Epifoam 1% Aerosol 10gm
It is used to treat skin irritation.
Drug Class
Topical Anesthetic; Topical Corticosteroid
Pharmacologic Class
Local Anesthetic; Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Epifoam is a medication that combines a numbing agent (pramoxine) and a steroid (hydrocortisone) to relieve pain, itching, and swelling caused by conditions like hemorrhoids or other skin irritations around the rectum. It comes as a foam that you apply to the affected area.
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's essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area.
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 Precautions
Do not cover the treated area with bandages, dressings, or tight-fitting clothing, unless your doctor instructs you to do so.
If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this may increase the amount of medication absorbed into the body.
Preparing the Medication for Use
Shake the container well before use.
Hold the container upright when applying the medication, and avoid turning it upside down.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the container upright with the cap on tight.
Protect the medication from heat, open flames, or sparks.
Do not puncture or burn the container, even if it appears empty.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
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 dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area.
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 Precautions
Do not cover the treated area with bandages, dressings, or tight-fitting clothing, unless your doctor instructs you to do so.
If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this may increase the amount of medication absorbed into the body.
Preparing the Medication for Use
Shake the container well before use.
Hold the container upright when applying the medication, and avoid turning it upside down.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the container upright with the cap on tight.
Protect the medication from heat, open flames, or sparks.
Do not puncture or burn the container, even if it appears empty.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
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 dose.
Lifestyle & Tips
- Maintain good hygiene in the affected area.
- Avoid prolonged sitting or straining during bowel movements.
- Increase fiber intake and fluid consumption to prevent constipation.
- Avoid harsh soaps or irritants in the affected area.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to the affected area 2 to 3 times daily. For anorectal use, apply externally or internally using an applicator.
Dose Range:
2 - 3 mg
Condition-Specific Dosing:
anorectal_disorders:
Apply 2 to 3 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for prolonged use due to potential for systemic absorption and HPA axis suppression.
Adolescent:
Not recommended for prolonged use due to potential for systemic absorption and HPA axis suppression.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Dialysis:
Considerations: Minimal systemic absorption, so dialysis considerations are generally not applicable.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Pharmacology
Mechanism of Action
Pramoxine is a topical local anesthetic that provides temporary relief from pain and itching by stabilizing the neuronal membrane and inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses. Hydrocortisone is a corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It induces phospholipase A2 inhibitory proteins, thereby controlling the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable for topical use; minimal systemic absorption.
Tmax:
Not well-defined for topical application; symptomatic relief typically within minutes.
FoodEffect:
Not applicable.
Distribution:
Vd:
Not applicable for topical use; minimal systemic distribution.
ProteinBinding:
Hydrocortisone is highly protein-bound in systemic circulation (if absorbed); Pramoxine binding not well-defined for topical use.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined for topical application; systemic hydrocortisone has a half-life of 8-12 hours.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Metabolites of hydrocortisone and pramoxine are primarily excreted renally.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Minutes (for symptomatic relief)
PeakEffect:
Within 30 minutes to 1 hour
DurationOfAction:
Several hours (typically 3-4 hours for symptomatic relief)
Confidence:
Medium
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, 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 a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
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
Irritation at the site where the medication was applied
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Dry skin
Burning
Itching
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, 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 a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
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
Irritation at the site where the medication was applied
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Dry skin
Burning
Itching
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:
- Symptoms worsen or do not improve within 7 days.
- Bleeding from the rectum.
- Signs of infection (e.g., pus, fever, severe pain).
- Severe burning, stinging, or irritation after application.
- Skin changes like thinning, discoloration, or stretch marks.
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.
* 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 current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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.
* 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 current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment and do not use this drug for longer than recommended by your doctor.
When administering this medication to children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this drug may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss the potential risks and benefits.
Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use. Avoid applying this medication to cuts, scrapes, or damaged skin. If you need to use this medication on a large area of skin, exercise caution and discuss this with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
When administering this medication to children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this drug may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss the potential risks and benefits.
Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use. Avoid applying this medication to cuts, scrapes, or damaged skin. If you need to use this medication on a large area of skin, exercise caution and discuss this with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use, especially over large areas or under occlusive dressings, can lead to systemic absorption of hydrocortisone, potentially causing Cushing's syndrome (e.g., moon face, weight gain, high blood pressure, muscle weakness), hyperglycemia, or adrenal suppression.
- Local skin atrophy, striae, or telangiectasias.
What to Do:
Discontinue use and consult a healthcare professional. Symptomatic and supportive treatment. For significant systemic absorption, gradual withdrawal of the steroid may be necessary. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of affected area (e.g., hemorrhoids, pruritus ani)
Rationale: To establish baseline severity and identify any signs of infection or other underlying conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom relief (pain, itching, inflammation)
Frequency: Daily
Target: Reduction or resolution of symptoms
Action Threshold: If symptoms worsen or do not improve within 7 days, re-evaluate diagnosis and treatment.
Local skin reactions (e.g., irritation, burning, atrophy, striae)
Frequency: Regularly during treatment
Target: Absence of adverse reactions
Action Threshold: Discontinue if severe irritation or signs of skin atrophy develop.
Symptom Monitoring
- Worsening of pain
- Increased itching
- Increased inflammation or redness
- Signs of infection (pus, fever, spreading redness)
- Skin thinning or discoloration
- Burning or stinging sensation at application site
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption of topical corticosteroids can occur.
Trimester-Specific Risks:
First Trimester:
Limited data, but systemic absorption is generally low with topical use. Avoid large areas or prolonged use.
Second Trimester:
Limited data, but systemic absorption is generally low with topical use. Avoid large areas or prolonged use.
Third Trimester:
Limited data, but systemic absorption is generally low with topical use. Avoid large areas or prolonged use. Potential for low birth weight or adrenal suppression in neonates with extensive maternal use.
Lactation
Caution is advised. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Weigh the benefits of breastfeeding against the potential risks.
Infant Risk:
Low risk with limited, short-term use on small areas. Avoid applying to areas that may come into direct contact with the infant's mouth or skin.
Pediatric Use
Not recommended for prolonged use in children due to a higher risk of systemic absorption and HPA axis suppression, Cushing's syndrome, and intracranial hypertension. Children may be more susceptible to topical corticosteroid-induced systemic toxicity due to a larger skin surface area to body weight ratio.
Geriatric Use
No specific dose adjustments are generally needed. However, geriatric patients may have thinner skin, which could increase the risk of local adverse effects (e.g., skin atrophy, purpura) and potentially systemic absorption. Monitor for skin integrity.
Clinical Information
Clinical Pearls
- Epifoam is for external use only. Do not ingest.
- Wash hands thoroughly before and after application.
- Do not use for longer than 7 days unless directed by a healthcare professional.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use on infected areas without concomitant antimicrobial therapy.
- Systemic absorption of hydrocortisone can occur, especially with prolonged use, large surface areas, occlusive dressings, or damaged skin. Monitor for signs of systemic corticosteroid effects.
Alternative Therapies
- Topical local anesthetics (e.g., lidocaine, benzocaine)
- Topical corticosteroids (e.g., hydrocortisone cream/ointment)
- Astringents (e.g., witch hazel)
- Stool softeners and dietary fiber for hemorrhoid management
Cost & Coverage
Average Cost:
Varies widely per 10gm foam
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for generic)
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.