Hydrocortisone But 0.1% Cream 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
Anti-inflammatory, Antipruritic
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Pharmacologic Class
Corticosteroid (Topical)
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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 cream is a mild steroid medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema, dermatitis, or insect bites. It helps calm down the skin's reaction.
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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 use on your skin 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 your 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 a drug take-back program in your area.

Missed Dose Instructions

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 cream.
  • Apply a thin layer only to the affected skin area, gently rubbing it in until it disappears.
  • Do not use more than directed or for longer than recommended by your doctor.
  • 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.
  • Do not use on broken, infected, or open skin without consulting a doctor.
  • 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 skin area 2 to 4 times daily, or as directed by a physician.

Condition-Specific Dosing:

eczema: Apply thinly 2-3 times daily.
dermatitis: Apply thinly 2-3 times daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, increased risk of systemic absorption)
Infant: Apply a thin film to the affected skin area 1 to 2 times daily, or as directed by a physician. Avoid prolonged use or large areas due to increased risk of systemic absorption.
Child: Apply a thin film to the affected skin area 1 to 2 times daily, or as directed by a physician. Avoid prolonged use or large areas due to increased risk of systemic absorption.
Adolescent: Apply a thin film 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 due to minimal systemic absorption.

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 by inducing phospholipase A2 inhibitory proteins, collectively called 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 polymorphonuclear leukocytes and reverse increased capillary permeability.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <1% to 5% depending on skin integrity, vehicle, area, and occlusion). Absorption is increased by inflammation, skin folds, and occlusive dressings.
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.
ProteinBinding: Approximately 90% (for systemically absorbed portion, primarily to transcortin and albumin).
CnssPenetration: Limited (for systemically absorbed portion).

Elimination:

HalfLife: Approximately 1.5-2 hours (for systemically absorbed portion).
Clearance: Not well-defined for topical application.
ExcretionRoute: Renal (for systemically absorbed portion).
Unchanged: Minimal.
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., reduced itching, redness).
PeakEffect: Days to weeks for full anti-inflammatory effect.
DurationOfAction: Varies with application frequency, typically requires multiple daily applications for sustained effect.

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, spreading redness, fever).
  • Severe burning, itching, or irritation at the application site.
  • Skin thinning, easy bruising, or stretch marks (striae) developing.
  • Unusual hair growth on the treated area.
  • Any signs of systemic side effects (very rare with topical 0.1%): unusual weight gain, swelling in ankles/feet, increased thirst/urination, vision problems.
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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 any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergy, be sure to describe the symptoms you experienced.

This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must 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 application.

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, requiring regular growth checks. Discuss this with your doctor to monitor your child's growth and adjust treatment as needed.

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, considering both your health and the baby's well-being.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use, especially over large areas or under occlusion, can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including:
  • Moon face
  • Central obesity
  • Thinning skin
  • Easy bruising
  • Muscle weakness
  • High blood pressure
  • Hyperglycemia
  • Adrenal suppression (especially in children)

What to Do:

If systemic symptoms are suspected, discontinue use gradually under medical supervision. Call 1-800-222-1222 (Poison Control Center) for advice. Treatment is symptomatic and supportive.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment (type of lesion, extent, signs of infection)

Rationale: To establish baseline for efficacy and identify contraindications (e.g., fungal infection).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in redness, itching, inflammation)

Frequency: Daily to weekly, depending on condition severity.

Target: Improvement in symptoms.

Action Threshold: If no improvement or worsening after 1-2 weeks, re-evaluate diagnosis or treatment.

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

Frequency: Regularly during treatment.

Target: Absence of new or worsening reactions.

Action Threshold: If severe or persistent, discontinue use and consult physician.

Signs of systemic absorption (rare: Cushing's syndrome, adrenal suppression)

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

Target: Absence of systemic symptoms.

Action Threshold: If suspected, discontinue use and perform appropriate endocrine evaluation.

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Symptom Monitoring

  • Itching
  • Redness
  • Swelling
  • Inflammation
  • Pain/Discomfort at application site
  • Skin thinning or discoloration
  • New skin lesions (e.g., acne, folliculitis)

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. Avoid large areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk with limited topical use.
Second Trimester: Low risk with limited topical use.
Third Trimester: Low risk with limited topical use, but prolonged or extensive use may lead to fetal growth restriction or adrenal suppression in the neonate (theoretical risk, more common with potent systemic steroids).
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Lactation

Considered compatible with breastfeeding when used topically in usual doses. Apply to the smallest area of skin possible and avoid application to the breast or nipple area to prevent infant ingestion.

Infant Risk: Low risk. Minimal systemic absorption in the mother means minimal drug in breast milk. Monitor infant for any unusual effects, though unlikely.
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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, growth retardation) due to a larger skin surface area to body weight ratio. Use the lowest effective dose for the shortest duration possible. Avoid occlusive dressings. Not recommended for use in neonates without specific medical advice.

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Geriatric Use

No specific dose adjustments are generally needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Use with caution and monitor for skin atrophy or other local side effects.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 0.1% is a low-potency topical corticosteroid, suitable for mild to moderate inflammatory dermatoses, especially on sensitive areas like the face, groin, or axillae.
  • Always apply a thin layer; 'less is more' with topical steroids.
  • Do not use for fungal or bacterial infections unless combined with appropriate antifungal/antibacterial agents, as steroids can worsen infections.
  • Discontinue use gradually after prolonged treatment to avoid rebound flares, especially for chronic conditions.
  • Educate patients on proper application technique and the importance of not exceeding recommended duration or frequency of use to minimize side effects.
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Alternative Therapies

  • Other low-potency topical corticosteroids (e.g., desonide, fluocinolone acetonide 0.01%)
  • Non-steroidal anti-inflammatory agents (e.g., topical calcineurin inhibitors like tacrolimus or pimecrolimus for eczema)
  • Emollients and moisturizers (for dry skin conditions)
  • Antihistamines (for itching)
  • Cool compresses
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Cost & Coverage

Average Cost: $10 - $30 per 45gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (often available over-the-counter, so insurance coverage may not apply or be necessary).
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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 for more information. 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 details about the overdose, including the medication taken, the amount, and the time it occurred.