Betadine 5% Op Solution
It is used to prepare the eye and areas around the eye for some procedures.
Drug Class
Ophthalmic Antiseptic
Pharmacologic Class
Iodophor; Halogenated Antiseptic
Pregnancy Category
Category C
FDA Approved
Mar 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Povidone-iodine ophthalmic solution is an antiseptic liquid used to clean and disinfect the surface of the eye before eye surgery or other procedures. It helps kill germs like bacteria and viruses to prevent infections.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Use this medication only as directed and follow all instructions precisely. This medication is for ophthalmic use only, meaning it is intended for application in the eye.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.
If you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.
If you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Do not touch the tip of the dropper to your eye or any other surface to avoid contamination.
- Follow your doctor's instructions precisely regarding application and rinsing.
- Do not use if the solution changes color or becomes cloudy.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For pre-operative ocular surface preparation: Instill 1-2 drops into the conjunctival cul-de-sac, allow to remain for 2 minutes, then flush with sterile saline.
Condition-Specific Dosing:
pre_operative_antisepsis:
Instill 1-2 drops into the conjunctival cul-de-sac, allow to remain for 2 minutes, then flush with sterile saline. For irrigation, a 0.25% solution may be used.
Pediatric Dosing
Neonatal:
For ophthalmia neonatorum prophylaxis (off-label use, often 2.5% solution): Instill 1-2 drops into each eye. Not established for routine pre-operative use in neonates.
Infant:
Not established for routine pre-operative use.
Child:
Similar to adult dosing for pre-operative ocular surface preparation, but specific pediatric studies are limited. Use with caution.
Adolescent:
Similar to adult dosing for pre-operative ocular surface preparation.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No specific considerations for ophthalmic use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Pharmacology
Mechanism of Action
Povidone-iodine is a broad-spectrum antiseptic that releases free iodine. Iodine oxidizes microbial cellular components (proteins, nucleotides, fatty acids), leading to rapid inactivation and death of bacteria, viruses, fungi, and protozoa. It disrupts cell membranes and denatures enzymes.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from ophthalmic application.
Tmax:
Not applicable for systemic effects; local action is rapid.
FoodEffect:
Not applicable.
Distribution:
Vd:
Not applicable for systemic effects; primarily local action.
ProteinBinding:
Not applicable for systemic effects; primarily local action.
CnssPenetration:
No (not intended for systemic absorption).
Elimination:
HalfLife:
Not applicable for systemic effects; local action is short-lived.
Clearance:
Not applicable for systemic effects.
ExcretionRoute:
Not applicable for systemic effects; excess topical solution is rinsed away.
Unchanged:
Not applicable for systemic effects.
Pharmacodynamics
OnsetOfAction:
Rapid (within seconds to minutes)
PeakEffect:
Within 2 minutes of application
DurationOfAction:
Short-lived (action ceases upon rinsing or dilution)
Safety & Warnings
Side Effects
Serious 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:
- Eye irritation
- 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.
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:
- Eye irritation
- 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:
- Severe burning or stinging that does not subside quickly
- Increased redness or swelling of the eye
- Itching or rash around the eye
- Any signs of an allergic reaction
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 because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, 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 other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. Always consult with your doctor and pharmacist to confirm that it is safe to take this medication 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 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 because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, 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 other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. Always consult with your doctor and pharmacist to confirm that it is safe to take this medication 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. If you are pregnant, planning to become pregnant, or are breastfeeding, be sure to discuss this with your doctor. This conversation will help you understand the potential benefits and risks of this medication for both you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Severe ocular irritation
- Chemical conjunctivitis
- Corneal damage (unlikely with proper use and rinsing)
What to Do:
Immediately flush the eye with copious amounts of sterile saline or water. If irritation persists, seek immediate medical attention. For systemic overdose (highly unlikely with ophthalmic use), contact a poison control center (e.g., 1-800-222-1222) or emergency services.
Drug Interactions
Major Interactions
- Mercury-containing compounds (e.g., thimerosal): Concurrent use with povidone-iodine can form caustic compounds, leading to severe irritation or chemical burns.
Monitoring
Baseline Monitoring
Ocular surface integrity
Rationale: To assess pre-existing conditions and ensure suitability for application.
Timing: Prior to administration
Allergy history (especially to iodine)
Rationale: To identify potential hypersensitivity reactions.
Timing: Prior to administration
Routine Monitoring
Ocular irritation/redness
Frequency: During and immediately after application
Target: Minimal to none
Action Threshold: Persistent or severe irritation; discontinue use and rinse thoroughly.
Signs of allergic reaction (e.g., swelling, itching)
Frequency: During and immediately after application
Target: None
Action Threshold: Any signs of allergic reaction; discontinue use and seek medical attention.
Symptom Monitoring
- Ocular pain
- Burning sensation
- Stinging
- Redness
- Swelling
- Itching
- Discharge (unusual)
Special Patient Groups
Pregnancy
Povidone-iodine is Pregnancy Category C. While systemic absorption from ophthalmic use is minimal, caution is advised. Use only if the potential benefit justifies the potential risk to the fetus. Consult with an ophthalmologist and obstetrician.
Trimester-Specific Risks:
First Trimester:
Minimal systemic absorption, but theoretical risk of iodine exposure. Use only if clearly needed.
Second Trimester:
Minimal systemic absorption, but theoretical risk of iodine exposure. Use only if clearly needed.
Third Trimester:
Minimal systemic absorption, but theoretical risk of iodine exposure to fetal thyroid. Use only if clearly needed.
Lactation
Povidone-iodine is considered L3 (Moderate Risk) for lactation due to potential for iodine absorption and excretion into breast milk, which could affect infant thyroid function. However, ophthalmic absorption is minimal. Use with caution; monitor infant for signs of thyroid dysfunction if used.
Infant Risk:
Low risk with ophthalmic use due to minimal absorption, but theoretical risk of iodine exposure to infant via breast milk. Monitor infant for signs of thyroid dysfunction.
Pediatric Use
Used in children and adolescents for pre-operative antisepsis, similar to adults. For neonates, a diluted solution (e.g., 2.5%) is sometimes used off-label for ophthalmia neonatorum prophylaxis, but other agents (erythromycin, silver nitrate) are more common. Caution is advised due to potential for systemic iodine absorption in very young infants, which could affect thyroid function.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. Use with caution in patients with pre-existing thyroid conditions, although systemic absorption from ophthalmic use is minimal.
Clinical Information
Clinical Pearls
- Povidone-iodine ophthalmic solution is the only FDA-approved antiseptic for pre-operative ocular surface preparation.
- It has a broad spectrum of activity against bacteria, viruses, fungi, and protozoa, making it highly effective for preventing post-operative infections.
- Transient stinging or burning upon instillation is common but usually resolves quickly.
- Ensure thorough rinsing with sterile saline after the recommended contact time to minimize irritation.
- Avoid contact with mercury-containing instruments or solutions due to the risk of caustic compound formation.
- While generally safe, caution is advised in patients with known iodine allergy or thyroid disorders, though systemic absorption is minimal.
Alternative Therapies
- Chlorhexidine (topical, not typically ophthalmic)
- Topical antibiotics (e.g., erythromycin, bacitracin for prophylaxis, but not broad-spectrum antiseptics)
- Silver nitrate (for ophthalmia neonatorum prophylaxis, but less common now)
Cost & Coverage
Average Cost:
$10 - $50 per 50 mL bottle
Generic Available:
Yes
Insurance Coverage:
Often covered as part of a surgical procedure or hospital supply; may not be a separate pharmacy benefit item for outpatient use.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.