Betadine 10% Solution 118ml
It is used to treat or prevent bacterial infections.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antiseptic, Disinfectant
Pharmacologic Class
Iodophor, Halogenated Antiseptic
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Povidone-iodine is an antiseptic solution used to kill germs (bacteria, viruses, fungi) on the skin. It's commonly used for cleaning minor cuts, scrapes, and burns, or for preparing the skin before surgery to prevent infections.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it or apply it to your mouth or eyes, as it may cause burning. Before and after application, wash your hands thoroughly, unless your hand is the treated area, in which case you should not wash it after application. You may cover the treated area with a bandage or dressing if necessary.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures and excessive heat. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure.
Missed Dose Instructions
If you miss a dose, apply 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 application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed application.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it or apply it to your mouth or eyes, as it may cause burning. Before and after application, wash your hands thoroughly, unless your hand is the treated area, in which case you should not wash it after application. You may cover the treated area with a bandage or dressing if necessary.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures and excessive heat. Keep all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure.
Missed Dose Instructions
If you miss a dose, apply 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 application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed application.
Lifestyle & Tips
- Clean the affected area before applying the solution.
- Apply a small amount directly to the wound or skin area.
- Do not use on large areas of skin, especially if the skin is broken or burned, without consulting a doctor.
- Avoid getting the solution in your eyes, nose, or mouth. If contact occurs, rinse thoroughly with water.
- Do not swallow the solution.
- Allow the solution to dry completely on the skin before covering with a dressing or clothing.
- Store at room temperature, away from direct light and heat.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply full strength as a paint, wet soak, or spray. May be used as often as needed.
Condition-Specific Dosing:
pre-operative skin preparation:
Apply undiluted to the operative site, allow to dry for at least 2 minutes, then blot with sterile towel.
minor cuts/abrasions:
Clean the affected area, apply a small amount to the wound 1 to 3 times daily.
Pediatric Dosing
Neonatal:
Not established; use with extreme caution and only if clearly indicated due to risk of systemic absorption and thyroid suppression.
Infant:
Not established; use with extreme caution and only if clearly indicated due to risk of systemic absorption and thyroid suppression.
Child:
Apply as directed by a healthcare professional. Avoid prolonged use or application to large areas.
Adolescent:
Apply as directed by a healthcare professional. Similar to adult dosing, but avoid prolonged use or application to large areas.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use on intact skin.
Moderate:
Use with caution, especially if applied to large areas or broken skin, due to potential for systemic iodine absorption.
Severe:
Avoid prolonged use or application to large areas due to risk of systemic iodine absorption and potential for accumulation.
Dialysis:
Avoid prolonged use or application to large areas. Consult nephrologist if systemic absorption is a concern.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Pharmacology
Mechanism of Action
Povidone-iodine is a broad-spectrum antiseptic. It works by releasing free iodine, which rapidly penetrates microbial cell walls and oxidizes proteins, nucleotides, and fatty acids, leading to cell death. It is effective against bacteria (Gram-positive and Gram-negative), fungi, viruses, protozoa, and spores.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from intact skin; significant absorption can occur from large areas of broken skin, mucous membranes, or burns.
Tmax:
Not well-defined for topical application; systemic iodine levels peak within hours if significant absorption occurs.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical application; if absorbed, iodine distributes throughout the body, concentrating in the thyroid gland.
ProteinBinding:
Iodine is bound to plasma proteins; povidone itself is not significantly absorbed.
CnssPenetration:
Limited penetration into CNS from topical application; systemic absorption could lead to some CNS distribution of iodine.
Elimination:
HalfLife:
Variable, depending on absorption; absorbed iodine has a half-life of several days.
Clearance:
Primarily renal for absorbed iodine.
ExcretionRoute:
Renal (urine) for absorbed iodine.
Unchanged:
Not applicable; iodine is released and then handled physiologically.
Pharmacodynamics
OnsetOfAction:
Rapid (seconds to minutes) for antimicrobial effect.
PeakEffect:
Within minutes of application.
DurationOfAction:
Sustained release of iodine provides prolonged antiseptic action, typically hours, depending on the formulation and presence of organic matter.
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, or 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:
- Irritation at the site where the drug was applied
- Any other side effects that bother you or do not go away
Reporting Side Effects
This list does not include all 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.
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, or 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:
- Irritation at the site where the drug was applied
- Any other side effects that bother you or do not go away
Reporting Side Effects
This list does not include all 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:
- Increased redness, swelling, pain, or pus around the wound (signs of infection)
- Rash, itching, or hives (signs of allergic reaction)
- If symptoms do not improve within 7 days or worsen, consult a healthcare professional.
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 allergic reaction and its symptoms.
If you have recently experienced an animal bite or a deep puncture wound.
If you have a severe burn or a deep cut.
If the affected area is large and requires treatment.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any existing health problems to ensure safe treatment.
Remember, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so in conjunction with your other medications and health conditions.
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 allergic reaction and its symptoms.
