption and risk of HPA axis suppression.
- Patients should be advised to report any signs of local irritation or systemic side effects.
- Consider alternative, less potent corticosteroids for maintenance therapy or less severe conditions.
Alternative Therapies
- Other high-potency topical corticosteroids (e.g., Clobetasol propionate, Betamethasone dipropionate augmented)
- Medium-potency topical corticosteroids (e.g., Triamcinolone acetonide, Mometasone furoate)
- Low-potency topical corticosteroids (e.g., Hydrocortisone)
- Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for steroid-sparing therapy, especially on sensitive areas.
- Vitamin D analogs (e.g., Calcipotriene) for psoriasis.
- Topical retinoids (e.g., Tazarotene) for psoriasis.
Cost & Coverage
Average Cost:
$50 - $200 per 15gm tube (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet; consult your pharmacist for more information. If you have any questions or concerns about this medication, 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.