Iodosorb 0.9% Gel 40gm
It is used to clean wounds.It is used to promote healing of skin ulcers and wounds.
Drug Class
Antiseptic, Wound Care Agent
Pharmacologic Class
Iodine-releasing agent, Oxidizing agent
Pregnancy Category
Not assigned by FDA for topical, but potential for systemic absorption and fetal thyroid effects warrants caution. Often considered Category D or X for systemic iodine.
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Iodosorb Gel is a special type of iodine-containing gel used for cleaning and healing wounds. It works by slowly releasing iodine, which kills germs in the wound, and by absorbing excess fluid and debris. This helps to create a clean environment for the wound to heal.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Before and after handling the medication, wash your hands thoroughly. It's also recommended to wear gloves when handling this drug to minimize exposure.
Application Instructions
Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Clean the affected area as directed before applying the medication. However, do not completely dry the area.
After removing the dressing, gently wash the affected area.
To apply, place the medication on a gauze pad and then put the gauze on the affected area.
Storage and Disposal
Store this medication at room temperature.
Keep all medications in a safe and 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 by your pharmacist.
If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
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 dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Before and after handling the medication, wash your hands thoroughly. It's also recommended to wear gloves when handling this drug to minimize exposure.
Application Instructions
Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Clean the affected area as directed before applying the medication. However, do not completely dry the area.
After removing the dressing, gently wash the affected area.
To apply, place the medication on a gauze pad and then put the gauze on the affected area.
Storage and Disposal
Store this medication at room temperature.
Keep all medications in a safe and 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 by your pharmacist.
If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
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 dose.
Lifestyle & Tips
- Follow your healthcare provider's instructions carefully regarding how often to apply the gel and change the dressing.
- Wash your hands thoroughly before and after applying the gel.
- Clean the wound as directed by your healthcare provider before applying the gel.
- Apply a thin layer of gel directly to the wound surface.
- Cover the wound with a sterile dressing as instructed.
- Change the dressing when the gel changes color from brown to grey/white, which means it's saturated with wound fluid.
- Do not use this product if you are allergic to iodine or have a thyroid condition, unless specifically advised by your doctor.
- Avoid prolonged use or applying to very large areas of skin without medical supervision.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer (approximately 3mm thick) directly to the wound surface. Typically applied 1 to 3 times per week, or as directed by a healthcare professional. The dressing should be changed when the gel becomes saturated with exudate and changes color (from brown to grey/white).
Condition-Specific Dosing:
maximum_single_application:
50g
maximum_weekly_application:
150g
maximum_duration_of_use:
Typically up to 3 months, or as clinically indicated with monitoring.
Pediatric Dosing
Neonatal:
Not recommended due to increased risk of systemic iodine absorption and potential for thyroid dysfunction.
Infant:
Not recommended due to increased risk of systemic iodine absorption and potential for thyroid dysfunction.
Child:
Not recommended for children under 12 years due to increased risk of systemic iodine absorption and potential for thyroid dysfunction.
Adolescent:
Use with caution and under medical supervision, especially if large areas or prolonged use. Monitor thyroid function.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required for topical use with minimal systemic absorption. Use with caution if significant absorption is anticipated.
Moderate:
No specific adjustment required for topical use with minimal systemic absorption. Use with caution if significant absorption is anticipated.
Severe:
No specific adjustment required for topical use with minimal systemic absorption. Use with caution if significant absorption is anticipated, as absorbed iodine is renally excreted.
Dialysis:
Considerations: Not well studied. Use with caution if significant systemic absorption is expected, as absorbed iodine is renally excreted.
Hepatic Impairment:
Mild:
No specific adjustment required for topical use.
Moderate:
No specific adjustment required for topical use.
Severe:
No specific adjustment required for topical use.
Pharmacology
Mechanism of Action
Cadexomer iodine is a spherical microbead matrix containing 0.9% iodine. When applied to a wound, it slowly releases iodine, which has broad-spectrum antimicrobial activity against bacteria, fungi, viruses, and protozoa. The cadexomer matrix also absorbs wound exudate, pus, and debris, helping to clean the wound bed and reduce bacterial load. This action promotes a moist wound healing environment and facilitates the removal of slough and necrotic tissue.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from intact skin. Can be absorbed from large, deep, or extensively denuded wounds, leading to elevated serum iodine levels.
Tmax:
Not applicable for topical application with minimal systemic absorption. If absorbed systemically, peak iodine levels can occur within hours.
