Betadine® 5%

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Povidone-Iodine 5% · ophthalmic solution

Misc.

Approved uses

Periocular and ocular surface antisepsis (procedural prep)

Prep lashes and lid margins with saturated sterile applicators, one or more per lid, repeat once; prep lids, brow and cheek with a saturated sterile sponge in an ever-expanding circular pattern, three times; irrigate cornea, conjunctiva and palpebral fornices by bulb syringe, leave 2 minutes, flush with sterile saline.

OFF-LABELNot in the FDA label for this product

Endophthalmitis prophylaxis before intravitreal injection

Topical 5% to the conjunctiva and the intended injection site immediately before injection, as the sole antiseptic; 2.5% or 1.25% dilutions were substituted for iodine-sensitive patients in the cited series.

Guideline · no randomized data

No trial has randomized patients to prep versus no prep. A 2014 expert-panel practice guideline recommends applying it to the intended injection site and found no evidence supporting routine pre-, peri- or postinjection antibiotics. In a single-practice retrospective review of 35,060 injections, endophthalmitis followed 0.04% of injections prepped with 5%, 0.02% of those prepped with dilute solution (2.5% down to 0.625%), and 0.31% of the 319 injections done with none, a single case; the authors' own conclusion was that dilute solution is an effective alternative in sensitive patients. A separate retrospective cohort of 154,198 injections found 5% versus 10% strength was not a significant predictor of endophthalmitis.

Avery RL, Bakri SJ, Blumenkranz MS, et al. Intravitreal injection technique and monitoring: updated guidelines of an expert panel. Retina. 2014;34 Suppl 12:S1-S18 (Practice Guideline per PubMed). Peden MC, Hammer ME, Suner IJ. Dilute povidone-iodine prophylaxis maintains safety while improving patient comfort after intravitreal injections. Retina. 2019;39(11):2219-2224 (retrospective chart review). Stem MS, Rao P, Lee IJ, et al. Predictors of endophthalmitis after intravitreal injection: a multivariable analysis based on injection protocol and povidone iodine strength. Ophthalmol Retina. 2019;3(1):3-7 (retrospective single-center cohort).

Adenoviral conjunctivitis and epidemic keratoconjunctivitis

One-time in-office application per the RAPID protocol: 1 drop proparacaine 0.5%, then 4 to 5 drops of 5% solution; lids closed 2 minutes with the eye rotating in all directions and a gauze pad moistened with the solution dabbed along the lid margins; then generous lavage of the eye and lid margins with non-preserved sterile saline. Non-preserved artificial tears QID afterward.

RCT n=56 · efficacy unproven

Efficacy at this strength is unproven. The randomized trial of one-time in-office 5% enrolled 56 participants (30 treated, 26 artificial tears) and measured safety and tolerability only: corneal fluorescein staining rose from 1.3 to 3.3 immediately after instillation (p = 0.004) and was back to baseline by day 1 (1.6, p = 0.63 versus baseline), visual acuity was unchanged, and the one adverse event was judged unrelated to treatment. A 2023 systematic review and meta-analysis of 5 randomized trials found no change in the probability of clinical resolution during the first week, RR 1.77 (95% CI 0.63 to 4.96) for povidone-iodine alone and RR 1.70 (95% CI 0.67 to 4.36) combined with dexamethasone, and concluded there is great uncertainty about its usefulness; the randomized efficacy signals that do exist used 1.0% or 0.6% formulations given with dexamethasone QID, not one-time 5%.

Shorter E, Whiteside M, Harthan J, et al. Safety and tolerability of a one-time, in-office administration of 5% povidone-iodine in the treatment of adenoviral conjunctivitis: the Reducing Adenoviral Patient Infected Days (RAPID) study. Ocul Surf. 2019;17(4):828-832 (Randomized Controlled Trial per PubMed; safety and tolerability endpoints, described by its authors as a planning trial). Gonzalez Martin-Moro J, Zarallo-Gallardo J, Guzman-Almagro E, Anton Rodriguez C. A systematic review and meta-analysis on the efficacy of topical povidone iodine in adenoviral conjunctivitis. Cont Lens Anterior Eye. 2023;46(5):101873. Diluted combination trials: Kovalyuk N, Kaiserman I, Mimouni M, et al. Acta Ophthalmol. 2017;95(8):e686-e692; Pepose JS, Ahuja A, Liu W, et al. Am J Ophthalmol. 2018;194:7-15 (Phase 2 randomized controlled trial).

Contraindications

Known sensitivity to iodine or to any other component of this product.

Available Forms

Ophthalmic solution, 30 mL (1 fl oz) single-use bottle, 5% povidone-iodine, 0.5% available iodine

Mechanism of Action

Iodophor antiseptic: the polyvinylpyrrolidone complex releases free iodine gradually at the application site, and that free iodine penetrates microbial membranes and reacts with cytoplasmic proteins, nucleotides and fatty acids, killing the organism rapidly. Spectrum is broad, covering gram-positive and gram-negative bacteria, fungi, protozoa, viruses and bacterial spores, with no reported resistance in topical ophthalmic use.

Warnings & Precautions

External use only: Not for intraocular injection and not for intraocular irrigation.
Thyroid disorders: No studies in these patients; iodine absorption is possible, so use with caution.
Anterior chamber entry: Solution that leaks into the anterior chamber can cause endothelial cell death, corneal decompensation with marked edema, and raised IOP.
Non-sterile bottle exterior: The bottle should not be used inside a sterile field.

Common Side Effects

Ocular: Local sensitivity, the only adverse reaction named in the label; no frequency given.
Ocular surface exposure: A transient rise in corneal punctate staining that was back to baseline by day 1 after a single 5% instillation in a randomized trial; stinging and temporary conjunctival and eyelid discoloration are the expected accompanying effects.
Repeated exposure: Reduced conjunctival goblet cell density and conjunctival squamous metaplasia, producing higher tear film osmolality, more severe corneal staining and increased ocular surface symptoms, with severity tracking the duration of ocular exposure.
Persistent epithelial defects: Reported among the complications of use in ophthalmic surgery.

Pregnancy & Lactation

Pregnancy: No animal reproduction studies conducted; whether it causes fetal harm or affects reproductive capacity is unknown; use in pregnancy only if clearly needed.

Lactation: Choose between discontinuing nursing and discontinuing the drug, weighing its importance to the mother, because of the potential for serious adverse reactions in nursing infants.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.