Ultravate 0.05% Cream 50gm
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Sep 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Halobetasol is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like psoriasis or eczema. It's a type of steroid cream.
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 treated area. 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 treated area. 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
- Wash hands before and after applying the cream.
- Apply a very thin layer only to the affected skin areas.
- Do not cover the treated area with bandages or tight dressings unless directed 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.
- Do not use for longer than 2 weeks unless advised by your doctor.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- Do not use on open wounds or broken skin.
Available Forms & Alternatives
Available Strengths:
Generic 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 the affected skin areas once or twice daily for up to 2 weeks. Treatment beyond 2 weeks is not recommended, and the total dosage should not exceed 50 g per week.
dermatitis:
Apply a thin layer to the affected skin areas once or twice daily for up to 2 weeks. Treatment beyond 2 weeks is not recommended, and the 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 absorption and adrenal suppression. If used, limit to the smallest amount for the shortest duration.
Adolescent:
Not recommended for children under 12 years of age due to increased risk of systemic absorption and adrenal suppression. If used, limit to the smallest amount for the shortest duration.
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 adjustment recommended 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 synthetic corticosteroid. Corticosteroids are thought to act by inducing phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that 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:
Minimal systemic absorption (less than 6%) after topical application, but can increase with occlusive dressings, prolonged use, or application to large surface areas or damaged skin.
Tmax:
Not precisely quantified for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not precisely quantified for topical application due to minimal systemic absorption.
ProteinBinding:
Not precisely quantified for topical application; systemically absorbed corticosteroids are highly protein-bound.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely quantified for topical application due to minimal systemic absorption; systemic corticosteroids have variable half-lives.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Primarily renal excretion of metabolites, if systemically absorbed.
Unchanged:
Not precisely quantified for topical application.
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Effects persist as long as applied; duration of relief after cessation varies.
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 experience no side effects or only mild ones. If you notice 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 a comprehensive 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.
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 experience no side effects or only mild ones. If you notice 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 a comprehensive 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 skin condition or new skin problems (e.g., severe burning, itching, irritation, dryness, redness, thinning of skin, stretch marks, acne, changes in skin color)
- Signs of infection (e.g., pus, fever, spreading redness)
- Unusual weight gain, especially in the face or trunk (moon face, buffalo hump)
- Increased thirst or urination
- Unusual tiredness or weakness
- Blurred vision or eye pain
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. It is not approved for use in children younger than 12 years old.
To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:
A complete list of your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you are experiencing.
Your doctor needs this information to determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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. It is not approved for use in children younger than 12 years old.
To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:
A complete list of your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you are experiencing.
Your doctor needs this information to determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 products on your skin, including soaps, consult with your doctor.
To ensure safe use, 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 with your doctor.
Adhere to your doctor's prescribed treatment duration and do not use this medication for longer than recommended. Additionally, do not use this medication to treat acne, rosacea, or a rash around the mouth.
This medication 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 are breastfeeding, consult your doctor to weigh the benefits and risks to you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or the 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.
To ensure safe use, 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 with your doctor.
Adhere to your doctor's prescribed treatment duration and do not use this medication for longer than recommended. Additionally, do not use this medication to treat acne, rosacea, or a rash around the mouth.
This medication 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 are breastfeeding, consult your doctor to weigh the benefits and risks to you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or the 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:
- Prolonged or excessive use can lead to systemic effects of corticosteroids, including adrenal suppression (Cushing's syndrome), hyperglycemia, and glucosuria.
- Local symptoms may include severe skin thinning, bruising, and stretch marks.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (type, extent, severity of dermatosis)
Rationale: To establish baseline for treatment efficacy and identify potential contraindications.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs of local adverse reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)
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 systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, HPA axis suppression)
Frequency: Periodically, especially with extensive use, occlusive dressings, or in pediatric patients.
Target: Normal adrenal function (e.g., normal cortisol levels).
Action Threshold: If suspected, perform appropriate tests (e.g., ACTH stimulation test, plasma cortisol, urinary free cortisol) and consider withdrawal or reduction of the drug.
Signs of infection (e.g., worsening redness, pus, fever)
Frequency: Regularly during treatment.
Target: Absence of infection.
Action Threshold: If infection develops, discontinue halobetasol and initiate appropriate antimicrobial therapy.
Symptom Monitoring
- Worsening of skin condition
- Increased redness, swelling, or pain at application site
- Development of new skin lesions (e.g., thinning, bruising, stretch marks)
- Unusual fatigue or weakness
- Weight gain, especially in the face or trunk
- Increased thirst or urination
Special Patient Groups
Pregnancy
Category C. Should be used 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 minimal.
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
L3 (Moderately safe). 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 is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with proper use, but potential for systemic effects if significant absorption occurs 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. Not recommended for children under 12 years of age. If used, limit to the smallest amount for the shortest duration possible, and monitor closely for signs of HPA axis suppression and Cushing's syndrome.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to local adverse effects such as skin atrophy and purpura. Monitor for skin integrity.
Clinical Information
Clinical Pearls
- Halobetasol propionate is a super high-potency topical corticosteroid (Class I). Use with caution and for short durations (typically up to 2 weeks).
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, due to increased risk of skin atrophy and other side effects in these sensitive areas.
- Occlusive dressings significantly increase systemic absorption and should generally be avoided unless specifically prescribed.
- Patients should be advised to report any signs of local irritation, infection, or systemic side effects.
- Abrupt discontinuation after prolonged, extensive use may lead to rebound flare of the dermatosis or signs of adrenal insufficiency.
Alternative Therapies
- Clobetasol propionate (another super high-potency topical corticosteroid)
- Betamethasone dipropionate (high-potency topical corticosteroid)
- Fluocinonide (high-potency topical corticosteroid)
- Tacrolimus ointment (non-steroidal topical calcineurin inhibitor)
- Pimecrolimus cream (non-steroidal topical calcineurin inhibitor)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200+ per 50gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 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 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, including the amount and time of ingestion.