FoodEffect:
Not applicable
Distribution:
Vd:
Not available (minimal systemic absorption)
ProteinBinding:
Not available (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not available (minimal systemic absorption). If absorbed, inorganic iodide has a half-life of several hours.
Clearance:
Not available (minimal systemic absorption). If absorbed, renally cleared.
ExcretionRoute:
Primarily renal excretion if absorbed systemically.
Unchanged:
Not available (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Antimicrobial action begins upon contact with the wound. Wound cleansing and exudate absorption effects are gradual.
PeakEffect:
Continuous release of iodine and absorption of exudate over the application period (typically 1-3 days).
DurationOfAction:
Up to 72 hours, or until the gel is saturated and changes color.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
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
Severe skin irritation
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 for advice:
Pain
Redness
* Swelling
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
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
Severe skin irritation
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 for advice:
Pain
Redness
* Swelling
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. 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 redness, swelling, pain, or pus around the wound (signs of worsening infection)
- Skin rash, itching, or severe burning at the application site (signs of allergic reaction or irritation)
- Unexplained weight changes, fatigue, feeling cold or hot, changes in heart rate, or swelling in your neck (signs of thyroid problems)
- Metallic taste in your mouth, increased saliva, or burning in your mouth/throat (signs of too much iodine absorption)
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.
A history of thyroid problems, including Hashimoto's disease, Graves' disease, or other thyroid conditions.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
If you are breastfeeding. You should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change 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.
A history of thyroid problems, including Hashimoto's disease, Graves' disease, or other thyroid conditions.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
If you are breastfeeding. You should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change 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.
Note that this drug is not effective in treating dry wounds and is intended for use on wounds with adequate moisture.
During the initial treatment phase, which may last a few days, the wound may appear larger due to the medication's effects. This is a normal part of the healing process.
Do not use this medication for more than 3 months without consulting your doctor to assess the need for continued treatment and to discuss any potential adjustments to your therapy.
Note that this drug is not effective in treating dry wounds and is intended for use on wounds with adequate moisture.
During the initial treatment phase, which may last a few days, the wound may appear larger due to the medication's effects. This is a normal part of the healing process.
Do not use this medication for more than 3 months without consulting your doctor to assess the need for continued treatment and to discuss any potential adjustments to your therapy.
Overdose Information
Overdose Symptoms:
- Acute iodine poisoning symptoms may include: metallic taste, burning in mouth and throat, sore gums and teeth, increased salivation, coryza, eye irritation, headache, skin rash (iododerma), gastrointestinal upset (nausea, vomiting, diarrhea), abdominal pain, and rarely, circulatory collapse.
- Chronic iodine exposure (from prolonged use or large areas) can lead to thyroid dysfunction (hypothyroidism or hyperthyroidism).
What to Do:
If you suspect an overdose or significant systemic absorption, discontinue use immediately and seek emergency medical attention. Call your local poison control center (e.g., 1-800-222-1222 in the US) or go to the nearest emergency room.
Drug Interactions
Contraindicated Interactions
- Patients with known or suspected iodine sensitivity.
- Patients with thyroid disorders (e.g., Hashimoto's thyroiditis, Graves' disease, nodular goiter) due to potential for iodine absorption affecting thyroid function.
Major Interactions
- Lithium (concurrent use may increase the risk of hypothyroidism due to additive thyroid-suppressing effects of iodine and lithium).
Moderate Interactions
- Enzymatic debriding agents (e.g., collagenase, papain): Iodine may inactivate these enzymes.
- Hydrogen peroxide: May inactivate iodine.
- Silver sulfadiazine: May inactivate iodine or be inactivated by it.
- Other topical antiseptics or heavy metal-containing preparations: Concurrent use may reduce efficacy or cause adverse reactions.
Monitoring
Baseline Monitoring
Wound assessment (size, depth, exudate, signs of infection)
Rationale: To establish baseline wound status and guide treatment.
Timing: Prior to first application
Thyroid function tests (TSH, T3, T4)
Rationale: To assess baseline thyroid status, especially in patients with pre-existing thyroid conditions or if prolonged use/large wound area is anticipated, due to potential for systemic iodine absorption.
Timing: Prior to initiation, if indicated
Routine Monitoring
Wound healing progress (reduction in size, exudate, slough, signs of granulation)
Frequency: At each dressing change (1-3 times per week)
Target: Improvement in wound characteristics
Action Threshold: Lack of improvement, worsening wound, or signs of infection warrant re-evaluation.
