TOBREX® — Tobramycin Ophthalmic Antibiotic — Eye Drops, Eye Ointment and TOBREX 2X Eye Drops
1- Disclaimer
This information is provided for general educational and reference purposes only and is not a substitute for the approved local product information, professional medical advice, diagnosis, or treatment. TOBREX is a prescription ophthalmic antibiotic and should be used only as directed by a qualified healthcare professional.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
Product composition, approved indications, dosage instructions, manufacturer, marketing authorization holder, storage conditions, and post-opening shelf life may differ between countries and formulations. The locally approved Egyptian package insert and product labeling should therefore take precedence. This is particularly important for TOBREX 2X, which has a formulation and approved dosing schedule different from conventional TOBREX eye drops.
2- Summary
TOBREX is a topical ophthalmic antibacterial medicine containing tobramycin, an aminoglycoside antibiotic. It is used to treat external infections of the eye and surrounding ocular tissues caused by bacteria susceptible to tobramycin. It does not treat viral, fungal, or non-infectious causes of eye inflammation.
Public Egyptian medicine and pharmacy listings show several TOBREX presentations, including TOBREX 0.3% eye drops 5 mL, TOBREX 0.3% eye ointment 3.5 g, and TOBREX 2X 0.3% eye drops 5 mL.
Importantly, TOBREX 2X should not simply be dosed according to the conventional TOBREX eye-drop schedule. Official TOBREX 2X product information describes a distinct formulation and a twice-daily maintenance regimen. ([Mohpublic][1])
3- Brand Name
TOBREX®
Depending on the country and formulation, the product may be marketed as:
- TOBREX Eye Drops
- TOBREX Eye Ointment
- TOBREX 2X Eye Drops
All contain tobramycin as the antibacterial active ingredient, but TOBREX 2X differs in formulation and dosing from conventional TOBREX eye drops. ([Novartis][2])
4- Category
Pharmacotherapeutic category: Ophthalmic antibacterial; aminoglycoside antibiotic.
ATC classification: S01AA12 – Tobramycin. ([Novartis][2])
5- Active Ingredient
Tobramycin
Tobramycin is a water-soluble aminoglycoside antibacterial agent.
Standard strengths used in TOBREX ophthalmic products are:
- Eye drops: 3 mg/mL (0.3% w/v)
- Eye ointment: 3 mg/g (0.3% w/w)
- TOBREX 2X eye drops: 3 mg/mL (0.3%) ([Novartis][2])
6- Pharmaceutical Form & Strength
TOBREX Eye Drops
Sterile ophthalmic solution containing tobramycin 3 mg/mL (0.3%).
A current European-authorized formulation contains benzalkonium chloride as preservative, together with boric acid, sodium sulfate, sodium chloride, tyloxapol, pH-adjusting agents and purified water. A common presentation is a 5 mL bottle. ([Novartis][2])
TOBREX Eye Ointment
Sterile ophthalmic ointment containing tobramycin 3 mg/g (0.3%).
Current authorized product information lists chlorobutanol 5 mg/g, liquid paraffin and white soft paraffin among the excipients. A common presentation is a 3.5 g ophthalmic tube.
TOBREX 2X Eye Drops
Contains tobramycin 3 mg/mL. Official TOBREX 2X information reviewed lists xanthan gum, mannitol, trometamol, boric acid, polysorbate 80 and benzododecinium bromide among the excipients. A 5 mL bottle is used in the referenced authorized presentation. ([Mohpublic][1])
Excipients can differ between countries, so the composition printed on the specific local package should always be checked.
7- Manufacturer & Marketing Authorization Holder
Manufacturer and marketing-authorization details are country-specific and should not be assumed to be identical worldwide.
For example, current authorized Maltese product information identifies Novartis Ireland Limited as the Marketing Authorization Holder and lists manufacturing facilities including Novartis Manufacturing NV, Belgium, and Novartis Farmacéutica, S.A., Spain. Australian and Canadian regulatory databases also list TOBREX products under Novartis entities.
For the Egyptian market, public medicine/pharmacy databases currently categorize the conventional 5 mL drops and TOBREX 2X under Novartis, while the 3.5 g ointment is listed under Alcon / United Company for Trading & Distribution. Such commercial database descriptions should not automatically be interpreted as the legal Marketing Authorization Holder or physical manufacturing site; the current Egyptian carton, leaflet and official registration data should be used for definitive identification.
8- Mechanism of Action
Tobramycin enters susceptible bacterial cells and binds to the 30S subunit of bacterial ribosomes. It interferes with formation of the initiation complex between messenger RNA and the 30S ribosomal subunit, thereby disrupting bacterial protein synthesis.
This antibacterial action is characteristic of aminoglycoside antibiotics. Current product information describes tobramycin as a rapidly acting bactericidal aminoglycoside that inhibits bacterial polypeptide-chain synthesis at the ribosomal level. ([Novartis][2])
9- Spectrum of Activity
Tobramycin has broad antibacterial activity, particularly against a number of aerobic Gram-negative ocular pathogens and susceptible Gram-positive organisms.
According to current Novartis product information, organisms categorized as susceptible include:
- Corynebacterium spp.
- Methicillin-susceptible Staphylococcus aureus.
- Methicillin-susceptible coagulase-negative Staphylococcus spp.
- Acinetobacter spp.
- Escherichia coli.
- Haemophilus influenzae.
