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Hydrocortisone 2.5% Cream 30gm

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
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 cream is a mild steroid medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema, dermatitis, and rashes. 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 are 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 well. 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 are 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 potential 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 scheduled dose, skip the missed dose and continue with your regular dosing 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 cream.
  • Apply a thin layer only to the affected area, gently rubbing it in until it disappears.
  • Do not use more than directed or for longer than prescribed.
  • 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.
  • Keep out of reach of children.
  • 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 area two to four times daily, or as directed by a physician.

Condition-Specific Dosing:

eczema: Apply 2-4 times daily.
dermatitis: Apply 2-4 times daily.
pruritus: Apply 2-4 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 two to four times daily. Use with caution, avoid prolonged use or large areas, and do not use occlusive dressings.
Child: Apply a thin film to the affected skin area two to four times daily. Use with caution, avoid prolonged use or large areas, and do not use occlusive dressings.
Adolescent: Apply a thin film to the affected skin area two to four times daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.
Dialysis: No specific considerations for topical use due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.

Pharmacology

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Mechanism of Action

Hydrocortisone is a corticosteroid that 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 vasoconstrictive properties.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <1-5% in intact skin, but can be significantly increased with inflammation, skin barrier disruption, occlusion, or application to large surface areas).
Tmax: Not readily quantifiable for topical systemic effects; local effect onset is rapid.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not readily quantifiable for topical systemic effects.
ProteinBinding: Approximately 90% (primarily to corticosteroid-binding globulin and albumin) if systemically absorbed.
CnssPenetration: Limited (if systemically absorbed).

Elimination:

HalfLife: Approximately 1.5-2 hours (systemic, if absorbed).
Clearance: Not readily quantifiable for topical formulation.
ExcretionRoute: Renal (as inactive metabolites) if systemically absorbed.
Unchanged: Negligible (if systemically absorbed).
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Pharmacodynamics

OnsetOfAction: Within hours for anti-inflammatory and antipruritic effects.
PeakEffect: Within 12-24 hours.
DurationOfAction: Effects persist for several hours after application, requiring multiple daily doses.

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
Changes in eyesight
 Severe headache
Irritation at the site of application
 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

Reporting Side Effects

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:

  • Skin irritation, burning, or stinging that worsens after application.
  • Signs of skin infection (e.g., pus, spreading redness, fever).
  • Skin thinning, easy bruising, or stretch marks appearing on the treated area.
  • Worsening of the original skin condition.
  • Any signs of systemic side effects, though rare (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination, vision problems).
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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 allergic reaction you experienced, including any symptoms that occurred.
 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 identify potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to determine the best course of treatment for you.
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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.

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, 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 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, ensure you 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 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:

  • Local skin irritation (burning, itching, redness)
  • Skin thinning or atrophy
  • If extensive or prolonged use, potential for systemic effects like Cushing's syndrome (e.g., weight gain, moon face, high blood pressure, high blood sugar), adrenal suppression.

What to Do:

Discontinue use. For local effects, symptomatic treatment. For suspected systemic effects, consult a healthcare professional immediately. Call 1-800-222-1222 for Poison Control.

Drug Interactions

Monitoring

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Baseline Monitoring

Assessment of skin condition (type, severity, extent of lesion)

Rationale: To establish baseline for treatment efficacy and identify contraindications.

Timing: Prior to initiation of therapy.

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Routine Monitoring

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

Frequency: Regularly, typically within 1-2 weeks of initiation.

Target: Improvement in symptoms and appearance of affected skin.

Action Threshold: Lack of improvement or worsening of condition after 1-2 weeks may indicate need for re-evaluation or alternative therapy.

Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, hypertrichosis)

Frequency: At each follow-up visit, especially with prolonged use.

Target: Absence of adverse effects.

Action Threshold: Presence of significant local adverse effects warrants reduction in frequency, potency, or discontinuation.

Signs of secondary infection

Frequency: At each follow-up visit.

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

Action Threshold: Presence of infection requires appropriate antimicrobial therapy and re-evaluation of corticosteroid use.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness or irritation at application site
  • Signs of skin thinning or damage (e.g., bruising, shiny skin)
  • Development of new skin lesions or infections
  • Unusual hair growth
  • Acne-like eruptions
  • Systemic effects (rare, but possible with extensive use or occlusion): weight gain, moon face, fatigue, muscle weakness (signs of Cushing's syndrome)

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 amounts, prolonged use, or application to large surface areas.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high doses of potent corticosteroids, but risk with low-potency topical hydrocortisone is considered low.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Risk of fetal adrenal suppression with extensive use of potent corticosteroids; risk with hydrocortisone 2.5% is low but still warrants caution.
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Lactation

L3 (Moderately Safe). Hydrocortisone is minimally absorbed systemically. Use with caution. Avoid applying to the breast or nipple area to prevent infant ingestion.

Infant Risk: Low risk of adverse effects to the infant due to minimal systemic absorption. Monitor for signs of adrenal suppression if mother uses large amounts or for prolonged periods.
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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.

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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 and purpura. Use with caution and monitor skin integrity.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 2.5% is considered a low-potency topical corticosteroid, suitable for mild to moderate inflammatory dermatoses.
  • It is often a first-line treatment for conditions like eczema, contact dermatitis, and insect bites.
  • Advise patients to apply a very thin layer; a little goes a long way.
  • Educate patients on the signs of skin atrophy (thinning, shininess, easy bruising) and to report them.
  • Avoid use on fungal or bacterial infections without concomitant antimicrobial therapy, as corticosteroids can worsen these conditions.
  • For facial use, caution is advised due to increased risk of skin thinning and perioral dermatitis; use for short durations only.
  • Patients should not use this product for more than 7 days without consulting a doctor if the condition persists or worsens.
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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, especially on sensitive areas.
  • Emollients and moisturizers for dry skin conditions.
  • Antihistamines (oral or topical) for pruritus.
  • Topical antifungals or antibacterials if infection is present.
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Cost & Coverage

Average Cost: $10 - $50 per 30gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Brand)
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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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.