OFLOXACIN solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OFLOXACIN (UNII: A4P49JAZ9H) (OFLOXACIN - UNII:A4P49JAZ9H)

Available from:

Rising Pharma Holdings, Inc.

INN (International Name):

OFLOXACIN

Composition:

OFLOXACIN 3 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: * Efficacy for this organism was studied in fewer than 10 infections Ofloxacin Ophthalmic Solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication (see Warnings).

Product summary:

Ofloxacin Ophthalmic Solution 0.3% is supplied sterile in a labeled translucent LDPE bottle with insert cap assembly comprising of tan colored HDPE screw cap over a LDPE nozzle with tamper-evident LDPE dust cover sealing the bottle cap. 5 mL in 5 mL bottle NDC 64980-515-05 10 mL in 10 mL bottle NDC 64980-515-01 Note: Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Rx Only Manufactured By: FDC Limited, B-8, MIDC Industrial Area, Waluj, Aurangabad - 431 136, Maharashtra, India Toll free number: 1-800-521-5340 Distributed by: Rising Pharmaceuticals, Inc. East Brunswick, NJ 08816 Revised: 03/2022 INSTRUCTIONS FOR USE Please follow these instructions carefully when using Ofloxacin Ophthalmic Solution. Use Ofloxacin ophthalmic solution as prescribed by your doctor. 1.      If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after the use of Ofloxacin ophthalmic solution. 2.      Wash hands before each use. 3.      Before using the medication for the first time, be sure the dust cover seal is unbroken. 4.      Refer (I-VI) Image Image Image Image Image Image 5.      OPHTHALMIC MEDICATIONS, IF HANDLED IMPROPERLY, CAN BECOME CONTAMINATED BY COMMON BACTERIA KNOWN TO CAUSE EYE INFECTIONS. SERIOUS DAMAGE TO THE EYE AND SUBSEQUENT LOSS OF VISION MAY RESULT FROM USING CONTAMINATED OPHTHALMIC MEDICATIONS. IF YOU THINK YOUR MEDICATION MAY BE CONTAMINATED, OR IF YOU DEVELOP AN EYE INFECTION, CONTACT YOUR DOCTOR IMMEDIATELY CONCERNING CONTINUED USE OF THIS BOTTLE. 6.      Repeat (V) and (VI) with the other eye if instructed to do by your doctor. 7.      The insert tip is designed to provide a premeasured drop; therefore, do NOT enlarge the hole of the insert tip. 8.      After you have used all doses, there will be some Ofloxacin Ophthalmic Solution left in the bottle. You should not be concerned since an extra amount of Ofloxacin Ophthalmic Solution has been added and you will get the full amount of Ofloxacin Ophthalmic Solution that your doctor prescribed. Do not attempt to remove excess medicine from the bottle. WARNING: KEEP OUT OF REACH OF CHILDREN. IF YOU HAVE ANY QUESTIONS ABOUT THE USE OF OFLOXACIN OPHTHALMIC SOLUTION, PLEASE CONSULT YOUR DOCTOR.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OFLOXACIN - OFLOXACIN SOLUTION
RISING PHARMA HOLDINGS, INC.
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OFLOXACIN OPHTHALMIC SOLUTION USP 0.3%
DESCRIPTION
Ofloxacin ophthalmic solution 0.3% is a sterile ophthalmic solution.
It is a fluorinated
carboxyquinolone anti-infective for topical ophthalmic use.
CHEMICAL NAME:
(±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-
oxo-_7H_ pyrido [1,2,3-_de_]-1,4 benzoxazine-6-carboxylic acid.
IMAGE
CONTAINS: ACTIVE: ofloxacin 0.3% (3 mg/mL)
PRESERVATIVE: benzalkonium chloride (0.005%)
INACTIVES: sodium chloride and water for injection. May also contain
hydrochloric acid
and/or sodium hydroxide to adjust pH.
Ofloxacin ophthalmic solution is unbuffered and formulated with a pH
of 6.4 (range 6.0
to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a
fluorinated 4-quinolone
which differs from other fluorinated 4-quinolones in that there is a
six member
(pyridobenzoxazine) ring from positions 1 to 8 of the basic ring
structure.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS:
Serum, urine and tear concentrations of ofloxacin were measured in 30
healthy women
at various time points during a ten-day course of treatment with
ofloxacin ophthalmic
solution. The mean serum ofloxacin concentration ranged from 0.4 ng/mL
to 1.9 ng/mL.
Maximum ofloxacin concentration increased from 1.1 ng/mL on day one to
1.9 ng/mL
on day 11 after QID dosing for 10 1/2 days. Maximum serum ofloxacin
concentrations
after ten days of topical ophthalmic dosing were more than 1000 times
lower than those
reported after standard oral doses of ofloxacin.
Tear ofloxacin concentrations ranged from 5.7 to 31 mcg/g during the
40 minute period
following the last dose on day 11. Mean tear concentration measured
four hours after
topical ophthalmic dosing was 9.2 mcg/g.
Corneal tissue concentrations of 4.4 mcg/mL were observed four hours
after beginning
topical ocular application of two drops of ofloxacin ophthalmic
solution every 30
minutes. Ofloxacin was excreted in the urine primarily unmodified.
MICROBIOLOGY:
Ofloxacin has _in vitro_ activ