HC Pramoxine 2.5-1% Cream 48gm
It is used to treat skin irritation.It is used to treat signs of hemorrhoids or rectal irritation.
Drug Class
Local Anesthetic; Corticosteroid
Pharmacologic Class
Local Anesthetic (ester type); 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's used to treat discomfort from conditions like hemorrhoids.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. 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 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.
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. Instead, consult your pharmacist for guidance on the proper disposal method. Many areas have drug take-back programs that can help you dispose of medications safely.
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. Avoid using two doses at the same time or taking 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 the information provided. 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 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.
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. Instead, consult your pharmacist for guidance on the proper disposal method. Many areas have drug take-back programs that can help you dispose of medications safely.
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. Avoid using two doses at the same time or taking extra doses, as this can increase the risk of adverse effects.
Lifestyle & Tips
- Clean the affected area gently before applying the cream.
- Wash hands thoroughly before and after application.
- Do not use for longer than 7 days unless directed by a doctor.
- Avoid straining during bowel movements; consider increasing fiber and fluid intake.
- Avoid prolonged sitting or standing.
- Do not insert the cream into the rectum unless specifically directed by the product instructions or your doctor (some formulations come with an applicator for internal use).
- Do not use occlusive dressings or tight clothing over the area unless advised by a doctor, as this can increase absorption.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply rectally 3 to 4 times daily, or as directed by physician.
Condition-Specific Dosing:
hemorrhoids:
Apply a small amount to the affected area, usually after bowel movements and at bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established; use with caution and under medical supervision due to potential for systemic absorption of hydrocortisone, especially with prolonged use or large surface areas.
Adolescent:
Similar to adult dosing, but caution advised for prolonged use.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required due to limited systemic absorption.
Moderate:
No adjustment typically required due to limited systemic absorption.
Severe:
No adjustment typically required, but caution with extensive or prolonged use due to theoretical risk of increased systemic exposure.
Dialysis:
Considerations: Not typically dialyzable; no specific dose adjustment needed for topical use.
Hepatic Impairment:
Mild:
No adjustment typically required due to limited systemic absorption.
Moderate:
No adjustment typically required due to limited systemic absorption.
Severe:
No adjustment typically required, but caution with extensive or prolonged use due to theoretical risk of increased systemic exposure to hydrocortisone.
Confidence:
Medium
Pharmacology
Mechanism of Action
Pramoxine is a topical 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:
Limited systemic absorption; absorption of hydrocortisone can increase with inflamed skin, occlusive dressings, or prolonged use. Pramoxine is poorly absorbed systemically.
Tmax:
Not precisely quantified for topical/rectal application; local effects are rapid.
FoodEffect:
Not applicable for topical/rectal administration.
Distribution:
Vd:
Not precisely quantified for topical/rectal application.
ProteinBinding:
Hydrocortisone is extensively bound to plasma proteins (transcortin and albumin). Pramoxine is rapidly metabolized.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely quantified for topical/rectal application; systemic half-life of hydrocortisone is approximately 1.5-2 hours.
Clearance:
Not precisely quantified for topical/rectal application.
ExcretionRoute:
Hydrocortisone and its metabolites are primarily excreted renally. Pramoxine metabolites are excreted renally.
Unchanged:
Minimal systemic excretion of unchanged drug.
Pharmacodynamics
OnsetOfAction:
Pramoxine: Within minutes. Hydrocortisone: Anti-inflammatory effects may take hours to days for full onset.
PeakEffect:
Pramoxine: Within 5-10 minutes. Hydrocortisone: Peak anti-inflammatory effect may be seen after several days of consistent use.
DurationOfAction:
Pramoxine: Approximately 2-4 hours. Hydrocortisone: Effects persist as long as applied, with residual anti-inflammatory action for some time after cessation.
Confidence:
Medium
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 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
+ Frequent urination
+ Flushing
+ Rapid 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 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:
Dry skin
Burning
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 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
+ Frequent urination
+ Flushing
+ Rapid 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 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:
Dry skin
Burning
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 or no improvement after 7 days of use.
- Increased pain, burning, itching, or irritation at the application site.
- Signs of infection (e.g., pus, fever, spreading redness).
- Rectal bleeding (new or increased).
- Any signs of allergic reaction (e.g., rash, hives, swelling, difficulty breathing).
- Unusual fatigue, weight gain, or swelling (rare signs of systemic steroid absorption).
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 is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital 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.
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 is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital 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.
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 about treatment.
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 about treatment.
Overdose Information
Overdose Symptoms:
- Systemic overdose is unlikely with proper topical/rectal use due to limited absorption.
