Hydrocortisone Butyr 0.1% Crm 45gm
It is used to treat skin irritation.It is used to treat skin rashes.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydrocortisone butyrate cream is a medicine applied to the skin to reduce swelling, redness, and itching caused by certain skin conditions like eczema or psoriasis. It works by calming down the body's 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 applying the medication.
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 are 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, 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 you are instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any 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 continue with 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 are treating a skin condition on your hand, do not wash your hand after applying the medication.
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 are 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, 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 you are instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any 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 continue with 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 cream 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 dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid applying the cream to the face, groin, or armpits unless specifically directed by your doctor, as these areas are more prone to side effects.
- Do not use for longer than prescribed, especially on children or on large areas of the body.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
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 area 2 to 4 times daily, or as directed by a physician.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
eczema:
Apply thinly to affected area 2-4 times daily.
psoriasis:
Apply thinly to affected area 2-4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Apply a thin film to the affected area 2 to 4 times daily. Use with caution; increased risk of systemic absorption and HPA axis suppression.
Child:
Apply a thin film to the affected area 2 to 4 times daily. Use with caution; increased risk of systemic absorption and HPA axis suppression.
Adolescent:
Apply a thin film to the affected area 2 to 4 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 topical corticosteroid. It acts 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. Corticosteroids also possess vasoconstrictive, antipruritic, and anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; varies with vehicle, skin integrity, and use of occlusive dressings. Approximately 1-5% absorption through intact skin.
Tmax:
Not applicable for topical local effect; systemic absorption peak is variable if significant absorption occurs.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable for topical local effect; if systemically absorbed, distributes widely.
ProteinBinding:
If systemically absorbed, extensively bound to plasma proteins (transcortin and albumin).
CnssPenetration:
Limited (if systemically absorbed).
Pharmacodynamics
OnsetOfAction:
Within hours of application for local anti-inflammatory effect.
PeakEffect:
Variable, depends on condition and frequency of application.
DurationOfAction:
Depends on frequency of application, typically 12-24 hours per application.
Safety & Warnings
Side Effects
Urgent 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
+ Difficulty 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
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of a weak adrenal gland, such as:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely 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 vision
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 symptoms that bother you or persist, contact your doctor for guidance:
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
+ Difficulty 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
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of a weak adrenal gland, such as:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely 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 vision
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 symptoms that bother you or persist, contact your doctor for guidance:
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:
- Worsening of your skin condition or no improvement after the prescribed treatment period.
- Signs of a new skin infection (e.g., increased redness, swelling, pus, fever).
- Severe burning, itching, or irritation at the application site.
- Development of skin thinning, stretch marks, or changes in skin color.
- Unusual hair growth at the application site.
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 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. 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 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 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. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before using any other medications or skin products, including soaps, consult with your doctor to ensure safe use.
When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. 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 on 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, and regular growth checks may be necessary. Discuss this with your doctor to determine the best course of action.
If you are breast-feeding and apply this medication to your breast or nipple, make sure to wash the area thoroughly before breast-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 on 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, and regular growth checks may be necessary. Discuss this with your doctor to determine the best course of action.
If you are breast-feeding and apply this medication to your breast or nipple, make sure to wash the area thoroughly before breast-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 occlusive dressings, can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, thinning skin, easy bruising, muscle weakness, high blood pressure, and elevated blood sugar.
- In children, chronic overdose can lead to growth retardation and delayed weight gain.
What to Do:
If systemic symptoms are suspected, contact your doctor or poison control center immediately (call 1-800-222-1222 in the US). Treatment involves gradual withdrawal of the drug under medical supervision.
Drug Interactions
Contraindicated Interactions
- None known for topical formulation
Major Interactions
- None known for topical formulation
Moderate Interactions
- None known for topical formulation
Minor Interactions
- None known for topical formulation
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any signs of infection or contraindications.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy of treatment
Frequency: Periodically, typically within 1-2 weeks of initiation
Target: Reduction in inflammation, pruritus, and lesion size.
Action Threshold: If no improvement or worsening, re-evaluate diagnosis and treatment plan.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)
Frequency: At each follow-up visit, especially with prolonged use or on sensitive areas.
Target: Absence of adverse reactions.
Action Threshold: If present, consider reducing frequency, potency, or discontinuing use.
Signs of skin infection (e.g., redness, warmth, pus)
Frequency: At each follow-up visit.
Target: Absence of infection.
Action Threshold: If present, treat infection appropriately; discontinue corticosteroid if infection worsens.
Symptom Monitoring
- Worsening of skin condition
- Increased redness or irritation at application site
- Burning or stinging sensation
- Itching that does not improve
- Development of new skin lesions (e.g., pimples, bumps)
- Signs of skin thinning (e.g., bruising, transparency)
- Signs of infection (e.g., pus, fever)
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:
Limited data, but systemic absorption is minimal with appropriate topical use. Risk of teratogenicity with high-dose systemic corticosteroids.
Second Trimester:
Limited data, but systemic absorption is minimal with appropriate topical use.
Third Trimester:
Limited data, but systemic absorption is minimal with appropriate topical use. Potential for low birth weight or adrenal insufficiency in neonates with extensive maternal use of potent corticosteroids.
Lactation
Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Systemic absorption is minimal, so infant exposure is likely low. Avoid applying to the breast area to prevent direct infant ingestion.
Infant Risk:
Low risk with appropriate use, but monitor infant for potential adverse effects if used on large areas or for prolonged periods.
Pediatric Use
Pediatric patients may be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) from topical corticosteroids due to a larger skin surface area to body weight ratio. Use the least potent effective dose for the shortest duration possible. Avoid occlusive dressings.
Geriatric Use
No specific dosage adjustments are typically needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for skin atrophy and other local side effects.
Clinical Information
Clinical Pearls
- Hydrocortisone butyrate 0.1% is a medium-potency topical corticosteroid, suitable for various inflammatory dermatoses.
- Advise patients to apply a very thin layer to the affected area and rub it in gently until it disappears.
- Avoid prolonged use (typically >2-4 weeks) on the face, groin, axillae, or under occlusion due to increased risk of local side effects (e.g., atrophy, striae, telangiectasias, perioral dermatitis) and systemic absorption.
- If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis and treatment plan.
- Tapering may be necessary after prolonged use on large areas to prevent rebound flares.
- Educate patients on signs of skin infection and to report them promptly.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., clobetasol, triamcinolone, fluocinonide, desonide, mometasone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy
- Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole)
- Emollients and moisturizers for barrier repair
- Systemic therapies for severe or widespread conditions (e.g., oral corticosteroids, biologics, phototherapy)
Cost & Coverage
Average Cost:
$20 - $60 per 45gm tube
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'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 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 details about the medication taken, the amount, and the time it happened.