Hydrocortisone 2.5% Oint 28.35gm

Manufacturer FOUGERA 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
Anti-inflammatory, Antipruritic
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Pharmacologic Class
Topical Corticosteroid, Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Jan 1952
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Hydrocortisone ointment is a type of steroid medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema, dermatitis, and allergic reactions. It works by calming down the body's 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'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, 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's 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 to make up for a missed one.
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Lifestyle & Tips

  • Apply a thin layer only to the affected skin area as directed by your doctor or pharmacist.
  • Wash your hands before and after applying the ointment.
  • 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 applying the ointment to the eyes, mouth, or inside the nose.
  • Do not use on broken, infected, or open skin unless directed by a healthcare professional.
  • Do not use for longer than prescribed, 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 area 2 to 4 times daily.

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.
pruritus: Apply a thin film to the affected area 2 to 4 times daily.
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Pediatric Dosing

Neonatal: Not established for routine use; use with extreme caution and only if clearly indicated due to risk of systemic absorption.
Infant: Apply a thin film to the affected area 2 to 4 times daily. Use with caution; avoid prolonged use or use under occlusive dressings due to increased risk of systemic absorption.
Child: Apply a thin film to the affected area 2 to 4 times daily. Use with caution; avoid prolonged use or use under occlusive dressings due to increased risk of systemic absorption.
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.
Moderate: No adjustment needed for topical application.
Severe: No adjustment needed for topical application.
Dialysis: No specific considerations for topical application.

Hepatic Impairment:

Mild: No adjustment needed for topical application.
Moderate: No adjustment needed for topical application.
Severe: No adjustment needed for topical application.

Pharmacology

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Mechanism of Action

Hydrocortisone is a corticosteroid that acts by binding to specific glucocorticoid receptors in the cytoplasm of target cells. This complex then translocates to the nucleus, where it modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and the inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines). It suppresses the migration of polymorphonuclear leukocytes and reverses increased capillary permeability.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (typically <1% to 5% systemically, depending on skin integrity, vehicle, site, and occlusion)
Tmax: Not typically reported for topical application due to minimal systemic absorption.
FoodEffect: Not applicable for topical application.

Distribution:

Vd: Not typically reported for topical application; if absorbed systemically, widely distributed.
ProteinBinding: Approximately 90% (to albumin and corticosteroid-binding globulin) if absorbed systemically.
CnssPenetration: Limited (if absorbed systemically, can cross blood-brain barrier).

Elimination:

HalfLife: Approximately 8-12 hours (systemic, if absorbed)
Clearance: Not typically reported for topical application.
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <1% (systemic, if absorbed)
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., pruritus, erythema)
PeakEffect: Days to weeks for full therapeutic effect on dermatosis.
DurationOfAction: Varies with frequency of application and severity of condition.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 help right away:

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. 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:

  • Worsening of your skin condition
  • Severe burning, itching, or irritation where the ointment is applied
  • Signs of skin infection (e.g., pus, spreading redness, fever)
  • Thinning of the skin, easy bruising, or stretch marks developing in the treated area
  • Unusual hair growth in the treated area
  • Changes in skin color
  • Any signs of systemic side effects like unusual weight gain, swelling in the face or ankles, or feeling very tired (especially with long-term or 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 and pharmacist identify 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 change 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 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. If you need to use it on a large area of skin, discuss this with your doctor to determine the best course of action.

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. 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 in children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Discuss this with your doctor to determine the best approach.

If you are breast-feeding and using this medication on your breast or nipple, ensure you wash the area thoroughly before feeding your child. Be aware that some formulations of this medication may not be suitable for all age groups of children, so consult with your doctor if you have any questions.

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 baby's well-being.
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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 body surface areas, especially under occlusion, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, central obesity, hypertension, hyperglycemia), adrenal suppression, and growth retardation in children.

What to Do:

If you suspect chronic overuse or systemic effects, contact your doctor immediately. For acute accidental ingestion, contact a poison control center (Call 1-800-222-1222 in the US) or emergency services. Management is supportive.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To determine the type and extent of dermatosis and establish a baseline for treatment efficacy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy of treatment

Frequency: Regularly, based on clinical response (e.g., weekly to bi-weekly initially)

Target: Reduction in erythema, pruritus, scaling, and inflammation.

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

Local adverse reactions

Frequency: At each follow-up visit and patient self-monitoring.

Target: Absence of skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, hypopigmentation, or secondary infection.

Action Threshold: Presence of these reactions requires reduction in frequency, discontinuation, or change in therapy.

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

Frequency: Periodically, especially with prolonged use, extensive body surface area application, or use under occlusion.

Target: Absence of weight gain, moon face, central obesity, hypertension, hyperglycemia, growth retardation (in children), or fatigue/weakness.

Action Threshold: Suspicion of systemic effects warrants immediate medical evaluation and potential discontinuation.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness or irritation at application site
  • Burning or stinging sensation
  • Thinning of skin (atrophy)
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Acne-like eruptions (folliculitis)
  • Increased hair growth (hypertrichosis)
  • Changes in skin color (hypopigmentation)
  • Signs of skin infection (pus, fever, increased pain)
  • Unusual weight gain or swelling (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. Systemic absorption is minimal, but high doses or prolonged use on large areas should be avoided.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk due to minimal systemic absorption. Avoid extensive use.
Second Trimester: Low risk with appropriate use. Avoid extensive use.
Third Trimester: Low risk with appropriate use. Avoid extensive use.
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Lactation

Use with caution. It is unknown if topical hydrocortisone is excreted in human milk. Due to minimal systemic absorption, infant exposure is expected to be low. Avoid applying to the breast area to prevent direct infant ingestion.

Infant Risk: Low risk with appropriate use; monitor infant for potential adverse effects if used extensively by mother.
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Pediatric Use

Children, especially infants, are more susceptible to systemic toxicity (e.g., Cushing's syndrome, adrenal suppression, growth retardation) due to a larger skin surface area to body weight ratio and immature skin barrier. 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 potentially increase systemic absorption. Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Topical hydrocortisone 2.5% is a low-potency corticosteroid, suitable for mild to moderate inflammatory dermatoses.
  • Always apply a thin layer; more is not better and can increase side effects.
  • Avoid using on the face, groin, or axillae for prolonged periods (more than a few weeks) without medical supervision due to increased risk of skin thinning and other local side effects.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis and treatment plan.
  • Patients should be advised not to use this product for fungal or bacterial infections without concomitant appropriate antimicrobial therapy, as corticosteroids can mask or worsen infections.
  • Educate patients on proper application technique and the importance of not exceeding the prescribed duration or frequency.
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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 symptomatic relief)
  • Systemic antihistamines (for severe pruritus)
  • Phototherapy (for chronic inflammatory skin conditions)
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Cost & Coverage

Average Cost: $20 - $50 per 28.35gm tube (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (most insurance plans)
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.