Hydrocortisone 1% Plus Cream 28.4gm

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 1% Plus Cream is a mild corticosteroid medicine applied to 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 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 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 applying the medication.

Before applying the medication, clean the affected area and dry it thoroughly. Then, gently rub a thin layer of the medication onto the affected skin. 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 your doctor specifically instructs you to do so.

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, 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 instructed to do so by your pharmacist. You can also check with your pharmacist about 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 dose, skip the missed dose and resume your regular 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 hands before and after applying the cream.
  • Apply a thin layer only to the affected skin area.
  • Do not use on broken skin, open wounds, or infections unless directed by a doctor.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Do not use for longer than recommended by your doctor, especially on the face, groin, or armpits.
  • 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 area 2 to 4 times daily, or as directed by a physician.

Condition-Specific Dosing:

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

Neonatal: Not established (use with extreme caution, if at all, due to high risk of systemic absorption)
Infant: Apply a thin film to the affected area 2 to 4 times daily, or as directed by a physician. Use with caution; avoid prolonged use or large surface areas.
Child: Apply a thin film to the affected area 2 to 4 times daily, or as directed by a physician. Use with caution; avoid prolonged use or large surface areas.
Adolescent: Apply a thin film to the affected 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 exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing phospholipase A2 inhibitory proteins, 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.
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Pharmacokinetics

Absorption:

Bioavailability: Varies (minimal systemic absorption, but can increase with skin integrity compromise, occlusion, or large surface areas)
Tmax: Not applicable for topical systemic effects; local effect is rapid.
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not applicable for topical use; systemically absorbed hydrocortisone distributes widely.
ProteinBinding: Approximately 90% (when systemically absorbed)
CnssPenetration: Limited (when systemically absorbed, can cross blood-brain barrier)

Elimination:

HalfLife: Approximately 1.5-2 hours (systemic, but local duration of action is longer)
Clearance: Not applicable for topical use; systemically absorbed hydrocortisone is cleared renally.
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within minutes to hours for symptomatic relief (e.g., itching, redness)
PeakEffect: Hours to days for full anti-inflammatory effect
DurationOfAction: Varies, typically 6-12 hours per application

Safety & Warnings

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Side Effects

Serious 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. 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 or seek medical attention if they bother you or do not go away:

Burning or stinging
Dryness
* Tingling

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact 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, itching, or irritation at the application site (signs of allergic reaction or worsening condition)
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Acne-like breakouts or folliculitis (inflammation of hair follicles)
  • Changes in skin color (lightening or darkening)
  • Signs of infection (pus, fever, spreading redness)
  • Unusual weight gain, swelling in ankles/feet, increased thirst/urination (rare signs of systemic absorption)
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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.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
A comprehensive list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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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.

Avoid applying this medication to cuts, scrapes, or damaged skin. When using it on a large area of skin, exercise caution and discuss it with your doctor.

If this medication is accidentally swallowed, seek immediate medical attention by calling a doctor or poison control center. Adhere to your doctor's prescribed duration of use and do not exceed it.

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 on 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, 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 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 potential benefits and risks of using this medication with you, considering both your health and the health of your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or extensive use, especially under occlusion, can lead to systemic absorption and symptoms similar to Cushing's syndrome (e.g., moon face, central obesity, thin skin, striae, hyperglycemia, hypertension, adrenal suppression).
  • Local skin atrophy, striae, telangiectasias.

What to Do:

Discontinue use. Systemic symptoms are rare with topical 1% hydrocortisone. If suspected, consult a healthcare professional immediately. For general overdose concerns, call a poison control center at 1-800-222-1222.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment (e.g., redness, swelling, itching, lesion type)

Rationale: To establish baseline severity and guide treatment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in symptoms, healing of lesions)

Frequency: Regularly, typically weekly or bi-weekly during initial treatment.

Target: Improvement or resolution of dermatological symptoms.

Action Threshold: Lack of improvement or worsening of symptoms after 1-2 weeks; consider alternative diagnosis or treatment.

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

Frequency: At each follow-up visit and patient self-monitoring.

Target: Absence of significant adverse effects.

Action Threshold: Presence of significant or persistent adverse effects; reduce frequency, discontinue, or switch to lower potency.

Signs of systemic absorption (rare, e.g., Cushing's syndrome, hyperglycemia, adrenal suppression)

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

Target: Absence of systemic effects.

Action Threshold: Any signs of systemic effects; discontinue or reduce use and consult physician.

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Symptom Monitoring

  • Reduction in itching
  • Decrease in redness
  • Decrease in swelling
  • Healing of skin lesions
  • Absence of new skin irritation
  • Absence of skin thinning or discoloration
  • Absence of increased hair growth at application site

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 amounts, prolonged use, or application to large surface areas.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, though systemic absorption is minimal. Use with caution.
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 hydrocortisone is excreted in human milk. Systemic absorption is minimal, so infant exposure is likely low. Avoid applying to the breast area to prevent direct infant ingestion.

Infant Risk: Low (L3 - Moderately safe)
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Pediatric Use

Children, especially infants and young 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) than adult patients. 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, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for skin atrophy and other local side effects.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 1% is a low-potency topical corticosteroid, suitable for mild to moderate inflammatory dermatoses, especially on sensitive areas like the face, groin, and armpits.
  • For optimal absorption and efficacy, apply to clean, dry skin.
  • Patients should be advised not to use this product for more than 7 days without consulting a doctor, especially if symptoms persist or worsen.
  • Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flares; gradual tapering may be necessary in such cases.
  • Educate patients on the difference between local irritation and signs of infection, and when to seek medical attention.
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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)
  • Topical antihistamines (for itching, but less effective for inflammation)
  • Emollients and moisturizers (for dry skin conditions)
  • Oral antihistamines (for systemic itching)
  • Phototherapy (for chronic inflammatory skin conditions)
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Cost & Coverage

Average Cost: $10 - $50 per 28.4gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Brand)
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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 taken, the amount, and the time it happened.