- Symptoms of excessive systemic corticosteroid absorption (rare): fluid retention, high blood pressure, muscle weakness, mood changes, hyperglycemia, Cushing's syndrome features (e.g., moon face, buffalo hump) with prolonged, extensive use.
- Symptoms of excessive local anesthetic absorption (extremely rare): dizziness, drowsiness, blurred vision, ringing in ears, nervousness, tremors, seizures, irregular heartbeat.
What to Do:
Discontinue use and seek immediate medical attention. For suspected systemic toxicity, supportive care and symptomatic treatment are indicated. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Minor Interactions
- Other topical corticosteroids (potential for additive systemic effects if significant absorption occurs, though rare with rectal cream)
- Drugs metabolized by CYP3A4 (theoretical interaction with hydrocortisone if significant systemic absorption occurs, but highly unlikely with topical/rectal use)
Monitoring
Baseline Monitoring
Assessment of rectal/perianal symptoms (pain, itching, inflammation, bleeding)
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy.
Inspection of affected area for skin integrity, signs of infection, or other pathology
Rationale: To rule out contraindications or identify need for additional treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom improvement (pain, itching, inflammation)
Frequency: Daily
Target: Reduction in severity
Action Threshold: Lack of improvement or worsening symptoms after 7 days may indicate need for re-evaluation.
Local adverse reactions (burning, itching, irritation, dryness, folliculitis, skin atrophy)
Frequency: Daily
Target: Absence or mild, transient reactions
Action Threshold: Persistent or severe local reactions warrant discontinuation and medical evaluation.
Signs of infection (redness, warmth, pus, fever)
Frequency: Daily
Target: Absence of signs of infection
Action Threshold: Presence of infection requires appropriate antimicrobial therapy and discontinuation of cream if infection is at application site.
Symptom Monitoring
- Persistent or worsening rectal pain
- Increased itching or burning at the application site
- Rectal bleeding (new or worsening)
- Signs of infection (fever, pus, spreading redness)
- Skin thinning or discoloration at the application site (with prolonged use)
- Signs of systemic corticosteroid absorption (rare: e.g., Cushing's syndrome symptoms, hyperglycemia, adrenal suppression, especially in children or with extensive use)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Limited systemic absorption is expected with topical/rectal use, but prolonged or extensive use should be avoided.
Trimester-Specific Risks:
First Trimester:
Avoid if possible; theoretical risk of teratogenicity with systemic corticosteroids, though very low with topical use.
Second Trimester:
Use with caution; limited data on topical corticosteroids.
Third Trimester:
Use with caution; theoretical risk of adrenal suppression in the neonate with prolonged, extensive maternal use, though unlikely with typical rectal application.
Lactation
Considered low risk for the infant with limited topical/rectal use. Hydrocortisone is excreted in breast milk in small amounts after systemic administration, but systemic absorption from topical use is minimal. Pramoxine is rapidly metabolized.
Infant Risk:
Low risk. Monitor infant for any unusual effects, though unlikely.
Pediatric Use
Use with caution. Children may absorb proportionally larger amounts of topical corticosteroids due to a larger skin surface area to body weight ratio, making them more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome). Prolonged use should be avoided. Not recommended for infants or young children without specific medical advice.
Geriatric Use
Generally safe for use in the elderly. However, elderly patients may have thinner skin, which could theoretically increase absorption, and may be more susceptible to skin atrophy with prolonged corticosteroid use. Monitor for local adverse effects.
Clinical Information
Clinical Pearls
- This combination cream provides both immediate symptomatic relief (pramoxine) and longer-term anti-inflammatory action (hydrocortisone).
- Advise patients to use the smallest effective amount for the shortest duration necessary to control symptoms, typically not exceeding 7 days without medical advice.
- Emphasize proper hygiene and gentle application to avoid further irritation.
- If symptoms persist or worsen after 7 days, or if signs of infection develop, patients should consult their healthcare provider.
- While systemic absorption is generally low, prolonged or extensive use, especially on broken skin, can increase the risk of corticosteroid-related systemic side effects.
Alternative Therapies
- Topical corticosteroids alone (e.g., hydrocortisone cream)
- Topical local anesthetics alone (e.g., lidocaine cream, benzocaine cream)
- Astringents (e.g., witch hazel pads)
- Protectants (e.g., zinc oxide, petrolatum)
- Stool softeners or fiber supplements (to address underlying constipation)
- Sitz baths
Cost & Coverage
Average Cost:
$20 - $80 per 48gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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.