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

Logo OCTIN (ophthalmic drops)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

OCTIN (ophthalmic drops)

COMPOSITION:
Each 5 mL contains
ofloxacin 15 mg (0.3% w/v).
Preservative:
Benzalkonium chloride 0.01% w/v

PHARMACOLOGICAL CLASSIFICATION:
A.15.1 Ophthalmic preparations with antibiotics and/or sulphonamides.

PHARMACOLOGICAL ACTION:
Ofloxacin is a fluorinated 4-quinolone antibacterial agent, and its antibactericidal action results from interference with the enzyme, DNA gyrase, which is needed for the synthesis of bacterial DNA. Vital information needed from the bacterial chromosomes cannot be transcribed, causing the breakdown of bacterial metabolism. Replicating and non-replicating stages of bacterial growth are affected by the bactericidal effect of ofloxacin and a broad spectrum of antibacterial activity is demonstrated. Studies have shown that 90% of most susceptible bacteria are eliminated within 4 hours and an inhibitory effect maintained on the cell growth for 6 - 8 hours after drug removal.
Ofloxacin has been shown to be effective against the following:
Gram-positive Cocci:
Micrococcus spp.        
Streptococcus spp., including - Streptococcus pneumoniae
        - Streptococcus viridans
        - ß-haemolytic Streptococcus
Staphylococcus spp., including - Staphylococcus aureus
        - Staphylococcus epidermidis

Gram-Negative Bacilli:
Pseudomonas spp., including - Pseudomonas aeruginosa
        - Pseudomonas cepacia
        - Pseudomonas fluorescens
Haemophilus influenzae
Serratia marcescens
Proteus spp., including - Proteus mirabilis
Morganella morganii
Enterobacter cloacae
Haemophilus aegyptius
(Koch-Weeks bacillus)
Acinetobacter calcoaceticus spp., including - Acinetobacter c . var. anitratus
        - Acinetobacter c . var. lwoffii
Klebsiella pneumoniae
Moraxella spp., including - Moraxella lacunata (Morax-Axenfeld bacillus)

Gram-Positive Bacilli:
Bacillus spp.
Corynebacterium spp.

Anaerobic Species:
Propionibacterium acnes
Ofloxacin has also been shown to have in vitro activity against most strains of the following organisms, but the clinical significance in ophthalmic infections is not known:

Gram-Positive Aerobes:
Streptococcus mitis
Staphylococcus spp., including - S. capitis
        - S. hominis
        - S. simulans
Listeria monocytogenes
Enterococcus faecalis

Gram-Negative Aerobes:
Shigella sonnei
Pseudomonas acidovorans
Neisseria gonorrhoeae
Moraxella catarrhalis
Klebsiella oxytoca
Haemophilus parainfluenzae
Escherichia coli
Enterobacter spp., including - E. aerogenes
        - E. agglomerans
Citrobacter spp., including - C. diversus
        - C. freundii

Other:
Chlamydia trachomatis

Pharmacokinetics (for ocular administration):
Extremely low serum levels of ofloxacin was detected after ocular administration.
Ofloxacin is eliminated mainly by the kidneys.

INDICATIONS:
For the treatment of conjunctivitis and corneal ulcers, caused by susceptible organisms.

CONTRA-INDICATIONS:
Hypersensitivity to fluoroquinolones or their derivatives.
Ofloxacin should not be used while wearing soft contact lenses.
Ofloxacin should not be used during pregnancy and lactation, since systemic quinolones have been shown to cause arthropathy in immature animals.
Safety and efficacy in infants under one year have not been established.

WARNINGS:
As the possibility of adverse effects on the corneal permeability and the subsequent danger of disruption of the corneal epithelium cannot be excluded with longterm or repeated use of benzalkonium chloride preserved ophthalmological preparations, regular ophthalmological examination is required in these instances.
Caution should be exercised when benzalkonium chloride preserved ophthalmic medication is used over a prolonged period in patients with extensive ocular surface disease.

