Hydrocortisone 0.5% W/aloe Cream

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; Anti-inflammatory
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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 0.5% cream is a mild steroid medicine used on 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 body's inflammatory 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 are 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 are 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 you are instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are 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 is 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.
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Lifestyle & Tips

  • Apply a thin layer to the affected skin area only, as directed by your doctor or pharmacist.
  • Wash your hands before and after applying the cream.
  • Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor, as this can increase absorption.
  • Avoid applying to the eyes, mouth, or other mucous membranes.
  • Do not use for longer than 7 days unless advised by a doctor.
  • Avoid using on large areas of the body or on broken skin.
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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 3 to 4 times daily.

Condition-Specific Dosing:

eczema: Apply a thin film to the affected area 3 to 4 times daily.
dermatitis: Apply a thin film to the affected area 3 to 4 times daily.
pruritus: Apply a thin film to the affected area 3 to 4 times daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to increased systemic absorption risk)
Infant: Apply a thin film to the affected area 3 to 4 times daily; use with caution, especially on large surface areas or under occlusion, due to increased systemic absorption risk.
Child: Apply a thin film to the affected area 3 to 4 times daily; use with caution, especially on large surface areas or under occlusion, due to increased systemic absorption risk.
Adolescent: Apply a thin film to the affected area 3 to 4 times daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.
Dialysis: No specific considerations for topical application due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.

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 (typically <1%)
Tmax: Not clinically relevant for topical application; systemic absorption is not intended.
FoodEffect: Not applicable

Distribution:

Vd: Not clinically significant for topical application
ProteinBinding: Not clinically significant for topical application (systemically, binds to transcortin and albumin)
CnssPenetration: Limited (not clinically significant for topical application)

Elimination:

HalfLife: Not clinically significant for topical application (systemically, approximately 8-12 hours)
Clearance: Not clinically significant for topical application
ExcretionRoute: Renal (systemically)
Unchanged: Not clinically significant for topical application
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Pharmacodynamics

OnsetOfAction: Within minutes to hours for symptomatic relief
PeakEffect: Variable, depends on condition and application frequency
DurationOfAction: Several hours

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:

  • Worsening of the skin condition
  • Signs of skin infection (e.g., pus, fever, increased pain)
  • Severe burning, itching, or irritation at the application site
  • Skin thinning, easy bruising, or stretch marks (striae) with prolonged use
  • Unusual hair growth
  • Acne-like rash
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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 assess 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 crucial to verify that this medication can be taken 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 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, seek immediate medical attention by calling 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 beyond the recommended timeframe.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor to discuss potential risks. 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 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.

Certain 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 both you and your baby.
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Overdose Information

Overdose Symptoms:

  • While rare with topical use, prolonged or extensive application, especially under occlusion, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, buffalo hump, weight gain, high blood pressure, muscle weakness), hyperglycemia, or adrenal suppression.

What to Do:

Discontinue use and consult a healthcare professional. For acute ingestion or significant systemic symptoms, call 911 or Poison Control at 1-800-222-1222.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment (redness, swelling, itching, lesions)

Rationale: To establish baseline severity of dermatological condition.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Daily to weekly, based on severity

Target: Improvement in symptoms

Action Threshold: Lack of improvement or worsening of symptoms after 7 days, or development of adverse effects.

Local skin reactions (atrophy, striae, telangiectasias, folliculitis, secondary infection)

Frequency: Weekly, or as symptoms arise

Target: Absence of adverse reactions

Action Threshold: Presence of any adverse reaction, especially with prolonged use.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness or irritation at application site
  • Signs of skin infection (pus, fever)
  • Skin thinning or discoloration
  • Unusual hair growth
  • Acne-like eruptions

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for increased risk, but data are limited for topical use. Avoid if possible.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Generally considered safer than first trimester, but still use with caution.
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Lactation

Use with caution. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited, short-term use on small areas. Higher risk with extensive or prolonged use.
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Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature adults because of a larger skin surface area to body weight ratio. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

No specific dosage adjustments are generally needed. However, geriatric 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 0.5% is a low-potency topical corticosteroid, suitable for mild to moderate inflammatory dermatoses.
  • It is often the first-line topical steroid for sensitive areas like the face, groin, and axillae, and for pediatric patients, but prolonged use in these areas should still be avoided.
  • Advise patients that 'W/aloe' is an emollient/soothing agent and does not change the primary action of hydrocortisone.
  • Educate patients on proper application technique: a thin layer, gently rubbed in, only to the affected area.
  • Warn against using on infected skin without concomitant antimicrobial therapy.
  • Long-term use, even of low-potency steroids, can lead to skin atrophy, telangiectasias, and striae.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinolone - higher potency)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - for eczema, steroid-sparing)
  • Emollients and moisturizers (for dry skin, barrier repair)
  • Antihistamines (for pruritus)
  • Topical non-steroidal anti-inflammatory drugs (NSAIDs)
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Cost & Coverage

Average Cost: Low cost (typically $5-$20) per 1 oz (28g) 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 your 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 medication, including the amount taken and the time it happened, to ensure you receive the best possible care.