Hydrocortisone 2.5% Cream

Manufacturer FOUGERA Active Ingredient Hydrocortisone Cream, Gel, Ointment, and Solution(hye droe KOR ti sone) Pronunciation hye droe KOR ti sone
It is used to treat skin irritation.It is used to treat skin rashes.
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Drug Class
Anti-inflammatory agent; Antipruritic
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Pharmacologic Class
Corticosteroid, Topical
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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 2.5% Cream is a mild corticosteroid medicine applied to the skin to reduce inflammation, redness, and itching caused by various skin conditions like eczema, dermatitis, and rashes. 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're treating a skin condition on your hand, do not wash your hand after application.

Before applying the medication, clean the affected area and dry it thoroughly. 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're treating a skin condition in the diaper area, do not use 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, 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 about 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 to make up for a missed one.
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Lifestyle & Tips

  • Wash hands before and after applying the cream.
  • Apply a thin layer to the affected area and rub in gently until it disappears.
  • Do not use more often or for longer than prescribed by your doctor.
  • Avoid applying to the eyes, mouth, or inside the nose.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption.
  • Avoid using on large areas of the body, especially in children, without medical supervision.
  • Keep out of reach of children.
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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 area 2 to 4 times daily, or as directed by a physician.

Condition-Specific Dosing:

eczema: Apply a thin film to the affected skin area 2 to 4 times daily.
dermatitis: Apply a thin film to the affected skin area 2 to 4 times daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to increased systemic absorption risk)
Infant: Apply a thin film to the affected skin area 2 to 4 times daily, or as directed by a physician. Use with caution; avoid prolonged use or large areas due to increased systemic absorption risk.
Child: Apply a thin film to the affected skin area 2 to 4 times daily, or as directed by a physician. Use with caution; avoid prolonged use or large areas due to increased systemic absorption risk.
Adolescent: Apply a thin film to the affected skin area 2 to 4 times daily, or as directed by a physician.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (topical application, minimal systemic absorption)
Moderate: No adjustment needed (topical application, minimal systemic absorption)
Severe: No adjustment needed (topical application, minimal systemic absorption)
Dialysis: No specific considerations (topical application, minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (topical application, minimal systemic absorption)
Moderate: No adjustment needed (topical application, minimal systemic absorption)
Severe: No adjustment needed (topical application, minimal systemic absorption)

Pharmacology

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Mechanism of Action

Hydrocortisone is a corticosteroid that acts by binding to glucocorticoid receptors in the cytoplasm, forming a complex that translocates to the nucleus. This complex modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines). It suppresses the migration of polymorphonuclear leukocytes and reverses increased capillary permeability.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (generally low systemic absorption; increased with damaged skin, inflammation, occlusion, large surface areas, and prolonged use)
Tmax: Not well-defined for topical application (local effect)
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not clinically relevant for topical application (minimal systemic distribution)
ProteinBinding: Not clinically relevant for topical application (minimal systemic distribution)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not clinically relevant for topical application (systemic half-life of absorbed hydrocortisone is approximately 8-12 hours)
Clearance: Not clinically relevant for topical application
ExcretionRoute: Renal (for systemically absorbed drug)
Unchanged: Minimal (for systemically absorbed drug)
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief
PeakEffect: Variable, depends on condition and application frequency
DurationOfAction: Several hours (local effect)

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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, 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, 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 do not go away, contact your doctor:

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 skin condition
  • Signs of skin infection (e.g., pus, spreading redness, fever)
  • Severe burning, itching, or irritation at the application site
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Unusual weight gain or swelling in the face (signs of systemic absorption, rare with proper 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 it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change the dose 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 use this medication safely, avoid applying it to cuts, scrapes, or damaged skin. When using it 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 a poison control center for assistance.

Adhere to your doctor's prescribed duration for using this medication. Do not exceed the recommended treatment period.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk.

Certain products may not be suitable for use in the diaper area. If you have any questions or concerns, consult with your doctor.

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, making regular growth checks 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, be sure to wash the area thoroughly before feeding your child.

Some formulations of this medication may not be suitable for all age groups of children. If you have any questions or concerns, consult with your doctor.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is crucial to discuss the potential 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:

  • Prolonged or excessive use, especially on large areas or under occlusion, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, and adrenal suppression.
  • Local skin atrophy, striae, telangiectasias.

What to Do:

Discontinue use gradually under medical supervision. Symptomatic and supportive treatment for systemic effects. Call 1-800-222-1222 (Poison Control) for advice.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any contraindications (e.g., active infection).

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Regularly during treatment (e.g., weekly or as clinically indicated)

Target: Improvement in symptoms

Action Threshold: Lack of improvement or worsening of symptoms after 1-2 weeks; consider re-evaluation of diagnosis or treatment.

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

Frequency: Regularly during treatment

Target: Absence of adverse reactions

Action Threshold: Presence of significant or persistent adverse reactions; consider reducing frequency, potency, or discontinuing.

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

Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings

Target: Absence of systemic effects

Action Threshold: Presence of signs/symptoms; consider discontinuing or reducing use, and consult endocrinologist if adrenal suppression is suspected.

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Symptom Monitoring

  • Redness
  • Swelling
  • Itching
  • Burning
  • Pain
  • Skin thinning
  • Stretch marks (striae)
  • Acne-like eruptions
  • Increased hair growth
  • Changes in skin color
  • Signs of infection (pus, fever)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Category C. Avoid large areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk with topical use.
Second Trimester: Low risk with topical use, but systemic absorption can occur.
Third Trimester: Low risk with topical use, but systemic absorption can occur. Potential for fetal growth restriction with high-potency or prolonged use.
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Lactation

Use with caution. It is not known whether topical hydrocortisone is excreted in human milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with proper topical use, but monitor infant for potential adverse effects if significant maternal absorption occurs.
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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 generally needed. Elderly patients may have thinner skin, which could potentially increase absorption, but this is usually not clinically significant with low-potency topical corticosteroids like hydrocortisone 2.5%.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 2.5% is a low-potency topical corticosteroid, suitable for mild to moderate inflammatory dermatoses, and often used on sensitive areas like the face or groin.
  • Educate patients on proper application technique: thin layer, gentle rubbing, and avoiding overuse.
  • Warn patients about potential for skin thinning (atrophy) with prolonged use, especially on delicate skin.
  • Not effective for fungal or bacterial infections; may worsen them if used inappropriately.
  • Consider a step-down approach or intermittent therapy for chronic conditions to minimize side effects.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinolone, clobetasol - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing effect
  • Emollients and moisturizers
  • Antihistamines (for pruritus)
  • Phototherapy
  • Systemic immunosuppressants (for severe cases)
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Cost & Coverage

Average Cost: Varies widely (e.g., $10-$50) per 30g tube
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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 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 overdose, including the medication taken, the amount, and the time it occurred.