Hydrocortisone 1% Cream

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
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% cream is a mild steroid medicine applied to the skin to reduce redness, itching, and swelling caused by various skin conditions like eczema, dermatitis, insect bites, or allergic reactions. It works by calming down the skin's natural 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. If the treated area is on your hand, do not wash your hand after application.

Prepare the affected area by cleaning it before use and drying it well. Apply a thin layer of the medication to the affected skin and gently rub it in. Unless directed by your doctor, do not cover the treated area with bandages or dressings. Also, avoid applying the medication to your face, underarms, or groin area unless instructed to do so by your doctor.

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 this medication at room temperature, avoiding freezing. 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. 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.

Missing a Dose

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 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 to the affected area only, gently rubbing it in until it disappears.
  • Do not use on the face, groin, or underarms unless directed by a doctor.
  • Avoid contact with eyes, nose, and mouth.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by a doctor, as this can increase absorption.
  • Do not use for more than 7 days without consulting a doctor for OTC use.
  • 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 layer to the affected area 3 to 4 times daily.

Condition-Specific Dosing:

pruritus: Apply as needed for relief, typically 3-4 times daily.
inflammation: Apply as needed for relief, typically 3-4 times daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, consult pediatrician)
Infant: Apply a thin layer to the affected area 3 to 4 times daily. Use with caution, especially on large areas or under occlusion, due to increased risk of systemic absorption.
Child: Apply a thin layer to the affected area 3 to 4 times daily. Use with caution, especially on large areas or under occlusion, due to increased risk of systemic absorption.
Adolescent: Apply a thin layer to the affected area 3 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 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 as an anti-inflammatory and antipruritic agent. It diffuses across cell membranes and binds to specific cytoplasmic glucocorticoid receptors. This complex then translocates into the nucleus, where it binds to DNA and modulates gene expression. This leads to the synthesis of proteins that inhibit the release of inflammatory mediators (e.g., prostaglandins, leukotrienes) and suppress the immune response, resulting in reduced inflammation, pruritus, and vasoconstriction.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (minimal systemic absorption, depends on skin integrity, vehicle, area, duration, and occlusion)
Tmax: Not applicable for topical systemic effects; local effect onset is rapid.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not applicable for topical use (primarily local action)
ProteinBinding: Approximately 90% (for systemically absorbed portion)
CnssPenetration: Limited (for systemically absorbed portion)

Elimination:

HalfLife: Approximately 8-12 hours (for systemically absorbed portion)
Clearance: Not applicable for topical use (primarily local action)
ExcretionRoute: Renal (for systemically absorbed portion)
Unchanged: Not significant for topical use
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Pharmacodynamics

OnsetOfAction: Within minutes to hours for symptomatic relief (e.g., reduced itching, redness)
PeakEffect: Within hours to days of consistent application
DurationOfAction: 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 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, 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 7 days.
  • 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 developing.
  • Allergic reaction symptoms (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing).
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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 identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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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 products on your skin, 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 this with your doctor.

If this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center.

Do not use this medication for an extended period beyond what your doctor has prescribed. Prolonged use may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this with your doctor.

Certain products may not be suitable for use in the diaper area, so consult with your doctor before application. When using this medication on children, exercise caution, as they may be at a higher risk of experiencing side effects.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, and your doctor should be consulted about this potential risk.

If you are breastfeeding and using this medication on your breast or nipple, make sure to wash the area thoroughly before feeding your child.

Some formulations of this medication may not be appropriate for all age groups of children. If you have any questions or concerns, discuss them with your doctor.

It is also important to inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor 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:

  • While rare with topical use, especially 1% cream, prolonged or extensive use, especially in children or under occlusion, can lead to systemic effects such as:
  • Cushing's syndrome (e.g., moon face, buffalo hump, central obesity)
  • Hyperglycemia (high blood sugar)
  • Adrenal suppression (fatigue, weakness, nausea, vomiting)
  • Growth retardation in children

What to Do:

Discontinue use and consult a healthcare professional. For accidental ingestion or significant systemic symptoms, call Poison Control (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of inflammation, pruritus, and any existing skin damage (e.g., infection, thinning).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in symptoms)

Frequency: Daily to weekly, depending on condition

Target: Subjective improvement in redness, itching, swelling.

Action Threshold: If no improvement after 7 days (OTC use) or worsening of symptoms, discontinue and consult healthcare provider.

Local adverse reactions

Frequency: Daily

Target: Absence of skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, or secondary infection.

Action Threshold: If any adverse reactions occur, reduce frequency, discontinue, or consult healthcare provider.

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Symptom Monitoring

  • Worsening of skin condition
  • Signs of skin infection (e.g., pus, increased pain, fever)
  • Skin thinning or atrophy
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Acne-like eruptions
  • Increased hair growth at application site
  • Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)

Special Patient Groups

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Pregnancy

Hydrocortisone 1% cream is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected with appropriate topical use.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk due to minimal systemic absorption. Avoid extensive use.
Second Trimester: Generally considered low risk due to minimal systemic absorption. Avoid extensive use.
Third Trimester: Generally considered low risk due to minimal systemic absorption. Avoid extensive use.
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Lactation

Hydrocortisone 1% cream is considered compatible with breastfeeding (L3). Systemic absorption is minimal, and transfer into breast milk is unlikely to cause adverse effects in the infant.

Infant Risk: Low risk. Avoid applying to the breast or nipple area to prevent direct infant ingestion.
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Pediatric Use

Children, especially infants and young children, are more susceptible to systemic adverse effects from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Use the lowest effective dose for the shortest duration possible. Avoid use on large areas or under occlusive dressings. Monitor for signs of systemic absorption (e.g., growth retardation, Cushing's syndrome, adrenal suppression). Not recommended for children under 2 years without physician consultation.

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Geriatric Use

No specific dose adjustments are typically needed. However, elderly patients may have thinner, more fragile skin, increasing the risk of local adverse effects like skin atrophy or purpura. Monitor skin integrity closely.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 1% cream is a low-potency topical corticosteroid, suitable for mild to moderate inflammatory skin conditions.
  • Always apply a thin layer; more cream does not mean better results and can increase the risk of side effects.
  • Avoid prolonged use (more than 7 days for OTC) without medical supervision to prevent skin thinning and other local side effects.
  • Do not use on infected skin without concomitant antimicrobial therapy, as corticosteroids can mask or worsen infections.
  • For conditions like diaper rash, ensure the area is clean and dry before application. Avoid tight-fitting diapers or plastic pants if possible.
  • Store at room temperature, away from heat and moisture.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinonide - higher potency for more severe conditions, prescription only)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - for eczema, prescription only)
  • Antihistamines (oral or topical, for itching)
  • Emollients/moisturizers (for dry skin, barrier repair)
  • Cool compresses (for acute inflammation/itching)
  • Oatmeal baths (for widespread itching)
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Cost & Coverage

Average Cost: $5 - $20 per 1 oz (28g) tube
Generic Available: Yes
Insurance Coverage: OTC (Over-The-Counter), generally not covered by prescription insurance unless prescribed by a doctor and submitted for reimbursement, or through FSA/HSA.
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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 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 facilitate prompt and effective treatment.