Analpram-HC 2.5% Lotion 59ml
It is used to treat skin irritation.It is used to treat signs of hemorrhoids or rectal irritation.
Drug Class
Topical corticosteroid and local anesthetic combination
Pharmacologic Class
Glucocorticoid; Local anesthetic
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Analpram-HC lotion contains two medicines: hydrocortisone, which is a steroid that reduces swelling, redness, and itching, and pramoxine, which is a numbing medicine that helps relieve pain and itching. It is used to treat itching and inflammation, especially around the rectal area.
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. Before each use, shake the medication well. This medication is designed for rectal use only and should not be taken orally. Wash your hands thoroughly before and after handling the medication.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing. Keep all medications in a secure location, out of 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 by your pharmacist. If you have questions about disposal, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.
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 once or using extra doses to make up for a missed one.
To use this medication safely and effectively, follow your doctor's instructions and read all accompanying information carefully. Before each use, shake the medication well. This medication is designed for rectal use only and should not be taken orally. Wash your hands thoroughly before and after handling the medication.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing. Keep all medications in a secure location, out of 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 by your pharmacist. If you have questions about disposal, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.
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 once or using extra doses to make up for a missed one.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the lotion.
- Clean and dry the affected area before application.
- Apply a thin film of the lotion to the affected area as directed by your doctor.
- Do not use more than the prescribed amount or for longer than recommended.
- Avoid contact with eyes, nose, mouth, or other mucous membranes.
- Do not cover the treated area with bandages or tight dressings unless directed by your doctor, as this can increase absorption.
- Maintain good hygiene in the affected area.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected area 3 to 4 times daily.
Condition-Specific Dosing:
pruritus:
Apply to perianal area after each bowel movement and at bedtime, or as directed by physician.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with caution, risk of systemic absorption and HPA axis suppression)
Child:
Not established (use with caution, risk of systemic absorption and HPA axis suppression)
Adolescent:
Apply a thin film to the affected area 3 to 4 times daily, or as directed by physician. Use with caution.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for topical use
Moderate:
No adjustment needed for topical use
Severe:
No adjustment needed for topical use
Dialysis:
No specific considerations for topical use
Hepatic Impairment:
Mild:
No adjustment needed for topical use
Moderate:
No adjustment needed for topical use
Severe:
No adjustment needed for topical use
Pharmacology
Mechanism of Action
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 by inhibiting the release of their common precursor, arachidonic acid. Pramoxine hydrochloride is a topical local anesthetic that provides temporary relief from pain and itching by stabilizing the neuronal membrane and inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (systemic absorption is generally low for topical application, but can increase with inflamed skin, occlusive dressings, or large surface areas)
Tmax:
Not available
FoodEffect:
Not applicable
Distribution:
Vd:
Not available
ProteinBinding:
Hydrocortisone: Approximately 90% (to albumin and transcortin); Pramoxine: Not available
CnssPenetration:
Limited (for topical application)
Elimination:
HalfLife:
Hydrocortisone: Approximately 1.5-2 hours (systemic); Pramoxine: Not available
Clearance:
Not available
ExcretionRoute:
Hydrocortisone: Renal (as metabolites); Pramoxine: Renal (as metabolites)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Pramoxine: Within minutes; Hydrocortisone: Hours to days for full anti-inflammatory effect
PeakEffect:
Not available
DurationOfAction:
Pramoxine: 2-4 hours; Hydrocortisone: Varies, generally 6-12 hours for topical effect
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
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 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 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 help right away:
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 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 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:
- Increased irritation, redness, or burning at the application site.
- Signs of skin infection (e.g., pus, fever, worsening pain).
- Thinning of the skin, easy bruising, or stretch marks in the treated area.
- Any signs of systemic side effects such as unusual fatigue, swelling, or weight gain (rare with proper topical use).
- If symptoms do not improve within 1-2 weeks 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 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 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 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.
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 may 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 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 may 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 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:
- Excessive or prolonged use, especially over large areas or under occlusive dressings, can lead to systemic absorption of hydrocortisone, potentially causing Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, and HPA axis suppression.
- Pramoxine overdose is unlikely with topical use but could theoretically cause central nervous system effects (dizziness, drowsiness, tremors) or cardiovascular effects (bradycardia, hypotension) if significant systemic absorption occurred.
What to Do:
Discontinue use and contact your doctor or poison control center immediately. For severe symptoms, seek emergency medical attention. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of affected skin area
Rationale: To establish baseline severity of pruritus, inflammation, and skin integrity.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (reduction in pruritus, inflammation)
Frequency: Daily to weekly, depending on severity
Target: Significant improvement in symptoms
Action Threshold: Lack of improvement or worsening of symptoms after 1-2 weeks of use may require re-evaluation.
Local skin reactions (e.g., irritation, burning, atrophy, striae)
Frequency: Daily
Target: Absence of adverse reactions
Action Threshold: Development of significant irritation, signs of infection, or skin atrophy warrants discontinuation and re-evaluation.
Signs of systemic corticosteroid absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings
Target: Absence of systemic effects
Action Threshold: Any signs of systemic effects require immediate medical attention and discontinuation.
Symptom Monitoring
- Persistent or worsening pruritus
- Increased redness or inflammation
- Development of new skin lesions
- Signs of skin infection (pus, fever, increased pain)
- Thinning of skin, easy bruising, striae
- Unusual fatigue, weight gain, swelling (signs of systemic absorption)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hydrocortisone is Pregnancy Category C. Animal studies have shown teratogenic effects with corticosteroids. Systemic absorption is generally low with topical use, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Avoid if possible, or use with extreme caution due to potential for teratogenicity with systemic corticosteroids.
Second Trimester:
Use with caution, minimal systemic absorption expected.
Third Trimester:
Use with caution, minimal systemic absorption expected.
Lactation
Use with caution. It is not known whether topical hydrocortisone or pramoxine are excreted in human milk. Systemic absorption is generally low, but caution is advised. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with proper topical application, but monitor infant for any unusual effects. Avoid direct contact with infant's skin.
Pediatric Use
Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Use the least potent effective corticosteroid for the shortest duration possible. Not recommended for infants or young children unless specifically directed by a physician.
Geriatric Use
No specific dosage adjustments are generally needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- This product is for external use only. Do not ingest.
- Apply sparingly as a thin film; excessive use does not improve efficacy and increases risk of side effects.
- Avoid prolonged use, especially on the face, groin, or axillae, or under occlusive dressings, due to increased risk of skin atrophy and systemic absorption.
- If irritation or sensitization occurs, discontinue use and consult a physician.
- Not for ophthalmic use.
- If using for perianal conditions, ensure proper hygiene and bowel regularity to maximize effectiveness.
Alternative Therapies
- Other topical corticosteroids (e.g., triamcinolone, fluocinonide)
- Other topical local anesthetics (e.g., lidocaine, benzocaine)
- Oral antihistamines for pruritus
- Sitz baths for perianal discomfort
Cost & Coverage
Average Cost:
Varies widely per 59ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand), Tier 1 (for generic)
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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.