Povidone-iodine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
Povidone-iodine is an antiseptic that is FDA approved for the prophylaxis of surgical handrub, aseptic handwash. Common adverse reactions include contact dermatitis and other dermatological manifestations.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Surgical hand scrub.
- Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
- Antiseptic hand wash.
- For handwashing to help reduce bacteria on the skin.
Admnistration
- Remove jewelry.
- Clean nails with an orangewood stick.
- Wet hands and forearms with water and apply 5 ml of the product.
- Wash/scrub hands and forearms for 5 minutes paying particular attention to nails, cuticles, and interdigital spaces rinse thoroughly with water.
- Wet hands and forearms with water and apply 5 ml of the product.
- Wash hands and forearms for 5 minutes.
- Rinse thoroughly with water.
Antiseptic Handwash
- Wet hands and forearms.
- Dispense a palmful of product to hands.
- Scrub hands and forearms for 20 seconds.
- Rinse thoroughly and dry.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Povidone-iodine in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Povidone-iodine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Povidone-iodine in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Povidone-iodine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Povidone-iodine in pediatric patients.
Contraindications
There is limited information regarding Povidone-iodine Contraindications in the drug label.
Warnings
- For external use only
- Do not use in eyes
- When using this product
if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop
- Stop use and ask a doctor if skin irritation and redness occurs for more than 72 hours.
- Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Povidone-iodine in the drug label.
Postmarketing Experience
Contact dermatitis
Drug Interactions
There is limited information regarding Povidone-iodine Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Povidone-iodine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Povidone-iodine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Povidone-iodine with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Povidone-iodine with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Povidone-iodine with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Povidone-iodine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Povidone-iodine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Povidone-iodine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Povidone-iodine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Povidone-iodine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Povidone-iodine in patients who are immunocompromised.
Administration and Monitoring
Administration
- Topical
Monitoring
There is limited information regarding Monitoring of Povidone-iodine in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Povidone-iodine in the drug label.
Overdosage
There is limited information regarding Povidone-iodine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
| |
Povidone-iodine
| |
| Systematic (IUPAC) name | |
| 2-Pyrrolidinone, 1-ethenyl-, homopolymer, compd. with iodine. | |
| Identifiers | |
| CAS number | |
| ATC code | D08 D09AA09 (WHO) (dressing) D11AC06 (WHO) G01AX11 (WHO) R02AA15 (WHO) S01AX18 (WHO) Template:ATCvet |
| PubChem | |
| Chemical data | |
| Formula | (C6H9NO)n·xI |
| Mol. mass | variable |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
? |
| Legal status | |
| Routes | topical |
Mechanism of Action
There is limited information regarding Povidone-iodine Mechanism of Action in the drug label.
Structure
There is limited information regarding Povidone-iodine Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Povidone-iodine in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Povidone-iodine in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Povidone-iodine in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Povidone-iodine in the drug label.
How Supplied
There is limited information regarding Povidone-iodine How Supplied in the drug label.
Storage
There is limited information regarding Povidone-iodine Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Povidone-iodine in the drug label.
Precautions with Alcohol
- Alcohol-Povidone-iodine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ECOLAB®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ "ECOLAB - povidone-iodine solution".
- ↑ "http://www.ismp.org". External link in
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