Povidone-Iodine is a topical broad-spectrum germicidal agent. It is an iodophor which consists of iodine complexed with a solubilizing agent or carrier such as polyvinylpyrrolidone (povidone). The spectrum of activity of povidone-iodine is the same as elemental iodine which includes bacteria, fungi, viruses, protozoa, and spores. Just as with elemental iodine, resistance to povidone-iodine is usually not observed with most organisms. Clinical applications for povidone-iodine include burn treatment adjunct, cleansing open wounds, operative wound infection antisepsis, and skin preparation prior to surgery. Compared to elemental iodine, povidone-iodine, as well as other iodophors, causes less pain when applied to wounds and abrasions. Povidone-iodine was FDA approved in December 1986.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-Povidone-iodine is for external use only. Do not apply over large areas of the body.
-Do not ingest topical solution or ointments or gels or apply to eyes.
Cream/Ointment/Lotion Formulations
-Clean affected area.
-Apply small amount topically to affected area 1 to 3 times daily.
-May cover with sterile bandage.
-Do not use for longer than 1 week.
Other Topical Formulations
Topical Solution
First aid antiseptic:
-Clean affected area.
-Apply small amount topically to affected area 1 to 3 times daily.
-May cover with sterile bandage. Let solution dry prior to covering with bandage.
-Do not use for longer than 1 week.
Skin preparation prior to surgery:
-Clean affected area.
-Apply topically to the operative site prior to surgery.
Surgical hand scrub:
-Clean under nails with nail pick. Maintain nails with 1 mm free edge.
-Wet hands and forearms.
-Apply palmful (approximately 5 mL) to hands and forearms.
-Scrub thoroughly. Ensure nails, cuticles, and interdigital spaces are properly scrubbed.
-Rinse and repeat scrub.
Topical Swab
Skin preparation prior to surgery:
-Open package and remove bottle and swabs
-Clean affected area.
-Dip 1 swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
-Scrub prep site for 2 minutes, working from clean to dirty using both sides of the swab.
-Repeat using a second swab
-Allow prep solution to dry. Do not blot.
Nasal preparation prior to surgery:
-Use a tissue to clean the inside of both nostrils including the inside tip of the nostril and discard tissue.
-Tilting the bottle slightly, dip 1 swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
-Insert swab comfortably into 1 nostril and rotate for 15 seconds, covering all surfaces. Then focus on the inside tip of the nostril and rotate for an additional 15 seconds.
-Using a new swab: Repeat steps with the other nostril.
-Repeat the application in both nostrils, using a fresh swab each time.
-Do not blow nose. If solution drips out of the nose, it can be lightly dabbed at with a tissue.
Ophthalmic Administration
NOTE: The outer surface of the ophthalmic prep solution bottle is not sterile and should not enter a sterile field. The contents of the bottle are sterile.
-NOTE: For prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices). NOT for intraocular injection or irrigation.
-Open the bottle by completely twisting off the tab; do not pull. Empty the entire contents of the bottle into a sterile prep cup.
-Saturate a sterile cotton-tipped applicator and apply solution to lashes and lid margin. Use at least one applicator per lid; repeat once.
-Saturate a sterile prep sponge and apply solution to lids, brow, and cheek in a circular ever-expanding motion until entire field is covered; repeat prep three times.
-Irrigate cornea, conjunctiva, and palpebral fornices by separating the lids and applying solution using a sterile bulb syringe.
-After the solution has remained in contact for two minutes, use sterile saline in a bulb syringe to flush residual prep from the cornea, conjunctiva, and palpebral fornices.
Other Administration Route(s)
Intranasal Administration*
-For daily use, apply a small amount of 10% solution in each nostril.
-For use prior to surgery, apply a small amount of 5% solution in each nostril for 30 seconds.
According to the manufacturer, use of povidone-iodine ophthalmic solution has been associated with reports of ocular irritation. Use care in product selection to avoid unintended adverse effects; topical povidone-iodine products are not approved for ophthalmic administration and should not come into contact with the eyes.
Local adverse reactions, such as erythema and skin irritation, may infrequently develop following administration of povidone-iodine. Allergic reactions may be local or systemic, and either immediate or delayed in nature. Delayed reactions have been reported hours after application. Allergic reactions reported include urticaria, vulvar edema, angioedema, and anaphylactoid reactions.
Patients receiving treatment with topical or vaginal povidone-iodine are at risk for excessive iodine absorption. Patients at risk for systemic exposure include those patients with burns, receiving prolonged administration (e.g., continuous irrigations or prolonged wound care), or those using products improperly (e.g., gargling or rectal use). Once in the systemic circulation, iodine blocks the production and release of thyroid hormones; in susceptible individuals this may result in transient hypothyroidism. If exposure to iodine is prolonged, the inhibitory effects are overcome by decreasing the active transfer of iodine into the thyroid gland. Some neonates born to mothers exposed to povidone-iodine during obstetric delivery have experienced shifts in thyroid hormone levels, TSH and have developed transient hypothyroidism after delivery or following breast-feeding that have been attributed to iodine systemic exposure. Some patients may experience hyperthyroidism following exposure to large doses of iodine or following improper use of topical or vaginal products.
