Zoxan

Zoxan

ciprofloxacin

Manufacturer:

FDC

Distributor:

Unimed
Full Prescribing Info
Contents
Ciprofloxacin hydrochloride.
Description
Each ml contains: Ciprofloxacin Hydrochloride 3.5mg to 3mg base, Benzalkonium chloride 0.01% w/v (as preservative).
Action
Pharmacology: Pharmacodynamics: Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organism. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA which is needed for the synthesis of bacterial DNA ciprofloxacin has been shown to be active against most strains of the following organisms both in vitro and in clinical infections: Gram Positive: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus (Viridans Group).
Gram-negative: Haemophilus influenzae, Pseudomonoas aeruginosa, Serratia marcescencs.
Ciprofloxacin has been shown to be active in vitro against most strains of the following organisms; however, the clinical significance of these data is unknown: Gram-Positive: Enterococcus faecalis (many strains are only moderately susceptible), Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Streptococcus pyogenes.
Gram-negative: Acinetobacter calcoaceticus, Escherichia coli, Proteus vulgaris, Susbsp. anitratus, Haemophilus ducreyi, Providencia rettgeri, Aeromonas hydrophila, Haemophilus parainfluenzae, Providencia stuartii, Brucella melitensis, Klebsiella oxytoca, Salmonella enteritidis, Campylobacter coli, Legionella pneumophila, Salmonella typhi, Campylobacter jejuni, Moraxella (Branhamelia) catarrhalis, Shigella sonneii, Citrobacter diversus, Morganella morganii, Shigella flexneri, Citrobacter freundii, Neisseria gonorrhoeae, Vibrio cholerae, Edwardsiella tarda, Neisseria meningitidis, Vibrio parahaemolyticus, Enterobacter aerogenes, Pasteurellia multocida, Vibrio vulnificus, Enterobacter cloacae, Proteus mirabilis, Yersinia enterocolitica.
Other organisms: Chlamydia trachomatis (only moderately susceptible) and Mycobacterium tuberculosis (only moderately susceptible).
Most strains of Pseudomonas cepacia and some strains of Pseudomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile. The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2. Resistance to ciprofloxacin in vitro usually develops slowly (multiple-step mutation). Ciprofloxacin does not cross-react with other antimicrobial agents such as beta-lactams or aminoglycosides; therefore, organisms resistant of these drugs may be susceptible to ciprofloxacin.
Pharmacokinetics: Systemic absorption: After topical ocular administration, ciprofloxacin is also absorbed systemically.
Indications/Uses
Zoxan eye drop is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed as follows: Corneal Ulcers: Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus (Viridans Group).
Conjunctivitis: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Haemophilus influenzae.
Dosage/Direction for Use
Corneal Ulcers: ZOXAN must be administered in the following intervals, even during night time: On the first day, 2 drops into the affected eye every 15 minutes for the first six hours and then 2 drops into the affected eye every 30 minutes for the remainder of the day.
On the second day, instill 2 drops in the affected eye hourly.
On the third through the fourteenth day, place two drops in the affected eye every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
The recommended dosage regimen for the treatment of bacterial conjunctivitis is: one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days every four hours while awake for the next five days.
Route of Administration: For Topical Use only.
Overdosage
A topical overdose of Zoxan Eye Drop may be flushed from the eye(s) with warm tap water.
Contraindications
Hypersensitivity to any component of this medication. The use of ZOXAN is also contraindicated in patients with hypersensitivity to other quinolones.
Warnings
FOR TOPICAL USE ONLY - NOT FOR INJECTION INTO THE EYE.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial oedema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated.
During therapy, soft contact lenses should not be worn.
Special Precautions
General: As with other antibacterial preparations, prolonged use of ciprofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If super infection occurs, appropriate therapy should be initiated. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.
Information for patients: Do not touch dropper tip to any surface, as this may contaminate the solution.
Use in Children: Safety and effectiveness is pediatric patients below the age of 1 have not been established. Although ciprofloxacin and other qunolones cause arthropathy in immature animals after oral administration, topical ocular administration of ciprofloxacin to immature animals did not cause any arthropathy, and there is no evidence that the ophthalmic dosage form has any effect on the weight bearing joints.
Use In Pregnancy & Lactation
Pregnancy: Reproduction studies in rats have revealed no evidence of impaired fertility or harm to fetus due to ciprofloxacin. There are no adequate and well controlled studies in pregnant women.
Lactation: It is not known whether topically applied ciprofloxacin is excreted in human milk, however, it is known that orally administered ciprofloxacin is excreted in the milk of lactating rats, and oral ciprofloxacin has been reported in human breast milk after a single 500mg dose. Caution should be exercised when Zoxan eye drop is administered to a nursing mother.
Adverse Reactions
The most frequently reported drug related adverse reaction was local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen. Other reactions occurring in fewer patients included lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia and a bad taste following instillation. Additional events occurring in less than 1% patients included corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision.
Drug Interactions
Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, to interfere with the metabolism of caffeine, and to enhance the effect of the oral anticoagulant, warfarin, and its derivatives. Transient elevation in serum creatinine has been reported in patients receiving cyclosporin concomitantly with systemic ciprofloxacin.
Storage
Store in a dry place, below 30ºC & Protect from light. Discard one month after opening.
Shelf-Life: 24 months.
ATC Classification
S01AE03 - ciprofloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
Presentation/Packing
Ophth soln 3.5 mg/mL (a clear, colourless solution) x 5 mL.
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