OFLOXACIN solution/ drops

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Lifestar Pharma LLC

Ievadīšanas:

OPHTHALMIC

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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) .

Produktu pārskats:

Ofloxacin Ophthalmic Solution, USP 0.3% is supplied sterile in white LDPE plastic bottles and white dropper tips with tan high density poly ethylene (HDPE) caps as follows: 5 mL in 10 mL bottle -NDC 70756-607-30 10 mL in 10 mL bottle- NDC 70756-650-30 Note: Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Rx only Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Product of Spain All trademarks are the property of their respective owners. Revised: June 2023, V-05

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

OFLOXACIN- OFLOXACIN SOLUTION/ DROPS
LIFESTAR PHARMA LLC
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OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%
STERILE
DESCRIPTION
OFLOXACIN OPHTHALMIC SOLUTION USP, 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-7_H_-
pyrido[1,2,3-_de_]-1,4-benzoxazine-6-carboxylic acid.
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, USP 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