Betadine 10% Solution 14.8ml
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
Pregnancy Category
Category C (for topical use, D for prolonged/large area use due to potential fetal thyroid effects)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Povidone-iodine is an antiseptic solution used on the skin to kill germs (bacteria, viruses, fungi) that can cause infections. It's commonly used for minor cuts, scrapes, burns, and before medical procedures to clean the skin.
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 this medication or apply it to your mouth or eyes, as it may cause burning. Before and after applying the medication, wash your hands thoroughly. However, if the treated area is on your hand, do not wash your hand after application.
You may cover the treated area with a bandage or dressing, if recommended by your doctor.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures. Protect the medication from heat sources. Keep all medications in a secure location, out of the reach of children and pets.
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 dose.
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 this medication or apply it to your mouth or eyes, as it may cause burning. Before and after applying the medication, wash your hands thoroughly. However, if the treated area is on your hand, do not wash your hand after application.
You may cover the treated area with a bandage or dressing, if recommended by your doctor.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures. Protect the medication from heat sources. Keep all medications in a secure location, out of the reach of children and pets.
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 dose.
Lifestyle & Tips
- Clean the affected area before applying the solution.
- Apply a small amount directly to the skin or wound.
- Allow the solution to dry completely before covering with a bandage or clothing.
- Do not use on large areas of skin, deep wounds, or for prolonged periods without consulting a doctor.
- Avoid contact with eyes, nose, mouth, and internal organs. If contact occurs, rinse thoroughly with water.
- Povidone-iodine can stain skin and clothing; stains on skin usually wash off, but clothing stains may be permanent.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply undiluted to affected area as needed
Condition-Specific Dosing:
skinAntisepsis:
Apply to clean, dry skin, allow to dry before dressing.
woundCare:
Apply to wound, allow to dry, may cover with sterile dressing.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to risk of systemic iodine absorption and thyroid suppression)
Infant:
Not established (use with caution, consult physician)
Child:
Apply undiluted to affected area as needed, under adult supervision.
Adolescent:
Apply undiluted to affected area as needed.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed for topical use.
Moderate:
No adjustment typically needed for topical use, but caution with prolonged or extensive use due to potential for systemic iodine absorption.
Severe:
Use with caution; avoid prolonged or extensive use due to potential for systemic iodine absorption and accumulation.
Dialysis:
Considerations: Avoid prolonged or extensive use. Iodine is dialyzable, but systemic absorption from topical use is variable.
Hepatic Impairment:
Mild:
No adjustment typically needed for topical use.
Moderate:
No adjustment typically needed for topical use.
Severe:
No adjustment typically needed for topical use.
Pharmacology
Mechanism of Action
Povidone-iodine is an iodophor, a complex of polyvinylpyrrolidone (PVP) and iodine. It slowly releases free iodine when in contact with skin and mucous membranes. Free iodine has broad-spectrum antimicrobial activity against bacteria (Gram-positive and Gram-negative), fungi, viruses, protozoa, and spores. It acts by oxidizing microbial cellular components (e.g., proteins, nucleotides, fatty acids), leading to cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Not quantifiable for topical use; minimal systemic absorption from intact skin, but significant absorption can occur from large areas of denuded skin, mucous membranes, or wounds.
Tmax:
Not applicable for topical use; systemic absorption is variable.
FoodEffect:
Not applicable for topical use.
Distribution:
Vd:
Not available (systemic distribution of absorbed iodine is wide)
ProteinBinding:
Not available (iodine binds to proteins)
CnssPenetration:
Limited (systemic iodine can cross blood-brain barrier to some extent)
Elimination:
HalfLife:
Not available (systemic iodine elimination half-life is variable, typically hours to days depending on thyroid status and renal function)
Clearance:
Not available
ExcretionRoute:
Primarily renal (urine); small amounts in feces, sweat, and breast milk.
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Rapid (within seconds to minutes)
PeakEffect:
Not applicable (continuous antimicrobial action as long as applied)
DurationOfAction:
Several hours, depending on concentration and presence of organic matter.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
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 resolve on their own
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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
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 resolve on their own
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:
- Severe skin irritation, redness, itching, or rash at the application site.
- Signs of an allergic reaction such as hives, swelling of the face/lips/tongue, or difficulty breathing (seek immediate medical attention).
- If the wound worsens or shows signs of infection (increased pain, pus, fever), consult a doctor.
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 cut.
If a large area of your body requires treatment with this medication.
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 use.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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 cut.
If a large area of your body requires treatment with this medication.
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 use.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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 use this drug more frequently or for an extended period than recommended.
If accidental ingestion occurs, this medication can be harmful. In the event of swallowing, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
If accidental ingestion occurs, this medication can be harmful. In the event of swallowing, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- If ingested: metallic taste, burning in mouth/throat, abdominal pain, diarrhea, nausea, vomiting, fever, swelling of salivary glands, skin rash, difficulty breathing, circulatory collapse.
