Analpram-HC 2.5-1% 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, Topical
Pharmacologic Class
Local Anesthetic; Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Analpram-HC cream is a medication used to relieve itching, pain, and inflammation caused by conditions like hemorrhoids or other irritation around the anal area. It contains two active ingredients: pramoxine, which is a numbing medicine (local anesthetic), and hydrocortisone, which is a mild steroid that reduces swelling and redness.
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.
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. 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. If you have questions about disposing 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 one.
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.
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. 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. If you have questions about disposing 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 one.
Lifestyle & Tips
- Clean the affected area gently before applying the cream.
- Wash your hands thoroughly before and after applying the cream.
- Use only a small amount of cream and apply it thinly to the affected area.
- Do not use for longer than recommended by your doctor (usually no more than 7 days) unless advised.
- Avoid straining during bowel movements; consider increasing fiber and fluid intake.
- Avoid prolonged sitting on the toilet.
- Do not use occlusive dressings unless specifically instructed by a healthcare professional.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a small amount to the affected area 3 to 4 times daily.
Dose Range:
3 - 4 mg
Condition-Specific Dosing:
hemorrhoids:
Apply externally or rectally using an applicator, 3-4 times daily.
pruritus_ani:
Apply externally to the perianal area, 3-4 times daily.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to risk of systemic absorption and HPA axis suppression)
Infant:
Not established (use with extreme caution due to risk of systemic absorption and HPA axis suppression)
Child:
Not established (use with extreme caution due to risk of systemic absorption and HPA axis suppression). If used, limit to smallest effective amount for shortest duration.
Adolescent:
Similar to adult dosing, but with caution and limited duration due to potential for systemic absorption.
Dose Adjustments
Renal Impairment:
Mild:
Not typically required due to minimal systemic absorption.
Moderate:
Not typically required due to minimal systemic absorption.
Severe:
Not typically required due to minimal systemic absorption.
Dialysis:
Not applicable due to minimal systemic absorption.
Hepatic Impairment:
Mild:
Not typically required due to minimal systemic absorption.
Moderate:
Not typically required due to minimal systemic absorption.
Severe:
Not typically required due to minimal systemic absorption.
Confidence:
Medium
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 low-potency 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 by inhibiting the release of their common precursor, arachidonic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemically for pramoxine; minimal systemic absorption for hydrocortisone (absorption increases with inflamed skin, prolonged use, or occlusive dressings).
Tmax:
Not applicable for systemic effects; local onset within minutes for pramoxine.
FoodEffect:
Not applicable.
Distribution:
Vd:
Not applicable systemically for topical use.
ProteinBinding:
Not applicable systemically for topical use.
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable for systemic effects; local duration of action for pramoxine is several hours.
Clearance:
Not applicable systemically for topical use.
ExcretionRoute:
Metabolites of hydrocortisone are excreted primarily by the kidneys.
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Pramoxine: within 3-5 minutes. Hydrocortisone: anti-inflammatory effects may take hours to days.
PeakEffect:
Not well-defined systemically for topical application.
DurationOfAction:
Pramoxine: 2-4 hours. Hydrocortisone: effects persist for several hours.
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
+ 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 are bothered by any of the following side effects or if they 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.
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
+ 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 are bothered by any of the following side effects or if they 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 irritation, redness, or burning at the application site.
- Development of a new rash or worsening of existing skin condition.
- Signs of infection, such as pus, fever, or increased pain.
- Any signs of systemic side effects, though rare (e.g., unusual weight gain, swelling, fatigue, changes in mood, increased thirst/urination).
- If symptoms do not improve within 7 days or worsen.
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 you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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 you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never 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 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:
- Local irritation (burning, itching, redness).
- If significant systemic absorption occurs (rare with proper use): signs of hypercorticism (e.g., Cushing's syndrome symptoms like moon face, central obesity, striae), adrenal suppression, hyperglycemia.
