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BETADINE* 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution)(0.5% available iodine) | Betadine [Alcon Laboratories, Inc.] | BioPortfolio

12:30 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

DESCRIPTION

Povidone-Iodine is a broad-spectrum microbicide with the chemical formulas:

2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine. The structural formula is as follows:

BETADINE* 5% Sterile Ophthalmic Prep Solution contains 5% povidone-iodine (0.5% available iodine) as a sterile dark brown solution stabilized by glycerin. Inactive Ingredients: purified water, citric acid, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide, and dibasic sodium phosphate.

CLINICAL PHARMACOLOGY

A placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed a mean log reduction of 3.05 log units in total aerobes at 10 minutes following prepping the skin with BETADINE* 5% Sterile Ophthalmic Prep Solution compared with reduction of 1.58 log units after prepping with vehicle free of the iodine complex. This placebo-controlled study indicates a mean log reduction by the iodine complex compared with the control solution of 1.47 log units at 10 minutes and 1.79 log units at 45 minutes. The base-line mean aerobic bacterial count was 7,586 organisms/cm.

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).

CONTRAINDICATIONS

Do not use on individuals known to be sensitive to iodine, or other components of this product.

WARNINGS

FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.

General

No studies are available in patients with thyroid disorders; therefore, caution is advised in using BETADINE* 5% Sterile Ophthalmic Prep Solution in these patients due to the possibility of iodine absorption.

No long term studies in animals have been performed to evaluate the carcinogenic or mutagenic potential of povidone-iodine. One report of the mutagenic potential of povidone-iodine indicated that it was positive in a modification of the Ames S. typhimurium model, but these results could not be reproduced by another researcher. Another test using mouse lymphoma and Balb/3T3 cells showed that povidone-iodine has no significant mutagenic or transformation capabilities. Other data indicated that it does not produce mutagenic effects in mice or hamsters according to the dominant lethal test, micronucleus test, and chromosome analysis.

Animal reproduction studies have not been conducted with BETADINE* 5% Sterile Ophthalmic Prep Solution. It is also not known whether BETADINE* 5% Sterile Ophthalmic Prep Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BETADINE* 5% Sterile Ophthalmic Prep Solution should only be used on a pregnant woman if clearly needed.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from BETADINE* 5% Sterile Ophthalmic Prep Solution, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.

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:

HOW SUPPLIED

BETADINE* 5% Sterile Ophthalmic Prep Solution is packaged under sterile conditions, and supplied in 1 fl oz (30 mL) form sealed blue HDPE bottles. Twenty-four (24) bottles are packed in each shipper.NDC 0065-0411-30

Store at 15°C to 25°C (59°F-77°F). Rx Only Single-use only

       

Manufactured for:Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134

Manufactured by:Catalent Pharma Solutions, LLCWoodstock, IL 60098

*BETADINE is a registered trademark of Purdue Products L.P.

Revised: June 2018  9008808

       

Principal Display Panel

NDC 0065-0411-30 Betadine* 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution) For Pre-Operative Prep and Irrigation of the Ocular and Periocular Surfaces Flush eye thoroughly with sterile saline solution after each use. Rx Only 1 Fl. Oz. (30 mL) Alcon a Novartis company Indications: For prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices). Contraindications: Do not use on individuals known to be sensitive to iodine or other components of this product. Warning: For external use only.NOT for intraocular injection or irrigation. Read package insert for full use and directions and precautions. Storage: 15°- 25°C (59°- 77°F). ©2014 Novartis Active Ingredient: povidone-iodine 5% (0.5% available iodine). Inactive Ingredients: purified water, citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide. Single use only. Manufactured for: Alcon Laboratories, Inc.Fort Worth, Texas 76134 Manufactured by: Catalent Pharma Solutions, LLCWoodstock, IL 60098 *BETADINE Reg. TM of Purdue Products L.P. Alcon Alcon Laboratories, Inc.6201 South FreewayFort Worth, Texas 76134 9008803-0514

Rx only  NDC 0065-0411-30 Betadine 5% Sterile Ophthalmic Prep Solution(povidone-iodine ophthalmic solution)(0.5% available iodine) 1 fl. oz. (30mL) SINGLE USE ONLY See package insert. Alcon Mfd. forAlcon Laboratories, Inc.Fort Worth, Texas 76134 USA H12639-0514

Manufacturer

Alcon Laboratories, Inc.

Active Ingredients

Source

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Clinical Trials [16 Associated Clinical Trials listed on BioPortfolio]

A Randomised Study to Assess Betadine in the Groin Wound of Patients Undergoing Primary Varicose Vein Surgery

To investigate whether Betadine can reduce infection rates and recurrence rates following varicose veins surgery in a randomized double blind placebo controlled study.

Effect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections

The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or re...

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The primary aim of this pilot study is to generate data needed to design a definitive trial to compare the safety and efficacy of standard care with artificial tears vs. Betadine 5% (5% po...

Betadine Pleurodesis Via Tunneled Pleural Catheters

The purpose of this study is to determine whether betadine (povidone-iodine) instillation during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in promoting pl...

Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery

This is a randomized trial comparing the effectiveness of 4 vaginal prep solutions (betadine, baby shampoo, TechniCare and Peridex) on reducing bacterial colony counts during surgery prepa...

PubMed Articles [1 Associated PubMed Articles listed on BioPortfolio]

Efficacy of Intraoperative Antiseptic Techniques in the Prevention of Periprosthetic Joint Infection: Superiority of Betadine.

Povidone-iodine (PI), chlorhexidine gluconate (CHG), and vancomycin (VANC) powder are common intrawound prophylactic agents to prevent periprosthetic joint infection during primary total joint arthrop...

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