Hydrocortisone 1% Cream 28.35gm

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
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, swelling, and itching caused by various skin conditions like eczema, dermatitis, and 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're treating a skin condition on your hand, do not wash your hand after application.

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 to the affected area and rub in gently until it disappears.
  • Do not cover the treated area with bandages or dressings unless directed by your doctor, as this can increase absorption.
  • Avoid applying to the eyes, mouth, or inside the nose.
  • Do not use on broken skin, deep wounds, or severe burns without medical advice.
  • Do not use for longer than directed, 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 film to the affected skin area 2 to 4 times daily, or as directed by a physician.

Condition-Specific Dosing:

eczema: Apply a thin film to the affected area 2-4 times daily.
dermatitis: Apply a thin film to the affected area 2-4 times daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, increased systemic absorption risk)
Infant: Apply a thin film to the affected skin area 2 to 4 times daily, or as directed by a physician. Use with caution, especially on large surface areas or under occlusion, due to increased risk of systemic absorption.
Child: Apply a thin film to the affected skin area 2 to 4 times daily, or as directed by a physician. Use with caution, especially on large surface areas or under occlusion, 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 (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Confidence: High

Pharmacology

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Mechanism of Action

Hydrocortisone is a corticosteroid that acts 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. It also possesses antipruritic and vasoconstrictive properties.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (varies with skin integrity, vehicle, area, occlusion)
Tmax: Not applicable (primarily local action)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (primarily local action)
ProteinBinding: Not applicable (primarily local action, systemically ~90% bound)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not applicable (primarily local action, systemic half-life of hydrocortisone is ~1.5-2 hours)
Clearance: Not applicable (primarily local action)
ExcretionRoute: Renal (for systemically absorbed portion)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within minutes to hours for symptomatic relief (e.g., itching), full anti-inflammatory effect may take days.
PeakEffect: Variable, depends on condition and application frequency.
DurationOfAction: Several hours per application.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 medical attention right away:

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. 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:

  • Skin irritation or burning that worsens
  • Signs of skin infection (pus, fever, spreading redness, warmth)
  • Thinning of the skin, easy bruising, or stretch marks in the treated area
  • Worsening of the original skin condition
  • Any signs of systemic side effects (very rare with 1% cream, but includes unusual weight gain, swelling in ankles/feet, increased thirst/urination, muscle weakness, mood changes) - seek medical attention immediately.
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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, any of 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 and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and 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.

Safe Use Precautions

Avoid applying this medication to cuts, scrapes, or damaged skin.
When using this medication on a large area of skin, exercise caution and discuss with your doctor.
In case of accidental ingestion, immediately contact a doctor or poison control center, as this medication can be harmful if swallowed.
Do not use this medication for an extended period beyond the duration prescribed by your doctor.

Potential Risks and Side Effects

Long-term use of this medication may increase the risk of developing cataracts or glaucoma; consult with your doctor to discuss potential risks.
Certain products may not be suitable for use in the diaper area; consult with your doctor for guidance.
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, and regular growth checks may be necessary; discuss with your doctor.
If you are breast-feeding and using this medication on your breast or nipple, ensure you wash the area thoroughly before breast-feeding your child.

Special Considerations

Some formulations of this medication may not be suitable for all age groups of children; if you have questions, consult with your doctor.
* If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor to discuss the benefits and risks of using this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or extensive use, especially in children or under occlusion, can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, buffalo hump, central obesity, thinning skin, easy bruising, striae, muscle weakness, high blood pressure, high blood sugar, and growth retardation in children.

What to Do:

Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice if accidental ingestion or significant systemic exposure is suspected.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin infections or integrity issues.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (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 1-2 weeks, consider re-evaluation.

Adverse skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)

Frequency: Weekly to monthly, or as symptoms arise

Target: Absence of adverse reactions

Action Threshold: Presence of adverse reactions, consider reducing frequency, potency, or discontinuing.

Signs of infection (e.g., increased redness, warmth, pus)

Frequency: Daily

Target: Absence of infection

Action Threshold: Presence of infection, consider appropriate antimicrobial therapy and/or discontinuation of hydrocortisone.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness or irritation at application site
  • Development of new skin lesions (e.g., pimples, thinning skin, stretch marks)
  • Signs of skin infection (pus, fever, spreading redness)
  • Unusual fatigue or weakness (rare, but indicates potential systemic absorption with prolonged/extensive use)

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: Potential for fetal harm, though systemic absorption is minimal. Use with caution.
Second Trimester: Use with caution, minimal systemic absorption expected.
Third Trimester: Use with caution, minimal systemic absorption expected.
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Lactation

L3 - Moderately safe. Minimal systemic absorption is expected. Avoid applying to the breast or nipple area to prevent infant ingestion.

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

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation). Use the least potent effective dose for the shortest duration possible. Avoid occlusion.

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Geriatric Use

Generally safe. Elderly patients may have thinner skin, which could theoretically increase absorption, but this is usually not clinically significant with 1% hydrocortisone. Monitor for skin atrophy and fragility.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 1% is a low-potency corticosteroid, suitable for mild to moderate inflammatory dermatoses.
  • Always apply a thin layer; more cream does not mean better results and can increase side effects.
  • Avoid prolonged use on the face, groin, or axillae, as these areas are more susceptible to steroid-induced skin atrophy.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis or consider a stronger corticosteroid under medical guidance.
  • Topical corticosteroids can mask or worsen skin infections; ensure any fungal or bacterial infections are treated appropriately.
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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
  • Emollients and moisturizers for dry skin conditions
  • Antihistamines (oral or topical) for pruritus
  • Topical non-steroidal anti-inflammatory drugs (NSAIDs) for pain/inflammation (less common for dermatoses)
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Cost & Coverage

Average Cost: $5 - $20 per 28.35gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 (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.