Hydrocortisone 1% Cream 454gm
It is used to treat skin irritation.It is used to treat skin rashes.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydrocortisone 1% cream is a mild steroid medication applied to the skin to reduce inflammation, itching, and redness caused by various skin conditions like eczema, dermatitis, insect bites, and allergic reactions. It works by calming down the body's immune response in the skin.
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. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Precautions
Do not cover the treated area with bandages, dressings, or other coverings unless your doctor instructs you to do so.
Avoid applying the medication to your face, underarms, or groin area unless your doctor specifically tells you to do so.
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, 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. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in local drug take-back programs.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Precautions
Do not cover the treated area with bandages, dressings, or other coverings unless your doctor instructs you to do so.
Avoid applying the medication to your face, underarms, or groin area unless your doctor specifically tells you to do so.
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, 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. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in local drug take-back programs.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer only to the affected skin area.
- Wash your hands before and after applying the cream.
- Do not cover the treated area with bandages or tight dressings unless directed by a doctor, as this can increase absorption.
- Avoid using on the face, groin, or armpits unless specifically advised by a doctor.
- Do not use on broken, infected, or weeping skin without medical advice.
- Do not use for diaper rash without consulting a doctor.
- Avoid contact with eyes, nose, and mouth. Rinse thoroughly if contact occurs.
- Do not use for more than 7 days without consulting a healthcare professional.
Available Forms & Alternatives
Available Strengths:
- Hydrocortisone 1% Ointment 28.35gm
- Hydrocortisone 2.5% Cream 30gm
- Hydrocortisone 1% Cream 28.35gm
- Hydrocortisone 2.5% Oint 28.35gm
- Hydrocortisone Val 0.2% Cream 15gm
- Hydrocortisone Val 0.2% Cream 45gm
- Hydrocortisone Val 0.2% Cream 60gm
- Hydrocortisone Val 0.2% Oint 15gm
- Hydrocortisone Val 0.2% Ont 45gm
- Hydrocortisone Val 0.2% Ont 60gm
- Hydrocortisone 2.5% Oint 453.6gm
- Hydrocortisone 1% Ointment 453.6gm
- Hydrocortisone 2.5% Ointment 20gm
- Hydrocortisone 2.5% Cream
- Hydrocortisone AC 25mg Rectal Supp
- Hydrocortisone 1% Cream
- Hydrocort Butyrate 0.1% Soln 60ml
- Hydrocortisone Ace 30mg Suppository
- Hydrocortisone Val 0.2% Cream 45gm
- Hydrocortisone But 0.1% Oint 15gm
- Hydrocortisone But 0.1% Oint 45gm
- Hydrocortisone Val 0.2% Cream 60gm
- Hydrocortisone Val 0.2% Cream 15gm
- Hydrocortisone But 0.1% Cream 15gm
- Hydrocortisone But 0.1% Cream 45gm
- Hydrocortisone 2.5% Ointment 454gm
- Hydrocortisone 2.5% Cream 20gm
- Hydrocort Butyrate 0.1% Soln 20ml
- Hydrocortisone 2.5% Lotion 59ml
- Hydrocortisone 2.5% Lotion 118ml
- Hydrocortisone 2.5% Cream 28.35gm
- Hydrocortisone 100mg Enema 7 X 60ml
- Hydrocortisone 10mg Tablets
- Hydrocortisone 20mg Tablets
- Hydrocortisone 5mg Tablets
- Hydrocortisone Butyr 0.1% Crm 60gm
- Hydrocortisone Butyr 0.1% Crm 45gm
- Hydrocortisone 1% Cream 454gm
- Hydrocortisone 1% Ointment 28gm
- Hydrocortisone 0.5% W/aloe Cream
- Hydrocortisone 2.5% Rectal Cream
- Hydrocortisone 1% Cream 14.2gm
- Hydrocortisone 1% Rectal Crm 28.4gm
- Hydrocortisone 1%/iodoquinol 1% Crm
- Hydrocortisone 1% Cream 28gm
- Hydrocortisone 10mg Tablets
- Hydrocortisone 20mg Tablets
- Hydrocortisone 5mg Tablets
- Hydrocortisone Val 0.2% Oint 45gm
- Hydrocortisone Val 0.2% Oint 60gm
- Hydrocortisone 1% Cream 28.4gm
- Hydrocortisone 1% Cream 454gm
- Hydrocortisone 2.5% Cream 454gm
- Hydrocortisone 100mg Enema 60ml
- Hydrocortisone But 0.1% Lotion 59ml
- Hydrocortisone 1% W/aloe Cream 28gm
- Hydrocortisone 1% Plus Cream 28.4gm
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected area 2-4 times daily.
