Hydrocortisone But 0.1% Oint 45gm

Manufacturer TARO 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 ointment is a mild corticosteroid medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema, dermatitis, and rashes. It works by calming down the body's inflammatory 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. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, eyes, or vagina, as it may cause irritation or burning.

Application Instructions

1. Wash your hands before and after applying the medication, unless your hand is the area being treated.
2. Clean the affected area before application and dry it thoroughly.
3. Apply a thin layer of the medication to the affected skin and gently rub it in.
4. Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
5. Avoid applying the medication to your face, underarms, or groin area unless your doctor specifically tells you to do so.
6. If the treated area is in the diaper region, do not use 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 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. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.

Missed Dose Instructions

If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with 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 your hands before and after applying the ointment.
  • Apply a thin layer to the affected area and rub it in gently until it disappears.
  • Do not cover the treated area with bandages or other dressings unless directed by your doctor, as this can increase absorption.
  • Avoid contact with eyes, nose, mouth, and genital areas. If contact occurs, rinse thoroughly with water.
  • Do not use on broken, infected, or weeping skin unless specifically instructed by your doctor.
  • 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 layer to the affected skin area 2 to 4 times daily, or as directed by a physician.

Condition-Specific Dosing:

eczema: Apply sparingly to affected areas 2-3 times daily.
dermatitis: Apply sparingly to affected areas 2-3 times daily.
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Pediatric Dosing

Neonatal: Not established. Use with extreme caution due to increased risk of systemic absorption and adrenal suppression.
Infant: Apply a thin layer to affected areas 1-2 times daily. Use with extreme caution, avoid prolonged use, and large surface areas. Avoid occlusive dressings.
Child: Apply a thin layer to affected areas 1-2 times daily. Use with caution, avoid prolonged use, and large surface areas. Avoid occlusive dressings.
Adolescent: Apply a thin layer to the affected skin area 2 to 4 times daily, or as directed by a physician.
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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: Variable; systemic absorption is generally low but can increase with prolonged use, large surface areas, occlusive dressings, or impaired skin barrier. Not quantifiable as a typical oral bioavailability.
Tmax: Not applicable for typical topical use; systemic levels are usually negligible.
FoodEffect: Not applicable.

Distribution:

Vd: Not applicable for typical topical use; primarily localized effect.
ProteinBinding: If absorbed systemically, binds to plasma proteins (e.g., transcortin, albumin).
CnssPenetration: Limited/No for topical application.

Elimination:

HalfLife: Not clinically relevant for typical topical use; systemic half-life of hydrocortisone is approximately 80-118 minutes.
Clearance: Not clinically relevant for typical topical use.
ExcretionRoute: Renal, if absorbed systemically.
Unchanged: Minimal, if absorbed systemically.
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Pharmacodynamics

OnsetOfAction: Hours to days for clinical effect.
PeakEffect: Days to weeks of consistent application.
DurationOfAction: Varies with application frequency and individual response.

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. 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 do not go away, contact your doctor:

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:

  • Increased redness, swelling, or pus at the application site (signs of infection).
  • Severe burning, itching, or irritation that worsens after application.
  • Thinning of the skin, easy bruising, or stretch marks (striae) in the treated area.
  • Changes in skin color (lightening or darkening).
  • Acne-like breakouts or increased hair growth in the treated area.
  • Any signs of systemic side effects such as unusual weight gain, swelling in the ankles/feet, increased thirst or urination, or changes in mood (rare, but possible with extensive use).
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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 because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.

To ensure your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Your doctor and pharmacist will work together to assess potential interactions and determine the best course of treatment for you.
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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, 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. 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 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, 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 apply this medication to 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, 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:

  • Prolonged or excessive use of topical hydrocortisone can lead to systemic absorption, potentially causing symptoms similar to Cushing's syndrome (e.g., moon face, central obesity, thinning skin, easy bruising, muscle weakness).
  • Adrenal suppression (the body stops producing its own natural steroids) can occur, especially in children or with extensive use.
  • Hyperglycemia (high blood sugar).

What to Do:

Discontinue use and consult a healthcare professional. Management is supportive and may involve gradual withdrawal if adrenal suppression is suspected. In case of accidental ingestion or significant systemic symptoms, 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 and extent of affected area

Rationale: To assess severity of dermatosis and guide treatment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Regularly during treatment (e.g., weekly to bi-weekly)

Target: Improvement in symptoms

Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation or alternative therapy.

Local skin adverse effects (e.g., atrophy, striae, telangiectasias, folliculitis)

Frequency: Regularly during treatment

Target: Absence of new or worsening skin changes

Action Threshold: Development of adverse effects may require discontinuation or reduction in frequency/potency.

Signs of systemic absorption (e.g., Cushing's syndrome, adrenal suppression, hyperglycemia, growth retardation in children)

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

Target: Absence of systemic signs/symptoms

Action Threshold: Presence of systemic signs/symptoms requires immediate medical evaluation and discontinuation.

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Symptom Monitoring

  • Burning
  • Itching
  • Irritation
  • Dryness
  • Folliculitis
  • Hypertrichosis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Maceration of the skin
  • Secondary infection
  • Skin atrophy
  • Striae
  • Miliaria
  • Weight gain (systemic absorption)
  • Moon face (systemic absorption)
  • Fatigue (systemic absorption)
  • Increased thirst/urination (hyperglycemia from systemic absorption)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large amounts, prolonged use, or application to large surface areas.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk with limited topical use. Avoid high potency or large areas.
Second Trimester: Generally considered low risk with limited topical use. Avoid high potency or large areas.
Third Trimester: Generally considered low risk with limited topical use. Avoid high potency or large areas. Potential for fetal growth restriction or adrenal suppression with extensive use of potent corticosteroids, though less likely with low-potency hydrocortisone.
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Lactation

Considered compatible with breastfeeding when used appropriately. Apply to the smallest area of skin for the shortest duration necessary. Avoid applying to the breast or nipple area to prevent infant ingestion.

Infant Risk: Low risk of adverse effects to the infant with proper use due to minimal systemic absorption. Monitor for any unusual symptoms in the infant.
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Pediatric Use

Children, especially infants and young children, are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and underdeveloped skin barrier. Use the lowest effective dose for the shortest duration possible. Monitor closely for signs of adrenal suppression (e.g., growth retardation, delayed weight gain) and Cushing's syndrome.

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Geriatric Use

No specific dosage adjustments are typically needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Topical hydrocortisone 0.1% is a low-potency corticosteroid, suitable for mild to moderate inflammatory dermatoses, especially on sensitive areas like the face, groin, and axillae.
  • Educate patients on the 'less is more' principle: a thin layer is sufficient. Overuse does not improve efficacy and increases risk of side effects.
  • Warn patients about potential for skin atrophy, striae, and telangiectasias with prolonged use, especially on thin skin.
  • For children, emphasize strict adherence to prescribed duration and frequency due to increased risk of systemic absorption and adrenal suppression.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis or consider a different treatment.
  • Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flare of the skin condition.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinolone, clobetasol - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, especially on sensitive areas.
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema.
  • Emollients and moisturizers for barrier repair.
  • Antihistamines (oral) for pruritus.
  • Systemic therapies (e.g., oral corticosteroids, immunosuppressants) for severe, widespread conditions.
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Cost & Coverage

Average Cost: $10 - $30 per 45gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred 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 medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.