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COMPOSITION
Each ml. contains 1 mg. dexamethasone, 3 mg. tobramycin.
Excipients: Benzalkonium chloride, edetate disodium, sodium chloride, sodium sulfate, tyloxapol, hydroxyethyl cellulose, sulfuric acid and/or sodium hydroxide and purified water.
ACTIVITY
This ophthalmic suspension contains two substances which have anti-inflammatory and antibiotic activity: dexamethasone and tobramycin.
INDICATIONS
TOBRADEX is indicated for the treatment of inflammatory ocular conditions where infection or a risk of infection exists.
CONTRAINDICATIONS
TOBRADEX is contraindicated in patients with known hypersensitivity to tobramycin or any other ingredients in this product. Its use is not recommended in patients with existing or suspected viral, fungal, or tuberculosis diseases of the eye. The use of this preparation is always contraindicated after uncomplicated removal of a corneal foreign body. Also see warnings about excipients.
PRECAUTIONS
Not for injection into the eye.
INTERACTIONS
None reported.
WARNINGS
Prolonged use of corticosteroids may result in damage to the optic nerve, defects in visual acuity and fields of vision and in posterior subcapsular cataract formation. Prolonged use of corticosteroids may also suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, dexamethasone may mask infection or enhance existing infection. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. Sensitivity to topically applied aminoglycosides may occur in some patients. If sensitivity reaction does occur, discontinue use.
It may cause an elevation of intraocular pressure (IOP) particularly in patients who have a family history of glaucoma. Therefore, it must be administered only under physician prescription and supervision.
Sportspersons should be aware that this medication contains dexamethasone which may give a positive test result in a doping control.
Pregnancy and lactation
Its possible use during pregnancy should be determined by your doctor.
Effects on the ability to drive and use machinery
Temporary blurred vision may occur immediately after administration therefore caution should be taken when driving a motor vehicle or using machinery.
Warnings about excipients:
This medication contains the excipient benzalkonium chloride, which may discolour soft contact lenses. If you use contact lenses, you should take them out before applying this product and they should not be worn until at least 10 to 15 minutes following the instillation of the drops.
POSOLOGY
The usual recommended dose is one or two drops into the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased to one to two drops every two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
It is not recommended to use this product for more than 14 days. The number of daily applications and duration of treatment may be changed by your physician.
Use in the elderly
No overall differences in safety or effectiveness have been observed between elderly and other adult patients therefore there is no need to modify dosage when administering to the elderly.
Use in children
Safety and effectiveness in children below the age of 1 year have not been established.
INSTRUCTIONS FOR THE CORRECT ADMINISTRATION OF THE PRODUCT
Follow these steps for the administration of this product:
1. Shake the bottle well before use.
2. Wash your hands thoroughly before you use TOBRADEX.
3. Sit down in front of a mirror so you can see what you are doing.
4. Remove the cap from the bottle.
5. Make sure that you do not let the dropper of the bottle touch anything as this may contaminate the contents.
6. Hold the bottle upside down in one hand (between your thumb and middle finger).
7. Gently pull the lower eyelid of the affected eye down using the forefinger of your other hand.
8. Place the dropper close to, but not touching the eye and gently tap or press the base of the bottle with your forefinger so that one or two drops fall into the conjunctival sac (gap between your eyelid and eye).
9. Release the lower eyelid and close your eyes gently for a few seconds to make sure the whole of the eye is covered by the suspension.
10. If necessary, repeat steps 6 to 9 for your other eye. Place the cap on the bottle and close it tightly.
Since it is a sterile solution, the following instructions should also be followed:
- Each patient should use their own bottle.
- Once you have finished your treatment you should dispose of the rest of the preparation even if you have not finished the contents of the bottle.
OVERDOSAGE
A topical overdose of TOBRADEX may be rinsed from the eye(s) with lukewarm tap water. In this case immediately consult your local poison control centre and indicate the medication and the amount taken.
SIDE EFFECTS
The most frequent adverse reactions to topical tobramycin are hypersensitivity and localized ocular toxicity, including lid itching and swelling and conjunctival erythema. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Infection of the cornea caused by fungi or other non-susceptible microorganisms to the antibiotic may occur, in which case the medication should be discontinued and your doctor consulted. The reactions due to dexamethasone are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of topical steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.
If you notice any other adverse effect not mentioned above, consult your doctor or pharmacist.
STORAGE
This medication does not require any special storage conditions.
Do not freeze.
EXPIRY
This medication must not be used after the expiry date indicated on the pack.
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