Povidone-iodine products are only approved for topical administration to the skin and eyes. If ingested orally or used topically in situations that may result in significant systemic absorption (e.g., burns, deep wounds, used for prolonged periods or used improperly), severe adverse events resulting from the iodine component may occur. Symptoms associated with systemic iodine exposure include metabolic acidosis, nausea, vomiting, diarrhea, gastroenteritis, hypotension, sinus tachycardia, and cyanosis. Acute renal failure (unspecified) and renal failure due to presumed renal tubular necrosis from iodine exposure have been reported with the use of povidone iodine preparations; these rare cases primarily have occurred after continuous irrigation to deeper wounds or mucosal administration of the agent.
Povidone-iodine is composed of iodine bound to a water soluble polymer. Patients with a sensitivity to any of the product components, including those individuals with a known iodine hypersensitivity, should not receive treatment with povidone-iodine.
Use of povidone-iodine solutions may rarely result in significant iodine absorption, particularly with prolonged use ; therefore, depending on the circumstances of use and route of administration, caution is advised when administering povidone-iodine to patients with thyroid disease.
Take measures to ensure povidone-iodine topical products do not come into contact with the eyes. If ocular exposure occurs, rinse eyes thoroughly with water. When preparing the field for ophthalmic surgery, only specialized povidone-iodine preparations should be used.
Povidone-iodine is indicated for prevention of infection in patients with minor burns, cuts, and scrapes. Instruct patients to seek the advice of their doctor or health care professional prior to administering povidone-iodine to deep puncture wounds, animal bites, or serious burns. For example, the administration of povidone-iodine topical solution irrigation into deep wounds via continuous irrigation (e.g., for mediastinitis) has resulted in case reports of worsening renal impairment presumably due to systemic iodine exposure.
Safety and efficacy of the non-prescription use of povidone-iodine products have not been established in infants or children. Use in the pediatric population should be under the prescription of a qualified health care professional; newborn exposure is typically not recommended for umbilical care due to the possibility of inducing hypothyroidism from iodine absorption. Store out of the reach of children.
Povidone-iodine topical and vaginal products are classified as FDA pregnancy risk category D; the ophthalmic solution is classified as FDA pregnancy risk category C. Studies have demonstrated significant iodine absorption in both the mother and fetus when povidone-iodine topical and vaginal products were used before labor and obstetric delivery; including application to the abdominal wall prior to caesarean section or prior to episiotomy; some of the neonates in these studies experienced transient hypothyroidism. It is not known if administration of the ophthalmic preparation to a pregnant woman can cause fetal harm or affect the reproductive system. Povidone-iodine should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus; non-prescription use should be avoided.
According to the manufacturer, a decision should be made to discontinue nursing or discontinue povidone-iodine, taking into account the importance of the drug to the mother. Topical use of povidone-iodine immediately prior to delivery has resulted in iodine overload in breast-feeding infants in the postpartum period, and may lead to transient hypothyroidism. Chlorhexidine has been proposed as an alternative agent when perinatal application has been needed. Benzalkonium chloride is not expected to cause adverse effects in breast-feeding infants and may also be an alternative for perinatal use; use during obstetrics and gynecology is common and systemic exposure is minimal. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to the maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Candida albicans, Gardnerella vaginalis, Trichomonas vaginalis
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
For the prevention of infection in minor burns and skin abrasion (cuts and scraps):
Topical dosage:
Adults: Apply a small amount topically to affected area 1 to 3 times daily. May cover with sterile bandage. If using the topical solution, allow solution to dry before applying bandage. Product is not indicated for deep puncture wounds, animal bites, serious burns, or treatment beyond 1 week.
Neonates, Infants, Children, and Adolescents: Safety and efficacy have not been established.
For surgical infection prophylaxis:
-for use as an antiseptic prior to surgery:
Topical dosage (solution and cleanser):
Adults: Apply topically to sterile operative site before surgery as directed by the specific product.
Ophthalmic dosage:
Adults: Before surgery, apply ophthalmic solution to eye lashes and lid margins using one or more sterile cotton-tipped applicators per lid; repeat process once. After preparing lashes and lid margins, apply solution using a sterile prep sponge to eye lids, brows, and cheeks in a circular ever-expanding motion. Ensure the entire field is covered; repeat preparation process 3 times. Next, using a sterile bulb syringe, irrigate the cornea, conjunctiva, and palpebral fornices with the ophthalmic solution. Allow the solution to remain in contact for 2 minutes. After 2 minutes flush the residue ophthalmic solution from the eye using sterile saline apply via a bulb syringe.
