Hydrocortisone 2.5% Cream 28.35gm

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
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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 corticosteroid medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema, dermatitis, and rashes.
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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 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'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. 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's close to the time for your next scheduled dose, skip the missed dose and resume your regular application 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 hands before and after applying the cream.
  • Apply a thin layer of cream to the affected skin area and rub in gently.
  • Do not cover the treated area with bandages or tight dressings unless directed by your doctor, as this can increase absorption.
  • Avoid applying the cream to the eyes, mouth, or inside the nose.
  • Do not use for longer than prescribed, especially on the face, groin, or armpits.
  • 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 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 to 4 times daily.
dermatitis: 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 due to increased systemic absorption risk)
Infant: Apply a thin film to the affected area 2 to 4 times daily, or as directed by a physician. Use with caution; avoid prolonged use or large areas due to increased systemic absorption risk.
Child: Apply a thin film to the affected area 2 to 4 times daily, or as directed by a physician. Use with caution; avoid prolonged use or large areas due to increased systemic absorption risk.
Adolescent: Apply a thin film to the affected 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 exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. These effects are mediated through the induction of 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.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption; varies with vehicle, skin integrity, site of application, and use of occlusive dressings. Can be up to 1-3% in normal skin, higher in damaged skin.
Tmax: Not well-defined for topical application due to minimal systemic absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not applicable for topical formulation (minimal systemic distribution).
ProteinBinding: Approximately 90% (if systemically absorbed, primarily to transcortin and albumin).
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

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

OnsetOfAction: Within minutes to hours for symptomatic relief.
PeakEffect: Variable, depends on condition and application frequency.
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 immediately or seek medical attention:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Changes in vision
Severe headache
Irritation at the site of application
Signs of skin infection: oozing, heat, swelling, redness, or pain
Skin changes (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 that bother you or do not go away, contact your doctor:

Burning or stinging sensation
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 redness, swelling, or pus at the application site (signs of infection)
  • Severe burning, itching, or irritation after application
  • Thinning of the skin, easy bruising, or stretch marks
  • Unusual hair growth
  • Acne-like breakouts
  • Any signs of systemic effects (very rare with topical use, but possible with extensive/prolonged use, especially in children): unexplained weight gain, moon face, fatigue, muscle weakness.
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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 any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergy, be sure to describe the symptoms you experienced.

Additionally, this medication may interact with other medications or health conditions. To ensure safe use, tell your doctor and pharmacist about:
- All prescription and over-the-counter (OTC) medications you are taking
- Any natural products or vitamins you are using
- Your health problems, both current and past

It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and 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.

Proper Use and Precautions

Avoid applying this medication to cuts, scrapes, or damaged skin.
When using this medication on a large area of skin, exercise caution and discuss with your doctor.
Ingestion of this medication can be harmful. If swallowed, immediately contact a doctor or poison control center.
Do not use this medication for an extended period beyond the duration prescribed by your doctor.

Potential Risks and Side Effects

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
Certain products may not be suitable for use in the diaper area. Consult with your doctor for guidance.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher. This medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.

Special Considerations

If you are breast-feeding and using this medication on your breast or nipple, wash the area thoroughly before breast-feeding your child.
Some forms of this medication may not be suitable for all age groups of children. 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. 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:

  • Prolonged or excessive use of topical corticosteroids can lead to systemic effects due to absorption, including Cushing's syndrome, hyperglycemia, and glucosuria.
  • Local symptoms include skin atrophy, striae, telangiectasias, and secondary infections.

What to Do:

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

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any contraindications (e.g., active infection).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Daily to weekly, based on patient response.

Target: Improvement in symptoms.

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

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

Frequency: At each follow-up visit, or if patient reports new symptoms.

Target: Absence of significant adverse effects.

Action Threshold: Presence of significant skin changes may require discontinuation or change in therapy.

Signs of secondary infection

Frequency: At each follow-up visit, or if patient reports new symptoms.

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

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

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Symptom Monitoring

  • Burning
  • Itching
  • Irritation
  • Dryness
  • Folliculitis
  • Hypertrichosis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Maceration of the skin
  • Secondary infection
  • Skin atrophy
  • Striae
  • Miliaria

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Category C. Avoid large areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Limited data, but systemic absorption is minimal. Use with caution.
Second Trimester: Limited data, but systemic absorption is minimal. Use with caution.
Third Trimester: Limited data, but systemic absorption is minimal. Use with caution.
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Lactation

Considered compatible with breastfeeding when used topically on small areas for short durations. 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 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 adverse effects (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension). Use the least potent effective dose for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

No specific dose adjustments are generally needed. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 2.5% is a low-potency topical corticosteroid, suitable for mild to moderate inflammatory dermatoses.
  • Always apply a thin layer; more cream does not mean better results and can increase the risk of side effects.
  • Avoid use on infected skin without concomitant antimicrobial therapy.
  • Prolonged use, especially on the face, intertriginous areas (skin folds), or in children, increases the risk of local and systemic side effects.
  • Patients should be advised to wash their hands thoroughly after application to avoid accidental transfer to eyes or other sensitive areas.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis or treatment plan.
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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, but less effective for inflammation)
  • Emollients and moisturizers (for barrier repair and hydration)
  • Oral antihistamines (for severe pruritus)
  • Phototherapy (for chronic conditions like eczema, psoriasis)
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Cost & Coverage

Average Cost: $15 - $40 per 28.35gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic usually preferred)
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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 emergency 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.