Hydrocortisone 2.5% Oint 453.6gm

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
Topical Corticosteroid; Anti-inflammatory
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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Pregnancy 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 ointment is a topical medication that belongs to a class of drugs called corticosteroids. It is used to reduce inflammation, itching, and redness caused by various skin conditions such as eczema, dermatitis, and allergic reactions. It works by calming the 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 specifically 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 to see if there are any 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 to make up for a missed dose.
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Lifestyle & Tips

  • Wash your hands thoroughly before and after applying the ointment.
  • Apply a thin film of the ointment to the affected skin area. Do not use more than directed.
  • Avoid applying the ointment to your eyes, mouth, or other mucous membranes.
  • Do not use on open wounds, broken skin, or infected areas unless specifically instructed by your doctor.
  • Do not bandage, wrap, or cover the treated area with an occlusive dressing (e.g., plastic wrap) unless your doctor tells you to, as this can increase absorption and side effects.
  • Use for the shortest duration possible, especially on sensitive areas like the face, groin, or armpits.
  • If using on children, apply sparingly and avoid tight-fitting diapers or plastic pants over the treated area.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to affected area 2 to 4 times daily.

Condition-Specific Dosing:

generalUse: Apply sparingly to affected skin areas.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, consult specialist)
Infant: Apply a thin film to affected area 2 to 4 times daily. Use lowest effective dose for shortest duration possible. Avoid occlusive dressings.
Child: Apply a thin film to affected area 2 to 4 times daily. Use lowest effective dose for shortest duration possible. Avoid occlusive dressings.
Adolescent: Apply a thin film to affected area 2 to 4 times daily.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment required for topical use.
Moderate: No specific adjustment required for topical use.
Severe: No specific adjustment required for topical use.
Dialysis: No specific adjustment required for topical use.

Hepatic Impairment:

Mild: No specific adjustment required for topical use.
Moderate: No specific adjustment required for topical use.
Severe: No specific adjustment required 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. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Corticosteroids also suppress the migration of neutrophils, reduce capillary permeability, and stabilize lysosomal membranes, thereby preventing the release of destructive enzymes.
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Pharmacokinetics

Absorption:

Bioavailability: Low, variable (typically 0.1% to 3% through intact skin; increased by inflammation, occlusion, vehicle, and site of application).
Tmax: Not applicable for topical absorption kinetics in typical use.
FoodEffect: Not applicable.

Distribution:

Vd: Not applicable for topical use.
ProteinBinding: High (to transcortin and albumin) once absorbed systemically.
CnssPenetration: Limited, primarily local effect.

Elimination:

HalfLife: Systemic half-life of absorbed hydrocortisone is approximately 8-12 hours.
Clearance: Primarily renal excretion of metabolites.
ExcretionRoute: Urine (metabolites).
Unchanged: Very little unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Hours to days for clinical effect.
PeakEffect: Days to weeks for maximal anti-inflammatory effect.
DurationOfAction: Varies with application frequency and severity of condition.

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 medical attention immediately:

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, difficulty 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 persist, contact your doctor for advice:

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 (signs of infection)
  • Severe burning, stinging, or irritation at the application site
  • Thinning of the skin (atrophy)
  • Stretch marks (striae)
  • Changes in skin color (hypopigmentation or hyperpigmentation)
  • Acne-like breakouts or increased hair growth in the treated area
  • Perioral dermatitis (rash around the mouth)
  • Allergic contact dermatitis (worsening rash or new rash due to allergy to the product)
  • Signs of systemic side effects (rare with proper topical use, but possible with extensive or prolonged use, especially in children or with occlusion): unusual weight gain, 'moon face', easy bruising, muscle weakness, fatigue, swelling in ankles/feet.
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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.
* Any existing health problems, as this medication may interact with other drugs or health conditions.

To ensure your safety, 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 skin products, such as 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, seek immediate medical attention by calling 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 beyond the recommended timeframe.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor to discuss potential risks. 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, and regular growth checks may be necessary. Consult with your doctor to discuss potential risks and benefits.

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. Certain formulations of this medication may not be suitable for all age groups of children, so it is essential to consult with your doctor if you have any questions or concerns.

If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication with you, considering both your health and the health of your baby.
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Overdose Information

Overdose Symptoms:

  • Acute overdose with topical hydrocortisone is unlikely due to minimal systemic absorption.
  • Chronic excessive use, use over large surface areas, or under occlusion can lead to systemic effects such as Cushing's syndrome, hyperglycemia, and adrenal suppression.

