GENTAMICIN SULFATE solution/ drops

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)

Sẵn có từ:

Pacific Pharma, Inc.

Tuyến hành chính:

OPHTHALMIC

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Gentamicin sulfate ophthalmic solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens . Gentamicin sulfate ophthalmic solution, USP is contraindicated in patients with known hypersensitivity to any of its components.

Tóm tắt sản phẩm:

Gentamicin sulfate ophthalmic solution, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle – NDC 60758-188-05 Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above). Revised :   1 0 /201 7 Distributed for: Allergan USA, Inc. Madison, NJ 07940  ©2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. Made in the U.S.A. v1.0USPI188

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
PACIFIC PHARMA, INC.
----------
GENTAMICIN SULFATE
OPHTHALMIC SOLUTION, USP 0.3%
STERILE
DESCRIPTION
Gentamicin sulfate ophthalmic solution, USP is a sterile, topical
anti-infective agent for ophthalmic use.
Gentamicin is obtained from cultures of _Micromonospora purpurea_. It
is a mixture of the sulfate salts of
gentamicin C , C , and C
. All three components appear to have similar antimicrobial
activity. Gentamicin sulfate occurs as a white to buff powder and is
soluble in water and insoluble in
alcohol. The structural formula is as follows:
EACH ML CONTAINS: ACTIVE: gentamicin sulfate equivalent to 3 mg (0.3%)
gentamicin base.
PRESERVATIVE: benzalkonium chloride. INACTIVES: edetate disodium;
polyvinyl alcohol 1.4%; purified
water; sodium chloride; sodium phosphate, dibasic; and hydrochloric
acid and/or sodium hydroxide may
be added to adjust pH. The solution is an aqueous, buffered solution
with a shelf life pH range of 6.5 to
7.5.
CLINICAL PHARMACOLOGY
MICROBIOLOGY
Gentamicin sulfate is active _in vitro_ against many strains of the
following microorganisms:
_Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus
pyogenes, Streptococcus pneumoniae,_
_Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae,
Klebsiella pneumoniae, Neisseria_
_gonorrhoeae, Pseudomonas aeruginosa, _and _Serratia marcescens_.
INDICATIONS AND USAGE
Gentamicin sulfate ophthalmic solution, USP is indicated in the
topical treatment of ocular bacterial
infections including conjunctivitis, keratitis, keratoconjunctivitis,
corneal ulcers, blepharitis,
blepharoconjunctivitis, acute meibomianitis, and dacryocystitis,
caused by susceptible strains of the
following microorganisms: _Staphylococcus aureus, Staphylococcus
epidermidis, Streptococcus pyogenes,_
_Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli,
Haemophilus influenzae, Klebsiella_
_pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa,_ and
_Serratia marcescens_.
CONTRAINDICATIONS
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