Hydrocort Butyrate 0.1% Soln 60ml
It is used to treat skin irritation.It is used to treat skin rashes.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydrocortisone butyrate is a topical corticosteroid medication used to reduce inflammation, redness, and itching caused by various skin conditions like eczema and psoriasis. It works by calming 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. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vagina.
Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if you are treating a skin condition on your hand, do not wash your hand after application.
Prepare the affected area by cleaning it before use and drying it well. Apply a thin layer of the medication to the affected skin and gently rub it in. Unless your doctor advises otherwise, do not cover the treated area with bandages or dressings. Also, avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
If you are treating a skin condition in the diaper area, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures. 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 the best way to dispose 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. However, 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 use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vagina.
Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if you are treating a skin condition on your hand, do not wash your hand after application.
Prepare the affected area by cleaning it before use and drying it well. Apply a thin layer of the medication to the affected skin and gently rub it in. Unless your doctor advises otherwise, do not cover the treated area with bandages or dressings. Also, avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
If you are treating a skin condition in the diaper area, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures. 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 the best way to dispose 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. However, 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.
Lifestyle & Tips
- Apply a thin layer only to the affected skin areas as directed by your doctor.
- Wash your hands before and after applying the medication.
- Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor, as this can increase absorption.
- Avoid contact with eyes, mouth, and other mucous membranes.
- Do not use on the face, groin, or armpits unless directed by your doctor.
- Do not use for longer than prescribed, especially in children, to minimize the risk of side effects.
Available Forms & Alternatives
Available Strengths:
- Hydrocortisone 1% Ointment 28.35gm
- Hydrocortisone 2.5% Cream 30gm
- Hydrocortisone 1% Cream 28.35gm
- Hydrocortisone 2.5% Oint 28.35gm
- Hydrocortisone Val 0.2% Cream 15gm
- Hydrocortisone Val 0.2% Cream 45gm
- Hydrocortisone Val 0.2% Cream 60gm
- Hydrocortisone Val 0.2% Oint 15gm
- Hydrocortisone Val 0.2% Ont 45gm
- Hydrocortisone Val 0.2% Ont 60gm
- Hydrocortisone 2.5% Oint 453.6gm
- Hydrocortisone 1% Ointment 453.6gm
- Hydrocortisone 2.5% Ointment 20gm
- Hydrocortisone 2.5% Cream
- Hydrocortisone AC 25mg Rectal Supp
- Hydrocortisone 1% Cream
- Hydrocort Butyrate 0.1% Soln 60ml
- Hydrocortisone Ace 30mg Suppository
- Hydrocortisone Val 0.2% Cream 45gm
- Hydrocortisone But 0.1% Oint 15gm
- Hydrocortisone But 0.1% Oint 45gm
- Hydrocortisone Val 0.2% Cream 60gm
- Hydrocortisone Val 0.2% Cream 15gm
- Hydrocortisone But 0.1% Cream 15gm
- Hydrocortisone But 0.1% Cream 45gm
- Hydrocortisone 2.5% Ointment 454gm
- Hydrocortisone 2.5% Cream 20gm
- Hydrocort Butyrate 0.1% Soln 20ml
- Hydrocortisone 2.5% Lotion 59ml
- Hydrocortisone 2.5% Lotion 118ml
- Hydrocortisone 2.5% Cream 28.35gm
- Hydrocortisone 100mg Enema 7 X 60ml
- Hydrocortisone 10mg Tablets
- Hydrocortisone 20mg Tablets
- Hydrocortisone 5mg Tablets
- Hydrocortisone Butyr 0.1% Crm 60gm
- Hydrocortisone Butyr 0.1% Crm 45gm
- Hydrocortisone 1% Cream 454gm
- Hydrocortisone 1% Ointment 28gm
- Hydrocortisone 0.5% W/aloe Cream
- Hydrocortisone 2.5% Rectal Cream
- Hydrocortisone 1% Cream 14.2gm
- Hydrocortisone 1% Rectal Crm 28.4gm
- Hydrocortisone 1%/iodoquinol 1% Crm
- Hydrocortisone 1% Cream 28gm
- Hydrocortisone 10mg Tablets
- Hydrocortisone 20mg Tablets
- Hydrocortisone 5mg Tablets
- Hydrocortisone Val 0.2% Oint 45gm
- Hydrocortisone Val 0.2% Oint 60gm
- Hydrocortisone 1% Cream 28.4gm
- Hydrocortisone 1% Cream 454gm
- Hydrocortisone 2.5% Cream 454gm
- Hydrocortisone 100mg Enema 60ml
- Hydrocortisone But 0.1% Lotion 59ml
- Hydrocortisone 1% W/aloe Cream 28gm
- Hydrocortisone 1% Plus Cream 28.4gm
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected skin areas twice daily.
Condition-Specific Dosing:
psoriasis:
Apply a thin film to the affected skin areas twice daily.
eczema:
Apply a thin film to the affected skin areas twice daily.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to increased systemic absorption risk)
Infant:
Apply a thin film to the affected skin areas once daily for shortest duration possible. Not established for routine use.
Child:
Apply a thin film to the affected skin areas once or twice daily for shortest duration possible.
Adolescent:
Apply a thin film to the affected skin areas twice daily.
