Hydrocortisone But 0.1% Lotion 59ml

Manufacturer LUPIN Active Ingredient Hydrocortisone Lotion(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 Receptor Agonist
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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 lotion is a type of steroid 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 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 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, 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, do not use tight-fitting diapers or plastic pants, as this can cause the medication to be absorbed into the body more easily. Before each use, shake the medication well.

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 by your pharmacist. You can also check with your pharmacist to see 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 resume your regular schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Wash hands before and after applying the lotion.
  • Apply a thin layer only to the affected skin areas as directed by your doctor.
  • Do not use more than prescribed or for longer than recommended.
  • Avoid applying to the face, groin, or armpits unless specifically instructed by a doctor, as these areas are more prone to side effects.
  • Do not cover the treated area with bandages or tight dressings unless advised by your doctor, as this can increase absorption and side effects.
  • Keep the treated skin moisturized with a non-medicated moisturizer as recommended by your doctor.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Store at room temperature, away from moisture and heat.
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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.

Condition-Specific Dosing:

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

Neonatal: Not established. Use with extreme caution, if at all, due to increased systemic absorption risk.
Infant: Apply a thin film to the affected skin areas once or twice daily. Use with caution, for shortest duration possible, and avoid occlusive dressings.
Child: Apply a thin film to the affected skin areas once or twice daily. Use with caution, for shortest duration possible, and avoid occlusive dressings.
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: Medium

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 vehicle, integrity of epidermal barrier, and use of occlusive dressings. Absorption is increased on inflamed or damaged skin.
Tmax: Not well-defined for systemic absorption from topical application.
FoodEffect: Not applicable

Distribution:

Vd: Not applicable for topical use (primarily local action). If systemically absorbed, distributes widely.
ProteinBinding: If systemically absorbed, binds to plasma proteins (primarily transcortin and albumin).
CnssPenetration: Limited/No (for topical application)

Elimination:

HalfLife: Not well-defined for topical application (local action). Systemically absorbed hydrocortisone has a half-life of approximately 80-118 minutes.
Clearance: Not applicable for topical use.
ExcretionRoute: Primarily renal (if systemically absorbed).
Unchanged: Minimal (if systemically absorbed)
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Pharmacodynamics

OnsetOfAction: Hours to days for clinical effect.
PeakEffect: Days to weeks of consistent application.
DurationOfAction: Varies with application frequency and individual response.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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
Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Changes in eyesight
Severe headache
Irritation at the site of application
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 the skin condition or no improvement after 2 weeks.
  • Signs of a skin infection (e.g., increased redness, swelling, pain, pus, fever).
  • Development of new skin problems like severe burning, itching, irritation, excessive hair growth, acne, skin thinning, or stretch marks.
  • Any signs of systemic side effects, though rare (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination).
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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 your safety, it is crucial to 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, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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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, 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, seek immediate medical attention by calling a doctor or poison control center. Do not use this medication for an extended period beyond the duration prescribed by your doctor.

Certain products may not be suitable for use in the diaper area, so consult with your doctor before application. Additionally, this medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk with your doctor.

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, necessitating regular growth checks. Consult with your doctor to determine the appropriate usage and monitoring.

Some formulations of this medication may not be suitable for all age groups of children, so if you have questions, consult with your doctor. If you are breastfeeding and apply this medication to your breast or nipple, be sure to wash the area thoroughly before nursing your child.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need 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:

  • Local skin atrophy (thinning, stretch marks, easy bruising)
  • Acne-like eruptions
  • Increased hair growth
  • Perioral dermatitis
  • If extensive or prolonged use, especially with occlusion, systemic effects like Cushing's syndrome (moon face, buffalo hump, central obesity), hyperglycemia, or adrenal suppression may occur, particularly in children.

What to Do:

Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. For accidental ingestion, call Poison Control (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment (type, severity, location of dermatosis)

Rationale: To establish baseline for treatment efficacy and identify areas of concern.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy of treatment (reduction in inflammation, pruritus, scaling)

Frequency: Regularly, at follow-up visits (e.g., weekly to monthly depending on severity)

Target: Improvement or resolution of symptoms

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

Local adverse skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, hypertrichosis, hypopigmentation)

Frequency: At each follow-up visit and patient self-monitoring

Target: Absence of adverse reactions

Action Threshold: Presence of significant adverse reactions may require dose reduction, discontinuation, or change in therapy.

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

Frequency: At each follow-up visit and patient self-monitoring

Target: Absence of infection

Action Threshold: Presence of infection requires appropriate antimicrobial therapy; corticosteroid may need to be temporarily discontinued.

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Symptom Monitoring

  • Reduction in itching
  • Decrease in redness and inflammation
  • Improvement in skin texture (less scaling, dryness)
  • Absence of new lesions
  • Worsening of rash or symptoms
  • Development of new skin irritation or burning
  • Signs of skin thinning (e.g., bruising easily, shiny skin)
  • Development of acne-like breakouts
  • Signs of infection (e.g., pus, increased pain, fever)

Special Patient Groups

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Pregnancy

Category C. Use 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 with high doses of potent corticosteroids, but data for topical hydrocortisone butyrate are limited. Use with caution.
Second Trimester: Use with caution; lowest effective dose for shortest duration.
Third Trimester: Use with caution; lowest effective dose for shortest duration. Risk of adrenal suppression in the neonate with prolonged or extensive use of potent corticosteroids.
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Lactation

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

Infant Risk: Low risk with appropriate use (minimal systemic absorption). Monitor infant for any signs of adverse effects.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension) due to a larger skin surface area to body weight ratio and immature skin barrier. Use the smallest amount for the shortest duration necessary. Avoid occlusive dressings. Not recommended for infants under 3 months.

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Geriatric Use

No specific dosage adjustments are typically required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption or susceptibility to local adverse effects (e.g., skin atrophy). Use with caution and monitor for adverse reactions.

Clinical Information

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Clinical Pearls

  • Hydrocortisone butyrate 0.1% is a medium-potency topical corticosteroid; it is stronger than over-the-counter hydrocortisone.
  • Educate patients on the 'less is more' principle: apply a very thin layer only to affected areas.
  • Warn against prolonged use, especially on the face, intertriginous areas (skin folds), or in children, due to increased risk of local and systemic side effects.
  • If no improvement is seen after 2 weeks, re-evaluate the diagnosis and treatment plan.
  • Tapering may be necessary after prolonged use to avoid rebound flares, especially for chronic conditions like eczema or psoriasis.
  • Always check for signs of infection before applying corticosteroids, as they can mask or worsen infections.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone acetonide, fluocinonide, clobetasol propionate - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema
  • Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Emollients and moisturizers for dry skin conditions
  • Antihistamines for pruritus (oral or topical, if appropriate)
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Cost & Coverage

Average Cost: $20 - $100+ per 59ml lotion
Generic Available: Yes
Insurance Coverage: Often covered as a Tier 1 or Tier 2 prescription. Some formulations may be available OTC.
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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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information, including the name of the medication taken, the amount, and the time it occurred.