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Hydrocortisone 1% W/aloe Cream 28gm

Manufacturer RUGBY LABORATORIES 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% 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. The aloe in this specific cream may help soothe 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'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 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'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 skin area, gently rubbing it in until it disappears.
  • Do not use more than directed or for longer than recommended by your doctor.
  • Avoid applying to the eyes, mouth, or inside the nose.
  • Do not use on broken, infected, or open skin unless specifically instructed by a doctor.
  • Do not cover the treated area with bandages or tight dressings unless advised by your doctor, especially in children, as this can increase absorption.
  • 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 affected area 2 to 4 times daily

Condition-Specific Dosing:

eczema: Apply 2-3 times daily
dermatitis: Apply 2-4 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 layer to affected area 1-2 times daily, for short durations. Avoid occlusive dressings.
Child: Apply a thin layer to affected area 1-2 times daily, for short durations. Avoid occlusive dressings.
Adolescent: Apply a thin layer to affected area 2-4 times daily, similar to adults.
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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 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 vasoconstrictive properties.
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Pharmacokinetics

Absorption:

Bioavailability: Varies significantly (generally low systemic absorption, but can be up to 5% or more depending on skin integrity, vehicle, area of application, and occlusion)
Tmax: Not precisely defined for topical application due to variable absorption; local effect is rapid.
FoodEffect: Not applicable for topical administration

Distribution:

Vd: Not precisely quantified for topical absorption; if absorbed systemically, widely distributed.
ProteinBinding: Approximately 90% (primarily to transcortin and albumin) if absorbed systemically.
CnssPenetration: Limited (if absorbed systemically, can cross blood-brain barrier)

Elimination:

HalfLife: Approximately 1.5-2 hours (systemic, if absorbed)
Clearance: Not precisely quantified for topical absorption
ExcretionRoute: Renal (primarily as inactive metabolites if absorbed systemically)
Unchanged: Minimal (if absorbed systemically)
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Pharmacodynamics

OnsetOfAction: Within minutes to hours for symptomatic relief
PeakEffect: Within hours
DurationOfAction: Several hours, requiring multiple daily applications

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 medical attention immediately:

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 unusual symptoms, contact your doctor for advice:

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 condition worsens or does not improve after 1-2 weeks of use.
  • Signs of skin infection develop (e.g., increased redness, swelling, pain, pus, fever).
  • Severe burning, itching, or irritation occurs at the application site.
  • Skin thinning, easy bruising, or stretch marks appear with prolonged use.
  • Any unusual or severe side effects.
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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 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. 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 taking this medication. Before using any other medications or skin products, including soaps, consult with your doctor to ensure safe use.

When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. If you need to use it on a large area of skin, discuss this with your doctor to minimize potential risks.

In case of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center. Do not use this medication for an extended period beyond the duration prescribed by your doctor.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk. Additionally, some 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 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 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. Certain formulations of this medication may not be suitable for all age groups of children, so consult with your doctor if you have any questions or concerns.

If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the 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:

  • Topical overdose is rare due to minimal systemic absorption.
  • Prolonged or extensive use, especially in children or with occlusive dressings, can lead to systemic effects such as Cushing's syndrome (e.g., weight gain, moon face, thinning skin, muscle weakness), or adrenal suppression (fatigue, weakness, low blood pressure).

What to Do:

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

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

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

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus, erythema)

Frequency: Daily to weekly, depending on severity

Target: Improvement in symptoms

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

Local adverse effects (skin atrophy, striae, telangiectasias, burning, itching, irritation)

Frequency: Weekly or as symptoms arise

Target: Absence of new or worsening adverse effects

Action Threshold: Presence of significant local adverse effects may require discontinuation or change in therapy.

Signs of infection (if applicable)

Frequency: Daily to weekly

Target: Absence of signs of bacterial, fungal, or viral infection

Action Threshold: Development of infection requires appropriate antimicrobial therapy and potential discontinuation of hydrocortisone.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, swelling, pain, or pus (signs of infection)
  • Severe burning, itching, or irritation at application site
  • Skin thinning, easy bruising, or stretch marks (signs of skin atrophy with prolonged use)
  • Unusual fatigue, weight gain, moon face, or muscle weakness (rare signs of systemic absorption/Cushing's syndrome, especially in children or with extensive/prolonged 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 areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is generally low.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: No specific risks identified beyond general corticosteroid effects; avoid large areas or prolonged use.
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Lactation

Caution is advised. It is not known whether topical hydrocortisone is excreted in human milk. Systemic absorption is generally low. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited, short-term use on small areas. Potential for adverse effects if significant systemic absorption occurs in mother and drug is excreted in milk, or if infant ingests directly from skin.
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Pediatric Use

Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio. Use the lowest effective dose for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

No specific dose adjustments are typically needed. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy. Monitor for skin fragility.

Clinical Information

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Clinical Pearls

  • Hydrocortisone 1% is a low-potency topical corticosteroid, suitable for mild to moderate inflammatory dermatoses.
  • The addition of aloe may provide additional soothing properties but does not alter the primary corticosteroid action.
  • Advise patients to apply a very thin layer; a little goes a long way.
  • Educate patients on the signs of skin atrophy (thinning, bruising, striae) and to report them.
  • Not for use on fungal, bacterial, or viral infections without concomitant antimicrobial therapy.
  • Avoid prolonged use on the face, groin, or axillae due to increased risk of skin atrophy and other local side effects.
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Alternative Therapies

  • Other low-potency topical corticosteroids (e.g., desonide, fluocinolone acetonide 0.01%)
  • Non-steroidal anti-inflammatory creams (e.g., tacrolimus, pimecrolimus for eczema)
  • Emollients and moisturizers (for dry skin conditions)
  • Antihistamines (oral or topical for pruritus)
  • Cool compresses
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Cost & Coverage

Average Cost: $5 - $20 per 28gm tube of 1% cream
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred 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 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.