HC Pramoxine 1-1% Cream 30gm
It is used to treat skin irritation.It is used to treat signs of hemorrhoids or rectal irritation.
Drug Class
Topical Anesthetic; Corticosteroid
Pharmacologic Class
Local Anesthetic; Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This cream contains two medicines: pramoxine, which numbs the skin to relieve pain and itching, and hydrocortisone, which is a steroid that reduces swelling, redness, and itching. It's used to treat discomfort from conditions like hemorrhoids or other skin irritations around the rectum.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions precisely. This medication is designed for rectal use only and should not be taken orally.
Before and after using the medication, wash your hands thoroughly to maintain hygiene.
Storing and Disposing of Your Medication
Store your medication at room temperature, avoiding freezing. Keep all medications in a secure location, 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. If you are unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions precisely. This medication is designed for rectal use only and should not be taken orally.
Before and after using the medication, wash your hands thoroughly to maintain hygiene.
Storing and Disposing of Your Medication
Store your medication at room temperature, avoiding freezing. Keep all medications in a secure location, 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. If you are unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the cream.
- Cleanse the affected area gently with mild soap and water, then pat dry before application.
- Avoid prolonged use (more than 7 days) unless directed by a doctor.
- Do not use with occlusive dressings unless advised by a healthcare professional.
- Maintain good hygiene to prevent recurrence of symptoms.
- Increase fiber and fluid intake to prevent constipation and straining, which can worsen hemorrhoids.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply externally to the affected area up to 3-4 times daily.
Condition-Specific Dosing:
rectal_application:
For rectal use, apply externally or insert using an applicator tip.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with caution, consult physician)
Child:
Not established (use with caution, consult physician)
Adolescent:
Apply externally to the affected area up to 3-4 times daily, under medical supervision.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required for topical use.
Moderate:
No adjustment typically required for topical use.
Severe:
No adjustment typically required for topical use.
Dialysis:
No specific considerations for topical use.
Hepatic Impairment:
Mild:
No adjustment typically required for topical use.
Moderate:
No adjustment typically required for topical use.
Severe:
No adjustment typically required for topical use.
Pharmacology
Mechanism of Action
Pramoxine is a topical anesthetic that works by stabilizing the neuronal membrane and inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, thereby producing local anesthesia. 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:
Minimal systemic absorption (less than 1%) for both components when applied to intact skin. Absorption may increase with inflammation, skin barrier disruption, or occlusive dressings.
Tmax:
Not applicable for topical action; systemic Tmax not well-defined due to minimal absorption.
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not applicable for topical action; systemically absorbed hydrocortisone distributes widely.
ProteinBinding:
Systemically absorbed hydrocortisone is highly protein bound (approximately 90%). Pramoxine protein binding not well-defined.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable for topical action; systemic half-life of hydrocortisone is approximately 8-12 hours.
Clearance:
Not applicable for topical action; systemically absorbed hydrocortisone is cleared renally.
ExcretionRoute:
Primarily renal (for systemically absorbed components).
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Pramoxine: Within minutes. Hydrocortisone: Hours to days for full anti-inflammatory effect.
PeakEffect:
Pramoxine: Within 5-10 minutes. Hydrocortisone: Days.
DurationOfAction:
Pramoxine: Approximately 2-4 hours. Hydrocortisone: Varies, but effects can persist for several hours after application.
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 immediate medical attention:
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
Severe rectal bleeding or rectal pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dry skin
Burning
* Itching
This is not a comprehensive list of all 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 immediate medical attention:
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
Severe rectal bleeding or rectal pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dry skin
Burning
* Itching
This is not a comprehensive list of all 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 pain, itching, or burning after application
- Signs of infection (pus, fever, worsening redness)
- Skin thinning, easy bruising, or changes in skin color at the application site
- Allergic reaction (rash, hives, swelling, severe dizziness, trouble breathing)
- No improvement in symptoms after 7 days of use
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 safely 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 safely 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 exceed the recommended usage period as advised by your doctor.
When administering this drug to children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Consult with your doctor to discuss the potential risks and benefits.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is crucial to have a discussion with your doctor about the potential benefits and risks of this medication to both you and your baby, allowing for an informed decision.
When administering this drug to children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Consult with your doctor to discuss the potential risks and benefits.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is crucial to have a discussion with your doctor about the potential benefits and risks of this medication to both you and your baby, allowing for an informed decision.
Overdose Information
Overdose Symptoms:
- Unlikely with topical use unless applied to large areas of broken skin or ingested.
- Symptoms of systemic corticosteroid absorption (e.g., Cushing's syndrome-like symptoms, adrenal suppression) with prolonged, excessive use.
- Symptoms of systemic local anesthetic toxicity (e.g., dizziness, drowsiness, blurred vision, tremors, seizures, irregular heartbeat) with massive ingestion or absorption.
What to Do:
Discontinue use. For suspected ingestion or significant systemic absorption, seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Management is supportive and symptomatic.
Drug Interactions
Monitoring
Routine Monitoring
Efficacy (symptom relief)
Frequency: Daily
Target: Reduction in itching, pain, inflammation
Action Threshold: Lack of improvement or worsening symptoms after 7 days, or signs of infection.
Local adverse reactions
Frequency: Daily
Target: Absence of irritation, burning, stinging, skin atrophy, or allergic reactions.
Action Threshold: Presence of significant local irritation, signs of skin thinning, or allergic reaction.
Symptom Monitoring
- Worsening of pain or itching
- Redness or swelling
- Signs of infection (pus, fever)
- Skin thinning or atrophy
- Increased irritation or burning at application site
- Allergic reactions (rash, hives, difficulty breathing)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hydrocortisone is Pregnancy Category C. Minimal systemic absorption is expected with topical use, but prolonged or extensive use should be avoided.
Trimester-Specific Risks:
First Trimester:
Avoid if possible, or use with caution and only if clearly needed.
Second Trimester:
Use with caution, minimal systemic absorption expected.
Third Trimester:
Use with caution, minimal systemic absorption expected.
Lactation
Use with caution. It is not known whether topical pramoxine or hydrocortisone are excreted in human milk. Systemic absorption is minimal, so infant exposure is likely low. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk with appropriate use, but monitor infant for any unusual symptoms.
Pediatric Use
Use with caution, especially in infants and young children, as they may be more susceptible to systemic absorption of corticosteroids due to a larger skin surface area to body weight ratio and underdeveloped skin barrier. Prolonged use should be avoided. Consult a physician.
Geriatric Use
No specific dose adjustments are typically required. However, elderly patients may have thinner, more fragile skin, increasing the risk of local adverse effects like skin atrophy. Monitor closely.
Clinical Information
Clinical Pearls
- This product is for external or rectal use only. Do not ingest.
- Do not use for more than 7 consecutive days unless directed by a healthcare professional.
- If symptoms persist or worsen, or if bleeding occurs, consult a doctor.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Store at room temperature, away from heat and moisture.
Alternative Therapies
- Topical witch hazel pads
- Sitz baths
- Fiber supplements and stool softeners
- Other topical hemorrhoid treatments (e.g., phenylephrine, zinc oxide, shark liver oil)
- Oral pain relievers (e.g., acetaminophen, ibuprofen)
Cost & Coverage
Average Cost:
Varies widely, typically $15 - $50+ per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
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.