Hydrocortisone 1% Ointment 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
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Pharmacologic Class
Glucocorticoid
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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 1% ointment is a mild corticosteroid medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema, dermatitis, or insect bites. 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 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 applying the medication.

Before applying the medication, clean the affected area and dry it thoroughly. Then, apply a thin layer of the medication to the affected skin and gently rub it in.

Important Application Guidelines

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 specifically tells 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 to see if there are any drug take-back programs in your area.

Missed Dose Instructions

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 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 ointment.
  • Apply a thin layer to the affected skin area and rub in gently.
  • 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.
  • 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 area 2 to 4 times daily
Dose Range: 2 - 4 mg

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 (increased risk of systemic absorption)
Infant: Apply a thin film to the affected area 2 to 4 times daily; use lowest effective dose for shortest duration. Avoid occlusive dressings.
Child: Apply a thin film to the affected area 2 to 4 times daily; use lowest effective dose for shortest duration. Avoid occlusive dressings.
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 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 as an anti-inflammatory and antipruritic agent. It induces 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: Minimal systemic absorption (typically <1%) through intact skin; increases with skin damage, inflammation, occlusion, and large surface areas.
Tmax: Not well-defined for topical application due to minimal systemic absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not well-defined for topical application; systemically absorbed hydrocortisone distributes widely.
ProteinBinding: Approximately 90% (to transcortin and albumin) for systemically absorbed hydrocortisone.
CnssPenetration: Limited for topical application; systemic absorption can lead to CNS penetration.

Elimination:

HalfLife: Approximately 1.5-2 hours (for systemically absorbed hydrocortisone)
Clearance: Not well-defined for topical application.
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <1% (for systemically absorbed hydrocortisone)
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., pruritus), but full anti-inflammatory effect may take days.
PeakEffect: Variable, depends on condition and duration of use.
DurationOfAction: Variable, typically requires multiple daily applications.

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: 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 application site
Signs of skin infection: oozing, heat, swelling, redness, or pain
Skin changes (acne, 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 persist, 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 irritation, burning, or stinging after application
  • Signs of skin infection (pus, spreading redness, fever)
  • Skin thinning, easy bruising, or stretch marks developing in the treated area
  • Acne-like breakouts
  • Unusual hair growth in the treated area
  • If symptoms do not improve after 1-2 weeks of use, or if they worsen, contact your doctor.
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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, any of 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) medications, natural products, and vitamins. This information will help your doctor assess 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 it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust 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 use this medication safely, avoid applying it to cuts, scrapes, or damaged skin. When using it on a large area of skin, exercise caution and discuss this with your doctor.

In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or poison control center for assistance.

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. Consult with your doctor to discuss 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 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 course of action.

If you are breastfeeding and using this medication on your breast or nipple, ensure you 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 concerns, consult with your doctor to determine the appropriate usage.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is essential to discuss the potential benefits and risks of using this medication to ensure the best outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Systemic overdose from topical hydrocortisone is rare but can occur with prolonged use, application to large areas, or under occlusive dressings, especially in children.
  • Symptoms may include: weight gain, moon face, thinning skin, easy bruising, fatigue, muscle weakness, high blood pressure, high blood sugar (signs of Cushing's syndrome or adrenal suppression).

What to Do:

If you suspect chronic overuse or systemic effects, contact your doctor immediately. For acute accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention. Management is supportive.

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 clinical response

Target: Visible improvement in skin lesions

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

Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, hypopigmentation)

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

Target: Absence of adverse effects

Action Threshold: Presence of significant local adverse effects may require dose reduction, discontinuation, or change in therapy.

Signs of systemic absorption (rare with 1% ointment, but possible with prolonged use, large areas, or occlusion, especially in children)

Frequency: Periodically, especially with long-term or extensive use

Target: Absence of Cushing's syndrome symptoms, adrenal suppression

Action Threshold: If suspected, consider laboratory evaluation (e.g., morning cortisol, ACTH stimulation test) and gradual withdrawal.

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Symptom Monitoring

  • Worsening redness or irritation at application site
  • Signs of skin infection (pus, increased pain, fever)
  • Skin thinning or bruising
  • Stretch marks (striae)
  • Acne-like eruptions
  • Increased hair growth at application site
  • Unusual fatigue or weakness (rare, systemic absorption)
  • Weight gain or swelling (rare, systemic absorption)

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.

Trimester-Specific Risks:

First Trimester: Limited data, but systemic absorption is minimal. Avoid extensive use.
Second Trimester: Limited data, but systemic absorption is minimal. Avoid extensive use.
Third Trimester: Limited data, but systemic absorption is minimal. Avoid extensive use.
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Lactation

Considered low risk for the infant when used topically. Avoid applying to the breast or nipple area to prevent direct infant exposure.

Infant Risk: Low risk, but caution with large areas or prolonged use.
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Pediatric Use

Children, especially infants, may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome). Use the smallest amount for the shortest duration necessary. Avoid occlusive dressings.

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Geriatric Use

No specific dose adjustments are typically needed. However, elderly patients may have thinner skin, which could increase susceptibility to local adverse effects like skin atrophy.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 1% ointment is a low-potency topical corticosteroid, suitable for mild to moderate inflammatory dermatoses.
  • Ointments are generally more potent than creams or lotions for the same concentration due to increased penetration and occlusive properties, and are preferred for dry, scaly lesions.
  • Advise patients to apply a thin layer and rub it in completely; excessive application does not increase efficacy but can increase side effects.
  • Avoid prolonged use on the face, groin, or axillae, as these areas are more susceptible to corticosteroid-induced skin atrophy.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis or consider a different treatment.
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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 dry skin conditions
  • Antihistamines (oral or topical) for pruritus
  • Topical antifungals or antibacterials if infection is present
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Cost & Coverage

Average Cost: $15 - $50 per 453.6gm ointment
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (usually covered by 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 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 medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.