Ultravate 0.05% Cream 15gm
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Corticosteroid, High Potency
Pregnancy Category
Category C
FDA Approved
Sep 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Halobetasol is a strong corticosteroid medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It works by calming down the 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 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 completely 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 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 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 completely 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 schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a very thin layer only to the affected skin areas as directed by your doctor.
- Wash your hands before and after applying the cream.
- 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 applying to the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more susceptible to side effects.
- Do not use for longer than 2 consecutive weeks, or more than 50 grams per week, without consulting your doctor.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- Do not use on children under 12 years of age without specific medical advice and close supervision.
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:
maximumDuration:
Treatment should not exceed 2 consecutive weeks. Total weekly dosage should not exceed 50 grams.
occlusion:
Avoid occlusive dressings unless directed by physician due to increased systemic absorption.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age due to increased risk of HPA axis suppression and other systemic effects. If used, limit to smallest amount for shortest duration.
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. Monitor closely for systemic effects.
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 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:
Systemic absorption varies depending on the vehicle, integrity of the epidermal barrier, and the use of occlusive dressings. Absorption is increased on inflamed or damaged skin, and in areas with thin stratum corneum (e.g., face, scrotum).
Tmax:
Not precisely defined for topical application due to variable absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely defined for topical application due to minimal systemic absorption.
ProteinBinding:
Not precisely defined for topical application; systemically absorbed corticosteroids are highly protein bound.
CnssPenetration:
Limited, unless significant systemic absorption occurs.
Elimination:
HalfLife:
Not precisely defined for topical application; systemically absorbed corticosteroids have variable half-lives.
Clearance:
Not precisely defined for topical application.
ExcretionRoute:
Primarily renal for systemically absorbed drug; minimal systemic absorption for topical use.
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Effects persist as long as applied; local effects can last for hours after application.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of Cushing's syndrome: weight gain in the upper back or belly, moon face, severe headache, or slow wound healing
Signs of adrenal gland problems: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Irritation at the application site
Thinning of the skin
Changes in vision
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 sensations
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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of Cushing's syndrome: weight gain in the upper back or belly, moon face, severe headache, or slow wound healing
Signs of adrenal gland problems: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Irritation at the application site
Thinning of the skin
Changes in vision
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 sensations
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:
- Increased redness, itching, or irritation at the application site.
- Skin thinning, easy bruising, or stretch marks (striae).
- Acne-like breakouts or increased hair growth in the treated area.
- Signs of infection (e.g., pus, worsening pain, fever).
- Unusual fatigue, weakness, weight loss, or dizziness (signs of systemic absorption/adrenal suppression).
- Blurred vision or other eye problems (if applied 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. 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 (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure that 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, such as foods or drugs. 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 (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure that 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, 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 directed by your doctor. This medication is not intended to treat acne, rosacea, or rashes around the mouth.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor to discuss potential risks.
If you are pregnant, planning to become pregnant, or breastfeeding, inform 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 pediatric patients, use this medication with caution, as the risk of certain side effects may be higher in children. In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks; consult with your doctor to monitor growth and development.
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 directed by your doctor. This medication is not intended to treat acne, rosacea, or rashes around the mouth.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor to discuss potential risks.
If you are pregnant, planning to become pregnant, or breastfeeding, inform 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 pediatric patients, use this medication with caution, as the risk of certain side effects may be higher in children. In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks; consult with your doctor to monitor growth and development.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects due to increased absorption, including:
- Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, high blood pressure, diabetes).
- Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure).
- Growth retardation in children.
- Intracranial hypertension in children (e.g., bulging fontanelles, headaches, bilateral papilledema).
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin integrity issues.
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 of new or worsening reactions.
Action Threshold: If severe or persistent reactions occur, discontinue use and reassess treatment.
Signs of HPA axis suppression (e.g., fatigue, weight loss, hypotension, weakness)
Frequency: Periodically, especially with extensive or prolonged use, or in pediatric patients.
Target: Normal adrenal function.
Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels. Discontinue or gradually withdraw if suppression is confirmed.
Signs of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity)
Frequency: Periodically, especially with extensive or prolonged use, or in pediatric patients.
Target: Absence of signs.
Action Threshold: If suspected, investigate for systemic absorption and HPA axis suppression.
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
- Fatigue
- Weakness
- Weight loss (unexplained)
- Headache
- Blurred vision
Special Patient Groups
Pregnancy
Halobetasol propionate is 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 or other adverse effects with high doses or prolonged use.
Third Trimester:
Risk of fetal growth restriction or other adverse effects with high doses or prolonged use.
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 in nursing mothers. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with appropriate use due to minimal systemic absorption, but potential for adverse effects if significant amounts are ingested by the infant or if high systemic levels occur in the mother.
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. Increased risk of HPA axis suppression, Cushing's syndrome, and intracranial hypertension. Not recommended for children under 12 years of age. If used, limit to the smallest amount for the shortest duration possible and monitor closely.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to skin atrophy and other local side effects. Monitor for skin integrity and adverse reactions.
Clinical Information
Clinical Pearls
- Halobetasol propionate is a very high potency topical corticosteroid; use it judiciously and for short durations.
- Educate patients on the 'less is more' principle: a thin layer is sufficient. Overuse increases the risk of local and systemic side effects.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, due to increased risk of skin atrophy, telangiectasias, and other side effects in these sensitive areas.
- Warn patients about the risk of rebound flares if the medication is stopped abruptly after prolonged use.
- Consider alternative, lower-potency corticosteroids for maintenance therapy or less severe conditions once acute inflammation is controlled.
Alternative Therapies
- Clobetasol propionate (another very high potency topical corticosteroid)
- Betamethasone dipropionate augmented (high potency)
- Fluocinonide (high potency)
- Mometasone furoate (medium potency)
- Triamcinolone acetonide (medium potency)
- Non-steroidal topical agents (e.g., calcineurin inhibitors like tacrolimus or pimecrolimus, phosphodiesterase-4 inhibitors like crisaborole) for long-term management or sensitive areas.
Cost & Coverage
Average Cost:
$100 - $300 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 for generic; Tier 3 or 4 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 for more information. If you have any questions or concerns about your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.