Hydrocortisone 1% Cream 14.2gm

Manufacturer TARO 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 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 1% cream is a mild corticosteroid medication applied to the skin. It helps reduce inflammation, redness, itching, and swelling caused by various skin conditions like eczema, dermatitis, and insect bites. It works by calming down the body's natural 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 are treating a skin condition on your hand, do not wash your hand after applying the medication.

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 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 cause the medication to be absorbed into the body more easily.

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 is close to the time for your next dose, skip the missed dose and continue with your regular 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

  • Apply a thin layer to the affected area exactly as directed by your doctor or pharmacist. Do not use more than prescribed or for longer than recommended.
  • Wash your hands thoroughly before and after applying the cream.
  • Avoid applying the cream to your eyes, mouth, or open wounds.
  • Do not use on large areas of skin or for prolonged periods without medical advice, especially in children.
  • Do not cover the treated area with bandages, plastic wrap, or tight dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Keep out of reach of children and pets.
  • 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 area 2 to 4 times daily.
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Pediatric Dosing

Neonatal: Not established; use with extreme caution and under strict medical supervision due to increased systemic absorption risk.
Infant: Not established; use with extreme caution and under strict medical supervision due to increased systemic absorption risk. Avoid occlusive dressings.
Child: Apply a thin film to the affected area 2 to 4 times daily. Use the lowest effective dose for the shortest duration. Avoid occlusive dressings.
Adolescent: Apply a thin film to the affected area 2 to 4 times daily.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No adjustment needed for topical application due to minimal systemic absorption.
Moderate: No adjustment needed for topical application due to minimal systemic absorption.
Severe: No adjustment needed for topical application due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Hydrocortisone, a corticosteroid, diffuses across cell membranes and binds to specific glucocorticoid receptors in the cytoplasm. This complex then translocates to the nucleus, where it binds to DNA and modulates gene expression. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines). This results in anti-inflammatory, antipruritic, and vasoconstrictive actions.
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Pharmacokinetics

Absorption:

Bioavailability: Varies significantly based on skin integrity, vehicle, site of application, and use of occlusive dressings. Generally low systemic absorption from intact skin.
Tmax: Not well-defined for topical systemic absorption.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not clinically relevant for topical application.
ProteinBinding: Systemically absorbed hydrocortisone is highly protein-bound (to transcortin and albumin).
CnssPenetration: Limited/Not clinically relevant for topical application.

Elimination:

HalfLife: Systemic hydrocortisone has a plasma half-life of approximately 1.5-2 hours. Topical absorption half-life is not well-defined.
Clearance: Not clinically relevant for topical application.
ExcretionRoute: Primarily renal (as inactive metabolites).
Unchanged: Very little.
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Days to weeks for full therapeutic effect.
DurationOfAction: Varies with frequency of application, generally 12-24 hours per application.

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 signs or symptoms, contact your doctor or seek medical attention immediately:

Allergic reaction symptoms, 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 minor 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

This is not a comprehensive list of all 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:

  • Worsening of your skin condition or no improvement after 1-2 weeks.
  • Signs of a skin infection (e.g., increased redness, swelling, pain, pus, fever).
  • Severe burning, itching, or irritation that was not present before.
  • Signs of skin thinning, such as easy bruising, stretch marks (striae), or visible blood vessels (telangiectasias).
  • Acne-like breakouts or unusual hair growth in the treated area.
  • Any signs of systemic side effects with extensive use (e.g., unusual weight gain, swelling in the face, fatigue).
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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 interact with other drugs or exacerbate certain health problems.

To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
Existing health problems or conditions

Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to:
Start taking this medication
Stop taking this medication
Change the dosage of this medication or any other medication you are taking
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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.

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; therefore, 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 may 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 if you have any 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 to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Systemic overdose is rare with topical use but prolonged, extensive use, especially under occlusion, can lead to symptoms of Cushing's syndrome (e.g., weight gain, moon face, high blood pressure, hyperglycemia) and adrenal suppression.
  • Local symptoms include severe skin atrophy, striae, and telangiectasias.

What to Do:

Discontinue use and contact a healthcare professional immediately. For accidental ingestion or significant systemic symptoms, call Poison Control at 1-800-222-1222.

Drug Interactions

Monitoring

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Baseline Monitoring

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

Rationale: To establish baseline for treatment efficacy, identify contraindications, and guide appropriate use.

Timing: Before initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus, erythema)

Frequency: Weekly to bi-weekly initially, then as needed based on patient progress.

Target: Resolution or significant improvement of symptoms.

Action Threshold: Lack of improvement, worsening symptoms, or signs of adverse effects (e.g., skin atrophy, infection).

Skin integrity (thinning, striae, telangiectasias, bruising, signs of infection)

Frequency: At each follow-up visit, especially with prolonged use or in sensitive areas.

Target: Absence of skin atrophy or other local adverse effects.

Action Threshold: Presence of skin atrophy, striae, telangiectasias, or signs of secondary infection.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, pain, or pus (signs of infection)
  • Severe burning, itching, or irritation at the application site
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Acne-like eruptions or unusual hair growth in treated areas
  • Signs of systemic absorption with extensive/prolonged use (e.g., weight gain, moon face, fatigue, delayed wound healing)

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 due to theoretical risk of systemic absorption.

Trimester-Specific Risks:

First Trimester: Potential for minimal systemic absorption; generally considered low risk with limited, short-term use.
Second Trimester: Similar to first trimester; minimal systemic absorption expected.
Third Trimester: Similar to first trimester; minimal systemic absorption expected. Risk of adrenal suppression in the neonate is theoretical with extensive maternal use, though unlikely with typical topical application.
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Lactation

L3 (Moderately safe). Use with caution. It is not known whether topical hydrocortisone is excreted in human milk. Systemic absorption is minimal, so infant exposure is likely low. Avoid applying to the breast area to prevent direct infant ingestion.

Infant Risk: Low risk with appropriate use. Monitor infant for any unusual adverse effects if used extensively by the mother.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, growth retardation). Use the lowest effective dose for the shortest duration. Avoid occlusive dressings. Not recommended for infants without specific medical advice.

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Geriatric Use

No specific dose adjustments needed. Elderly patients may have thinner skin, potentially increasing absorption, but generally well-tolerated. Use with caution and monitor for skin atrophy.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 1% cream is a low-potency corticosteroid, making it suitable for mild to moderate inflammatory dermatoses, especially on sensitive areas like the face, groin, or intertriginous zones.
  • Educate patients on proper application technique: a thin layer, gently rubbed in, avoiding eyes and mucous membranes.
  • Warn patients against prolonged use, especially in children or on the face, to prevent local side effects such as skin atrophy, telangiectasias, striae, and acne-like eruptions.
  • If no improvement is observed after 1-2 weeks of consistent use, re-evaluate the diagnosis or consider a higher potency steroid or alternative treatment.
  • Topical corticosteroids are not effective for fungal or bacterial infections unless combined with an appropriate antifungal or antibiotic. They may worsen untreated infections.
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Alternative Therapies

  • Other topical corticosteroids of varying potencies (e.g., triamcinolone, fluocinonide, clobetasol)
  • Topical calcineurin inhibitors (tacrolimus, pimecrolimus) for atopic dermatitis
  • Emollients and moisturizers for dry skin conditions
  • Oral or topical antihistamines for pruritus
  • Phototherapy for certain chronic skin conditions
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Cost & Coverage

Average Cost: Typically $10-$30 per 14.2gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) for prescription formulations; often available OTC.
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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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.