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
Hydrocortisone butyrate is a corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. These effects are mediated through the induction of 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.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (generally low, <5% for intact skin; increases with skin damage, occlusion, or large surface areas)
Tmax:
Not well-defined for topical application (onset of action is within hours)
FoodEffect:
Not applicable
Distribution:
Vd:
Not available (systemic distribution if absorbed)
ProteinBinding:
High (for hydrocortisone, ~90%)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not well-defined for topical application (systemic hydrocortisone half-life is ~80-118 minutes)
Clearance:
Not available
ExcretionRoute:
Renal (as inactive metabolites)
Unchanged:
<1% (systemically)
Pharmacodynamics
OnsetOfAction:
Within hours (for symptomatic relief)
PeakEffect:
Days to weeks (for full therapeutic effect)
DurationOfAction:
Up to 12-24 hours (per application)
Safety & Warnings
Side Effects
Serious 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 signs or symptoms, contact your doctor or seek medical help right away:
Allergic reaction symptoms, 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 a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Changes in eyesight
Severe headache
Irritation at the site of application
Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have 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
Dryness
* Tingling
This is not an exhaustive list of 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 signs or symptoms, contact your doctor or seek medical help right away:
Allergic reaction symptoms, 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 a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Changes in eyesight
Severe headache
Irritation at the site of application
Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have 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
Dryness
* Tingling
This is not an exhaustive list of 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:
- Severe burning, itching, or irritation at the application site
- Signs of skin infection (e.g., pus, spreading redness, fever)
- Skin thinning, easy bruising, or stretch marks developing
- Unusual weight gain, swelling in ankles/feet, or increased thirst/urination (rare, signs of systemic 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. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Do not initiate, discontinue, 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 as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Do not initiate, discontinue, 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. If you need to use it on a large area of skin, discuss this with your doctor to minimize potential risks.
In case of accidental ingestion, immediately contact a doctor or poison control center, as this medication can be harmful if swallowed. Adhere to your doctor's prescribed treatment duration and do not use this medication for an extended period.
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk. Additionally, some products may not be suitable for use in the diaper area, so it is crucial to consult with your doctor before application.
When using this medication in children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Discuss this with your doctor to ensure proper monitoring.
If you are breast-feeding and apply this medication to your breast or nipple, make sure to wash the area thoroughly before feeding your child. Certain forms of this medication may not be suitable for all age groups of children, so consult with your doctor if you have any questions or concerns.
If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the benefits and risks of using this medication with you to ensure the best possible outcome for you and your baby.
When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. If you need to use it on a large area of skin, discuss this with your doctor to minimize potential risks.
In case of accidental ingestion, immediately contact a doctor or poison control center, as this medication can be harmful if swallowed. Adhere to your doctor's prescribed treatment duration and do not use this medication for an extended period.
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk. Additionally, some products may not be suitable for use in the diaper area, so it is crucial to consult with your doctor before application.
When using this medication in children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Discuss this with your doctor to ensure proper monitoring.
If you are breast-feeding and apply this medication to your breast or nipple, make sure to wash the area thoroughly before feeding your child. Certain forms of this medication may not be suitable for all age groups of children, so consult with your doctor if you have any questions or concerns.
If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the benefits and risks of using this medication with you to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use, especially over large surface areas or under occlusion, can lead to systemic corticosteroid effects such as Cushing's syndrome, hyperglycemia, and adrenal suppression.
- Symptoms may include moon face, buffalo hump, central obesity, skin thinning, easy bruising, muscle weakness, fatigue, and high blood pressure.
What to Do:
Discontinue use 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 and extent of affected area
Rationale: To assess severity and guide treatment duration.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in inflammation, pruritus)
Frequency: Weekly to bi-weekly during initial treatment, then as needed
Target: Significant improvement in symptoms
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation or alternative therapy.
Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, burning, itching)
Frequency: At each follow-up visit
Target: Absence of significant adverse effects
Action Threshold: Presence of significant adverse effects may require dose reduction, discontinuation, or change in therapy.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, adrenal suppression)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings
Target: Normal endocrine function
Action Threshold: Any signs or symptoms warrant immediate medical evaluation and potential discontinuation.
Symptom Monitoring
- Increased redness or irritation at application site
- Skin thinning or bruising
- Stretch marks (striae)
- Acne-like eruptions
- Increased hair growth
- Signs of infection (pus, fever)
- Unusual weight gain or swelling (rare, indicative of systemic absorption)
- Fatigue, weakness, dizziness (rare, indicative of systemic absorption)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical corticosteroids is limited and generally low risk.
Second Trimester:
Generally considered safer than first trimester, but still use with caution.
Third Trimester:
Risk of fetal growth retardation or adrenal suppression with prolonged or high-dose 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 appropriate use, but monitor infant for potential adverse effects (e.g., growth suppression) if significant maternal systemic absorption occurs.
Pediatric Use
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension, growth retardation). Use the smallest amount for the shortest duration necessary. Not recommended for infants without specific medical guidance.
Geriatric Use
No specific dose adjustments are typically needed. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy and bruising. Monitor closely.
Clinical Information
Clinical Pearls
- Hydrocortisone butyrate is a medium-potency topical corticosteroid, suitable for conditions requiring more potency than hydrocortisone but less than super-potent agents.
- The solution formulation is often preferred for hairy areas or weeping lesions.
- Educate patients on proper application technique: apply a thin film, rub in gently, and do not use more than prescribed.
- Warn patients about the risk of skin atrophy, especially with prolonged use on sensitive areas like the face or skin folds.
- Adrenal suppression is a rare but serious systemic side effect, particularly in children or with extensive/occlusive use.
Alternative Therapies
- Other topical corticosteroids (e.g., triamcinolone, fluocinolone, clobetasol)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
- Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
- Emollients and moisturizers for dry skin conditions
Cost & Coverage
Average Cost:
$50 - $200 per 60ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.