Hydrocortisone 1% Ointment 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
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 medicine applied to the skin to reduce redness, itching, and swelling 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 the 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 local drug take-back programs.

Missed Dose

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.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on broken, infected, or open wounds 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.
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Pediatric Dosing

Neonatal: Not established
Infant: Apply a thin film to the affected area 2 to 4 times daily, for short durations and small areas. Avoid occlusive dressings. Increased risk of systemic absorption.
Child: Apply a thin film to the affected area 2 to 4 times daily, for short durations and small areas. Avoid occlusive dressings. 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 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 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: Minimal systemic absorption; varies with skin integrity, vehicle, and use of occlusive dressings. Can be up to 1-3% for intact skin, higher for damaged skin.
Tmax: Not applicable for topical systemic effects; local effect onset is rapid.
FoodEffect: Not applicable for topical use.

Distribution:

Vd: Not precisely quantified for topical systemic absorption, but if absorbed, distributes widely.
ProteinBinding: Approximately 90% (primarily to corticosteroid-binding globulin and albumin) if systemically absorbed.
CnssPenetration: Limited for topical application; significant penetration only with extensive systemic absorption.

Elimination:

HalfLife: Approximately 1.5-2 hours (systemic, if absorbed).
Clearance: Not precisely quantified for topical systemic absorption.
ExcretionRoute: Renal excretion of inactive metabolites if systemically absorbed.
Unchanged: <1% (systemic, if absorbed)
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Pharmacodynamics

OnsetOfAction: Within minutes to hours for symptomatic relief (e.g., itching, redness).
PeakEffect: Hours to days depending on condition and frequency of application.
DurationOfAction: Varies with formulation and individual response, typically several 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 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. 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
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 the skin condition or no improvement after 1-2 weeks.
  • Signs of skin infection (e.g., pus, increased pain, fever, spreading redness).
  • Severe burning, itching, or irritation at the application site.
  • Development of new skin problems like acne, thinning skin, stretch marks, or changes in skin color.
  • Rarely, signs of systemic absorption with prolonged or extensive use: unusual weight gain, swelling in the face, fatigue, muscle weakness.
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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 health problems you have, 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 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.

When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. If you need to use it on a large area of skin, discuss this with your doctor to minimize potential risks.

In case of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center. Do not use this medication for an extended period beyond the duration prescribed by your doctor.

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 applying it to this area.

When using this medication in 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. Discuss this with your doctor to determine the best course of action.

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. Certain forms of this medication may not be suitable for all age groups of children, so 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 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:

  • Topical overdose is extremely rare and unlikely to cause acute life-threatening symptoms due to minimal systemic absorption.
  • Chronic overuse or application to large areas, especially under occlusion, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension, hyperglycemia), adrenal suppression, or growth retardation in children.

What to Do:

Discontinue the medication. If systemic effects are suspected, consult a healthcare professional immediately. For accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To determine the severity and type of dermatosis, and to identify any signs of infection or contraindications.

Timing: Prior to initiation of therapy.

Area of application

Rationale: To ensure appropriate coverage and avoid excessive use, especially on large or sensitive areas.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in symptoms)

Frequency: Daily to weekly, depending on severity.

Target: Visible improvement in redness, itching, and inflammation.

Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks may indicate need for re-evaluation or alternative therapy.

Local adverse reactions (e.g., skin atrophy, striae, irritation, folliculitis)

Frequency: Weekly to monthly, or as symptoms arise.

Target: Absence of new or worsening skin changes.

Action Threshold: Development of significant skin thinning, striae, or persistent irritation warrants discontinuation or reduction in frequency/potency.

Signs of infection

Frequency: As needed, especially if condition worsens.

Target: Absence of pus, increased pain, fever, or spreading redness.

Action Threshold: Presence of infection requires appropriate antimicrobial therapy and possible discontinuation of hydrocortisone.

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Symptom Monitoring

  • Worsening of skin condition (redness, itching, inflammation)
  • Development of new skin lesions (e.g., pimples, boils)
  • Signs of skin thinning (e.g., bruising, transparency)
  • Increased pain or burning at application site
  • Signs of systemic absorption (rare): weight gain, moon face, fatigue, muscle weakness (especially with prolonged, extensive use or in children)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Category C. Avoid large areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Limited data, but systemic absorption is minimal. Use with caution.
Second Trimester: Limited data, but systemic absorption is minimal. Use with caution.
Third Trimester: Limited data, but systemic absorption is minimal. Use with caution. Potential for fetal growth restriction with prolonged, high-dose systemic corticosteroids, but unlikely with topical hydrocortisone.
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Lactation

Use with caution. It is not known whether topical hydrocortisone is excreted in human milk. Systemic absorption is minimal. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk due to minimal systemic absorption, but monitor infant for any unusual effects. Avoid direct contact with infant's skin.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, growth retardation). Use the lowest effective dose for the shortest duration possible. Avoid occlusive dressings. Close monitoring is recommended.

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Geriatric Use

No specific dose adjustments are generally needed. However, elderly patients may have thinner skin, which could increase susceptibility to local adverse effects like skin atrophy or purpura. Use with caution and monitor skin integrity.

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 and occlusive than creams or lotions, making them suitable for dry, scaly lesions.
  • Advise patients to use a very thin layer; a little goes a long way.
  • Avoid prolonged use (typically more than 2-4 weeks) without re-evaluation, especially on the face, groin, or axillae, to minimize risk of skin atrophy, telangiectasias, or perioral dermatitis.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis or consider a different treatment.
  • Topical corticosteroids can mask signs of infection; if infection is suspected, appropriate antimicrobial therapy should be initiated.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinolone, clobetasol - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy, especially on sensitive areas.
  • 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: $5 - $20 per 28.35gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic) or Tier 2 (Generic)
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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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.