INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo OKACYN Eye Drops

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

OKACYN Eye Drops

COMPOSITION:
Each 1 mL contains:
Lomefloxacin 3 mg
(used as lomefloxacin hydrochloride 3,31 mg)
Benzalkonium chloride 0,002% m/v
(as preservative).

PHARMACOLOGICAL CLASSIFICATION:
15.1 Ophthalmic preparations with antibiotics.

PHARMACOLOGICAL ACTION:
Lomefloxacin is a diflourinated quinolone. It is bactericidal with a broad spectrum of antibacterial activity. It has in vitro activity against a wide spectrum of gram-positive and gram-negative organisms.
Lomefloxacin acts selectively to inhibit the A-subunit of DNA gyrase in bacterial cells only. Mammalian cells have a similar type II DNA topisomerase that is only inhibited at much higher concentrations (100-1 000 micrograms/mL) and this accounts for Lomefloxacin’s selective toxicity. The A-subunit carries out its strand cutting function by introducing negative coils which prevent the “overwinding” of the DNA strands and allow a segment of DNA to be replicated or transcribed. As a result chromosomal information cannot be transcribed, this cause a break down in bacterial metabolism and eventually kills the bacteria.

INDICATIONS:
Bacterial conjuctivitis due to susceptible organisms.

CONTRA-INDICATIONS:
Hypersensitivity to quinolones, lomefloxacin, or any component of this medication.
Since systemic quinolones have been shown to cause arthropathy in immature animals, it is recommended that Okacyn not be used by pregnant or lactating women.

WARNINGS:
Long term treatment with antibiotics may enhance development of secondary fungal infections or may support growth of non-susceptible bacteria.
Contact lenses should not be worn in the presence of infectious eye diseases and the product should not be instilled while wearing contact lenses.
In order to avoid a reduction in efficacy, no ophthalmic preparations containing heavy metals such as zinc should be used 15 minutes preceding and following instillation of Okacyn.
Bacteriostatic ophthalmic antibiotics should not be used concomitantly.
As the possibility of adverse effects on corneal permeability and the danger of disruption of corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparation cannot be excluded, regular ophthalmological examination is required.
Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.
When 2 or more ophthalmic preparations are used concomitantly, an interval of at least 5 minutes should be observed between instillations, in order to avoid washing out of the drug.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children (above 1 year of age):
At the beginning of therapy on Day 1 instil 5 drops into the conjuctival sac within 20 minutes. Thereafter, until Day 7-9 instil 1 drop 3 times daily into the conjuctival sac.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Mild, transient sensations of burning, irritation or pain may be experienced on instillation.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment : symptomatic and supportive

IDENTIFICATION:
It is a clear, colourless to slightly yellowish, odourless solution, free from visible particulate matter.

PRESENTATION:
A white LDPE bottle with 5 mL fill volume and a LDPE dropper with a white HDPE cap.

STORAGE INSTRUCTIONS:
Store below 25°C.
Keep well closed.
Protect from light.
Keep away from children.
Do not use for more than 30 days after opening.

REGISTRATION NUMBER:
32/15.1/0480

NAME AND BUSINESS ADDRESS OF APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston
Private Bag X69, Bryanston, 2021

Under licence from Novartis Ophthalmics Ltd.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
24/02/2000

New addition to this site: May 2004
Source: Pharmaceutical Industry

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