(and dosage form):
Viscous Ophthalmic Drops
Each gram of FUCITHALMIC consists of fusidic acid hemihydrate B.P. equivalent to 10 mg anhydrous fusidic acid and is preserved with 0,01% m/m benzalkonium chloride.
A. 15.1 Ophthalmic Preparations with Antibiotics and/or Sulphonamides
FUCITHALMIC is active against Staphylococcus aureus. The formulation ensures contact with the conjunctival sac and it penetrates well into the aqueous humor.
FUCITHALMIC® is indicated for the topical treatment of staphylococcal conjunctivitis caused by susceptible organisms.
Hypersensitivity to any of its components.
Should not be used when contact lenses are being worn. When given as a single active ingredient, resistance, as indicated by in-vitro and in-vivo studies, frequently develops.
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations 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.
DOSAGE AND DIRECTIONS FOR USE:
For all ages: One FUCITHALMIC® drop to be instilled into the conjunctival sac, twice daily. Treatment should be continued for two days after the eye returns to normal.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Transient stinging after application has been encountered.
Hypersensitivity may occur.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
FUCITHALMIC® is a viscous white to off-white aqueous suspension.
FUCITHALMIC® is available in 5 g tubes.
Store below 25°C. Keep the tube tightly closed. The tube should be discarded one month after opening. Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X 69
Under licence from Leo Pharmaceutical Products, Ballerup, Denmark.
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
® Registered Trademark.
New addition to this site: April 2004
Source: Pharmaceutical Industry
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