Hydrocortisone 2.5% Cream 454gm

Manufacturer CROWN 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 cream is a mild steroid medicine applied to the skin to reduce redness, itching, and swelling caused by various skin conditions like eczema, dermatitis, and allergic reactions.
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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.

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 specifically instructed to do so by your doctor.

If you are 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, avoiding freezing. 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. If you have questions about disposing of medications, 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 hands before and after applying the cream.
  • Apply a thin layer of cream to the affected area and rub it in gently 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 and side effects.
  • Avoid using on large areas of the body or on broken skin without medical advice.
  • 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 area 2-4 times daily.
dermatitis: Apply a thin film to the affected area 2-4 times daily.
pruritus: Apply a thin film to the affected area 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 2 to 4 times daily. Use lowest effective dose for shortest duration. Avoid occlusive dressings.
Child: Apply a thin film to the affected skin area 2 to 4 times daily. Use lowest effective dose for shortest duration. Avoid occlusive dressings.
Adolescent: Apply a thin film to the affected skin area 2 to 4 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.

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. Corticosteroids also suppress the migration of polymorphonuclear leukocytes and reverse increased capillary permeability.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (depends on skin integrity, vehicle, area of application, duration of exposure, and use of occlusive dressings); systemic absorption can occur.
Tmax: Not precisely defined for topical absorption, but effects are local.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not precisely defined for topical absorption; if absorbed systemically, widely distributed.
ProteinBinding: Approximately 90% (if absorbed systemically)
CnssPenetration: Limited (if absorbed systemically, can cross BBB)

Elimination:

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

OnsetOfAction: Within hours for symptomatic relief (local)
PeakEffect: Variable, sustained with continued application (local)
DurationOfAction: Hours (local)

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 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:

  • Increased irritation, redness, or burning at the application site.
  • Signs of skin infection (pus, fever, worsening pain).
  • Skin thinning, easy bruising, or stretch marks.
  • Unusual weight gain, swelling in the face, or fatigue (signs of too much medicine absorbed into the body).
  • Blurred vision or other eye 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 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

Carefully review your medication regimen and health status with your doctor to confirm that it is safe to take this medication in conjunction with your other drugs and health conditions. Do not initiate, discontinue, or modify the dosage 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 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 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 you will need to discuss the 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:

  • Acute overdose with topical hydrocortisone is unlikely due to minimal systemic absorption.
  • Chronic overuse or use on large areas/occluded skin can lead to systemic effects such as Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension, hyperglycemia), adrenal suppression, growth retardation in children.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment for systemic effects. Call 1-800-222-1222 for poison control advice.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin infections or damage.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy of treatment (reduction in inflammation, pruritus)

Frequency: Daily to weekly, depending on severity.

Target: Improvement in symptoms.

Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks may require re-evaluation.

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

Frequency: Regularly during treatment.

Target: Absence of significant adverse effects.

Action Threshold: Development of significant skin changes or irritation warrants discontinuation or dose reduction.

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

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings.

Target: Absence of systemic effects.

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

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Symptom Monitoring

  • Worsening skin redness or irritation
  • Development of new skin lesions (e.g., acne, folliculitis)
  • Thinning of skin (atrophy)
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Easy bruising
  • Increased hair growth at application site
  • Signs of infection (pus, fever, spreading redness)
  • Unusual weight gain, moon face, fatigue (signs of systemic absorption)

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.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though low with topical use.
Second Trimester: Risk of fetal growth restriction or adrenal suppression, especially with high doses or prolonged use.
Third Trimester: Risk of fetal adrenal suppression, especially with high doses or prolonged use.
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Lactation

L3 (Moderately Safe). Use with caution. It is not known whether topical hydrocortisone is excreted in human milk. Systemic corticosteroids are excreted in breast milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk of adverse effects with typical topical use due to minimal systemic absorption. Monitor infant for any unusual signs.
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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 lowest 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 and be more prone to local adverse effects like skin atrophy and purpura. Monitor closely.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 2.5% is a low-potency topical corticosteroid, suitable for mild to moderate dermatoses, especially on sensitive areas like the face, groin, and axillae.
  • Educate patients on the 'less is more' principle: a thin layer is sufficient. Overuse can lead to local skin atrophy and potential systemic absorption.
  • For optimal absorption and efficacy, apply to clean, dry skin.
  • If a skin infection is present, it should be treated concurrently with an appropriate antimicrobial agent.
  • Long-term continuous use, especially on the face or intertriginous areas, should be avoided to minimize side effects like perioral dermatitis or striae.
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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
  • Topical antihistamines (for pruritus, short-term)
  • Emollients and moisturizers (for dry skin conditions)
  • Oral antihistamines (for systemic pruritus)
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Cost & Coverage

Average Cost: $15 - $50 per 454gm tube/jar
Generic Available: Yes
Insurance Coverage: Tier 1 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 details. 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 information about the medication taken, the amount, and the time it happened.