Signs of local irritation (redness, itching, pain, swelling)
Frequency: At each dressing change
Target: Absence of irritation
Action Threshold: Presence of irritation may require discontinuation or reduced frequency.
Signs of systemic iodine absorption/thyroid dysfunction (e.g., fatigue, weight changes, neck swelling, nervousness, tremors)
Frequency: Periodically, especially with prolonged use or large wound areas
Target: Absence of symptoms
Action Threshold: Presence of symptoms warrants immediate medical evaluation and thyroid function testing.
Symptom Monitoring
- Local irritation (redness, itching, burning, pain) at the application site
- Signs of systemic iodine toxicity (metallic taste, increased salivation, burning in mouth/throat, eye irritation, skin rash, gastrointestinal upset, diarrhea)
- Signs of thyroid dysfunction (fatigue, lethargy, weight gain or loss, cold intolerance, hair loss, dry skin, nervousness, tremors, palpitations, neck swelling/goiter)
Special Patient Groups
Pregnancy
Use generally not recommended due to potential for systemic iodine absorption and subsequent fetal hypothyroidism. Iodine crosses the placenta and can affect fetal thyroid development. If use is considered absolutely necessary, monitor maternal and fetal thyroid function closely.
Trimester-Specific Risks:
First Trimester:
Potential for fetal thyroid effects, though less pronounced than later trimesters.
Second Trimester:
Increased risk of fetal hypothyroidism as fetal thyroid gland develops and becomes active.
Third Trimester:
Highest risk of fetal hypothyroidism and goiter due to active fetal thyroid gland and increased iodine uptake.
Lactation
Use generally not recommended due to potential for systemic iodine absorption and subsequent infant hypothyroidism. Iodine is excreted in breast milk and can affect infant thyroid function. If use is considered absolutely necessary, monitor infant thyroid function closely.
Infant Risk:
High risk of infant hypothyroidism, especially in premature or low birth weight infants, or those with underlying thyroid conditions.
Pediatric Use
Not recommended for children under 12 years of age due to increased risk of systemic iodine absorption and potential for thyroid dysfunction (hypothyroidism). Children, especially neonates and infants, have a higher surface area to body weight ratio and immature thyroid function, making them more susceptible to adverse effects from absorbed iodine. If used in older children/adolescents, extreme caution and close monitoring of thyroid function are required.
Geriatric Use
Generally safe for use in geriatric patients. However, caution should be exercised in patients with pre-existing thyroid conditions, as they may be more susceptible to iodine-induced thyroid dysfunction. Monitor for signs of thyroid dysfunction.
Clinical Information
Clinical Pearls
- Cadexomer iodine is effective for chronic, exuding wounds, particularly those with slough and infection.
- The gel changes color (from brown to grey/white) when it is saturated with exudate, indicating it's time for a dressing change.
- Always rinse the wound with sterile saline or water before applying a new layer of gel to remove residual product and exudate.
- Avoid using in patients with known iodine allergy or pre-existing thyroid disorders (hyperthyroidism, hypothyroidism, goiter) due to the risk of systemic iodine absorption and thyroid dysfunction.
- Do not use concurrently with enzymatic debriding agents, hydrogen peroxide, or silver sulfadiazine, as these may inactivate the iodine or be inactivated by it.
- Prolonged use or application to large wound areas should be avoided, especially in pregnant/lactating women and children, due to the risk of systemic iodine absorption and thyroid effects.
Alternative Therapies
- Silver-containing wound dressings (e.g., silver alginate, silver foam dressings)
- Honey-based wound dressings (e.g., Medihoney)
- Antimicrobial dressings (e.g., PHMB dressings)
- Hydrogel dressings (for moist wound environment)
- Alginate dressings (for highly exuding wounds)
- Foam dressings (for moderate to heavy exudate)
- Debriding agents (e.g., enzymatic debriders, autolytic debridement products)
- Topical antibiotics (e.g., mupirocin, silver sulfadiazine, for specific infections)
Cost & Coverage
Average Cost:
$30 - $70 per 40gm tube
Generic Available:
Yes
Insurance Coverage:
Often covered under medical benefit for wound care supplies, or as a prescription drug. Coverage varies by insurance plan (e.g., Tier 2 or 3).
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.