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Hydrocortisone 1% Cream 28.4gm

Manufacturer CROWN LABORATORIES 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 1% cream is a mild steroid medicine applied to the skin to reduce redness, swelling, and itching caused by skin conditions like eczema, dermatitis, and insect bites. It works by calming down the skin's immune 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 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, avoid using 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 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 one.
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Lifestyle & Tips

  • Wash your hands before and after applying the cream.
  • Apply a thin layer of cream only to the affected skin area. Do not use more than directed.
  • Gently rub the cream into the skin until it disappears.
  • 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 told to by your doctor, as this can increase absorption and side effects.
  • Do not use on broken, infected, or weeping skin unless advised by a doctor.
  • Do not use for longer than recommended by your doctor, especially on the face, groin, or armpits, or in 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.
pruritus: 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, increased risk of systemic absorption)
Infant: Apply a thin film to the affected skin area 2 to 4 times daily. Use smallest effective amount for shortest duration. Avoid prolonged use, especially on large surface areas or under occlusion.
Child: Apply a thin film to the affected skin area 2 to 4 times daily. Use smallest effective amount for shortest duration. Avoid prolonged use, especially on large surface areas or under occlusion.
Adolescent: Apply a thin film to the affected skin area 2 to 4 times daily. Use smallest effective amount for shortest duration.
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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 binding to glucocorticoid receptors in the cytoplasm, leading to a cascade of gene expression changes. This results in anti-inflammatory, antipruritic, and vasoconstrictive actions. It inhibits the release of lysosomal enzymes, antagonizes the effects of histamine and kinin release, and reduces the synthesis and release of prostaglandins and leukotrienes by inhibiting phospholipase A2.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (typically <5% for intact skin, significantly higher with damaged skin, inflammation, or occlusive dressings)
Tmax: Not precisely quantified for topical absorption; systemic effects can be observed within hours to days with extensive use.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely quantified for topical absorption; if absorbed systemically, distributes widely.
ProteinBinding: Approximately 90% (primarily to corticosteroid-binding globulin and albumin) if absorbed systemically.
CnssPenetration: Limited (for topical application, systemic absorption is minimal)

Elimination:

HalfLife: Approximately 1.5-2 hours (systemic, if absorbed)
Clearance: Not precisely quantified for topical absorption.
ExcretionRoute: Renal (if absorbed systemically)
Unchanged: Minimal (if absorbed systemically)
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., reduced itching, redness)
PeakEffect: Variable, depends on severity of condition and frequency of application.
DurationOfAction: Several hours, requiring multiple daily applications.

Safety & Warnings

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Side Effects

Serious 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
+ 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 fainting
+ 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. 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:

  • Skin irritation, burning, or stinging that gets worse
  • New or worsening redness, swelling, or pus (signs of infection)
  • Thinning of the skin, easy bruising, or stretch marks (striae)
  • Increased hair growth on the treated area
  • Acne-like breakouts
  • If using on a child, watch for signs of slowed growth or weight gain (rare, with extensive 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 identify potential interactions between this medication and other substances.
* 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. Always consult your doctor before starting, stopping, or changing the dose of any 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.

To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When using this medication on a large area of skin, exercise caution and discuss this with your doctor.

In case of accidental ingestion, immediately contact a doctor or a 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; therefore, consult with your doctor to discuss potential risks. 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 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 monitor growth and development.

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

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, considering both your health and the health of your baby.
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Overdose Information

Overdose Symptoms:

  • Unlikely with acute topical overdose.
  • Chronic overuse or use on large areas/broken skin can lead to systemic effects such as Cushing's syndrome (e.g., weight gain, moon face, thinning skin, high blood sugar), adrenal suppression (fatigue, weakness), or slowed growth in children.

What to Do:

Discontinue use. If systemic symptoms occur, seek medical attention. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • None significant for topical use
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Major Interactions

  • None significant for topical use
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Moderate Interactions

  • None significant for topical use
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Minor Interactions

  • None significant for topical use

Monitoring

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Baseline Monitoring

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

Rationale: To establish baseline for treatment efficacy and identify contraindications (e.g., active infection).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in redness, itching, inflammation)

Frequency: Daily to weekly, depending on severity.

Target: Symptom improvement.

Action Threshold: Lack of improvement or worsening symptoms 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: Weekly to monthly, especially with prolonged use.

Target: Absence of new or worsening skin changes.

Action Threshold: Appearance of these effects warrants discontinuation or reduction in frequency/potency.

Signs of secondary infection (e.g., bacterial, fungal)

Frequency: Regularly, especially if condition worsens.

Target: Absence of pus, increased pain, fever.

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

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

Frequency: Rarely needed for 1% cream, but consider with extensive, prolonged use, especially in children or with occlusive dressings.

Target: Normal growth, blood glucose, cortisol levels.

Action Threshold: Clinical suspicion or laboratory abnormalities warrant investigation and discontinuation.

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Symptom Monitoring

  • Persistent or worsening skin irritation
  • Burning or stinging sensation
  • New skin thinning or bruising
  • Development of stretch marks (striae)
  • Increased hair growth at application site
  • Acne-like eruptions
  • Signs of infection (pus, fever, increased pain)
  • Unusual fatigue or weakness (rare, systemic absorption)

Special Patient Groups

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Pregnancy

Use with caution during pregnancy. Hydrocortisone is classified as Pregnancy Category C. Animal studies have shown adverse effects, but human data are limited. Use 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, though low for topical use.
Second Trimester: Risk of fetal growth restriction or adrenal suppression with high doses/prolonged use.
Third Trimester: Risk of fetal adrenal suppression with high doses/prolonged use.
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Lactation

Considered low risk (L3). Minimal systemic absorption is expected with topical application. Use on the smallest area of skin for the shortest duration. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk of adverse effects to the infant due to minimal transfer into breast milk.
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Pediatric Use

Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Use the lowest effective dose for the shortest duration. Avoid prolonged use, especially on the face, groin, or under occlusive dressings. Monitor for signs of adrenal suppression (e.g., slowed growth, weight gain) and Cushing's syndrome.

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Geriatric Use

Generally safe for use in the elderly. However, geriatric patients may have thinner, more fragile skin, increasing the risk of local adverse effects like skin atrophy, bruising, and telangiectasias. Use with caution and monitor skin integrity.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 1% is a low-potency topical corticosteroid, suitable for mild to moderate inflammatory dermatoses.
  • It is often the first-line topical steroid for sensitive areas like the face, groin, and armpits, and for pediatric patients.
  • Advise patients to apply thinly and sparingly; a little goes a long way.
  • Avoid using on infected skin without concomitant antimicrobial therapy.
  • Prolonged use, especially on the face or in skin folds, can lead to skin atrophy, telangiectasias, and perioral dermatitis.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis or consider a higher potency steroid or alternative treatment.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinolone, betamethasone - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - for eczema, steroid-sparing)
  • Topical antihistamines (e.g., diphenhydramine cream - for mild itching, but can cause sensitization)
  • Emollients and moisturizers (for dry skin, barrier repair)
  • Oral antihistamines (for systemic itching)
  • Phototherapy (for chronic inflammatory skin conditions)
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Cost & Coverage

Average Cost: $5 - $20 per 28.4gm 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 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.