Betadine Prep

Antiseptics and Disinfectants, Excluding Hand Products
Ocular Antiseptics

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.

Clean affected area.
Apply small amount topically to affected area 1—3 times daily.
May cover with sterile bandage.
Do not use for longer than 1 week.

Topical Solution
First aid antiseptic:
Clean affected area.
Apply small amount topically to affected area 1—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.

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.

angioedema / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
cyanosis / Early / Incidence not known
renal failure (unspecified) / Delayed / Incidence not known
renal tubular necrosis / Delayed / Incidence not known

erythema / Early / 1.0-10.0
hyperthyroidism / Delayed / 0-1.0
hypothyroidism / Delayed / 0-1.0
hypotension / Rapid / Incidence not known
sinus tachycardia / Rapid / Incidence not known
metabolic acidosis / Delayed / Incidence not known

ocular irritation / Rapid / 1.0-10.0
skin irritation / Early / 1.0-10.0
urticaria / Rapid / Incidence not known
vomiting / Early / Incidence not known
diarrhea / Early / Incidence not known
nausea / Early / Incidence not known

Betadine, Betadine Prep, First Aid, GRx Dyne, GRx Dyne Scrub, Povidex, Povidex Peri

OTC, Rx

Topical broad-spectrum germicidal agent.
Spectrum of activity includes bacteria, fungi, viruses, protozoa, and spores.
Uses include skin preparation before surgery, and infection prophylaxis in minor burns, cuts, scraps.

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.

Apply topically to sterile operative site before surgery as directed by the specific product.

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.

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.

Specific guidelines for dosage adjustments are not available; it appears no dosage adjustments are needed.

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.

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.

Betadine Prep Ophthalmic Sol: 5%
Betadine Topical Aer: 5%
Betadine/GRx Dyne/GRx Dyne Scrub/Povidex/Povidex Peri/Povidone-Iodine Topical Sol: 7.5%, 10%
First Aid/Povidone-Iodine Topical Ointment: 10%

1 application prior to surgery for ophthalmic prep solution; 3 applications/day for up to 7 days for topical products.

1 application prior to surgery for ophthalmic prep solution; 3 applications/day for up to 7 days for topical products.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

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.

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.