BETADINE- povidone-iodine solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Rebel Distributors Corp

INN (International Name):

POVIDONE-IODINE

Sammensetning:

IODINE 5 mg in 1 mL

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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). Do not use on individuals known to be sensitive to iodine, or other components of this product. Safety and effectiveness in pediatric patients have not been established. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Produkt oppsummering:

BETADINE® 5% Sterile Ophthalmic Prep Solution is packaged under sterile conditions and supplied in 1 fl.oz. (30 mL) form sealed blue HDPE bottles (NDC #42254-006-30). Store at 15-25°C (59-77°F). Rx Only Single use only         Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134          Manufactured by: Catalent Pharma Solutions, LLC Woodstock, IL 60098 Relabeled by: Rebel Distributors Corp Thousand Oaks, CA 91320        BETADINE® is a registered trademark of The Purdue Frederick Company.         9002984-1007

Autorisasjon status:

New Drug Application

Preparatomtale

BETADINE- POVIDONE-IODINE SOLUTION
REBEL DISTRIBUTORS CORP
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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: 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 per
square cm.
10
10
10
10
10
10
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 the possibility of iodine
absorption.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT O