ZYMAR 0.3% w/v Ophthalmic solution (2019)
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Περιεχόμενα
Name of the medicinal product
ZYMAR.
Indications and clinical use
ZYMAR (gatifloxacin ophthalmic solution 0.3%) is indicated for the treatment of patients 1 year of age and older with bacterial conjunctivitis caused by susceptible strains of the following bacteria: ...
Contraindications
ZYMAR is contraindicated in individuals who have shown hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication. (See DOSAGE FORMS, STRENGTH AND COMPOSITION). ...
Warnings and precautions
General NOT FOR INJECTION INTO THE EYE. FOR TOPICAL OPHTHALMIC USE ONLY. ZYMAR should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. ZYMAR ...
Adverse reactions
7.1 Adverse Reaction Overview In clinical studies 364 patients were treated with ZYMAR for up to 5 days. Treatment-related adverse events were reported for 14.6% (53/364) of patients. The most frequently ...
Drug interactions
8.1 Overview Specific drug interaction studies have not been conducted with ZYMAR ophthalmic solution. Limited information is available on the concurrent use of ZYMAR with other ophthalmic products. 8.2 ...
Dosage and administration
3.1 Recommended Dose and Dosage Adjustment The recommended dosage regimen for ZYMAR in the treatment of patients 1 year of age and older with bacterial conjunctivitis is: <u>Days 1 and 2:</u> Instill one ...
Overdosage
For management of a suspected drug overdose, including accidental ingestion, contact your regional Poison Control Centre. A topical overdosage of ZYMAR is considered to be a remote possibility. Discontinue ...
Action and clinical pharmacology
9.1 Mechanism of Action ZYMAR is a sterile solution for topical ophthalmic use. Gatifloxacin is an 8-methoxy synthetic fluoroquinolone antibacterial agent with in vitro activity against gram-negative and ...
Storage and stability
ZYMAR should be stored at 15°C to 25°C. Protect from freezing. Keep bottle tightly closed in the outer carton (to protect from light) and discard 28 days after opening. Keep out of the reach and sight ...
Dosage forms, composition and packaging
ZYMAR is supplied sterile in a white, low density polyethylene bottle with a controlled dropper tip and a tan, high density polyethylene (HIPS) cap. ZYMAR is supplied in 1.0 mL, 2.5 mL and 5.0 mL sizes. ...
Pharmaceutical information
Drug Substance <u>Common name:</u> gatifloxacin <u>Chemical name:</u> (±)-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1- piperazinyl)-4-oxo-3-quinolinecarboxylic acid sesquihydrate <u>Structural ...
Detailed pharmacology
Preclinical Pharmacology Pharmacokinetics Ocular Administration The table below summarizes the single- and multiple-dose pharmacokinetic studies conducted to study the ocular absorption, distribution, ...
Microbiology
Gatifloxacin has <em>in vitro</em> activity against a wide range of gram-negative and gram-positive aerobic and anaerobic microorganisms. Gatifloxacin also has <em>in vitro</em> activity against clinically ...
Toxicology
Topical, Ocular Administration Subacute and Chronic Toxicity Gatifloxacin ophthalmic solution was evaluated in repeat dose ocular toxicity studies in rabbits and dogs, up to 1 month and 3 months in duration, ...
Marketing authorization holder
Allergan Inc., Markham, Ontario, L6G 0B5
Submission control number
224198
Date of approval
Date of Preparation: August 24, 2004
Date of revision
June 25, 2019
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