-for use as an antiseptic hand scrub prior to surgery:
Topical dosage (solution and cleanser):
Adults: Before application of solution or cleanser, clean under nails using nail pick. Wet hands and forearms. Apply a palmful (approximately 5 mL) to hands and forearms. Scrub thoroughly ensuring nails, cuticles, and interdigital spaces are properly scrubbed. Rinse and repeat scrubbing process.
For methicillin-resistant S. aureus decolonization* using methicillin-resistant S. aureus nasal carriage eradication* to reduce the risk of infection among high-risk persons:
-for methicillin-resistant S. aureus decolonization* using methicillin-resistant S. aureus nasal carriage eradication* to reduce the risk of infection among high-risk inpatients:
Intranasal dosage (10% solution):
Adults: Apply a small amount in each nostril twice daily for 5 days. Consider using in combination with daily chlorhexidine baths.
-for preoperative methicillin-resistant S. aureus decolonization* using methicillin-resistant S. aureus nasal carriage eradication* to prevent postoperative infections:
Intranasal dosage (5% solution):
Adults: Apply a small amount in each nostril over 30 seconds twice (for 2 applications) within 2 hours before surgery. Consider using in combination with chlorhexidine baths.
Maximum Dosage Limits:
-Adults
1 application prior to surgery for ophthalmic prep solution; 3 applications/day for up to 7 days for topical products.
-Geriatric
1 application prior to surgery for ophthalmic prep solution; 3 applications/day for up to 7 days for topical products.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments are not available; it appears no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed when labeled directions of products are followed. Use caution when using off-label techniques, such as continuous topical solution irrigation techniques (e.g., mediastinal irrigation), as cases of worsening renal impairment has been reported in the literature, presumably due to iodine exposure systemically.
*non-FDA-approved indication
Benzalkonium Chloride: (Moderate) The use of iodine (iodine; potassium iodide, KI or povidone-iodine) with benzalkonium chloride aqueous solutions may be incompatible.
Benzalkonium Chloride; Benzocaine: (Moderate) The use of iodine (iodine; potassium iodide, KI or povidone-iodine) with benzalkonium chloride aqueous solutions may be incompatible.
Bupivacaine Liposomal: (Moderate) Bupivacaine liposomal should not come into contact with topical antiseptics (e.g., povidone-iodine). If a topical antiseptic is applied to the surgical site, allow the site to dry completely before administering bupivacaine liposomal.
Bupivacaine: (Moderate) Bupivacaine liposomal should not come into contact with topical antiseptics (e.g., povidone-iodine). If a topical antiseptic is applied to the surgical site, allow the site to dry completely before administering bupivacaine liposomal.
Bupivacaine; Epinephrine: (Moderate) Bupivacaine liposomal should not come into contact with topical antiseptics (e.g., povidone-iodine). If a topical antiseptic is applied to the surgical site, allow the site to dry completely before administering bupivacaine liposomal.
Bupivacaine; Lidocaine: (Moderate) Bupivacaine liposomal should not come into contact with topical antiseptics (e.g., povidone-iodine). If a topical antiseptic is applied to the surgical site, allow the site to dry completely before administering bupivacaine liposomal.
Bupivacaine; Meloxicam: (Moderate) Bupivacaine liposomal should not come into contact with topical antiseptics (e.g., povidone-iodine). If a topical antiseptic is applied to the surgical site, allow the site to dry completely before administering bupivacaine liposomal.
Collagenase: (Contraindicated) Collagenase can interact with other topically-applied medication products. Povidone-iodine inactivates collagenase and concurrent use should be avoided.
Fibrin Sealant, Human: (Moderate) If povidone-iodine has been used to clean the wound area, thoroughly rinse and dry prior to application of fibrin sealant. The sealer protein and thrombin solutions of Artiss, TachoSil, and Tisseel can be denatured by povidone-iodine.
Povidone-iodine is a combination of iodine and a water soluble polymer known as polyvinylpyrrolidone. The antimicrobial action of povidone-iodine occurs after iodine disassociates from the complex. Once in the free form, iodine rapidly penetrates microbial cell membranes and interacts with proteins, nucleotides, and fatty acids in the cytoplasm and cytoplasmic membrane. This interaction ultimately results in rapid cell death. Povidone-iodine has a wide antimicrobial spectrum with activity against gram-positive and gram-negative bacteria, fungi, protozoa, tubercle bacilli, viruses, and bacterial spores. Data show that povidone-iodine is bactericidal, fungicidal, and virucidal.
Povidone-iodine products are administered topically to the skin and via the ophthalmic route to the eyes. No specific data regarding pharmacokinetics of povidone-iodine are available.