povidone-iodine 50 MG/ML Ophthalmic Solution [Betadine]
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povidone-iodine 50 MG/ML Ophthalmic Solution [Betadine]
50 MG/ML · Ophthalmic Solution · ophthalmic
A form of povidone-iodine →
povidone-iodine 50 MG/ML Ophthalmic Solution [Betadine] — Iodine products. INDICATIONS AND USAGE: BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and…
![povidone-iodine 50 MG/ML Ophthalmic Solution [Betadine]](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4a7a627c-505d-992b-e063-6394a90a54ca&name=mm01.jpg)
Active ingredient
Classification
Iodine productsAntiseptic
Drug interactions
The label outlines several drug interactions associated with Bupivacaine Hydrochloride Injection and corticosteroids.
- majorlocal anesthetics — toxic effects are additive
- majornitrates — increased risk of developing methemoglobinemia
- majornitrites — increased risk of developing methemoglobinemia
- majorantineoplastic agents — increased risk of developing methemoglobinemia
- majorantibiotics — increased risk of developing methemoglobinemia
- majorantimalarials — increased risk of developing methemoglobinemia
- majoranticonvulsants — increased risk of developing methemoglobinemia
- unknownamphotericin B — may lead to hypokalemia when used with corticosteroids
- unknownpotassium-depleting agents — may lead to hypokalemia when used with corticosteroids
- moderatewarfarin — inhibition of response to warfarin
- moderateantidiabetic agents — dosage adjustments may be required due to increased blood glucose concentrations
- moderateisoniazid — serum concentrations may be decreased
- moderateCYP3A4 inhibitors — may cause increased plasma concentration of triamcinolone leading to adverse reactions
- majordigitalis glycosides — increased risk of arrhythmias due to hypokalemia
- moderateestrogens — may decrease hepatic metabolism of certain corticosteroids
- moderatehepatic enzyme inducers — may enhance metabolism of corticosteroids
- moderateNSAIDs — increases the risk of gastrointestinal side effects
- moderatevaccines — may exhibit a diminished response due to inhibition of antibody response
Real-world adverse events (FAERS)
Off Label Use466Endophthalmitis422Drug Hypersensitivity368Toxic Anterior Segment Syndrome282Rash254Drug Ineffective230Nausea222Pain205
Indications
INDICATIONS AND USAGE: BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).
Dosage
DOSAGE AND ADMINISTRATION: While the inner surface and contents of the immediate container (i.e. bottle) are sterile, the outer surface of the bottle is not sterile. The use of the bottle in a sterile field should be avoided. BETADINE* 5% Sterile Ophthalmic Prep Solution is used as follows: BETADINE* 5% Sterile Ophthalmic Prep Solution is used as follows: Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB, do not pull off. Gently pour entire contents of bottle into a sterile prep cup. Saturate sterile cotton-tipped applicator to prep lashes and lid margins using one or more applicators per lid; repeat once. Saturate sterile prep sponge or other suitable material to prep lids, brow and cheek in a circular ever-expanding fashion until the entire field is covered; repeat prep three (3) times. While separating the lids, irrigate the cornea, conjunctiva and palpebral fornices with BETADINE* 5% Sterile Ophthalmic Prep Solution using a sterile bulb syringe. After the BETADINE* 5% Sterile Ophthalmic Prep Solution has been left in contact for two minutes, sterile saline solution in a bulb syringe should be used to flush the residual prep solution from the cornea, conjunctiva, and the palpebral fornices.
Warnings
WARNINGS: FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.
Contraindications
CONTRAINDICATIONS: Do not use on individuals known to be sensitive to iodine, or other components of this product.
Mechanism of action
CLINICAL PHARMACOLOGY: A placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed a mean log10 reduction of 3.05 log10 units in total aerobes at 10 minutes following prepping the skin with BETADINE* 5% Sterile Ophthalmic Prep Solution compared with reduction of 1.58 log10 units after prepping with vehicle free of the iodine complex. This placebo-controlled study indicates a mean log10 reduction by the iodine complex compared with the control solution of 1.47 log10 units at 10 minutes and 1.79 log10 units at 45 minutes. The base-line mean aerobic bacterial count was 7,586 organisms/cm2.
Source: RxNorm + openFDA + RxClass + FAERS · 2026
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