Povidone-iodine

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Povidone-iodine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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 (FDA): C

  • Pregnancy Category


Pregnancy Category (AUS):

  • 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

Povidon-Iod.png
Povidone-iodine
Systematic (IUPAC) name
2-Pyrrolidinone, 1-ethenyl-, homopolymer, compd. with iodine.
Identifiers
CAS number 25655-41-8
ATC code D08AG02 D09AA09 (WHO) (dressing) D11AC06 (WHO) G01AX11 (WHO) R02AA15 (WHO) S01AX18 (WHO) Template:ATCvet
PubChem 410087
Chemical data
Formula (C6H9NO)n·xI
Mol. mass variable
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status

OTC(US)

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

Package and Label Display Panel

Iodine.jpg
This image of the FDA label is provided by the National Library of Medicine.
DailyMed - ECOLAB - povidone-iodine solution .png
This image of the FDA label is provided by the National Library of Medicine.

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

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. "ECOLAB - povidone-iodine solution".
  2. "http://www.ismp.org". External link in |title= (help)

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