HC Pramoxine 2.5-1% Cream 30gm

Manufacturer TRUPHARMA Active Ingredient Pramoxine and Hydrocortisone Rectal Cream(pra MOKS een & hye droe KOR ti sone) Pronunciation pra-MOKS-een & hye-droe-KOR-ti-sone
It is used to treat skin irritation.It is used to treat signs of hemorrhoids or rectal irritation.
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Drug Class
Anorectal Agent, Anti-inflammatory, Local Anesthetic
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Pharmacologic Class
Glucocorticoid, Local Anesthetic (Ester-type)
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This cream contains two medicines: pramoxine, which is a numbing agent 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 or anal itching.
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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.
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Lifestyle & Tips

  • Maintain good anal hygiene by gently cleaning the area after bowel movements.
  • Avoid excessive straining during bowel movements.
  • Increase fiber intake and fluid consumption to prevent constipation.
  • Avoid prolonged sitting or standing.
  • Avoid scratching the affected area, as this can worsen irritation and lead to infection.
  • Wear loose-fitting, breathable underwear.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply externally to the affected area up to 3-4 times daily. For internal use, use applicator and apply a small amount up to 3-4 times daily.

Condition-Specific Dosing:

hemorrhoids: Apply to the affected area up to 3-4 times daily, especially after bowel movements or at bedtime.
analpruritus: Apply to the affected area up to 3-4 times daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (use only under medical supervision, generally not recommended for prolonged use due to potential for systemic absorption of hydrocortisone)
Adolescent: Not established (use only under medical supervision, generally not recommended for prolonged use due to potential for systemic absorption of hydrocortisone)
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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

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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.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption for both components when applied topically/rectally to intact skin/mucosa. Absorption may increase with inflammation, skin barrier disruption, or prolonged use.
Tmax: Not applicable for topical/rectal systemic effects; local onset is rapid for pramoxine (minutes).
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (primarily local action)
ProteinBinding: Hydrocortisone: Approximately 90% (to albumin and corticosteroid-binding globulin) if systemically absorbed. Pramoxine: Not well-documented for systemic binding, but minimal systemic absorption.
CnssPenetration: Limited (primarily local action)

Elimination:

HalfLife: Hydrocortisone: Approximately 1.5-2 hours (systemic). Pramoxine: Not well-documented due to minimal systemic absorption.
Clearance: Not applicable (primarily local action)
ExcretionRoute: Hydrocortisone: Renal (as metabolites) if systemically absorbed. Pramoxine: Not well-documented due to minimal systemic absorption.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Pramoxine: Within 3-5 minutes (for local anesthetic effect). Hydrocortisone: Hours to days for full anti-inflammatory effect.
PeakEffect: Pramoxine: 5-10 minutes. Hydrocortisone: Varies, sustained with continued use.
DurationOfAction: Pramoxine: Approximately 2-4 hours. Hydrocortisone: Several hours to days depending on formulation and extent of absorption.

Safety & Warnings

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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 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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of symptoms or no improvement after 7 days of use.
  • Increased pain, bleeding, or swelling.
  • Signs of infection (e.g., fever, pus, spreading redness, severe tenderness).
  • Severe burning, stinging, or irritation at the application site.
  • Allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat).
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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.
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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.
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Overdose Information

Overdose Symptoms:

  • Systemic effects are unlikely with proper topical/rectal use due to minimal absorption.
  • With excessive or prolonged use, especially over large areas or broken skin, systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression) could theoretically occur, though rare.
  • Local anesthetic systemic toxicity (e.g., CNS excitation followed by depression, cardiovascular effects) is extremely rare with pramoxine topical/rectal use.

What to Do:

Discontinue use. For suspected systemic effects, seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222).

Drug Interactions

Monitoring

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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

Rationale: To identify any pre-existing skin breakdown, infection, or other conditions that may contraindicate use or require alternative treatment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Symptom relief (pain, itching, inflammation)

Frequency: Daily

Target: Reduction or resolution of symptoms

Action Threshold: If symptoms worsen or do not improve within 7 days, re-evaluate diagnosis and treatment.

Local adverse reactions (burning, stinging, irritation, dryness, folliculitis, skin atrophy)

Frequency: Daily

Target: Absence of new or worsening local reactions

Action Threshold: Discontinue use if severe irritation or allergic reaction occurs. Consult healthcare provider.

Signs of infection

Frequency: Daily

Target: Absence of redness, warmth, swelling, pus

Action Threshold: Discontinue use and seek medical attention if signs of infection develop.

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Symptom Monitoring

  • Pain
  • Itching
  • Burning
  • Stinging
  • Redness
  • Swelling
  • Discharge
  • Bleeding
  • Signs of infection (fever, pus, spreading redness)

Special Patient Groups

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Pregnancy

Use with caution during pregnancy. Hydrocortisone is Category C, meaning animal studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. The potential benefit may justify the potential risk. Minimal systemic absorption is expected with topical/rectal use.

Trimester-Specific Risks:

First Trimester: Avoid if possible, or use only if clearly needed and benefits outweigh risks.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Generally considered safer than first trimester, but still use with caution.
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Lactation

Use with caution during lactation (L3). Minimal systemic absorption of hydrocortisone and pramoxine is expected, making transfer into breast milk unlikely to cause significant harm to the infant. However, avoid applying to areas where the infant may ingest the medication.

Infant Risk: Low risk with proper use due to minimal systemic absorption. Monitor infant for any unusual effects.
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Pediatric Use

Not recommended for prolonged use in children without medical supervision due to the potential for systemic absorption of hydrocortisone, which can lead to growth retardation, adrenal suppression, and other corticosteroid-related adverse effects. Children may absorb proportionally larger amounts of topical corticosteroids.

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Geriatric Use

Generally safe for use in the elderly. However, elderly patients may have thinner skin, which could potentially increase systemic absorption of hydrocortisone. Monitor for skin atrophy or other local adverse effects with prolonged use.

Clinical Information

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Clinical Pearls

  • This product is for external and/or intra-rectal use only. Do not ingest.
  • Wash hands thoroughly before and after application.
  • Do not use for more than 7 consecutive days unless directed by a healthcare professional.
  • If using the applicator, clean it thoroughly after each use.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Prolonged use of corticosteroids, even topical, can lead to skin thinning, striae, and potential systemic effects, though rare with rectal use.
  • If symptoms persist or worsen, or if bleeding occurs, consult a doctor to rule out more serious conditions.
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Alternative Therapies

  • Topical corticosteroids (e.g., hydrocortisone cream 1%)
  • Topical local anesthetics (e.g., lidocaine cream, benzocaine cream)
  • Astringents (e.g., witch hazel pads, zinc oxide)
  • Protectants (e.g., petrolatum, mineral oil)
  • Sitz baths
  • Dietary fiber supplements and stool softeners
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Cost & Coverage

Average Cost: $20 - $50 per 30gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.