Condition-Specific Dosing:
generalUse:
Apply thinly to affected area 2-4 times daily. Do not use for more than 7 days without consulting a healthcare professional.
Pediatric Dosing
Neonatal:
Not established for routine use. Use with extreme caution, if at all, on small areas for short durations under medical supervision due to high risk of systemic absorption and adrenal suppression.
Infant:
Apply a thin layer to affected area 2-4 times daily. Use with caution on large surface areas or under occlusion due to increased systemic absorption risk and potential for adrenal suppression.
Child:
Apply a thin layer to affected area 2-4 times daily. Use with caution on large surface areas or under occlusion due to increased systemic absorption risk and potential for adrenal suppression.
Adolescent:
Apply a thin layer to affected area 2-4 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed for topical application due to minimal systemic absorption.
Moderate:
No adjustment typically needed for topical application due to minimal systemic absorption.
Severe:
No adjustment typically needed for topical application due to minimal systemic absorption.
Dialysis:
No specific considerations for topical application due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically needed for topical application due to minimal systemic absorption.
Moderate:
No adjustment typically needed for topical application due to minimal systemic absorption.
Severe:
No adjustment typically needed for topical application due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Hydrocortisone is a low-potency corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It acts by inducing phospholipase A2 inhibitory proteins, lipocortins, which 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.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; varies with skin integrity, vehicle, and occlusion. Absorption is increased on inflamed or damaged skin, with occlusion, and in areas with thinner skin (e.g., face, groin, axillae).
Tmax:
Not well-defined for topical absorption; systemic levels are generally negligible with proper use.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical absorption; systemically absorbed hydrocortisone distributes widely.
ProteinBinding:
Systemically absorbed hydrocortisone is highly protein bound (approximately 90%) to transcortin (corticosteroid-binding globulin) and albumin.
CnssPenetration:
Limited systemic penetration from topical application; not clinically significant for CNS effects.
Elimination:
HalfLife:
Systemic half-life of hydrocortisone is approximately 8-12 hours, but topical absorption half-life is not clinically relevant for most uses.
Clearance:
Not well-defined for topical absorption.
ExcretionRoute:
Renal (as inactive metabolites).
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief (e.g., reduction in itching, redness).
PeakEffect:
Days to weeks for full therapeutic effect, depending on the condition being treated.
DurationOfAction:
Varies with application frequency and individual response; effects typically last until next application.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, 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
Changes in vision
Severe headache
Irritation at the site of application
Signs of skin infection: oozing, heat, swelling, redness, or pain
Skin changes (acne, stretch marks, slow healing, excessive hair growth)
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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:
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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, 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
Changes in vision
Severe headache
Irritation at the site of application
Signs of skin infection: oozing, heat, swelling, redness, or pain
Skin changes (acne, stretch marks, slow healing, excessive hair growth)
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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:
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.
Seek Immediate Medical Attention If You Experience:
- Increased redness, swelling, or irritation at the application site.
- Signs of skin infection (e.g., pus, warmth, fever).
- Skin thinning, easy bruising, or stretch marks (striae).
- Acne-like breakouts or unusual hair growth.
- Lack of improvement in symptoms after 7 days of use.
- Any signs of systemic effects, though rare (e.g., unusual weight gain, swelling in ankles/feet, muscle weakness, vision problems).
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.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions.
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.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions.
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, immediately contact a doctor or poison control center, as this medication can be harmful if swallowed. Adhere to your doctor's prescribed treatment duration and do not use this medication for an extended period.
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult 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 on children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Your doctor will help monitor this and provide guidance.
If you are breast-feeding and apply this medication to your breast or nipple, make sure to wash the area thoroughly before feeding your child. Certain forms of this medication may not be suitable for all age groups of children, so if you have any questions or concerns, consult with your doctor.
If you are pregnant, planning 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 baby's well-being.
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, immediately contact a doctor or poison control center, as this medication can be harmful if swallowed. Adhere to your doctor's prescribed treatment duration and do not use this medication for an extended period.
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult 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 on children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Your doctor will help monitor this and provide guidance.
If you are breast-feeding and apply this medication to your breast or nipple, make sure to wash the area thoroughly before feeding your child. Certain forms of this medication may not be suitable for all age groups of children, so if you have any questions or concerns, consult with your doctor.
