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Hydrocortisone But 0.1% Cream 15gm

Manufacturer TARO 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
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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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 or psoriasis. It works by calming down the body's immune 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 your hand is the treated area, do not wash it 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 directed by your doctor, do not cover the treated area with bandages or dressings. Also, avoid applying the medication to your face, underarms, or groin area unless instructed to do so by your doctor.

If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this may 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 have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

Missed Dose

If you miss a dose, apply it as soon as you remember. 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.
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Lifestyle & Tips

  • Wash hands before and after applying the cream.
  • Apply a thin layer of cream to the affected area, gently rubbing it in until it disappears.
  • Do not cover the treated area with bandages or other dressings unless directed by your doctor, as this can increase absorption.
  • Avoid applying the cream to the eyes, mouth, or inside the nose.
  • Do not use on broken or infected skin unless specifically instructed by your doctor.
  • Do not use for longer than prescribed or on large areas of the body without consulting your doctor.
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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 once or twice daily, or as directed by a physician.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

psoriasis: Apply once or twice daily.
eczema: Apply once or twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Apply a thin film to the affected skin areas once or twice daily. Use with caution; increased risk of systemic absorption and adrenal suppression.
Child: Apply a thin film to the affected skin areas once or twice daily. Use with caution; increased risk of systemic absorption and adrenal suppression.
Adolescent: Apply a thin film to the affected skin areas once or twice 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)
Confidence: High

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 suppress the migration of polymorphonuclear leukocytes and reverse increased capillary permeability.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <5% in intact skin, but can be higher with inflamed skin, occlusive dressings, or large surface areas)
Tmax: Not applicable for topical systemic effects; local effects are rapid.
FoodEffect: Not applicable

Distribution:

Vd: Not applicable for topical use (minimal systemic distribution)
ProteinBinding: Highly protein-bound if absorbed systemically (e.g., to transcortin and albumin)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not precisely determined for topical; systemic half-life of hydrocortisone is 8-12 hours.
Clearance: Not precisely determined for topical.
ExcretionRoute: Renal (if systemically absorbed)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours for anti-inflammatory and antipruritic effects.
PeakEffect: Within days of consistent application.
DurationOfAction: Effects persist for several hours after application.

Safety & Warnings

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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 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Burning or stinging
 Dryness
* Tingling

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 new skin problems (e.g., severe irritation, burning, itching, redness)
  • Signs of skin infection (e.g., pus, fever, spreading redness)
  • Thinning of the skin, easy bruising, or stretch marks in the treated area
  • Unusual hair growth
  • If you experience any signs of systemic absorption (rare with proper use): weight gain, moon face, fatigue, muscle weakness (especially in children or with extensive 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, 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 you are taking.
* 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 safely with all your current medications and health conditions. Never 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 products on your skin, including soaps, consult with your doctor.

To ensure safe use, avoid applying this medication to cuts, scrapes, or damaged skin. When using this medication on a large area of skin, exercise caution and discuss this with your doctor.

In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or poison control center. Adhere to your doctor's prescribed duration of use and do not exceed it.

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 the risk of certain side effects may be higher. In some cases, this medication may 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 using this medication on 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 if you have any questions or concerns, consult with your doctor.

If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. It is essential to discuss the benefits and risks of using this medication 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 or under occlusive dressings, can lead to systemic effects such as Cushing's syndrome (weight gain, moon face, stretch marks, high blood pressure, diabetes), adrenal suppression, or growth retardation in children.

What to Do:

If you suspect chronic overuse or systemic effects, contact your doctor immediately. For acute accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention. Acute overdose is unlikely with topical application.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition (e.g., inflammation, erythema, pruritus, lesions)

Rationale: To assess the severity of the dermatological condition and establish a baseline for treatment efficacy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, itching, lesion size)

Frequency: Daily to weekly, depending on severity.

Target: Improvement in symptoms.

Action Threshold: If no improvement or worsening after 1-2 weeks, re-evaluate diagnosis and treatment.

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

Frequency: Regularly, at each follow-up visit.

Target: Absence of adverse reactions.

Action Threshold: If present, consider reducing frequency, changing to lower potency, or discontinuing.

Signs of skin infection (e.g., pus, increased redness, warmth)

Frequency: Regularly, at each follow-up visit.

Target: Absence of infection.

Action Threshold: If present, treat infection appropriately; discontinue corticosteroid if infection worsens.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness or irritation at application site
  • Burning or stinging sensation
  • Thinning of skin (atrophy)
  • Stretch marks (striae)
  • Acne-like eruptions
  • Increased hair growth (hypertrichosis)
  • Signs of infection (pus, fever)

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: Limited data, but generally avoided unless clearly necessary.
Second Trimester: Use with caution, minimal systemic absorption expected with proper use.
Third Trimester: Use with caution, minimal systemic absorption expected with proper use.
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Lactation

L3 (Moderately safe). Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with proper use, but monitor for potential adverse effects if significant systemic absorption occurs in the mother.
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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, growth retardation). Use the least potent effective dose for the shortest duration possible. Avoid occlusive dressings and prolonged use.

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Geriatric Use

No specific dosage adjustments are typically needed. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy or purpura.

Clinical Information

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Clinical Pearls

  • Hydrocortisone butyrate 0.1% is a medium-potency topical corticosteroid, more potent than plain hydrocortisone 1% or 2.5%.
  • Always apply a thin layer; more cream does not mean better results and can increase side effects.
  • Avoid prolonged use (typically more than 2-4 weeks) on the face, groin, or axillae due to increased risk of skin atrophy and other local side effects.
  • Do not use for rosacea or perioral dermatitis, as corticosteroids can worsen these conditions.
  • Tapering off the medication may be necessary after prolonged use to prevent rebound flares of the skin condition.
  • Educate patients on the signs of skin atrophy (thinning, shininess, visible blood vessels) and to report them.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinonide, clobetasol for higher potency; desonide, hydrocortisone for lower potency)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema
  • Emollients and moisturizers for dry skin conditions
  • Systemic therapies (e.g., oral corticosteroids, biologics) for severe conditions
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Cost & Coverage

Average Cost: $15 - $50 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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.