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

Logo TOBRADEX® Ophthalmic suspension
TOBRADEX® Ophthalmic ointment

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

TOBRADEX® Ophthalmic suspension
TOBRADEX
® Ophthalmic ointment

COMPOSITION:
TOBRADEX
® ophthalmic suspension contains 1 mg dexamethasone and 3 mg tobramycin per mL with 0,01% (m/v) benzalkonium chloride as preservative.
TOBRADEX ophthalmic ointment contains 1 mg dexamethasone and 3 mg tobramycin per g with 0,5% (m/m) chlorobutanol as preservative.

PHARMACOLOGICAL CLASSIFICATION:
A.15.3. Combination antibiotics and corticosteroids.

PHARMACOLOGICAL ACTION:
Dexamethasone is a potent corticosteroid with an anti-inflammatory potency approximately 25 times that of hydrocortisone.Therapeutic concentrations are attained in the aqueous humor of the eye following application into the conjunctival sac. Topical ophthalmic steroids suppress inflammation of the outer eye and anterior segment including the lids, conjunctiva cornea, iris and ciliary body.
Tobramycin is an aminoglycoside antibiotic, active against most Gram-negative microorganisms including Pseudomonas and Proteus species and Gram-positive bacteria Staphylococcus aureus and S. epidermis (including penicillin resistant staphylococci) and some Streptococcus pneumoniae.
Tobramycin acts against susceptible bacteria to inhibit protein synthesis and is bactericidal. Gram-negative bacilli are inhibited by low concentrations of tobramycin. The majority of strains of Pseudomonas aeruginosa, Escherichia coli, Klebsiella, Enterobacter and Proteus are inhibited in vitro by low tobramycin concentrations.
While the gram-negative enteric spectrum of tobramycin essentially parallels that of gentamicin, tobramycin is more effective against Pseudomonas aeruginosa and some strains of Proteus species. Tobramycin is inactivated by fewer bacterial enzymes than gentamicin and although cross resistance with other aminoglycoside antibiotics occurs, some gentamicin resistant strains of Pseudomonas aeruginosa are susceptible to tobramycin. Topical ocular tobramycin (0,3%) is effective in the eradication/control of the bacteria present in eyelash and conjunctival isolates.

INDICATIONS:
TOBRADEX
ophthalmic suspension and TOBRADEX ophthalmic ointment are indicated for the reduction of ocular inflammation and prophylaxis of infection due to susceptible organisms, following intraocular surgery.

CONTRA-INDICATIONS:
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to any component of the medication. The use of this combination is always contraindicated after uncomplicated removal of a corneal foreign body. Topical corticosteroids should not be used in the treatment of mechanical lacerations and abrasions of the eye. They delay healing and promote the development and spread of infection.

WARNINGS:
Prolonged use of topical ophthalmic steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior subcapsular cataract formation. IF THESE PRODUCTS ARE USED FOR 10 DAYS OR LONGER INTRAOCULAR PRESSURE SHOULD BE ROUTINELY MONITORED EVEN THOUGH IT MAY BE DIFFICULT IN CHILDREN AND UNCO-OPERATIVE PATIENTS. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. Corneal ulceration may be aggravated when corticosteroids are applied. It is important that corneal ulcers are correctly diagnosed before treatment with corticosteroids is initiated. In acute purulent conditions of the eye, steroids may mask progression of infection until sight is lost or enhance existing infection. Not for injection into the eye.
This product contains benzalkonium chloride and is not recommended for use whilst soft contact lenses are being worn. Sensitivity to topically applied aminoglycosides may occur in some patients. It a sensitivity reaction does occur, discontinue use.

DOSAGE AND DIRECTIONS FOR USE:
TOBRADEX ophthalmic suspension:
Instil one drop into the operative eye every four hours whilst awake for three days prior to surgery and one drop immediately upon conclusion of surgery. Beginning at the first dressing change one day following surgery, instil two drops every two hours whilst awake for two days. From post-operative day three, instil one drop into the eye four times a day for one week. Thereafter, instil one drop per day for ten days as maintenance therapy.
Not more than 20 mL should be prescribed initially and the prescription should not be repeated without further evaluation as outlined under PRECAUTIONS.
SHAKE WELL BEFORE USE. STORE UPRIGHT.

TOBRADEX ophthalmic ointment:
Apply approximately 1,5 cm ribbon into the operative eye three times a day, three days prior to surgery. Apply a 1,5 cm ribbon into the eye immediately upon completing surgery. Beginning at the first dressing change on day one following surgery, apply a 1,5 cm ribbon three times a day, for the first nine days following surgery.
For maintenance therapy apply a 1,5 cm ribbon per day from day ten and continue till day twenty. Not more than 7 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
SIDE-EFFECTS: The most frequent side effects to topical ocular tobramycin are localised ocular toxicity and hypersensitivity, including lid itching and swelling and conjunctival erythema. If topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics care should be taken to monitor the total serum concentration. Prolonged use of tobramycin may lead to skin sensitisation or result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

PRECAUTIONS: A steroid glaucoma may be produced after a week or more of treatment in patients predisposed to chronic simple glaucoma. Topical corticosteroid therapy frequently induces intraocular hypertension in normal eyes and increases pressure in eyes with initially elevated pressure. Glaucoma has not always been reversible on cessation of corticosteroid treatment. The local administration of corticosteroids to the eyes of patients with bacterial, viral and fungal conjunctivitis may mask evidence of progression of infection until sight is lost. Corticosteroids may cause progression of the dendritic keratitis (herpes simplex infection), resulting in irreversible clouding of the cornea.
Secondary infection: Prolonged use of steroids may suppress the host response and thus increase the hazard of secondary ocular infection. Fungal Infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following supression of host responses also occurs. Steroid medication may also give rise to serious exacerbations of herpes infections of the eye.
Ophthalmic ointments may retard corneal healing.
Pregnancy: The safety of TOBRADEX during pregnancy has not yet been established.
Nursing mothers: It is not known whether TOBRADEX ophthalmic suspension or TOBRADEX ophthalmic ointment are excreted in human milk, therefore caution should be observed when it is administered to a nursing mother.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See the side-effects and special precautions above. Discontinue use immediately.

IDENTIFICATION:
TOBRADEX
ophthalmic suspension is a white to off-white sterile suspension.
TOBRADEX ophthalmic ointment is a white to off-white sterile homogenous ointment.

PRESENTATION:
TOBRADEX
ophthalmic suspension: Low density polyethylene DROP-TAINER
® dispenser containing 5 mL
TOBRADEX ophthalmic ointment: An ophthalmic ointment tube containing 3,5 g

STORAGE INSTRUCTIONS:
Store in a cool place, below 25°C. KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
TOBRADEX
ophthalmic suspension: X/15.3/91
TOBRADEX ophthalmic ointment: X/15.3/92

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (S.A.) (Pty) Ltd
Surrey Avenue
RANDBURG 2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19 December 1990
® Registered trademark
0693 34768-B
347681

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