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Hydrocortisone 2.5% Ointment 454gm

Manufacturer PERRIGO PHARMACEUTICAL COMPANY 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 2.5% ointment is a medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema or dermatitis. 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 as directed and follow all instructions carefully.

Application Instructions

Do not take this medication by mouth. It is for skin use only.
 Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina.
 Continue using the medication as directed, even if your symptoms improve.
Wash your hands before and after applying the medication, unless your hand is the treated area.
 Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.

Special Precautions

 Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Avoid applying the medication to your face, underarms, or groin area unless your doctor tells you to do so.
 If the treated area is in the diaper region, do not use tight-fitting diapers or plastic pants, as this may increase the amount of medication absorbed into the body.

Storage and Disposal

Store the medication at room temperature and do not freeze it.
 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. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in a drug take-back program in your area.

Missed Dose Instructions

 If you miss a dose, apply it as soon as you remember.
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 ointment.
  • Apply a thin layer only to the affected skin area, gently rubbing it in until it disappears.
  • Do not use more often or for longer than prescribed by your doctor.
  • Avoid applying to the face, groin, or armpits unless specifically directed by your doctor, as these areas are more sensitive.
  • Do not cover the treated area with bandages or tight dressings unless instructed by your doctor, as this can increase absorption and side effects.
  • Keep the ointment away from your eyes, nose, and mouth.
  • Moisturize regularly, even when not using the ointment, to maintain skin barrier function.
  • Avoid known irritants or allergens that trigger your skin condition.
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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 affected areas 2-3 times daily.
dermatitis: Apply a thin film to affected areas 2-3 times daily.
psoriasis: Apply a thin film to affected areas 2-4 times daily, may use occlusive dressing for severe cases under medical supervision.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, increased systemic absorption risk due to higher surface area to body weight ratio and immature skin barrier).
Infant: Apply a thin film to affected areas once daily, or as directed by a physician. Avoid prolonged use, large surface areas, and occlusive dressings due to increased risk of systemic absorption and adrenal suppression.
Child: Apply a thin film to affected areas 1-2 times daily, or as directed by a physician. Limit duration of therapy and avoid occlusive dressings.
Adolescent: Apply a thin film to affected areas 2-3 times daily, or as directed by a physician. Similar to adult dosing, but monitor for adverse effects.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption).
Moderate: No adjustment needed (minimal systemic absorption).
Severe: No adjustment needed (minimal systemic absorption).
Dialysis: No specific considerations for topical use.

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption).
Moderate: No adjustment needed (minimal systemic absorption).
Severe: No adjustment needed (minimal systemic absorption).

Pharmacology

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Mechanism of Action

Hydrocortisone is a corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It acts by inducing phospholipase A2 inhibitory proteins, lipocortins, which 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: Varies significantly; systemic absorption depends on the vehicle, integrity of the epidermal barrier, duration of exposure, skin site, and use of occlusive dressings. Generally, minimal systemic absorption with intact skin.
Tmax: Not precisely quantifiable for topical application due to variable absorption; local effects are rapid.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely quantifiable for topical application; if systemically absorbed, distributed throughout the body.
ProteinBinding: If systemically absorbed, binds to plasma proteins (primarily corticosteroid-binding globulin and albumin).
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

HalfLife: Systemic half-life of hydrocortisone is approximately 8-12 hours, but topical absorption is minimal and highly variable.
Clearance: Primarily hepatic metabolism followed by renal excretion.
ExcretionRoute: Renal (as inactive metabolites).
Unchanged: Negligible amount excreted unchanged.
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Pharmacodynamics

OnsetOfAction: Within hours for anti-inflammatory and antipruritic effects.
PeakEffect: Within 12-24 hours of consistent application.
DurationOfAction: Varies with formulation and 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

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 immediate medical attention:

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. Many people experience no side effects or only mild 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 an exhaustive list of 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 the skin condition or no improvement after 1-2 weeks.
  • Signs of skin infection (e.g., pus, increased pain, fever, spreading redness).
  • Skin thinning, easy bruising, or stretch marks in the treated area.
  • Increased hair growth in the treated area.
  • Changes in skin color (lightening or darkening).
  • New rash or irritation where the ointment was applied.
  • Unusual fatigue, weight gain, or swelling (rare, but can indicate systemic absorption).
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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.
 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.
* Any existing health problems, as this medication may interact with other medical conditions.

To ensure safe treatment, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or change 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 products on your skin, including soaps, consult with your doctor.

To ensure safe use, 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.

If this medication is accidentally swallowed, it can cause harm. In such cases, immediately contact a doctor or a poison control center.

