Analpram-HC 1% Cream 30gm
It is used to treat skin irritation.It is used to treat signs of hemorrhoids or rectal irritation.
Drug Class
Anorectal preparation, Anti-inflammatory
Pharmacologic Class
Local anesthetic, Topical corticosteroid
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 hemorrhoids and other anal itching.
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.
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, take 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 take two doses at the same time or use 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.
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, take 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 take two doses at the same time or use 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.
- Avoid prolonged standing or sitting.
- Increase fiber intake and fluid consumption to prevent constipation and straining during bowel movements.
- Avoid scratching the affected area, as this can worsen irritation and lead to infection.
- Do not use for longer than recommended by your doctor, typically no more than 7 days, without medical advice.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to the affected area up to 3-4 times daily
Condition-Specific Dosing:
hemorrhoids:
Apply externally or internally using applicator, up to 3-4 times daily.
pruritusAni:
Apply externally to the perianal area up to 3-4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with caution, consult physician)
Child:
Not established (use with caution, consult physician; prolonged use may lead to systemic effects)
Adolescent:
Similar to adult dosing, but use with caution and for limited duration due to potential for systemic absorption of corticosteroid.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Pramoxine is a topical local anesthetic that works by stabilizing the neuronal membrane, 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 components when applied topically to intact skin/mucosa. Absorption of hydrocortisone can increase with inflammation, skin barrier disruption, or occlusive dressings.
Tmax:
Not well-defined for topical/rectal application; local anesthetic effect of pramoxine is rapid (minutes).
FoodEffect:
Not applicable (topical/rectal).
Distribution:
Vd:
Not well-defined for topical/rectal application.
ProteinBinding:
Hydrocortisone: ~90% (to albumin and transcortin) if systemically absorbed. Pramoxine: Not well-defined for topical.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Hydrocortisone: ~1.5-2 hours (systemic). Pramoxine: Not well-defined for topical.
Clearance:
Not well-defined for topical/rectal application.
ExcretionRoute:
Hydrocortisone metabolites are primarily excreted renally. Pramoxine metabolites are likely excreted renally.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Pramoxine: Within 3-5 minutes. Hydrocortisone: Hours to days for full anti-inflammatory effect.
PeakEffect:
Pramoxine: Within 5-10 minutes. Hydrocortisone: Varies, sustained with regular application.
DurationOfAction:
Pramoxine: Approximately 2-4 hours. Hydrocortisone: Varies, dependent on application frequency.
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
+ Fruity-smelling breath
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 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 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
+ Fruity-smelling breath
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 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:
- Symptoms worsen or do not improve within 7 days.
- Bleeding from the rectum occurs.
- Severe burning, stinging, or irritation develops.
- Signs of infection (e.g., fever, pus, severe pain) appear.
- Any signs of allergic reaction (e.g., rash, hives, swelling).
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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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.
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 breastfeeding, notify your doctor. It is crucial to weigh the benefits and risks of this medication for both you and your baby, and your doctor will help you make 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 breastfeeding, notify your doctor. It is crucial to weigh the benefits and risks of this medication for both you and your baby, and your doctor will help you make an informed decision.
Overdose Information
Overdose Symptoms:
- Systemic corticosteroid effects (e.g., Cushing's syndrome symptoms like weight gain, moon face, fatigue, muscle weakness) if applied excessively over large areas or for prolonged periods.
- Local skin atrophy (thinning, bruising, stretch marks) with prolonged use.
What to Do:
Discontinue use and seek medical attention. For accidental ingestion, call a poison control center (1-800-222-1222) immediately.
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 (skin integrity, signs of infection)
Rationale: To identify contraindications or conditions requiring alternative treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom improvement (pain, itching)
Frequency: Daily
Target: Reduction in severity
Action Threshold: Lack of improvement after 7 days or worsening symptoms may indicate need for re-evaluation.
Local adverse reactions (burning, stinging, irritation, skin atrophy)
Frequency: Daily
Target: Absence or mild, transient reactions
Action Threshold: Persistent or severe reactions warrant discontinuation and medical evaluation.
Signs of infection
Frequency: Daily
Target: Absence of redness, warmth, swelling, pus
Action Threshold: Presence of infection signs requires discontinuation and appropriate antimicrobial therapy.
Symptom Monitoring
- Worsening of pain or itching
- Increased redness or swelling
- Development of pus or discharge
- Severe burning or stinging at application site
- Thinning or discoloration of skin in the treated area (with prolonged use)
- Signs of systemic corticosteroid absorption (e.g., unexplained weight gain, moon face, fatigue, if used extensively or for prolonged periods)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected with topical use, but prolonged or extensive use should be avoided.
Trimester-Specific Risks:
First Trimester:
Avoid if possible; minimal data.
Second Trimester:
Use with caution; minimal systemic absorption expected.
Third Trimester:
Use with caution; minimal systemic absorption expected.
Lactation
L3 (Moderately Safe). Minimal systemic absorption is expected, making transfer into breast milk unlikely to cause significant harm to the infant. However, caution is advised, and application to the breast area should be avoided.
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption by the mother.
Pediatric Use
Use with caution. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, growth retardation). Prolonged use should be avoided. Not recommended for infants or young children without specific medical advice.
Geriatric Use
No specific dose adjustments are typically needed. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects (e.g., skin atrophy) or slightly increased systemic absorption. Monitor for skin integrity and adverse reactions.
Clinical Information
Clinical Pearls
- This product is for external or rectal use only. Do not ingest.
- Apply sparingly as a thin film. Excessive use, especially under occlusion or on broken skin, can increase systemic absorption of hydrocortisone.
- If symptoms do not improve within 7 days, or if they worsen, consult a healthcare provider to rule out other conditions.
- Prolonged use (beyond 7 days) of corticosteroid-containing products in the anal area can lead to skin thinning, atrophy, and increased risk of infection.
- For internal hemorrhoids, use the provided applicator as directed. Clean the applicator thoroughly after each use.
Alternative Therapies
- Topical anesthetics (e.g., Lidocaine cream)
- Topical corticosteroids (e.g., Hydrocortisone cream 1%)
- Astringents (e.g., Witch hazel pads)
- Protectants (e.g., Zinc oxide, Petroleum jelly)
- Sitz baths
Cost & Coverage
Average Cost:
$50 - $150 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic), Tier 3 or higher (for brand)
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 your 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.