Hydrocortisone 2.5% Lotion 59ml

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
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Pharmacologic Class
Glucocorticoid Receptor Agonist; Anti-inflammatory Agent
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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 steroid medicine applied to the skin to reduce redness, itching, and swelling 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 are 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 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 specifically instructs you to do so.

If you are treating a skin condition in the diaper area, avoid using 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 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 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.
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Lifestyle & Tips

  • Wash hands before and after applying.
  • Apply a thin layer only to the affected area.
  • Do not use more often or for longer than prescribed.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Do not use on broken or infected skin unless directed by a doctor.
  • Do not cover the treated area with bandages or tight dressings unless instructed by your doctor, as this can increase absorption.
  • Inform your doctor if your condition worsens or does not improve after 1-2 weeks.
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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.
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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 2 to 4 times daily, for short periods, under medical supervision due to increased systemic absorption risk.
Child: Apply a thin film to the affected area 2 to 4 times daily, for short periods, under medical supervision due to increased systemic absorption risk.
Adolescent: Apply a thin film to the affected area 2 to 4 times daily.
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Dose Adjustments

Renal Impairment:

Mild: No specific dosage adjustment required for topical application due to minimal systemic absorption.
Moderate: No specific dosage adjustment required for topical application due to minimal systemic absorption.
Severe: No specific dosage adjustment required for topical application due to minimal systemic absorption. Use with caution if extensive application or prolonged use is anticipated, as systemic absorption could theoretically increase.
Dialysis: No specific considerations for topical application due to minimal systemic absorption.

Hepatic Impairment:

Mild: No specific dosage adjustment required for topical application due to minimal systemic absorption.
Moderate: No specific dosage adjustment required for topical application due to minimal systemic absorption.
Severe: No specific dosage adjustment required for topical application due to minimal systemic absorption. Use with caution if extensive application or prolonged use is anticipated, as systemic absorption could theoretically increase.

Pharmacology

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Mechanism of Action

Hydrocortisone is a low-potency corticosteroid. It acts by binding to glucocorticoid receptors in the cytoplasm, leading to a cascade of gene expression changes. This results in anti-inflammatory, antipruritic, and vasoconstrictive effects. It inhibits the release of hydrolytic enzymes from leukocytes, prevents macrophage accumulation in inflamed areas, reduces leukocyte adhesion to capillary walls, and decreases the permeability of capillary membranes. It also inhibits the synthesis and release of various inflammatory mediators like prostaglandins and leukotrienes.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (depends on skin integrity, vehicle, area of application, occlusion). Systemic absorption is generally low but can increase with damaged skin, large surface areas, prolonged use, or occlusive dressings.
Tmax: Not applicable for topical application; local effect is primary.
FoodEffect: Not applicable for topical application.

Distribution:

Vd: Not well-quantified for topical use; systemically absorbed hydrocortisone distributes widely.
ProteinBinding: Approximately 90% (for systemically absorbed hydrocortisone, primarily to corticosteroid-binding globulin and albumin).
CnssPenetration: Limited (for topical application, systemic levels are usually too low to cause significant CNS effects).

Elimination:

HalfLife: Approximately 8-12 hours (for systemically absorbed hydrocortisone).
Clearance: Not well-quantified for topical use; systemically absorbed hydrocortisone is cleared renally.
ExcretionRoute: Renal (primarily as inactive metabolites).
Unchanged: <1% (for systemically absorbed hydrocortisone).
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., reduction in itching, redness).
PeakEffect: Variable, often within days of consistent application.
DurationOfAction: Depends on application frequency; local effects persist for 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: 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 application site
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 guidance:

Burning or stinging sensation
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:

  • Increased redness, itching, or swelling at the application site
  • Burning or stinging sensation
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Acne-like breakouts
  • Hair growth in treated areas
  • Signs of skin infection (pus, fever)
  • Any signs of systemic effects like unusual weight gain, swelling in ankles/feet, or increased thirst/urination (rare with topical hydrocortisone)
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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 this medication can be taken with all your other 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 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 this 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 avoid using 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, and your doctor should be informed to monitor this potential side effect.

