Hydrocortisone 2.5% Lotion 118ml

Manufacturer PERRIGO PHARMACEUTICALS Active Ingredient Hydrocortisone Lotion(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
Corticosteroid, Topical Anti-inflammatory
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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 lotion is a mild corticosteroid medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema, dermatitis, and rashes. It works by calming down the immune response in the skin.
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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 well. 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 instructs 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. Before each use, shake the medication well.

Storage and Disposal

Store the 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 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 dose.
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Lifestyle & Tips

  • Wash hands before and after applying the lotion.
  • Apply a thin layer to the affected area and rub in gently until it disappears.
  • Do not use more than directed or for longer than prescribed.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Do not apply to open wounds or broken skin unless directed by a doctor.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption.
  • Avoid using on the face, groin, or armpits unless directed by a doctor, as these areas are more susceptible to side effects.
  • 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 a thin film to the affected skin area 2 to 4 times daily.
dermatitis: Apply a thin film to the affected skin area 2 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 skin area 2 to 4 times daily, or as directed by a physician. Use with caution, especially on large surface areas or under occlusive dressings, due to increased systemic absorption risk.
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 occlusive dressings, due to increased systemic absorption risk.
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.

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: Variable (typically low, but increased by inflammation, skin barrier defects, occlusion, and application to large surface areas)
Tmax: Not well-defined for topical application; systemic absorption is gradual.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not available (systemic distribution occurs if absorbed)
ProteinBinding: Approximately 90% (to albumin and corticosteroid-binding globulin) if systemically absorbed.
CnssPenetration: Limited (primarily local action, but systemic absorption can lead to CNS effects).

Elimination:

HalfLife: Approximately 1.5-2 hours (systemic, if absorbed)
Clearance: Not available (systemic, if absorbed)
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Days to weeks of consistent application for maximal therapeutic effect.
DurationOfAction: Varies with frequency of application and severity of condition.

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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Signs of skin infection: oozing, heat, swelling, redness, or pain
Skin changes, such as acne, stretch marks, slow healing, or excessive hair growth
Changes in vision
Severe headache
Irritation at the site of application
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 unusual symptoms that bother you or persist, contact your doctor for advice:

Burning or stinging sensation
Dryness
* Tingling

This is not an exhaustive list of potential 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:

  • Increased redness, itching, or irritation at the application site.
  • Signs of skin infection (pus, fever, worsening pain).
  • Skin thinning, easy bruising, or stretch marks developing.
  • Acne-like breakouts or increased hair growth in the treated area.
  • Any signs of systemic side effects like unusual weight gain, swelling in the face, or muscle weakness (rare with topical use but possible with prolonged or extensive use).
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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 and pharmacist identify 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. Never start, stop, or adjust 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 using this medication. Before using any other medications or skin products, including 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 the treatment plan with your doctor.

In case of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center. Adhere to your doctor's prescribed treatment duration, and do not use this medication for an extended period.

Certain products may not be suitable for use in the diaper area, so consult with your doctor before application. Additionally, this medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk with your doctor.

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 determine the appropriate treatment plan.

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

If you are breastfeeding and apply this medication to your breast or nipple, ensure you wash the area thoroughly before feeding your child. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Chronic overuse or application to large areas can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, buffalo hump, central obesity, thinning skin, easy bruising, muscle weakness, high blood pressure, high blood sugar, and adrenal suppression.

What to Do:

Discontinue use and consult a healthcare professional. For acute ingestion, call a poison control center immediately (1-800-222-1222). Management is supportive.

Drug Interactions

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Contraindicated Interactions

  • None for topical hydrocortisone
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Major Interactions

  • None significant for topical hydrocortisone at recommended doses
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Moderate Interactions

  • None significant for topical hydrocortisone at recommended doses
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Minor Interactions

  • None significant for topical hydrocortisone at recommended doses

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any contraindications (e.g., fungal infections).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Daily to weekly, depending on severity.

Target: Symptom improvement.

Action Threshold: Lack of improvement after 1-2 weeks, or worsening symptoms, warrants re-evaluation.

Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)

Frequency: Weekly to monthly, or at each follow-up visit.

Target: Absence of adverse effects.

Action Threshold: Presence of adverse effects warrants reduction in frequency, potency, or discontinuation.

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

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

Target: Absence of systemic effects.

Action Threshold: Any signs or symptoms warrant immediate medical evaluation and discontinuation.

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Symptom Monitoring

  • Redness
  • Itching
  • Swelling
  • Burning
  • Stinging
  • Skin thinning (atrophy)
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Acne-like eruptions
  • Increased hair growth
  • Changes in skin color
  • Signs of infection (pus, fever)
  • Unusual fatigue
  • Weight gain (especially in face/trunk)
  • Muscle weakness

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Category C. Avoid large amounts, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though low with topical use. Use with caution.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Risk of fetal growth restriction or adrenal suppression with high doses/prolonged use. Use with caution.
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Lactation

Hydrocortisone is considered moderately safe (L3). Use with caution. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate use (limited area, short duration). Potential for systemic effects in infant if significant absorption occurs from mother's skin and transferred via milk, or direct contact.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects, including HPA axis suppression and Cushing's syndrome. Use the least potent effective dose for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

Elderly patients may have thinner skin and be more susceptible to local adverse effects (e.g., skin atrophy, purpura). Use with caution and monitor closely.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 2.5% is a low-to-medium potency topical corticosteroid, suitable for mild to moderate inflammatory dermatoses.
  • Educate patients on the 'less is more' principle: a thin layer is sufficient. Overuse does not improve efficacy but increases side effects.
  • Advise patients to avoid using on the face, groin, or axillae for prolonged periods without medical supervision due to increased risk of skin atrophy, telangiectasias, and perioral dermatitis in these sensitive areas.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis or consider a different treatment.
  • Warn about the potential for rebound flare-ups if discontinued abruptly after prolonged use, especially for chronic conditions.
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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, especially on sensitive areas)
  • Emollients and moisturizers (for barrier repair and mild irritation)
  • Antihistamines (oral, for pruritus)
  • Topical antifungals (if fungal infection is suspected)
  • Topical antibiotics (if bacterial infection is suspected)
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Cost & Coverage

Average Cost: $15 - $50 per 118ml lotion
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 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. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.