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

Logo TOBREX® ophthalmic solution
TOBREX® ophthalmic ointment

                34354-1

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

TOBREX® ophthalmic solution
TOBREX
® ophthalmic ointment

COMPOSITION:
TOBREX
®ophthalmic solution: A sterile ophthalmic solution containing 3 mg tobramycin base per mL, preserved with 0,01% (m/v) benzalkonium chloride.
TOBREX
®ophthalmic ointment: A sterile ophthalmic ointment containing 3 mg tobramycin base per g preserved with chlorobutanol 0,5% (m/m).

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

PHARMACOLOGICAL ACTION:
Tobramycin is a basic water-soluble aminoglycoside antibiotic with a spectrum of activity similar to that of gentamicin. It is active in vitro against Staph. aureus, most of the family Enterobacteriaceae, and Pseud. aeruginosa.
Most staphylococci are inhibited by 1 ug/mL or less; most gram-negative bacteria by 2 ug/mL or less; and Pseudomonas, by 5 to 10 ug/mL or less. About 70% of Klebsiella and Enterobacter (aerobacter) are suppressed by 0,75 ug/mL and over 50% of E. Coli and indole-positive and-negative Proteus are inhibited by at least 3 ug/mL.
Tobramycin is bactericidal for susceptible microbial species. It is less active in vitro than gentamicin for most gram negative bacteria but at least two to four times more active against Pseudomonas. There is evidence of transmissible resistance, although some organisms, especially staphylococci, may be resistant to other aminoglycosides and sensitive to tobramycin.

INDICATIONS:
TOBREX is a topical antibiotic indicated in the treatment of external bacterial infections of the eye and its adnexa caused by susceptible organisms. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX.

CONTRA-INDICATIONS:
TOBREX is contra-indicated in patients hypersensitive to tobramycin.

WARNINGS:
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 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:
TOBREX ophthalmic solution:
Instil one or two drops into the affected eye(s) every four hours. In severe, infections instil two drops into the eye(s) every hour until improvement following which treatment should be reduced prior to discontinuation.

TOBREX ophthalmic ointment:
In mild to moderate disease, apply a ribbon of about 10 mm (½ inch) into the affected eye(s) two or three times per day. In severe infections, instil a ribbon of about 10 mm (½ inch) into the affected eye(s) every three to four hours until improvement following which treatment should be reduced prior to discontinuation.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Localised ocular toxicity and hypersensitivity can occur. If topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
Warning: Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to tobramycin occurs discontinue use.
Precautions: Prolonged use may lead to skin sensitisation or result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs appropriate therapy should be initiated.
Ophthalmic ointments may retard corneal healing.
Pregnancy: There are no adequate and well controlled studies of tobramycin in pregnant women. Therefore, this drug should only be used during pregnancy, if the potential benefits outweigh the possible risks.
Nursing mothers: Because of the potential for adverse reactions in nursing infants, from TOBREX a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.
Interaction with other drugs: Care should be exercised when tobramycin is given to patients receiving other drugs with neuromuscular blocking activity or which are ototoxic. Tobramycin and carbenicillin have been reported to have an enhanced effect. However, since an in vitro incompatibility with carbenicillin sodium has been demonstrated, the two antibiotics should be administered separately when both are required.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS:
See Side effects and special precautions.

IDENTIFICATION:
TOBREX ophthalmic solution:
A clear, colourless to very pale yellow solution.
TOBREX ophthalmic ointment: White or off-white homogeneous ointment.

PRESENTATION:
TOBREX ophthalmic solution:
Low density polyethylene ophthalmic DROP-TAINER™ dispenser containing 5 mL.
TOBREX ophthalmic ointment: Ophthalmic ointment tube containing 3,5 g.

STORAGE INSTRUCTIONS:
TOBREX ophthalmic solution:
Protect from light. Store below 25°C. KEEP OUT OF REACH OF CHILDREN. DO NOT USE MORE THAN 30 DAYS AFTER OPENING.
TOBREX ophthalmic ointment: Store below 25°C. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
TOBREX ophthalmic solution:
P/15.1/58.
TOBREX ophthalmic ointment: P/15.1/205.

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
TOBREX ophthalmic solution:
27 October 1981
TOBREX ophthalmic ointment: 24 May 1982

0497                34354-1

Updated on this site: November 1999

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