BETADINE- povidone-iodine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)

Available from:

Alcon Laboratories, Inc.

INN (International Name):

POVIDONE-IODINE

Composition:

IODINE 5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

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

Product summary:

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 @2021 Alcon Inc. Alcon Manufactured for: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 Manufactured by: Woodstock Sterile Solutions, Inc. Woodstock, IL 60098 *BETADINE is a registered trademark of Purdue Products L.P. STW-AC6024-642R01        

Authorization status:

New Drug Application

Summary of Product characteristics

BETADINE- POVIDONE-IODINE SOLUTION
ALCON LABORATORIES, INC.
----------
BETADINE* 5%
STERILE OPHTHALMIC
PREP SOLUTION
(POVIDONE-IODINE OPHTHALMIC SOLUTION)
(0.5% AVAILABLE IODINE)
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 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.
INDICATIONS AND USAGE: BETADINE* 5% Sterile Ophthalmic Prep Solution
for the
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.
PRECAUTIONS:
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