- From extensive topical absorption: symptoms of iodine toxicity or thyroid dysfunction (e.g., hypothyroidism or hyperthyroidism).
What to Do:
If ingested, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). For topical overdose leading to systemic symptoms, discontinue use and seek medical attention. Treatment is supportive.
Drug Interactions
Contraindicated Interactions
- Patients with known hypersensitivity to iodine or povidone.
- Patients with hyperthyroidism or other acute thyroid diseases (unless directed by physician).
- Before and after radioiodine therapy (due to iodine absorption).
Major Interactions
- Lithium (concurrent use, especially if systemic absorption occurs, may increase risk of hypothyroidism due to additive thyroid-suppressing effects).
- Mercury-containing compounds (e.g., mercurial antiseptics like merbromin, thimerosal) - may form corrosive compounds with iodine.
Moderate Interactions
- Other topical antiseptics (e.g., hydrogen peroxide, silver sulfadiazine, chlorhexidine) - may inactivate povidone-iodine or cause skin irritation.
- Enzyme preparations (e.g., collagenase, trypsin) - povidone-iodine may inhibit their activity.
Confidence Interactions
Monitoring
Baseline Monitoring
Skin integrity and presence of open wounds
Rationale: To assess potential for systemic absorption.
Timing: Prior to first application.
Thyroid function tests (TSH, T3, T4)
Rationale: Consider for patients with pre-existing thyroid conditions or if extensive/prolonged use is anticipated, especially in neonates or patients with renal impairment.
Timing: Prior to initiation of extensive/prolonged therapy.
Routine Monitoring
Local skin reaction (redness, irritation, itching, swelling)
Frequency: Daily or with each application
Target: Absence of significant irritation
Action Threshold: Discontinue use if severe irritation or allergic reaction occurs.
Signs of systemic iodine absorption (e.g., metallic taste, increased salivation, gastrointestinal upset, thyroid dysfunction symptoms)
Frequency: Periodically, especially with extensive or prolonged use
Target: Absence of symptoms
Action Threshold: Consult physician if symptoms develop.
Symptom Monitoring
- Skin irritation (redness, itching, burning, rash)
- Allergic reaction (hives, swelling, difficulty breathing)
- Signs of systemic iodine toxicity (metallic taste, increased salivation, sore throat, diarrhea, abdominal pain, fever, skin eruptions, swelling of salivary glands, thyroid dysfunction symptoms like fatigue, weight changes, mood changes).
Special Patient Groups
Pregnancy
Use with caution and only if clearly needed. Avoid prolonged or extensive use, especially during the second and third trimesters, due to the risk of systemic iodine absorption which can affect fetal thyroid function and potentially cause fetal hypothyroidism.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk for topical use, but systemic absorption should be minimized.
Second Trimester:
Increased risk of fetal thyroid effects due to developing fetal thyroid gland. Use with caution.
Third Trimester:
Highest risk of fetal thyroid effects. Avoid prolonged or extensive use.
Lactation
Use with caution. Iodine can be excreted in breast milk and may affect infant thyroid function. Avoid prolonged or extensive use. Monitor the infant for signs of thyroid dysfunction.
Infant Risk:
Risk level: Moderate (L3). Potential for infant thyroid suppression, especially in premature or low birth weight infants, or if mother uses extensively.
Pediatric Use
Use with caution, especially in neonates and infants, due to their immature thyroid function and higher skin surface area to body weight ratio, which increases the risk of systemic iodine absorption and potential for hypothyroidism. Consult a physician before use in infants under 2 years old.
Geriatric Use
Generally safe for topical use in the elderly. No specific dose adjustments are typically needed. However, caution should be exercised in patients with pre-existing thyroid conditions or renal impairment if extensive or prolonged use is anticipated.
Clinical Information
Clinical Pearls
- Povidone-iodine is effective against a wide range of microorganisms, making it a versatile antiseptic.
- It can cause temporary brown staining of the skin, which typically washes off. Stains on clothing may be permanent.
- Avoid using povidone-iodine with mercury-containing compounds, as this can form corrosive substances.
- Do not use on deep puncture wounds, animal bites, or serious burns without consulting a healthcare professional.
- Prolonged or extensive use, especially on broken skin or mucous membranes, can lead to significant systemic iodine absorption, potentially affecting thyroid function.
- Always allow the solution to dry completely before applying dressings or drapes to ensure full antiseptic effect and prevent irritation.
Alternative Therapies
- Chlorhexidine gluconate (e.g., Hibiclens)
- Isopropyl alcohol
- Hydrogen peroxide
- Benzalkonium chloride
- Topical antibiotics (e.g., bacitracin, neomycin, polymyxin B for wound care)
Cost & Coverage
Average Cost:
$5 - $20 per 14.8ml bottle
Generic Available:
Yes
Insurance Coverage:
Over-the-counter (OTC), generally not covered by insurance unless prescribed.
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.