Hydrocort Butyrate 0.1% Soln 20ml
It is used to treat skin irritation.It is used to treat skin rashes.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Corticosteroid, Medium Potency
Pregnancy Category
Category C
FDA Approved
Jun 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydrocortisone butyrate is a topical corticosteroid medication used on the skin to reduce inflammation, itching, and redness caused by various skin conditions like eczema and 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. 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're treating a skin condition on your hand, do not wash your hand after application.
Before applying the medication, clean the affected area and dry it well. Then, gently rub a thin layer of the medication onto the affected skin. 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 specifically instructs you to do so.
If you're treating a skin condition in the diaper area, do not use tight-fitting diapers or plastic pants, as this can cause the medication to be absorbed into the body more easily.
Storage and Disposal
Store this 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 instructed to do so by your pharmacist. You may also want to check with your pharmacist about drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it's 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 one.
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're treating a skin condition on your hand, do not wash your hand after application.
Before applying the medication, clean the affected area and dry it well. Then, gently rub a thin layer of the medication onto the affected skin. 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 specifically instructs you to do so.
If you're treating a skin condition in the diaper area, do not use tight-fitting diapers or plastic pants, as this can cause the medication to be absorbed into the body more easily.
Storage and Disposal
Store this 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 instructed to do so by your pharmacist. You may also want to check with your pharmacist about drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it's 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 one.
Lifestyle & Tips
- Apply a thin layer of the solution to the affected skin areas as directed by your doctor, usually 2 to 3 times a day.
- Gently rub it in until it disappears.
- 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 and side effects.
- Avoid applying the solution to your eyes, mouth, or inside your nose.
- Do not use for longer than prescribed, especially on the face, groin, or armpits, as this can lead to skin thinning or other side effects.
- Inform your doctor if your condition worsens or does not improve after 2 weeks of treatment.
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 layer to the affected skin areas 2 to 3 times daily.
Condition-Specific Dosing:
eczema:
Apply a thin layer to the affected skin areas 2 to 3 times daily.
psoriasis:
Apply a thin layer to the affected skin areas 2 to 3 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Apply a thin layer to the affected skin areas 2 to 3 times daily. Use with caution; increased risk of systemic absorption.
Child:
Apply a thin layer to the affected skin areas 2 to 3 times daily. Use with caution; increased risk of systemic absorption.
Adolescent:
Apply a thin layer to the affected skin areas 2 to 3 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed for topical use.
Moderate:
No adjustment typically needed for topical use.
Severe:
No adjustment typically needed for topical use.
Dialysis:
No specific considerations for topical use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically needed for topical use.
Moderate:
No adjustment typically needed for topical use.
Severe:
No adjustment typically needed for topical use.
Pharmacology
Mechanism of Action
Hydrocortisone butyrate is a medium-potency 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:
Minimal systemic absorption (<1% to 3% or more depending on skin integrity, vehicle, and occlusion)
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not clinically relevant for topical application.
ProteinBinding:
Systemically absorbed corticosteroids are extensively bound to plasma proteins, primarily corticosteroid-binding globulin and albumin.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not clinically relevant for topical application due to minimal systemic absorption.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
Systemically absorbed metabolites are primarily excreted in the urine.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Days to weeks of consistent application.
DurationOfAction:
Varies depending on the condition and frequency of application.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
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 immediately:
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 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 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 or seek medical attention:
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 symptoms, contact your doctor or seek medical attention immediately:
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 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 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 or seek medical attention:
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:
- Increased redness, swelling, or pus (signs of infection)
- Severe burning, itching, or irritation at the application site
- Skin thinning, easy bruising, or stretch marks (striae)
- Acne-like breakouts
- Increased hair growth in the treated area
- Any signs of systemic side effects like unusual weight gain, swelling in the face, or fatigue (rare, but possible with extensive or prolonged 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. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Do not initiate, discontinue, or modify 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Do not initiate, discontinue, or modify 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.
To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When using this medication on a large area of skin, exercise caution and discuss this with your doctor.
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; therefore, consult with your doctor to discuss potential risks. Certain 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 the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss potential risks and benefits.
If you are breast-feeding and using this medication on your breast or nipple, ensure you wash the area thoroughly before breast-feeding your child. Some formulations of this medication may not be suitable for all age groups of children, so it is essential to 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 potential benefits and risks of this medication to you and your baby.
To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When using this medication on a large area of skin, exercise caution and discuss this with your doctor.
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; therefore, consult with your doctor to discuss potential risks. Certain 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 the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss potential risks and benefits.
If you are breast-feeding and using this medication on your breast or nipple, ensure you wash the area thoroughly before breast-feeding your child. Some formulations of this medication may not be suitable for all age groups of children, so it is essential to 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 potential benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use, especially over large areas or under occlusion, can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, thinning skin, easy bruising, muscle weakness, and hyperglycemia.
- Adrenal suppression (fatigue, weakness, nausea, vomiting) can also occur.
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 assessment
Rationale: To establish baseline severity of dermatosis and identify any signs of infection or skin breakdown.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus, erythema)
Frequency: Regularly during treatment, typically weekly or bi-weekly.
Target: Improvement in symptoms.
Action Threshold: Lack of improvement or worsening symptoms warrants re-evaluation.
Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)
Frequency: Regularly during treatment, especially with prolonged use.
Target: Absence of adverse effects.
Action Threshold: Development of adverse effects warrants discontinuation or change in therapy.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with extensive use, prolonged use, or in pediatric patients.
Target: Normal adrenal function, normal blood glucose.
Action Threshold: Symptoms or lab abnormalities warrant investigation and potential discontinuation.
Symptom Monitoring
- Worsening of skin condition
- Signs of skin infection (pus, increased redness, warmth)
- Skin thinning or atrophy
- Stretch marks (striae)
- Easy bruising
- Increased hair growth at application site
- Acne-like eruptions
- Changes in vision (rare, with systemic absorption)
- Unusual fatigue or weakness (rare, with systemic absorption)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but potential for fetal harm cannot be ruled out.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally avoided unless clearly necessary.
Second Trimester:
Use with caution; minimal systemic absorption expected.
Third Trimester:
Use with caution; minimal systemic absorption expected.
Lactation
L3 (Moderately Safe). Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Systemic absorption is minimal, but caution is advised. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with appropriate use (minimal systemic absorption, avoid breast area).
Pediatric Use
Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported. Use the least potent effective dose for the shortest duration possible. Avoid occlusive dressings.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for local and systemic adverse effects.
Clinical Information
Clinical Pearls
- Hydrocortisone butyrate is a medium-potency topical corticosteroid, suitable for various inflammatory dermatoses.
- Apply sparingly and only to affected areas. A 'thin layer' means just enough to cover the lesion.
- Avoid prolonged use, especially on the face, intertriginous areas (skin folds), or under occlusion, due to increased risk of skin atrophy, striae, and systemic absorption.
- Patients should be advised not to use this product for longer than the prescribed duration or on areas not affected by the condition.
- Rebound flares can occur upon abrupt discontinuation after prolonged use; gradual tapering may be necessary for chronic conditions.
- Not for ophthalmic use. Avoid contact with eyes.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., triamcinolone, fluocinonide, clobetasol)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term use
- Emollients and moisturizers for barrier repair
- Systemic therapies for severe or widespread conditions
Cost & Coverage
Average Cost:
$20 - $100+ per 20ml solution
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.