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Hydrocortisone 2.5% Cream 20gm

Manufacturer PERRIGO 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; Anti-inflammatory
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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, or insect bites. 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. If the treated area is on your hand, do not wash your hand 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 location, 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 disposal, 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 your 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 use more cream than directed or apply it more often than prescribed.
  • Avoid applying the cream to your eyes, mouth, or inside your nose.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption.
  • Do not use on open wounds, broken skin, or infected areas unless directed by a doctor.
  • If using on the face, be extra careful to avoid eyes and use for short periods only.
  • 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 sparingly to affected areas 2-3 times daily.
dermatitis: Apply sparingly to affected areas 2-3 times daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, if at all, due to high risk of systemic absorption and HPA axis suppression)
Infant: Apply a thin film to the affected skin area 2 to 4 times daily, or as directed by a physician. Use lowest effective strength for shortest duration. Avoid occlusive dressings.
Child: Apply a thin film to the affected skin area 2 to 4 times daily, or as directed by a physician. Use lowest effective strength for shortest duration. Avoid occlusive dressings.
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 for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.
Dialysis: No specific considerations for topical use.

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, 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. Corticosteroids also suppress the immune response by inhibiting the migration of macrophages and leukocytes to the site of inflammation, reversing capillary permeability, and causing vasoconstriction.
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Pharmacokinetics

Absorption:

Bioavailability: Varies significantly; systemic absorption depends on the vehicle, integrity of the epidermal barrier, site of application, duration of exposure, and use of occlusive dressings. Generally low systemic absorption with intact skin.
Tmax: Not well-defined for topical systemic absorption; local effects are seen within hours.
FoodEffect: Not applicable

Distribution:

Vd: Not typically quantified for topical application; if absorbed systemically, distributes widely.
ProteinBinding: Approximately 90% bound to plasma proteins (transcortin and albumin) if absorbed systemically.
CnssPenetration: Limited for topical application; systemic absorption can lead to CNS effects.

Elimination:

HalfLife: Systemic half-life of hydrocortisone is approximately 80-118 minutes, but the biological half-life is longer (8-12 hours). Not directly applicable to topical local action.
Clearance: Not typically quantified for topical application.
ExcretionRoute: Primarily renal (metabolites).
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect: Days to weeks of consistent application.
DurationOfAction: Varies with application frequency and individual response; effects persist for several hours after application.

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, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of a weak adrenal gland, such as:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ 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 wound healing
Changes in vision
 Severe headache
Irritation at the site of application
 Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Skin changes, including:
+ 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 unusual symptoms, contact your doctor for advice:

Burning or stinging
 Dryness
* Tingling

This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 or burning that worsens after application
  • Signs of skin infection (e.g., pus, spreading redness, fever)
  • Skin thinning, stretch marks, or changes in skin color where the cream is applied
  • Worsening of the original skin condition
  • Development of new skin problems (e.g., acne-like rash, excessive hair growth)
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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 other medications and health conditions. Never start, stop, or adjust 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 products on your skin, including soaps, consult with your doctor.

Avoid applying this medication to cuts, scrapes, or damaged skin. When using it on a large area of skin, exercise caution and discuss it with your doctor.

If this medication is ingested, it can be harmful. In the event of accidental ingestion, immediately contact a doctor or a poison control center.

Do not use this medication for an extended period beyond what your doctor has prescribed. Prolonged use may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor.

Certain 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 at a higher risk of experiencing certain side effects.

In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Discuss this with your doctor.

If you are breastfeeding and apply this medication to your breast or nipple, ensure you wash the area thoroughly before feeding your child.

Some formulations of this medication may not be appropriate for all age groups of children, so if you have any questions, consult with your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of using this medication to both you and 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 absorption and symptoms of Cushing's syndrome (e.g., moon face, central obesity, thinning skin, easy bruising, high blood pressure, muscle weakness).
  • In children, this can also lead to growth retardation and HPA axis suppression.

What to Do:

Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice if significant systemic exposure is suspected.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatological condition (e.g., inflammation, erythema, pruritus, scaling) and identify any pre-existing skin integrity issues.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Daily to weekly, depending on severity.

Target: Improvement in symptoms.

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

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

Frequency: Weekly to monthly, or at each follow-up visit.

Target: Absence of these effects.

Action Threshold: Presence of these effects, especially skin atrophy, requires discontinuation or reduction in strength/frequency.

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

Frequency: Daily, especially if skin barrier is compromised.

Target: Absence of infection.

Action Threshold: Presence of infection requires appropriate antimicrobial therapy and potential discontinuation of corticosteroid.

Signs of systemic absorption (rare with proper use, but possible with extensive/prolonged use, especially in children or with occlusion: e.g., Cushing's syndrome symptoms, HPA axis suppression)

Frequency: Periodically, if extensive or prolonged use is anticipated.

Target: Absence of systemic effects.

Action Threshold: Any signs of systemic effects warrant immediate medical evaluation and discontinuation.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness or irritation at application site
  • Development of new skin lesions (e.g., pimples, bumps)
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Signs of skin infection (pus, fever, increased pain)
  • Unusual fatigue, weight gain, or swelling (rare, indicative of systemic absorption)

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: Limited data, but systemic absorption is generally low. Avoid if possible.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: No specific increased risks identified, but systemic absorption should still be minimized.
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Lactation

Low risk. Hydrocortisone is minimally absorbed systemically from topical application. If used, apply to the smallest area possible and avoid application to the breast or nipple area to prevent infant ingestion.

Infant Risk: Low risk of adverse effects in breastfed infants with appropriate maternal use.
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Pediatric Use

Children are more susceptible to systemic absorption and adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio. Use the lowest effective strength for the shortest duration. Avoid occlusive dressings. Close monitoring for systemic effects is crucial.

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Geriatric Use

No specific dose adjustments are typically needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Use with caution and monitor for skin atrophy or other local adverse effects.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 2.5% cream is a low-potency topical corticosteroid, suitable for mild to moderate inflammatory dermatoses.
  • Always apply a thin layer; 'less is more' with topical steroids to minimize side effects.
  • Educate patients on the importance of not using the cream for longer than prescribed, especially on the face, groin, or axillae, to prevent skin atrophy and other local side effects.
  • Not effective for fungal, viral, or bacterial skin infections; may even worsen them. Ensure proper diagnosis before use.
  • Avoid abrupt discontinuation after prolonged use on sensitive areas, as this can lead to rebound dermatitis. Tapering may be necessary.
  • Occlusive dressings significantly increase absorption and risk of side effects; generally avoid unless specifically instructed by a physician for certain conditions.
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Alternative Therapies

  • Other topical corticosteroids of varying potencies (e.g., triamcinolone, fluocinonide, clobetasol)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for certain inflammatory skin conditions, especially on sensitive areas or for long-term use.
  • Emollients and moisturizers for dry skin and barrier repair.
  • Antihistamines (oral or topical) for pruritus.
  • Phototherapy for chronic conditions like eczema or psoriasis.
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Cost & Coverage

Average Cost: $10 - $30 per 20gm tube of 2.5% cream
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic) or Tier 2 (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 your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.