Analpram-HC 2.5% Cream (4gm Tubes)
It is used to treat skin irritation.It is used to treat signs of hemorrhoids or rectal irritation.
Drug Class
Anti-inflammatory, Antipruritic
Pharmacologic Class
Topical Corticosteroid; Topical Local Anesthetic
Pregnancy 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 itching and pain, and hydrocortisone, which reduces swelling, redness, and itching. It is used to treat discomfort from conditions like hemorrhoids or itchy skin around the rectum.
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 note that this medication is 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 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. Instead, consult your pharmacist for guidance on the proper disposal method. Many areas offer drug take-back programs, which can be a safe and environmentally friendly way to dispose of unwanted medications.
Managing Missed Doses
If you miss a dose, take it as soon as you remember. However, if the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or using 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 note that this medication is 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 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. Instead, consult your pharmacist for guidance on the proper disposal method. Many areas offer drug take-back programs, which can be a safe and environmentally friendly way to dispose of unwanted medications.
Managing Missed Doses
If you miss a dose, take it as soon as you remember. However, if the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or using extra doses, as this can increase the risk of adverse effects.
Lifestyle & Tips
- Maintain good hygiene in the affected area.
- Avoid scratching the affected area, as this can worsen irritation and lead to infection.
- Avoid prolonged use unless directed by a healthcare professional.
- Do not use occlusive dressings or tight clothing over the treated area unless specifically instructed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to the affected area 3 to 4 times daily. For rectal use, apply externally or insert rectally using the applicator.
Condition-Specific Dosing:
hemorrhoids:
Apply a thin film to the affected area 3 to 4 times daily.
pruritusAni:
Apply a thin film to the affected area 3 to 4 times daily.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to increased systemic absorption risk)
Infant:
Not established (use with extreme caution due to increased systemic absorption risk)
Child:
Not established (use with caution, generally not recommended for prolonged use or large areas)
Adolescent:
Similar to adult dosing, but with caution regarding prolonged use or large areas.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment needed for topical use due to minimal systemic absorption.
Severe:
No specific adjustment needed for topical use due to minimal systemic absorption.
Dialysis:
No specific considerations for topical use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment needed for topical use due to minimal systemic absorption.
Severe:
No specific adjustment needed for topical use due to minimal systemic absorption.
Confidence:
Medium
Pharmacology
Mechanism of Action
Pramoxine is a topical local anesthetic that works by stabilizing the neuronal membrane, thereby inhibiting 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 (lipocortins), which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption for both components when applied topically to intact skin. Absorption can increase with inflammation, skin barrier disruption, prolonged use, or occlusive dressings.
Tmax:
Not well characterized for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well characterized for topical application.
ProteinBinding:
Hydrocortisone is extensively protein-bound in systemic circulation (approximately 90%). Pramoxine's protein binding is not well characterized for topical use.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not well characterized for topical application due to minimal systemic absorption.
Clearance:
Not well characterized for topical application.
ExcretionRoute:
Primarily renal for systemically absorbed components.
Unchanged:
Not well characterized for topical application.
Pharmacodynamics
OnsetOfAction:
Pramoxine: Rapid (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, effects can persist for hours after application.
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 immediately or seek emergency 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a weak adrenal gland, including:
+ Severe stomach upset 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
+ Fruity-smelling breath
Irritation at the site of application
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, don't hesitate to reach out to 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 immediately or seek emergency 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a weak adrenal gland, including:
+ Severe stomach upset 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
+ Fruity-smelling breath
Irritation at the site of application
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, don't hesitate to reach out to 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:
- If your condition worsens or does not improve within 7 days.
- If you develop severe burning, itching, or irritation at the application site.
- If you notice signs of infection (e.g., pus, fever, spreading redness).
- If you experience any unusual side effects or systemic symptoms.
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 identify potential interactions between this medication and other substances.
* Any health problems you have, 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. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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 identify potential interactions between this medication and other substances.
* Any health problems you have, 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. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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 a child, exercise caution, as the risk of certain side effects may be increased in pediatric patients. In some cases, this drug may impact growth in children and teenagers, necessitating regular growth assessments. 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. A discussion about the benefits and risks of this medication to both you and your baby is necessary to ensure informed decision-making.
When administering this medication to a child, exercise caution, as the risk of certain side effects may be increased in pediatric patients. In some cases, this drug may impact growth in children and teenagers, necessitating regular growth assessments. 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. A discussion about the benefits and risks of this medication to both you and your baby is necessary to ensure informed decision-making.
Overdose Information
Overdose Symptoms:
- Systemic overdose from topical application is rare but can occur with extensive or prolonged use, especially in children or on damaged skin.
- Symptoms of corticosteroid overdose may include Cushing's syndrome-like symptoms (e.g., moon face, central obesity, thin skin), hyperglycemia, and adrenal suppression.
- Symptoms of pramoxine overdose (if significant systemic absorption occurs) could include central nervous system effects (e.g., dizziness, drowsiness, seizures) or cardiovascular effects (e.g., bradycardia, hypotension).
What to Do:
Discontinue use and seek medical attention. For accidental ingestion, call a poison control center (1-800-222-1222) or emergency services immediately.
Drug Interactions
Monitoring
Routine Monitoring
Clinical response (reduction in symptoms)
Frequency: Daily
Target: Symptom improvement
Action Threshold: Lack of improvement or worsening symptoms after 7 days of use, or development of adverse reactions.
Local skin reactions (e.g., irritation, burning, itching, atrophy, striae)
Frequency: Daily, with each application
Target: Absence of adverse reactions
Action Threshold: Presence of significant irritation, signs of infection, or skin changes (thinning, discoloration).
Symptom Monitoring
- Worsening of itching or pain
- Increased redness or swelling
- Development of new skin lesions
- Signs of infection (pus, fever)
- Skin thinning or discoloration at application site
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Topical corticosteroids should not be used extensively, in large amounts, or for prolonged periods in pregnant patients.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, though systemic absorption is minimal. Use with caution.
Second Trimester:
Use with caution, minimal systemic absorption expected.
Third Trimester:
Use with caution, minimal systemic absorption expected. Avoid large areas or prolonged use.
Lactation
Use with caution. It is not known whether topically administered corticosteroids are excreted in human milk. Systemic absorption is minimal, but caution is advised. Avoid applying to the breast area if breastfeeding.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption, but monitor for any unusual symptoms.
Pediatric Use
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension). Use the smallest effective amount for the shortest duration possible. Not recommended for prolonged use or on large body surface areas.
Geriatric Use
No specific dosage adjustments are generally required. Use with caution in patients with very thin or fragile skin, as they may be more susceptible to local adverse effects like skin atrophy.
Clinical Information
Clinical Pearls
- This product is for external or rectal use only. Do not ingest.
- Wash hands thoroughly before and after application.
- Apply a thin layer to the affected area. Do not use more than directed.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use for more than 7 days unless directed by a healthcare professional.
- If symptoms persist or worsen, or if irritation develops, discontinue use and consult a doctor.
- Prolonged use, especially on large areas or under occlusive dressings, can increase the risk of systemic corticosteroid side effects.
Alternative Therapies
- Topical hydrocortisone cream (e.g., Cortizone-10)
- Topical pramoxine cream (e.g., Prax)
- Witch hazel pads (e.g., Tucks)
- Phenylephrine rectal preparations (e.g., Preparation H)
- Sitz baths
- Dietary fiber and stool softeners for hemorrhoids
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 4gm tube
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or 3 for brand-name, Tier 1 for generic formulations. Coverage varies by insurance plan.
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 taken, the amount, and the time it occurred.