HC Pramoxine 2.5-1% Cream 120gm
It is used to treat skin irritation.It is used to treat signs of hemorrhoids or rectal irritation.
Drug Class
Anesthetic, Local; Corticosteroid, Rectal
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 is a numbing medicine to relieve pain and itching, and hydrocortisone, which is a steroid to reduce swelling and inflammation. It is used to treat discomfort from conditions like hemorrhoids or other rectal irritations.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed by your healthcare provider.
This medication is designed for rectal use only and should never be taken orally. Before and after using the medication, wash your hands thoroughly to maintain hygiene and prevent the spread of infection.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. Instead, consult with your pharmacist to determine the best disposal method. Many communities have drug take-back programs that provide a safe and environmentally responsible way to dispose of unwanted medications.
Managing Missed Doses
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, as this can increase the risk of adverse effects.
To use this medication safely and effectively, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed by your healthcare provider.
This medication is designed for rectal use only and should never be taken orally. Before and after using the medication, wash your hands thoroughly to maintain hygiene and prevent the spread of infection.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. Instead, consult with your pharmacist to determine the best disposal method. Many communities have drug take-back programs that provide a safe and environmentally responsible way to dispose of unwanted medications.
Managing Missed Doses
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, as this can increase the risk of adverse effects.
Lifestyle & Tips
- Maintain good anal hygiene.
- Avoid excessive straining during bowel movements.
- Increase fiber intake and fluid consumption to prevent constipation.
- Avoid prolonged sitting on the toilet.
- Consider warm sitz baths for additional relief.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a small amount to the affected area 3 to 4 times daily. For internal hemorrhoids, use the applicator provided.
Condition-Specific Dosing:
hemorrhoids:
Apply to the perianal area and/or insert rectally using the applicator 3-4 times daily.
pruritusAni:
Apply to the perianal area 3-4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with caution and physician supervision due to potential for systemic absorption of hydrocortisone)
Child:
Not established (use with caution and physician supervision due to potential for systemic absorption of hydrocortisone)
Adolescent:
Generally, adult dosing may be considered under physician supervision, but caution is advised due to potential for systemic absorption of hydrocortisone.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed for topical/rectal use.
Moderate:
No adjustment typically needed for topical/rectal use.
Severe:
No adjustment typically needed for topical/rectal use.
Dialysis:
No specific considerations for topical/rectal use, as systemic absorption is minimal.
Hepatic Impairment:
Mild:
No adjustment typically needed for topical/rectal use.
Moderate:
No adjustment typically needed for topical/rectal use.
Severe:
No adjustment typically needed for topical/rectal use.
Pharmacology
Mechanism of Action
Pramoxine is a local 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 (lipocortins), which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption for both active ingredients when applied topically/rectally to intact skin/mucosa. Absorption of hydrocortisone can increase with inflammation, occlusion, or application to large surface areas.
Tmax:
Not precisely quantifiable for topical/rectal application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical/rectal cream.
Distribution:
Vd:
Not precisely quantifiable for topical/rectal application.
ProteinBinding:
Hydrocortisone is extensively protein-bound in systemic circulation (approximately 90%). Pramoxine binding is not well-characterized for topical use.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not precisely quantifiable for topical/rectal application due to minimal systemic absorption. Systemically absorbed hydrocortisone has a plasma half-life of approximately 1.5-2 hours.
Clearance:
Not precisely quantifiable for topical/rectal application.
ExcretionRoute:
Primarily renal for systemically absorbed portions of both drugs.
Unchanged:
Minimal for systemically absorbed portions.
Pharmacodynamics
OnsetOfAction:
Pramoxine: Within minutes (local anesthetic effect). Hydrocortisone: Hours to days for full anti-inflammatory effect.
PeakEffect:
Pramoxine: Within 5-10 minutes. Hydrocortisone: Days.
DurationOfAction:
Pramoxine: Approximately 2-4 hours. Hydrocortisone: Several hours to a day per application.
Safety & Warnings
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 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. While many people may not experience any side effects or only have mild 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 do not go away, contact your doctor:
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.