If you are pregnant, planning 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 baby's well-being.
Overdose Information
Overdose Symptoms:
- Overdose from topical application is rare but 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, thin skin, striae), adrenal suppression, hyperglycemia, and growth retardation in children.
What to Do:
If you suspect an overdose or significant systemic absorption, discontinue use and seek immediate medical attention. Call 1-800-222-1222 (Poison Control) or go to the nearest emergency room.
Drug Interactions
Contraindicated Interactions
- None known for topical hydrocortisone due to minimal systemic absorption.
Major Interactions
- None known for topical hydrocortisone due to minimal systemic absorption.
Moderate Interactions
- None known for topical hydrocortisone due to minimal systemic absorption.
Minor Interactions
- None known for topical hydrocortisone due to minimal systemic absorption.
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of inflammation, pruritus, and other symptoms.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in symptoms)
Frequency: Daily to weekly, depending on condition.
Target: Improvement in redness, itching, swelling.
Action Threshold: Lack of improvement or worsening of symptoms after 7 days (for OTC use) warrants medical re-evaluation.
Local adverse effects
Frequency: Daily with application.
Target: Absence of skin thinning, striae, telangiectasias, folliculitis, perioral dermatitis, or signs of infection.
Action Threshold: Development of new or worsening skin irritation, signs of infection, or skin atrophy warrants discontinuation and medical evaluation.
Signs of systemic absorption (rare)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusion.
Target: Absence of Cushing's syndrome symptoms (e.g., weight gain, moon face, striae), hyperglycemia, or adrenal suppression.
Action Threshold: Any signs of systemic effects warrant immediate medical evaluation and discontinuation.
Symptom Monitoring
- Persistent or worsening redness
- Increased itching or burning
- Swelling
- Pus or signs of infection (e.g., warmth, fever)
- Skin thinning or fragility
- Stretch marks (striae)
- Acne-like eruptions
- Unusual hair growth
- Changes in skin color
Special Patient Groups
Pregnancy
Hydrocortisone is Pregnancy Category C. Use with caution during pregnancy, especially on large areas, for prolonged periods, or under occlusion, due to the theoretical risk of systemic absorption and potential fetal effects. The decision to use should weigh the potential benefits against the potential risks.
Trimester-Specific Risks:
First Trimester:
Risk of fetal harm generally considered low with topical use, but systemic absorption can occur. Avoid large areas/prolonged use.
Second Trimester:
Risk of fetal harm generally considered low with topical use, but systemic absorption can occur. Avoid large areas/prolonged use.
Third Trimester:
Risk of fetal harm generally considered low with topical use, but systemic absorption can occur. Avoid large areas/prolonged use. Potential for adrenal suppression in the neonate if used extensively near term.
Lactation
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 infant exposure with proper topical use on small areas. Monitor infant for any unusual effects, though unlikely.
Pediatric Use
Use with extreme caution, especially in infants and young children, due to a higher risk of systemic absorption and adrenal suppression. Children have a larger skin surface area to body weight ratio, increasing absorption. Avoid prolonged use, use on large surface areas, or use under occlusion. Consult a pediatrician before use in children under 2 years of age.
Geriatric Use
No specific dose adjustments needed. Use with caution in elderly patients who may have thinner, more fragile skin, increasing the risk of local adverse effects like skin atrophy or purpura.
Clinical Information
Clinical Pearls
- Hydrocortisone 1% is a low-potency topical corticosteroid, making it suitable for mild inflammatory dermatoses and for use on sensitive areas like the face (with caution and medical advice).
- For OTC use, advise patients not to use for more than 7 days without consulting a healthcare professional.
- Systemic absorption is increased with higher potency corticosteroids, larger surface areas of application, prolonged use, occlusion, and impaired skin barrier.
- Patients should be educated on proper application technique (thin layer, gentle rubbing) and to avoid contact with eyes.
- If symptoms do not improve or worsen, or if signs of infection develop, patients should seek medical attention.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., triamcinolone, fluocinolone, clobetasol for more severe conditions, by prescription)
- Emollients and moisturizers (for dry skin, eczema)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus for eczema, by prescription)
- Oral antihistamines (for systemic itching)
- Topical anesthetics (e.g., lidocaine, benzocaine for localized itch/pain)
Cost & Coverage
Average Cost:
$5 - $20 per 454gm cream
Generic Available:
Yes
Insurance Coverage:
Not typically covered by insurance as it is an over-the-counter (OTC) medication.
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 details. 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 information about the medication taken, the amount, and the time it happened.