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 this with your doctor, and note that some formulations of this medication may not be suitable for all age groups of children.

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, consult with your doctor to weigh the benefits and risks of using this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use, especially on large areas or under occlusion, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, central obesity, striae), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Local symptoms include severe skin atrophy, telangiectasias, and striae.

What to Do:

Discontinue use and consult a healthcare professional. Management is supportive. For acute overdose, call 1-800-222-1222 (Poison Control).

Drug Interactions

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Minor Interactions

  • No significant systemic drug-drug interactions are expected with topical hydrocortisone due to minimal systemic absorption. However, caution is advised if applied to large surface areas or under occlusion, as systemic absorption could theoretically increase, potentially leading to interactions seen with systemic corticosteroids (e.g., with CYP3A4 inducers/inhibitors, antidiabetics, anticoagulants).

Monitoring

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Baseline Monitoring

Skin condition assessment (type of lesion, area, severity)

Rationale: To establish baseline for efficacy and identify contraindications (e.g., fungal infections).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Daily by patient, weekly/bi-weekly by clinician if condition persists.

Target: Significant improvement in symptoms.

Action Threshold: Lack of improvement after 1-2 weeks, worsening symptoms, or development of adverse effects.

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

Frequency: Daily by patient, at each follow-up visit by clinician.

Target: Absence of adverse effects.

Action Threshold: Presence of any adverse effect, especially skin atrophy or infection.

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

Frequency: Rarely needed for low-potency topical hydrocortisone unless extensive, prolonged use, or in pediatric patients. Consider if symptoms arise.

Target: Normal endocrine function.

Action Threshold: Symptoms like weight gain, moon face, striae, or growth retardation in children. May warrant HPA axis testing (e.g., ACTH stimulation test).

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Symptom Monitoring

  • Reduction in redness
  • Reduction in itching
  • Healing of lesions
  • Absence of skin irritation
  • Absence of skin thinning
  • Absence of new infections

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 areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk with topical use due to minimal systemic absorption. Avoid high potency or large areas.
Second Trimester: Similar to first trimester. Risk of systemic effects to mother and fetus increases with extensive or prolonged use.
Third Trimester: Similar to first and second trimesters. Neonatal adrenal insufficiency is a theoretical risk with extensive maternal use of potent corticosteroids, but unlikely with low-potency hydrocortisone lotion.
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Lactation

L3 (Moderately safe). Hydrocortisone is minimally absorbed systemically. It is generally considered compatible with breastfeeding when used topically on small areas. Avoid applying to the breast or nipple area to prevent direct infant ingestion.

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

Children, especially infants and young children, are more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) 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 occlusive dressings.

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Geriatric Use

No specific dosage adjustments are generally required. However, geriatric patients may have thinner skin, making them more susceptible to local adverse effects like skin atrophy and purpura. Use with caution and monitor for skin integrity.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 2.5% is a low-potency topical corticosteroid, suitable for mild to moderate inflammatory dermatoses.
  • Lotion formulations are generally less potent than creams or ointments of the same concentration, and are suitable for hairy areas or weeping lesions.
  • Educate patients on proper application technique: thin layer, rub in gently, do not use on face/groin/axillae unless specifically directed by a physician due to increased risk of side effects in these sensitive areas.
  • Prolonged use, especially on the face or in intertriginous areas, can lead to skin atrophy, telangiectasias, and striae.
  • Always rule out fungal or bacterial infections before initiating corticosteroid therapy, as steroids can worsen these conditions.
  • HPA axis suppression is rare with low-potency topical hydrocortisone but can occur with extensive use, especially in children or with occlusive dressings.
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Alternative Therapies

  • Other topical corticosteroids of varying potencies (e.g., triamcinolone, fluocinonide, clobetasol)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing effect
  • Emollients and moisturizers for barrier repair
  • Antihistamines (oral) for pruritus
  • Phototherapy for certain dermatoses
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Cost & Coverage

Average Cost: Low to Moderate per 59ml lotion
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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.