What to Do:
Discontinue use. For local irritation, wash the area and apply cool compresses. For suspected systemic effects, seek immediate medical attention. Call a poison control center (1-800-222-1222) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of symptoms (pain, itching, inflammation)
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy.
Inspection of affected area for skin integrity, signs of infection
Rationale: To ensure appropriate use and identify contraindications or need for additional treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom improvement (pain, itching, inflammation)
Frequency: Daily
Target: Reduction or resolution of symptoms.
Action Threshold: Lack of improvement or worsening of symptoms after 7 days warrants re-evaluation.
Local adverse reactions (burning, stinging, irritation, rash, skin atrophy)
Frequency: Daily
Target: Absence of new or worsening local reactions.
Action Threshold: Development of significant local irritation or signs of skin atrophy warrants discontinuation or re-evaluation.
Signs of secondary infection
Frequency: Daily
Target: Absence of redness, pus, increased pain, or fever.
Action Threshold: Presence of signs of infection warrants discontinuation and appropriate antimicrobial therapy.
Signs of systemic corticosteroid effects (e.g., Cushing's syndrome, HPA axis suppression)
Frequency: Rarely, only with extensive, prolonged use or in susceptible populations (e.g., pediatric patients).
Target: Absence of systemic effects.
Action Threshold: Any signs of systemic effects (e.g., weight gain, moon face, striae, hyperglycemia) warrant immediate medical evaluation and discontinuation.
Symptom Monitoring
- Persistent or worsening pain
- Increased itching or burning
- Development of rash or new skin irritation
- Signs of infection (redness, swelling, pus, fever)
- Bleeding from the rectum
- Signs of systemic corticosteroid absorption (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination, fatigue, mood changes)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but topical corticosteroids should be used with caution, especially on large surface areas or for prolonged periods.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk due to minimal systemic absorption. Use only if clearly needed.
Second Trimester:
Low risk due to minimal systemic absorption. Use with caution.
Third Trimester:
Low risk due to minimal systemic absorption. Use with caution.
Lactation
L3 (Moderately Safe). It is not known whether pramoxine or hydrocortisone are excreted in human milk following topical administration. Systemic absorption is minimal, so infant exposure is expected to be low. Use with caution. Avoid applying to areas where the infant may come into direct contact, especially the breast.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption by the mother. Monitor infant for any unusual symptoms.
Pediatric Use
Use with extreme caution, especially in infants and young children. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, growth retardation). Limit the amount applied and duration of therapy. Avoid use on large surface areas or under occlusive dressings.
Geriatric Use
No specific dosage adjustments are typically required. However, geriatric patients may have thinner skin, which could potentially increase systemic absorption or susceptibility to local adverse effects (e.g., skin atrophy). Use with caution and monitor for adverse reactions.
Clinical Information
Clinical Pearls
- This product is for external or rectal use only. Do not ingest.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use for prolonged periods (typically more than 7 days) without consulting a healthcare professional, as prolonged use of corticosteroids can lead to skin thinning (atrophy) or, rarely, systemic side effects.
- If symptoms do not improve within 7 days, or if they worsen, discontinue use and consult a doctor.
- This cream can mask signs of infection; if an infection is present, appropriate antimicrobial therapy should be initiated.
- Proper hygiene and dietary changes (e.g., increased fiber, fluids) can help manage underlying conditions like hemorrhoids.
Alternative Therapies
- Topical anesthetics alone (e.g., lidocaine cream, benzocaine cream)
- Topical corticosteroids alone (e.g., hydrocortisone cream 1%)
- Astringents (e.g., witch hazel pads)
- Protectants (e.g., zinc oxide, petrolatum)
- Sitz baths
- Dietary fiber supplements and stool softeners for hemorrhoid management
Cost & Coverage
Average Cost:
Varies widely ($30 - $150+) per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2-3 (often covered by most insurance plans, especially generic versions)
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 happened.