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 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. While many people may not experience any side effects or only have mild 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 do not go away, contact your doctor:
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:
- Worsening of symptoms (pain, itching, bleeding)
- Signs of infection (e.g., fever, pus, severe pain)
- Severe burning, stinging, or irritation at the application site
- Any unusual or unexpected side effects
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
Please describe the allergy and the symptoms you experienced.
This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Discuss all your health problems with your doctor
You must verify that it is safe to take this medication with all your other medications and health conditions.
Do not start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
Please describe the allergy and the symptoms you experienced.
This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Discuss all your health problems with your doctor
You must verify that it is safe to take this medication with all your other medications and health conditions.
Do not start, stop, or change the dose 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 for certain side effects. In some cases, this drug may impact growth in children and teenagers, making regular growth checks necessary. Consult with your doctor to discuss the potential effects and necessary monitoring.
If you are pregnant, planning to become pregnant, or 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 about treatment.
When administering this medication to children, exercise caution, as they may be at a higher risk for certain side effects. In some cases, this drug may impact growth in children and teenagers, making regular growth checks necessary. Consult with your doctor to discuss the potential effects and necessary monitoring.
If you are pregnant, planning to become pregnant, or 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 about treatment.
Overdose Information
Overdose Symptoms:
- Unlikely with typical topical/rectal use due to minimal systemic absorption.
- Excessive or prolonged use, especially over large areas or broken skin, could rarely lead to systemic corticosteroid effects such as Cushing's syndrome symptoms (e.g., weight gain, moon face, thinning skin, high blood sugar) or adrenal suppression.
- Symptoms of pramoxine overdose (if absorbed systemically, which is rare) could include dizziness, blurred vision, tremors, or seizures.
What to Do:
Discontinue use and contact a healthcare provider. For suspected overdose, call 911 or a poison control center (1-800-222-1222).
Drug Interactions
Monitoring
Symptom Monitoring
- Resolution of itching, pain, and inflammation
- Signs of local irritation or allergic reaction (e.g., redness, swelling, worsening itching)
- Signs of secondary infection (e.g., pus, fever)
- Signs of systemic corticosteroid effects with prolonged or excessive use (e.g., adrenal suppression, Cushing's syndrome symptoms - rare with proper topical/rectal use)
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Category C for hydrocortisone. Minimal systemic absorption is expected with proper topical/rectal use.
Trimester-Specific Risks:
First Trimester:
Avoid if possible, or use with caution and only if clearly needed.
Second Trimester:
Use with caution and only if clearly needed.
Third Trimester:
Use with caution and only if clearly needed.
Lactation
Use with caution. Hydrocortisone is excreted in breast milk in small amounts after systemic administration; topical/rectal absorption is minimal, so infant exposure is likely low. Pramoxine is not well-studied in lactation but is generally considered low risk due to minimal systemic absorption.
Infant Risk:
Low risk (L3)
Pediatric Use
Use with caution, especially in infants and young children, due to a higher surface area to body weight ratio, which can lead to increased systemic absorption of hydrocortisone and potential for adrenal suppression. Not recommended for children under 12 without physician supervision.
Geriatric Use
Generally safe for use in the elderly. No specific dose adjustments are typically required. Use with caution in patients with very thin or fragile skin.
Clinical Information
Clinical Pearls
- This product is for external and/or rectal use only. Do not ingest.
- Wash hands thoroughly before and after application.
- For internal application, ensure the applicator is cleaned thoroughly after each use.
- Do not use for prolonged periods (e.g., more than 7 days) without consulting a healthcare provider, as prolonged corticosteroid use can lead to skin thinning or systemic effects.
- If symptoms do not improve within 7 days or worsen, consult a healthcare provider.
- Avoid contact with eyes.
Alternative Therapies
- Other topical anesthetics (e.g., lidocaine cream/ointment)
- Astringents (e.g., witch hazel pads)
- Protectants (e.g., zinc oxide, petrolatum)
- Sitz baths
- Dietary modifications (fiber, fluids) and stool softeners to manage constipation
- Oral pain relievers (e.g., acetaminophen, ibuprofen) for systemic discomfort
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200+ per 120gm tube
Generic Available:
Yes
Insurance Coverage:
Often Tier 1 or 2 for generic versions; higher tiers for brand names. Coverage varies by insurance plan.
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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.