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Gatifloxacin

Generic Name
Gatifloxacin
Brand Names
Zymar, Zymaxid
Drug Type
Small Molecule
Chemical Formula
C19H22FN3O4
CAS Number
112811-59-3
Unique Ingredient Identifier
81485Y3A9A

Overview

Gatifloxacin is an antibiotic agent and a member of the fourth-generation fluoroquinolone family. It works by inhibiting the bacterial enzymes DNA gyrase and topoisomerase IV. It was first introduced by Bristol-Myers Squibb in 1999 under the brand name Tequin® for the treatment of respiratory tract infections. Gatifloxacin is available as tablets and in various aqueous solutions for intravenous therapy. It is also available as eye drops under the brand name Zymar® marketed by Allergan. The FDA withdrew its approval for the use of non-ophthalmic drug products containing gatifloxacin due to the high prevalence of gatifloxacin-associated dysglycemia adverse event reports and the high incidence of hyperglycemic and hypoglycemic episodes in patients taking gatifloxacin compared to those on macrolide antibiotics.

Background

Gatifloxacin is an antibiotic agent and a member of the fourth-generation fluoroquinolone family. It works by inhibiting the bacterial enzymes DNA gyrase and topoisomerase IV. It was first introduced by Bristol-Myers Squibb in 1999 under the brand name Tequin® for the treatment of respiratory tract infections. Gatifloxacin is available as tablets and in various aqueous solutions for intravenous therapy. It is also available as eye drops under the brand name Zymar® marketed by Allergan. The FDA withdrew its approval for the use of non-ophthalmic drug products containing gatifloxacin due to the high prevalence of gatifloxacin-associated dysglycemia adverse event reports and the high incidence of hyperglycemic and hypoglycemic episodes in patients taking gatifloxacin compared to those on macrolide antibiotics.

Indication

For the treatment of bronchitis, sinusitis, community-acquired pneumonia, and skin infections (abscesses, wounds) caused by S. pneumoniae, H. influenzae, S. aureus, M. pneumoniae, C. pneumoniae, L. pneumophila, S. pyogenes

Associated Conditions

  • Bacterial Conjunctivitis
  • Ocular Infections, Irritations and Inflammations

FDA Approved Products

Gatifloxacin
Manufacturer:Sandoz Inc
Route:OPHTHALMIC
Strength:5 mg in 1 mL
Approved: 2016/04/20
NDC:61314-672
gatifloxacin
Manufacturer:Pacific Pharma, Inc.
Route:OPHTHALMIC
Strength:5 mg in 1 mL
Approved: 2023/01/17
NDC:60758-615
Gatifloxacin
Manufacturer:LUPIN LIMITED
Route:OPHTHALMIC
Strength:5 mg in 1 mL
Approved: 2016/05/09
NDC:57297-435
Gatifloxacin
Manufacturer:Akorn
Route:OPHTHALMIC
Strength:5 mg in 1 mL
Approved: 2022/03/11
NDC:50383-189
ZYMAXID
Manufacturer:Physicians Total Care, Inc.
Route:OPHTHALMIC
Strength:5 mg in 1 mL
Approved: 2012/02/06
NDC:54868-6303

Singapore Approved Products

ZYMAR OPHTHALMIC SOLUTION 0.3%
Manufacturer:ALLERGAN SALES LLC
Form:SOLUTION
Strength:3 mg/ml
Online:Yes
Approved: 2004/11/05
Approval:SIN12612P
CALCIUM GLUCONATE INJECTION USP 10%
Manufacturer:AMERICAN PHARMACEUTICAL PARTNERS INC
Form:INJECTION
Strength:4.5 mg/ml
Online:Yes
Approved: 1995/11/24
Approval:SIN08451P

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