DOSAGE AND DIRECTIONS FOR USE:
Do not touch the applicator tip to any surface (including the eye).
Keep the eyes closed for 1 - 2 minutes after application.
OCTIN should be used for the complete treatment period.
Treatment should not exceed 10 days.
Conjunctivitis:
Day 1 and 2 : 1 drop every 2 - 4 hours.
Day 3 - 5 : 1 drop every 6 hours.
Bacterial corneal ulcers:
Day 1 and 2 : 1-2 drops into the affected eye(s) every 30 minutes while awake.
        : 1-2 drops after 4 and 6 hours after retiring.
Day 3 - 7 : 1-2 drops hourly while awake.
Day 7 –9 or until completion : 1-2 drops 4 times daily.


SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Transient ocular irritation may occur. This may include burning, dryness, tearing, stinging, redness, itching or photophobia.
Less frequently, haemorrhagic conjunctivitis with palpebral oedema, due to an allergic reaction, may occur.
Since small amounts of ofloxacin is systemically absorbed after ocular administration, side-effects associated with systemic administration could possibly occur and the following side-effects have been reported (with systemic use):
Headache and dizziness are among the most common effects on the central nervous system. Other effects may include visual disturbances (e.g. double and abnormal colour vision), sleep disturbances, nightmares, paraesthesia, peripheral neuropathy, tremor, unsteady gait and more rarely, hallucinations, convulsions, psychotic reactions (e.g. restlessness, agitation, anxiety, confusion), depression and disturbances of taste and smell.
These reactions are more likely to occur in elderly patients and those with impaired renal function.
Gastro-intestinal disturbances including nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. Should severe and persistent diarrhoea occur during or after therapy with ofloxacin, a medical practitioner should be informed, since this may indicate a serious intestinal disorder (pseudomembranous colitis), requiring immediate medical treatment. Treatment with OCTIN should be discontinued immediately.
In addition to rash and pruritus, hypersensitivity reaction affecting the skin may less frequently include vasculitis, petechiae, haemorrhagic bullae and papules, Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis. Skin reactions on exposure to strong sunlight, have also been reported.
Facial and glottal oedema, swollen tongue, tachycardia, dyspnoea and signs of imminent shock and anaphylaxis have been reported. Transient increases in serum creatinine or blood urea nitrogen, elevated liver enzyme values, crystalluria, jaundice, hepatitis and less frequently acute renal failure, have been reported.
There have been reports of muscle and joint pain with the use of ofloxacin. Cardiovascular effects may include tachycardia, and blood dyscrasias (e.g. leucopenia, agranulocytosis, thrombocytopenia and anaemia) have been reported.
Super-infection may occur with prolonged use. If clinical improvement does not occur within a reasonable period, it is recommended that treatment with ofloxacin be discontinued and appropriate therapy instituted.
Special precautions:
See ‘Warnings’.
Care is necessary in patients with impaired hepatic or renal function, glucose-6-phosphate dehydrogenase deficiency, or myasthenia gravis. Possible photophobic reactions may occur. Wearing sunglasses and avoiding prolonged exposure to bright light, is advised.
OCTIN should be used with caution in patients with known hypersensitivity to other quinolone antibacterial agents.
Seek medical advice if the condition does not improve within 7 days.
Interactions:
Concurrent administration of a non-steroidal anti-inflammatory drug, eg. fenbufen, or theophylline, may potentiate the central nervous stimulant effects of ofloxacin.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See ‘Side-effects and Special Precautions’.
Accidental ingestion of 10 mL OCTIN (30 mg ofloxacin) does not appear to be of clinical significance in terms of overdosage.
An increased potential for systemic side-effects may be expected. Should hypersensitivity reactions develop, therapy with ophthalmic ofloxacin should be discontinued. Topical overdosage may be treated with a topical ocular irrigant. Mild hypersensitivity reactions may be treated with antihistamines and, if necessary, glucocorticoids.
Treatment is symptomatic and supportive.

IDENTIFICATION:
A pale yellow, clear sterile solution.

PRESENTATION:
Dropper bottles of 5 mL sterile solution.
Storage instructions:
Store below 25ºC.
Do not use more than 30 days after opening.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
36/15.1/0002

NAME AND BUSINESS ADDRESS OF APPLICANT
CIPLA LIFE SCIENCES (PTY) LTD.
Rosen Heights, Pasita Street,
Rosen Park, Bellville 7530 RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 2003.

304 WC
© Cipla Life Sciences 2003

New addition to this site: December 2016
Source: Company website
http://www.cipla.co.za/wp-content/uploads/2013/10/sep_octin.pdf

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