Each 1 mL contains: Active Ingredient: Norfloxacin 3.0 mg.
Chemical name: 1-ethyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.
Molecular formula: C16H18FN3O3.
Molecular weight: 319.34.
White to pale yellow crystalline powder, odorless and bitter.
Freely soluble in glacial acetic acid, sparingly soluble in dichloromethane, very slightly soluble in methanol and in ethanol and practically insoluble in water and in ether.
It dissolves in dilute hydrochloric acid and sodium hydroxide TS.
It is discolored by light and is hygroscopic.
Melting point: 220-224°C.
Osmotic Pressure ratio: Approx. 1.
Identification code: pH 005.
Excipient/Inactive Ingredient: Disodium edetate.
Pharmacology: Norfloxacin has activity against a broad spectrum of gram-positive and gram-negative bacteria. It acts bactericidal by inhibiting the reproduction of DNA.
Resistance to norfloxacin is a rare occurrence, and norfloxacin, in ophthalmological field, stays long at conjunctival sac. Norfloxacin has great effect on ophthalmological infection.
The following infections caused by Staphylococcus sp., Streptococcus sp., Streptococcus pneumoniae, Enterococcus sp., Corynebacterium sp., Micrococcus sp., Serratia sp., Branhamella catarrhalis, Klebsiella sp., Enterobacter sp., Proteus sp., Pseudomonas sp., Pseudomonas aeruginosa, Flavobacterium sp., Haemophillus sp., [H. influenzae, H. aegyptius (Koch-weeks bacillus)], Moraxella sp., Acinetobacter sp., and Alcaligenes sp.
Susceptible to norfloxacin: Blepharitis, hordeolum, dacryocystitis, conjunctivitis, tarsadenitis, keratitis, corneal ulcer and postoperative infection.
Instill 1 drop a time, 3 times per day.
The dosage may be adjusted according to symptoms.
Precautions related to Dosage & Administration: As a general rule, the duration of treatment with this drug should be limited to a minimum required for the treatment of diseases, after the susceptibility being confirmed, in order to avoid possible occurrence of resistant bacteria.
Do not administer MITATONIN Ophthalmic Solution to the following patients: Patients with a history of hypersensitivity to norfloxacin or the quinolone group of antibacterial agents.
General Caution: Avoid long-term use.
Caution in Use: Route of administration: Ophthalmic use only.
Store MITATONIN Ophthalmic Solution in a light resistant container at room temperature.
Avoid storage of MITATONIN Ophthalmic Solution at low temperature for long term.
S01AE02 - norfloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
Ophth soln (bottle) 0.3% (colorless, clear) x 5 mL.