HC Pramoxine 2.5-1% Cream 30gm
Overview
What is this medicine?
How to Use This Medicine
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
- 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.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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).
Before Using This Medicine
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.
Precautions & Cautions
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 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
Baseline Monitoring
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy
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
Routine Monitoring
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.
Frequency: Daily
Target: Absence of new or worsening local reactions
Action Threshold: Discontinue use if severe irritation or allergic reaction occurs. Consult healthcare provider.
Frequency: Daily
Target: Absence of redness, warmth, swelling, pus
Action Threshold: Discontinue use and seek medical attention if signs of infection develop.
Symptom Monitoring
- Pain
- Itching
- Burning
- Stinging
- Redness
- Swelling
- Discharge
- Bleeding
- Signs of infection (fever, pus, spreading redness)
Special Patient Groups
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:
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.
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.
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
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.
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