Do not use this medication for an extended period beyond what your doctor has prescribed. Prolonged use may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor about this potential risk.

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 on children, exercise caution, as they may be at a higher risk of experiencing certain side effects.

In some cases, this medication may affect growth in children and teenagers, making regular growth checks necessary. Discuss this potential risk with your doctor.

If you are breast-feeding and using this medication on your breast or nipple, make sure to wash the area thoroughly before feeding your child.

Some formulations of this medication may not be suitable for all age groups of children. If you have any questions or concerns, consult with your doctor.

It is vital to inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Your doctor will help you weigh 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 surface areas, especially with occlusion, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, thin skin, easy bruising, muscle weakness), adrenal suppression, hyperglycemia, and growth retardation in children.

What to Do:

If systemic symptoms are suspected, contact your doctor immediately. For acute ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention. Management is supportive; gradual withdrawal of the corticosteroid may be necessary if adrenal suppression occurs.

Drug Interactions

Monitoring

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Baseline Monitoring

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

Rationale: To establish a baseline for evaluating treatment efficacy and identifying potential adverse effects.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical improvement of dermatosis (e.g., reduction in erythema, pruritus, scaling)

Frequency: Regularly, at each follow-up visit (e.g., weekly to monthly depending on condition).

Target: Significant reduction or resolution of symptoms.

Action Threshold: Lack of improvement or worsening of symptoms after 1-2 weeks of therapy warrants re-evaluation of diagnosis and treatment plan.

Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, hypertrichosis, hypopigmentation)

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

Target: Absence of adverse effects.

Action Threshold: Presence of adverse effects warrants reduction in frequency, change to lower potency steroid, or discontinuation.

Signs of secondary infection

Frequency: At each follow-up visit.

Target: Absence of infection.

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

Signs of systemic absorption (e.g., Cushing's syndrome, adrenal suppression, hyperglycemia, glucosuria) - rare with appropriate topical use

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

Target: Normal endocrine function.

Action Threshold: Any signs or symptoms warrant immediate investigation (e.g., plasma cortisol levels, ACTH stimulation test) and discontinuation of therapy.

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Symptom Monitoring

  • Reduction in itching
  • Decrease in redness and inflammation
  • Healing of skin lesions
  • Absence of new skin irritation or rash
  • Absence of skin thinning or bruising
  • Absence of increased hair growth in treated areas
  • Absence of signs of infection (pus, fever, increased pain)

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Topical corticosteroids are generally considered low risk due to minimal systemic absorption, but high-potency steroids or large-area/prolonged use should be avoided.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk due to minimal systemic absorption. Avoid high doses or prolonged use.
Second Trimester: Generally considered low risk. Monitor for signs of systemic absorption.
Third Trimester: Generally considered low risk. Monitor for signs of systemic absorption.
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Lactation

Hydrocortisone is considered compatible with breastfeeding when used topically in usual doses. Systemic absorption is minimal, and excretion into breast milk is unlikely to be clinically significant. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk. Monitor infant for any unusual effects, though unlikely.
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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) than adult patients. Use the least potent effective dose for the shortest duration possible. Avoid occlusive dressings and application to large surface areas.

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Geriatric Use

Elderly patients may have thinner skin and be more susceptible to local adverse effects such such as skin atrophy, purpura, and telangiectasias. Use with caution and monitor skin integrity.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 2.5% ointment is a mid-potency topical corticosteroid. Ointments are generally more potent than creams or lotions for the same concentration due to increased penetration and occlusion.
  • This formulation is particularly useful for dry, scaly, or lichenified skin conditions.
  • Educate patients on the 'less is more' principle: a thin layer is sufficient. Over-application does not increase efficacy but increases the risk of side effects.
  • Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flares of the skin condition.
  • Long-term use, especially on the face, intertriginous areas (skin folds), or under occlusion, significantly increases the risk of local side effects like skin atrophy, striae, and telangiectasias.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis and treatment plan. Consider fungal or bacterial infection, or contact dermatitis.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinonide, clobetasol - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, especially on sensitive areas or for long-term use.
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for mild-to-moderate atopic dermatitis.
  • Emollients and moisturizers for barrier repair and symptomatic relief.
  • Antihistamines (oral) for severe pruritus.
  • Systemic immunosuppressants (e.g., methotrexate, cyclosporine) for severe, refractory conditions.
  • Phototherapy (UVB, PUVA) for widespread or severe psoriasis/eczema.
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Cost & Coverage

Average Cost: $20 - $100+ per 454gm ointment
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.