What to Do:

Discontinue use and seek medical attention. Symptomatic and supportive care should be provided. For suspected overdose or adverse effects, contact a poison control center immediately. Call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • None known for topical use.
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Major Interactions

  • None known for topical use.
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Moderate Interactions

  • None known for topical use.
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Minor Interactions

  • None known for topical use.

Monitoring

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Baseline Monitoring

Skin condition assessment (e.g., erythema, scaling, pruritus, lesion type)

Rationale: To establish baseline severity and monitor treatment efficacy and potential adverse effects.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Skin condition assessment

Frequency: Regularly, as per clinical judgment (e.g., weekly to bi-weekly initially, then as needed).

Target: Reduction in inflammation, pruritus, and other symptoms; improvement in skin appearance.

Action Threshold: Lack of improvement after 1-2 weeks, worsening symptoms, or signs of adverse effects (e.g., skin atrophy, infection, irritation).

Signs of systemic absorption (e.g., HPA axis suppression, Cushing's syndrome symptoms)

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

Target: Normal adrenal function.

Action Threshold: Symptoms such as weight gain, moon face, easy bruising, or if HPA axis suppression is suspected (e.g., via ACTH stimulation test if clinically indicated).

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Symptom Monitoring

  • Skin irritation
  • Burning
  • Itching
  • Dryness
  • Folliculitis
  • Hypertrichosis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Maceration of the skin
  • Secondary infection
  • Skin atrophy
  • Striae
  • Miliaria
  • Signs of systemic absorption (e.g., hyperglycemia, glucosuria, Cushing's syndrome symptoms, adrenal suppression - rare with proper topical use)

Special Patient Groups

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Pregnancy

Use with caution during pregnancy. Hydrocortisone is classified as Pregnancy Category C. Avoid large areas, prolonged use, or occlusive dressings. Systemic absorption can occur, and corticosteroids have been shown to be teratogenic in animal studies.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, though data for topical corticosteroids is limited. Use only if the potential benefit justifies the potential risk to the fetus.
Second Trimester: Similar considerations as first trimester. Risk of systemic absorption leading to potential fetal effects.
Third Trimester: Similar considerations. Risk of adrenal suppression in the neonate if used extensively near term. Corticosteroids can cross the placenta.
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Lactation

Use with caution during lactation. Hydrocortisone is considered L3 (Moderately Safe). Systemic absorption is minimal, but apply to the smallest area possible and for the shortest duration. Avoid applying to the breast area to prevent direct infant ingestion.

Infant Risk: Low risk with proper use, but monitor the infant for signs of systemic effects (e.g., growth suppression, adrenal suppression), though these are highly unlikely with typical topical use.
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Pediatric Use

Use with extreme caution. Children may absorb proportionally larger amounts of topical corticosteroids due to a higher skin surface area to body weight ratio, leading to an increased risk of systemic toxicity (e.g., hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, growth retardation). Use the lowest effective dose for the shortest duration possible. Avoid occlusive dressings and tight-fitting diapers/plastic pants over treated areas.

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Geriatric Use

No specific dosage adjustments are typically needed. Elderly patients may have thinner skin, which could potentially increase absorption, but generally, topical hydrocortisone is well-tolerated with appropriate use. Monitor for skin atrophy and other local side effects.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 2.5% is considered a low-potency topical corticosteroid, making it suitable for use on sensitive areas such as the face, groin, and axillae, and for mild to moderate dermatoses.
  • Ointment formulations are generally more potent and occlusive than creams or lotions, providing better penetration and hydration, making them ideal for dry, scaly, or lichenified lesions.
  • Emphasize to patients the importance of applying a 'thin film' and avoiding overuse to minimize potential local and systemic side effects.
  • Prolonged use, especially on the face or intertriginous areas, can lead to irreversible skin atrophy, telangiectasias, and perioral dermatitis.
  • If there is no improvement in the skin condition after 1-2 weeks of consistent use, re-evaluate the diagnosis and treatment plan, as a different medication or a stronger corticosteroid may be needed, or an underlying infection may be present.
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Alternative Therapies

  • Other topical corticosteroids of varying potencies (e.g., triamcinolone, fluocinonide, clobetasol)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy
  • Emollients and moisturizers for barrier repair
  • Antihistamines (oral or topical) for pruritus
  • Phototherapy (UVB, PUVA) for widespread or severe conditions
  • Systemic immunosuppressants (e.g., methotrexate, cyclosporine) for severe, refractory cases.
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Cost & Coverage

Average Cost: Highly variable, check current pharmacy pricing. per 453.6gm ointment
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 for generic formulations; may vary for specific brands.
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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 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 information about the medication taken, the amount, and the time it happened.