If you have recently experienced an animal bite or a deep puncture wound.
If you have a severe burn or a deep cut.
If the affected area is large and requires treatment.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any existing health problems to ensure safe treatment.
Remember, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so in conjunction with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the prescribed dosage and duration of treatment, and do not exceed the recommended frequency or duration of use.
In the event of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
In the event of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- If ingested: metallic taste, burning in mouth/throat, abdominal pain, nausea, vomiting, diarrhea, swelling of salivary glands, skin eruptions, fever, headache, confusion, weakness, circulatory collapse.
- Excessive topical absorption (rare): symptoms of iodism (metallic taste, increased salivation, rhinitis, conjunctivitis, skin eruptions), or thyroid dysfunction (hyperthyroidism or hypothyroidism).
What to Do:
In case of accidental ingestion or suspected overdose, seek immediate medical attention. Call a Poison Control Center at 1-800-222-1222. Treatment is supportive and symptomatic.
Drug Interactions
Contraindicated Interactions
- Lithium (concurrent use may lead to hypothyroidism)
- Mercury-containing compounds (e.g., mercuric chloride, thimerosal) due to formation of caustic compounds.
Major Interactions
- Thyroid function tests (can interfere with results due to iodine absorption)
Moderate Interactions
- Other topical antiseptics (potential for inactivation or irritation)
- Enzyme preparations (e.g., collagenase, trypsin) - povidone-iodine can inactivate them.
Monitoring
Baseline Monitoring
Thyroid function (TSH, T4)
Rationale: To establish baseline, especially in patients with pre-existing thyroid conditions or if large areas/prolonged use is anticipated, due to potential for systemic iodine absorption.
Timing: Prior to initiation of large-area or prolonged therapy.
Routine Monitoring
Skin integrity and irritation
Frequency: Daily during use
Target: Absence of redness, swelling, itching, or rash.
Action Threshold: Discontinue use if irritation or allergic reaction occurs.
Signs of systemic iodine absorption (e.g., iodism, thyroid dysfunction symptoms)
Frequency: Periodically, especially with prolonged or extensive use
Target: Absence of metallic taste, increased salivation, rhinitis, conjunctivitis, skin eruptions, or symptoms of hyper/hypothyroidism.
Action Threshold: Consult physician if symptoms develop.
Symptom Monitoring
- Skin irritation (redness, itching, burning, rash)
- Allergic reactions (hives, swelling, difficulty breathing - rare)
- Symptoms of iodism (metallic taste, increased salivation, rhinitis, conjunctivitis, skin eruptions - rare with topical use)
- Symptoms of thyroid dysfunction (fatigue, weight changes, palpitations, anxiety - rare with topical use)
Special Patient Groups
Pregnancy
Category C. Use with caution and only if clearly needed. Avoid prolonged use or application to large areas due to potential for systemic iodine absorption, which could affect fetal thyroid function.
Trimester-Specific Risks:
First Trimester:
Potential for fetal thyroid effects if significant absorption occurs.
Second Trimester:
Potential for fetal thyroid effects if significant absorption occurs.
Third Trimester:
Potential for fetal thyroid effects (e.g., transient hypothyroidism, goiter) if significant absorption occurs, especially near term.
Lactation
Use with caution. Iodine is excreted in breast milk and can potentially affect infant thyroid function. Avoid application to the breast area to prevent direct infant ingestion.
Infant Risk:
Risk L3 (Moderate concern) - Potential for infant thyroid suppression or dysfunction.
Pediatric Use
Use with extreme caution in neonates and premature infants due to their immature thyroid function and higher skin absorption. Prolonged use or application to large areas should be avoided in all pediatric age groups unless specifically directed by a physician, due to the risk of systemic iodine absorption and thyroid dysfunction.
Geriatric Use
Generally safe for topical use in the elderly. However, caution should be exercised in patients with pre-existing thyroid conditions or renal impairment if large areas or prolonged use is anticipated, due to potential for systemic iodine absorption.
Clinical Information
Clinical Pearls
- Povidone-iodine is a widely used, effective broad-spectrum antiseptic.
- It can stain skin and fabrics brown, but these stains are usually washable.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use on deep or puncture wounds, animal bites, or serious burns without consulting a doctor.
- Discontinue use if irritation or allergic reaction occurs.
- While generally safe for topical use, systemic absorption can occur, especially with large surface areas, broken skin, or prolonged use, leading to potential thyroid dysfunction or iodism.
Alternative Therapies
- Chlorhexidine gluconate (e.g., Hibiclens)
- Ethyl alcohol (70%)
- Isopropyl alcohol (70%)
- Hydrogen peroxide
- Benzalkonium chloride
- Octenidine dihydrochloride
Cost & Coverage
Average Cost:
Varies widely (typically $5-$20) per 118ml bottle
Generic Available:
Yes
Insurance Coverage:
Generally not covered by prescription insurance as it is an OTC product. May be covered by FSA/HSA.
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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.