Hydrocortisone 1% Ointment 28gm

Manufacturer PERRIGO 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
Corticosteroid, Topical
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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 1% ointment is a mild steroid medicine applied to the skin. It helps reduce redness, itching, and swelling caused by various skin conditions like eczema, dermatitis, or insect bites. It works by calming down the body's natural response to irritation.
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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.

Prepare the affected area by cleaning it before use and drying it well. Apply a thin layer of the medication to the affected skin and gently rub it in. 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 specifically instructed to do so by your doctor.

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, avoiding freezing. 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, who may be aware of 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 once or use extra doses to make up for a missed one.
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Lifestyle & Tips

  • Wash hands thoroughly before and after applying the ointment.
  • Apply a thin layer only to the affected skin area.
  • Do not cover the treated area with bandages or tight dressings unless directed by your doctor, as this can increase absorption.
  • Avoid using on the face, groin, or underarms unless specifically instructed by a healthcare professional.
  • Do not use in or near the eyes, mouth, or nose.
  • Do not use for longer than recommended by your doctor, typically no more than 7 days for over-the-counter use.
  • 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 affected area 2-4 times daily
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, increased systemic absorption risk)
Infant: Apply a thin film to affected area 2-4 times daily, use lowest effective dose for shortest duration possible due to increased systemic absorption risk.
Child: Apply a thin film to affected area 2-4 times daily, use lowest effective dose for shortest duration possible due to increased systemic absorption risk.
Adolescent: Apply a thin film to affected area 2-4 times daily, use lowest effective dose for shortest duration possible.
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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 (minimal systemic absorption)

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 acts as a glucocorticoid receptor agonist. It exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It inhibits the release of hydrolytic enzymes from leukocytes, prevents the accumulation of macrophages and leukocytes at sites of inflammation, interferes with the adhesion of leukocytes to capillary walls, reduces the permeability of capillary membranes, and inhibits the synthesis of prostaglandins and leukotrienes.
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Pharmacokinetics

Absorption:

Bioavailability: Variable, depends on skin integrity, vehicle, duration of use, and occlusion. Generally low systemic absorption (<5% for intact skin, higher for damaged skin or with occlusion).
Tmax: Not well-defined for topical systemic absorption; local effect is rapid.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not well-defined for topical systemic absorption; if absorbed, distributes widely.
ProteinBinding: High (to albumin and transcortin) if systemically absorbed.
CnssPenetration: Limited (if systemically absorbed).

Elimination:

HalfLife: Approximately 8-12 hours (systemic, if absorbed).
Clearance: Not well-defined for topical.
ExcretionRoute: Renal (if systemically absorbed).
Unchanged: Minimal (if systemically absorbed).
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Pharmacodynamics

OnsetOfAction: Minutes to hours (local effect).
PeakEffect: Hours (local effect).
DurationOfAction: Hours (local effect).

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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 site of application
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. However, 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 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, burning, itching, or irritation at the application site.
  • Development of new skin problems like acne, folliculitis (inflamed hair follicles), or skin thinning.
  • Signs of skin infection (pus, warmth, spreading redness).
  • If your skin condition worsens or does not improve after 7 days of use.
  • Rarely, signs of systemic absorption such as unusual weight gain, swelling in the face, or fatigue (especially with prolonged use on large areas).
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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 is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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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. When using this medication on a large area of skin, exercise caution and discuss this with your doctor.

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; therefore, consult with your doctor to discuss potential risks. 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 in children, exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks; consult with your doctor to monitor growth and development.

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. Some formulations of this medication may not be suitable for all age groups of children, so 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, as they will need to discuss the benefits and risks of using this medication with you to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Rare with topical use, but prolonged or excessive use on large areas, especially under occlusion, can lead to systemic effects.
  • Symptoms of systemic absorption may include: Cushing's syndrome (e.g., moon face, central obesity, striae), hyperglycemia (high blood sugar), glucosuria (sugar in urine), adrenal suppression (fatigue, weakness, low blood pressure).

What to Do:

Discontinue use and seek medical attention. For accidental ingestion or significant systemic symptoms, contact a poison control center immediately (e.g., 1-800-222-1222 in the US).

Drug Interactions

Monitoring

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Routine Monitoring

Skin condition (redness, itching, swelling)

Frequency: Daily, with each application

Target: Improvement of symptoms

Action Threshold: Worsening of symptoms, no improvement after 7 days, or signs of adverse effects.

Signs of local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis)

Frequency: Periodically, especially with prolonged use

Target: Absence of adverse effects

Action Threshold: Appearance of adverse effects; discontinue or reduce frequency/potency.

Signs of secondary infection

Frequency: Daily, with each application

Target: Absence of infection

Action Threshold: Pus, increased pain, fever; seek medical attention.

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Symptom Monitoring

  • Skin irritation
  • Burning
  • Itching
  • Redness
  • Thinning of skin
  • Striae (stretch marks)
  • Folliculitis
  • Acneiform eruptions
  • Hypopigmentation
  • Signs of infection (pus, warmth, increased pain)
  • Signs of systemic absorption (rare: weight gain, moon face, fatigue, high blood sugar, adrenal suppression)

Special Patient Groups

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Pregnancy

Use with caution during pregnancy. Hydrocortisone is classified as Pregnancy Category C. It should be used only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Low risk with topical use due to minimal systemic absorption. Avoid prolonged use or large areas.
Second Trimester: Low risk with topical use due to minimal systemic absorption. Avoid prolonged use or large areas.
Third Trimester: Low risk with topical use due to minimal systemic absorption. Avoid prolonged use or large areas.
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Lactation

Use with caution during lactation. It is generally considered safe due to minimal systemic absorption, but avoid applying to the breast area to prevent direct infant exposure.

Infant Risk: Low
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Pediatric Use

Children, especially infants and young children, are more susceptible to systemic absorption and adverse effects (e.g., adrenal suppression, Cushing's syndrome) due to a larger skin surface area to body weight ratio. Use the lowest effective dose for the shortest duration possible. Avoid prolonged use or use under occlusive dressings.

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Geriatric Use

No specific dose adjustments are typically needed. Use with caution in elderly patients who may have thinner, more fragile skin, increasing 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.
  • Ointment formulations are generally more potent and occlusive than creams or lotions, making them suitable for dry, scaly, or lichenified lesions.
  • Avoid prolonged use (typically more than 7 days for OTC, or as directed by physician) to minimize the risk of local side effects such as skin atrophy, striae, telangiectasias, and systemic absorption.
  • Do not use for fungal or bacterial infections without concomitant appropriate antimicrobial therapy, as corticosteroids can mask or worsen infections.
  • Patients should be educated on proper application technique, including applying a thin film and avoiding excessive use or application to large body surface areas.
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Alternative Therapies

  • Other topical corticosteroids of varying potencies (e.g., triamcinolone, fluocinolone, betamethasone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, especially on sensitive areas like the face.
  • Emollients and moisturizers for dry skin conditions.
  • Oral antihistamines for severe itching.
  • Phototherapy for chronic skin conditions like psoriasis or severe eczema.
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Cost & Coverage

Average Cost: $10 - $30 per 28gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 (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 information about the medication taken, the amount, and the time it happened.