Hydrocortisone But 0.1% Oint 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 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 ointment is a medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema and psoriasis. It's a type of steroid that works by calming down the body's inflammatory response.
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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 as directed and follow all instructions carefully.

Application Instructions

Do not take this medication by mouth. It is for skin use only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina.
Continue using the medication as directed, even if your symptoms improve.
Wash your hands before and after applying the medication, unless your hand is the treated area.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.

Special Precautions

Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Avoid applying the medication to your face, underarms, or groin area unless your doctor tells you to do so.
If the treated area is in the diaper region, do not use tight-fitting diapers or plastic pants, as this may increase the amount of medication absorbed into the body.

Storage and Disposal

Store the medication at room temperature and do not freeze it.
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. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in a drug take-back program in your area.

Missed Dose Instructions

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

  • Apply a thin layer only to the affected skin areas as directed by your doctor.
  • Wash your hands before and after applying the ointment.
  • 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 ointment to the face, groin, or armpits unless directed by your doctor, as these areas are more susceptible to side effects.
  • Do not use for longer than prescribed, especially on children.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
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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:

eczema: Apply a thin film to the affected skin areas 2 to 3 times daily.
psoriasis: 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, increased risk of systemic effects)
Infant: Apply a thin film to the affected skin areas 2 to 3 times daily. Use with caution, avoid occlusive dressings, and limit treatment to the smallest area and shortest duration possible.
Child: Apply a thin film to the affected skin areas 2 to 3 times daily. Use with caution, avoid occlusive dressings, and limit treatment to the smallest area and shortest duration possible.
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. Topical corticosteroids exert their anti-inflammatory, antipruritic, and vasoconstrictive actions primarily through the induction of phospholipase A2 inhibitory proteins, collectively called 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.
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Pharmacokinetics

Absorption:

Bioavailability: Not quantifiable for topical application; systemic absorption is minimal but can increase with inflammation, skin barrier disruption, occlusion, and application to thin skin areas.
Tmax: Not applicable for topical systemic absorption (variable and minimal)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable for topical (minimal systemic absorption)
ProteinBinding: Not applicable for topical (minimal systemic absorption)
CnssPenetration: Limited (only if significant systemic absorption occurs)

Elimination:

HalfLife: Not precisely determined for topical (variable systemic absorption)
Clearance: Not precisely determined for topical (variable systemic absorption)
ExcretionRoute: Renal (if systemically absorbed)
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Hours to days (for anti-inflammatory effect)
PeakEffect: Days to weeks (for maximal therapeutic effect)
DurationOfAction: Varies with application frequency and individual response

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 symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Changes in vision
Severe headache
Irritation at the site of application
Signs of skin infection: oozing, heat, swelling, redness, or pain
Skin changes (acne, stretch marks, slow healing, excessive 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 sensation
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 2-4 weeks.
  • Signs of skin infection (e.g., pus, fever, increased pain or redness).
  • Severe burning, itching, irritation, or dryness of the treated skin.
  • Skin thinning, easy bruising, stretch marks, or changes in skin color.
  • Unusual fatigue, weight gain (especially in the face or trunk), muscle weakness, or swelling (signs of possible systemic absorption).
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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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.

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

All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. 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 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. If you need to use it on a large area of skin, discuss this with your doctor to determine the best course of action.

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 in 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, making regular growth checks necessary. Discuss this with your doctor to determine the best approach.

If you are breast-feeding and apply this medication to your breast or nipple, be sure to wash the area thoroughly before 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 potential benefits and risks of using this medication with you, considering both your health and the health of your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use, especially over large areas or under occlusion, can lead to systemic effects such as Cushing's syndrome (moon face, buffalo hump, central obesity), hyperglycemia, and adrenal suppression.
  • In children, growth retardation may occur.

What to Do:

Discontinue use and consult a healthcare professional. Management is supportive and may involve gradual withdrawal of the corticosteroid if adrenal suppression is suspected. For immediate concerns, call 1-800-222-1222 (Poison Control).

Drug Interactions

Monitoring

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Baseline Monitoring

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

Rationale: To establish a baseline for treatment efficacy and identify potential contraindications or areas of increased absorption risk.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus, lesion size)

Frequency: Regularly, typically weekly or bi-weekly during initial treatment

Target: Improvement in symptoms and skin appearance

Action Threshold: Lack of improvement or worsening of condition after 2-4 weeks, or development of adverse effects, warrants re-evaluation.

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

Frequency: At each follow-up visit

Target: Absence of new or worsening adverse effects

Action Threshold: Presence of significant adverse effects warrants discontinuation or change in therapy.

Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, adrenal suppression, growth retardation in children)

Frequency: Periodically, especially with extensive or prolonged use, or use under occlusion.

Target: Absence of systemic signs/symptoms

Action Threshold: Presence of signs/symptoms warrants immediate medical evaluation and discontinuation of therapy.

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Symptom Monitoring

  • Worsening of skin condition
  • New or increased redness, itching, burning, stinging at application site
  • Skin thinning, easy bruising, stretch marks (striae)
  • Acne-like eruptions (folliculitis)
  • Increased hair growth in treated areas
  • Changes in skin color (lightening)
  • Signs of infection (pus, fever)
  • Unusual fatigue, weight gain (especially in face/trunk), muscle weakness (signs of systemic absorption)

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 low risk with appropriate use.
Second Trimester: Risk of systemic absorption and potential fetal effects (e.g., growth restriction) if used extensively or for prolonged periods.
Third Trimester: Risk of systemic absorption and potential fetal effects (e.g., growth restriction) if used extensively or for prolonged periods.
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Lactation

Compatible with caution. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution, avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate use. Monitor infant for any signs of adverse effects if mother uses extensively.
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Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature adults because of a larger skin surface area to body weight ratio. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings. Monitor growth and development.

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Geriatric Use

No specific dosage adjustments are typically needed. However, geriatric patients may have thinner skin and be more susceptible to local adverse effects like skin atrophy and purpura. Use with caution and monitor skin integrity.

Clinical Information

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Clinical Pearls

  • Hydrocortisone butyrate is a medium-potency topical corticosteroid, suitable for various inflammatory dermatoses.
  • Educate patients on proper application technique: thin layer, rub in gently, avoid eyes/mucous membranes.
  • Emphasize the importance of not using occlusive dressings unless specifically instructed by a physician, especially in children.
  • Warn about potential local side effects like skin atrophy, striae, and telangiectasias with prolonged use, particularly on sensitive areas.
  • If no improvement is seen after 2-4 weeks, re-evaluate the diagnosis and treatment plan.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinolone, clobetasol - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema
  • Emollients and moisturizers (as adjunctive therapy)
  • Systemic therapies (for severe cases, e.g., methotrexate, biologics)
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Cost & Coverage

Average Cost: $15 - $50 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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 information about the medication taken, the amount, and the time it happened.