Uramaxin 45% Gel 28ml
It is used to treat some skin problems. It is used to treat some nail problems.
Drug Class
Keratolytic Agent; Emollient; Humectant
Pharmacologic Class
Urea derivative
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Uramaxin 45% Gel is a topical medication containing urea, which helps to soften and remove rough, dry, or scaly skin. It also helps your skin hold onto moisture, making it softer and smoother. It's commonly used for conditions like calluses, corns, and certain types of dry, thickened skin.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Application Instructions
Apply this medication only to your nails, as directed by your doctor. Do not take this medication by mouth. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Storing and Disposing of Your Medication
Store this medication at room temperature, away from heat sources. Do not freeze. Keep the lid tightly closed to maintain the medication's effectiveness.
Managing Missed Doses
If you miss a dose, apply it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Application Instructions
Apply this medication only to your nails, as directed by your doctor. Do not take this medication by mouth. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Storing and Disposing of Your Medication
Store this medication at room temperature, away from heat sources. Do not freeze. Keep the lid tightly closed to maintain the medication's effectiveness.
Managing Missed Doses
If you miss a dose, apply it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Apply only to the affected skin areas as directed by your doctor or pharmacist.
- Wash your hands thoroughly before and after applying the gel.
- Avoid contact with eyes, nose, mouth, or other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not apply to open wounds, broken, or severely irritated skin unless specifically instructed by a healthcare professional, as it may cause stinging or burning.
- Keep the treated area covered with clothing or a bandage if recommended by your doctor.
- Store at room temperature, away from heat and direct light. Keep out of reach of children.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected skin area 1-3 times daily or as directed by a physician. Rub in until absorbed.
Condition-Specific Dosing:
hyperkeratotic_conditions:
Apply to thickened or hyperkeratotic areas, such as calluses, corns, psoriasis plaques, or ichthyosis.
Pediatric Dosing
Neonatal:
Not established (use with caution and under medical supervision)
Infant:
Not established (use with caution and under medical supervision)
Child:
Apply to affected skin area 1-3 times daily or as directed by a physician. Use with caution on large areas or broken skin.
Adolescent:
Apply to affected skin area 1-3 times daily or as directed by a physician.
Dose Adjustments
Renal Impairment:
Mild:
No systemic dose adjustment required for topical application due to minimal systemic absorption.
Moderate:
No systemic dose adjustment required for topical application due to minimal systemic absorption.
Severe:
No systemic dose adjustment required for topical application due to minimal systemic absorption.
Dialysis:
No systemic dose adjustment required for topical application due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No systemic dose adjustment required for topical application due to minimal systemic absorption.
Moderate:
No systemic dose adjustment required for topical application due to minimal systemic absorption.
Severe:
No systemic dose adjustment required for topical application due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Urea is a keratolytic agent that softens and dissolves the intercellular matrix of the stratum corneum, promoting desquamation and shedding of scales. It also has humectant properties, attracting and retaining moisture in the skin, thereby increasing the water-binding capacity of the stratum corneum. At higher concentrations (e.g., 45%), its keratolytic action is more pronounced.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption through intact skin; increased absorption through broken or inflamed skin.
Tmax:
Not applicable for systemic effect; local effect is immediate.
FoodEffect:
Not applicable.
Distribution:
Vd:
Not applicable due to minimal systemic absorption.
ProteinBinding:
Not applicable due to minimal systemic absorption.
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable for topical use due to minimal systemic absorption.
Clearance:
Not applicable for topical use due to minimal systemic absorption.
ExcretionRoute:
Any systemically absorbed urea is primarily excreted renally.
Unchanged:
Not applicable for topical use due to minimal systemic absorption.
Pharmacodynamics
OnsetOfAction:
Hydrating effect is immediate. Keratolytic effect may be observed within days to weeks of consistent application.
PeakEffect:
Full keratolytic effect typically seen after several weeks of continuous use.
DurationOfAction:
Requires continuous application for sustained therapeutic effect.
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious allergic reaction:
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
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Burning or stinging
Itching
Irritation at the site where the medication was applied
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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 when taking this medication. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious allergic reaction:
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
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Burning or stinging
Itching
Irritation at the site where the medication was applied
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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:
- Severe burning, stinging, or irritation at the application site that does not subside.
- Development of a rash or worsening of skin condition.
- Signs of an allergic reaction such as swelling, hives, or difficulty breathing (rare, but seek immediate medical attention).
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 is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust 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 is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust 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 use this drug for longer than recommended by your doctor.
In the event of accidental ingestion, this medication can be harmful. If you or someone else swallows this drug, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication during this time to ensure the best possible outcome for you and your baby.
In the event of accidental ingestion, this medication can be harmful. If you or someone else swallows this drug, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication during this time to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive local skin irritation (redness, burning, stinging, peeling)
- Systemic overdose is highly unlikely with topical application due to minimal absorption.
What to Do:
If excessive local irritation occurs, wash the area thoroughly with water and discontinue use. If ingested, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222).
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of hyperkeratosis, dryness, or other skin conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin irritation (redness, burning, stinging, itching)
Frequency: Daily, with each application.
Target: Minimal to no irritation.
Action Threshold: Discontinue use if severe irritation occurs; consult physician if persistent or worsening.
Improvement in skin texture and appearance
Frequency: Weekly to bi-weekly.
Target: Softening of skin, reduction in scaling, improved hydration.
Action Threshold: If no improvement after several weeks, re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Severe skin irritation
- Burning sensation
- Stinging sensation
- Redness
- Itching
- Rash
- Signs of allergic reaction (e.g., swelling, difficulty breathing - rare for topical urea)
Special Patient Groups
Pregnancy
Urea topical is generally considered safe for use during pregnancy (Category B) due to minimal systemic absorption. Consult with a healthcare provider before use.
Trimester-Specific Risks:
First Trimester:
Low risk; minimal systemic absorption.
Second Trimester:
Low risk; minimal systemic absorption.
Third Trimester:
Low risk; minimal systemic absorption.
Lactation
Urea topical is likely safe for use during lactation (L3) as systemic absorption is minimal, making transfer into breast milk unlikely to cause adverse effects in the infant. Consult with a healthcare provider.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption and excretion into breast milk.
Pediatric Use
Use with caution in infants and young children, especially on large surface areas or broken skin, as their skin barrier is more permeable, potentially leading to increased absorption. Always use under medical supervision.
Geriatric Use
No specific dose adjustments are typically needed for geriatric patients. Generally well-tolerated, but monitor for skin sensitivity or irritation, which may be more common in elderly skin.
Clinical Information
Clinical Pearls
- Urea 45% gel is highly effective for severe hyperkeratotic conditions, such as thick calluses, corns, and psoriatic plaques, due to its strong keratolytic action.
- Patients should be advised that a mild stinging or burning sensation may occur, especially on broken or inflamed skin. This is usually transient.
- Consistent and regular application is key to achieving optimal results for keratolytic effects.
- Can be used in conjunction with other topical treatments (e.g., corticosteroids) for enhanced efficacy, but apply urea first and allow to dry before applying other products.
- Emphasize the importance of avoiding contact with eyes and mucous membranes.
Alternative Therapies
- Salicylic acid (topical)
- Lactic acid (topical)
- Ammonium lactate (topical)
- Alpha hydroxy acids (AHAs)
- Topical retinoids (e.g., tazarotene, calcipotriene for psoriasis)
- Emollients and moisturizers (for dryness and hydration)
Cost & Coverage
Average Cost:
Not available per 28ml gel
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription plans, but may vary by concentration and formulation (OTC vs. Rx).
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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.