Hydrocortisone Butyr 0.1% Crm 60gm

Manufacturer GLENMARK Active Ingredient Hydrocortisone Cream, Gel, Ointment, and Solution(hye droe KOR ti sone) Pronunciation hye droe KOR ti sone BYOO ti rate
It is used to treat skin irritation.It is used to treat skin rashes.
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Drug Class
Topical corticosteroid
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Pharmacologic Class
Corticosteroid, medium potency
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Pregnancy Category
Category C
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FDA Approved
Aug 1978
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Hydrocortisone butyrate cream is a medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema and psoriasis. It works by calming down the body's inflammatory response in the skin.
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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.

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 specifically instructs you to do so.

If you're 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, 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. If you're unsure about the best way to dispose of your medication, 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'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.
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Lifestyle & Tips

  • Wash hands before and after applying the cream.
  • Apply a thin layer of cream only to the affected skin areas as directed by your doctor.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • 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 on children or on large areas of the body.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas 2 to 3 times daily.

Condition-Specific Dosing:

psoriasis: Apply a thin film to the affected skin areas 2 to 3 times daily.
eczema: Apply a thin film to the affected skin areas 2 to 3 times daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, if at all, due to high risk of systemic absorption and HPA axis suppression)
Infant: Apply a thin film to the affected skin areas 2 to 3 times daily. Use with caution; limit treatment to the least amount necessary for therapeutic effect. Avoid occlusive dressings and prolonged use.
Child: Apply a thin film to the affected skin areas 2 to 3 times daily. Use with caution; limit treatment to the least amount necessary for therapeutic effect. Avoid occlusive dressings and prolonged use.
Adolescent: Apply a thin film to the affected skin areas 2 to 3 times daily.
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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

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Mechanism of Action

Hydrocortisone butyrate is a medium-potency 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 antipruritic and vasoconstrictive properties.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption; varies with site, vehicle, skin integrity, and use of occlusive dressings. Absorption is higher on thin skin (e.g., face, genitals) and with inflamed or damaged skin.
Tmax: Not applicable for topical systemic absorption; local effect is rapid.
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not applicable for topical administration; systemically absorbed portion distributes widely.
ProteinBinding: Not applicable for topical administration; systemically absorbed corticosteroids are highly protein-bound.
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not precisely defined for topical; systemically absorbed hydrocortisone has a plasma half-life of approximately 1.5-2 hours.
Clearance: Not precisely defined for topical; systemically absorbed hydrocortisone is cleared primarily by hepatic metabolism.
ExcretionRoute: Renal (for systemically absorbed metabolites)
Unchanged: Less than 1% (systemically absorbed)
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., reduction in itching, redness)
PeakEffect: Days to weeks for maximal therapeutic effect (e.g., resolution of inflammation)
DurationOfAction: Varies with application frequency and individual response; typically requires multiple daily applications.

Safety & Warnings

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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 signs or symptoms, contact your doctor or seek immediate medical attention:

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 fainting
+ 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 where the medication was applied
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 mild 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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of your skin condition or no improvement after a few days/weeks of use.
  • Signs of skin infection (e.g., pus, increased pain, fever).
  • Severe burning, itching, or irritation at the application site.
  • New skin changes like thinning, stretch marks, or easy bruising.
  • Unusual hair growth on the treated area.
  • Any signs of systemic side effects, such as unexplained weight gain, swelling in the face, or feeling unusually tired or weak (rare with proper topical use).
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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, any of 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 interact with other drugs or exacerbate certain health problems.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions

Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to take this medication in conjunction with your other drugs and health conditions. Do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before using any other medications or skin products, such as soaps, consult with your doctor to ensure safe use.

To 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, seek immediate medical attention by calling a doctor or poison control center. Adhere to your doctor's prescribed treatment duration and avoid using 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 on children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks; consult with your doctor to monitor growth and development.

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 if you have questions or concerns, consult with your doctor.

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.
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Overdose Information

Overdose Symptoms:

  • Chronic overuse or misuse (especially on large areas, with occlusion, or in children) can lead to systemic effects such as Cushing's syndrome (e.g., moon face, central obesity, striae), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
  • Local symptoms include severe skin atrophy, striae, telangiectasias.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment for systemic effects. Call 1-800-222-1222 (Poison Control Center) for advice in case of suspected overdose.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis, identify signs of infection, and determine appropriate treatment duration.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Regularly during treatment (e.g., weekly or bi-weekly)

Target: Improvement in symptoms and skin appearance

Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.

Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation)

Frequency: Regularly during treatment

Target: Absence or minimal signs of adverse reactions

Action Threshold: Presence of significant or worsening local adverse reactions may require discontinuation or change in therapy.

Signs of secondary infection

Frequency: Regularly during treatment

Target: Absence of signs of infection (e.g., pus, increased redness, warmth)

Action Threshold: Presence of infection requires appropriate antimicrobial therapy or discontinuation of corticosteroid.

HPA axis suppression (especially with extensive use, prolonged use, or in children)

Frequency: Consider periodically if risk factors present (e.g., ACTH stimulation test, morning plasma cortisol)

Target: Normal HPA axis function

Action Threshold: Evidence of HPA axis suppression requires gradual withdrawal of the drug or reduction in frequency/potency.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, swelling, or pain at application site
  • Pus or discharge from skin lesions
  • New skin changes (e.g., thinning, bruising, stretch marks)
  • Increased hair growth at application site
  • Acne-like eruptions
  • Signs of systemic absorption (e.g., weight gain, moon face, fatigue, weakness, hyperglycemia, blurred vision)

Special Patient Groups

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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 are limited and generally reassuring for low-potency agents. Avoid high-potency or extensive use.
Second Trimester: Risk of HPA axis suppression in the fetus with extensive maternal use of potent corticosteroids.
Third Trimester: Risk of HPA axis suppression in the fetus with extensive maternal use of potent corticosteroids; potential for low birth weight.
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Lactation

L3 (Moderately Safe). 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 (minimal systemic absorption). Monitor infant for signs of systemic corticosteroid effects if mother uses extensively.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects, including HPA axis suppression and Cushing's syndrome. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings. Monitor growth and development.

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Geriatric Use

Generally safe. Elderly patients may have thinner skin, which could potentially increase systemic absorption, but overall, no specific dose adjustments are typically needed. Monitor for skin atrophy and other local side effects.

Clinical Information

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Clinical Pearls

  • Hydrocortisone butyrate is a medium-potency topical corticosteroid, suitable for conditions requiring more than low-potency but less than high-potency steroids.
  • Educate patients on proper application technique: thin film, gentle rubbing, and avoiding overuse.
  • Warn patients against using on the face, groin, or axillae unless specifically instructed by a physician, due to increased risk of local side effects (e.g., skin atrophy, telangiectasias).
  • Consider the risk of HPA axis suppression, especially in children or with prolonged/extensive use, and advise gradual withdrawal if needed.
  • Topical corticosteroids can mask or worsen skin infections; ensure any underlying infection is treated appropriately.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone acetonide, fluocinolone acetonide, betamethasone valerate for similar potency; clobetasol propionate for higher potency; hydrocortisone 1% for lower potency)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, especially on sensitive areas.
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema.
  • Emollients and moisturizers for barrier repair.
  • Systemic therapies (e.g., oral corticosteroids, biologics) for severe, widespread conditions.
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Cost & Coverage

Average Cost: $30 - $100+ per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 1-3 (depends on insurance plan and whether generic or brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. 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, the amount, and the time it happened.