- Klebsiella spp.
- Moraxella spp.
- Morganella morganii.
- Pseudomonas aeruginosa.
In the current Novartis European product information reviewed, methicillin-resistant Staphylococcus spp., Streptococcus pneumoniae and other Streptococcus spp. are categorized in the resistant group. ([Novartis][2])
However, resistance patterns may vary geographically and over time. In addition, susceptibility breakpoints developed for systemic antibiotic therapy cannot be directly extrapolated to topical ophthalmic treatment, because substantially higher antibiotic concentrations can be achieved locally at the site of ocular administration. Current product information specifically notes that topical therapy may remain effective against some isolates that would be classified as resistant using systemic susceptibility breakpoints. ([Novartis][2])
Bacterial resistance may develop, particularly with prolonged or inappropriate antibiotic exposure.
10- Pharmacokinetics
Systemic absorption of tobramycin following topical ophthalmic administration is low.
Pharmacokinetic data cited in current Novartis product information include a study in which an ophthalmic suspension containing tobramycin 0.3% and dexamethasone 0.1% was administered as one drop to each eye four times daily for two consecutive days. Plasma tobramycin concentrations were not quantitatively measurable in 9 of 12 subjects, and the highest measurable plasma concentration was 0.25 µg/mL. ([Novartis][2])
Systemically absorbed tobramycin is primarily eliminated unchanged by renal glomerular filtration. The systemic plasma half-life is approximately two hours, and plasma protein binding is low.
Closing the eyelids and gently applying nasolacrimal occlusion after instillation can further reduce systemic absorption of ophthalmic medicines. ([Novartis][2])
Clinically important systemic aminoglycoside exposure becomes more relevant when ophthalmic tobramycin is used together with systemic aminoglycosides.
11- Indications
TOBREX is indicated for the topical treatment of external bacterial infections of the eye and its adnexa caused by organisms susceptible to tobramycin. ([Novartis][2])
Examples may include susceptible bacterial infections affecting the conjunctiva, eyelids and other external ocular tissues, depending on clinical diagnosis and local approved labeling.
TOBREX should not be used as treatment for viral or fungal eye infections, or for eye redness or irritation that is not caused by susceptible bacteria.
12- Administration
Treatment should be prescribed according to infection severity, clinical response, patient age and the exact TOBREX formulation being used.
Conventional TOBREX Eye Drops 0.3%
For mild to moderate infections, commonly approved dosing is 1 or 2 drops into the affected eye(s) every 4 hours.
For severe infections, the current Novartis European SmPC reviewed specifies 1 or 2 drops into the affected eye(s) every hour until improvement, after which the frequency should be progressively reduced before discontinuation. Some other authorized product labels specify 2 drops hourly; therefore, the dosing instructions in the locally approved product information and the prescriber's directions should be followed. ([Novartis][2])
TOBREX Eye Ointment 0.3%
For mild to moderate infection, apply a small amount of ointment into the affected eye(s) 2 or 3 times daily. Some professional product information specifies approximately a 1–1.5 cm ribbon.
For severe infection, it may be applied approximately every 3–4 hours until improvement, followed by reduction of treatment frequency.
TOBREX 2X Eye Drops 0.3%
The dosing schedule is different from conventional TOBREX drops.
Official TOBREX 2X information reviewed specifies one drop into the treated eye twice daily, morning and evening, for one week.
For severe infections, the referenced product information specifies one drop four times on the first day, followed by one drop twice daily for six days. ([Mohpublic][1])
Therefore, conventional TOBREX drops and TOBREX 2X should not be dosed as though they were identical formulations.
13- Method of Preparation
TOBREX eye drops and ointment are ready-to-use ophthalmic preparations. They do not require dilution or reconstitution before administration.
Wash the hands before use. Avoid touching the dropper or tube tip to the eye, eyelids, fingers or any other surface, because this may contaminate the product.
For eye drops, instill the prescribed dose into the conjunctival sac. Closing the eyelid and gently occluding the nasolacrimal duct for approximately two minutes can reduce systemic absorption.
When several topical ophthalmic medicines are prescribed, they should generally be administered at least 5 minutes apart; some product information specifies 5–10 minutes. Ophthalmic ointments should normally be applied last. ([Novartis][2])
14- Contraindications
Current Novartis product information for conventional TOBREX eye drops lists the formal contraindication as hypersensitivity to tobramycin or to any excipient in the specific formulation. ([Novartis][2])
Cross-hypersensitivity with other aminoglycoside antibiotics may occur and should be taken into consideration. Some national product labels and formulations, including the reviewed TOBREX 2X labeling, additionally list known hypersensitivity to other aminoglycoside antibiotics among the contraindications. ([Mohpublic][1])
The contraindications stated in the locally approved product information for the specific formulation should therefore be followed.
15- Warnings & Precautions
TOBREX is for topical ophthalmic use only and must not be injected into the eye.
Hypersensitivity to topical aminoglycosides may occur. Reactions can range from localized itching, erythema or swelling to severe generalized allergic reactions. Treatment should be stopped and medical advice obtained if significant hypersensitivity occurs.
Cross-sensitivity among aminoglycoside antibiotics may occur.
Prolonged antibiotic use may promote overgrowth of nonsusceptible organisms, including fungi. If superinfection develops, appropriate alternative treatment should be considered.
Systemic aminoglycosides can cause nephrotoxicity, ototoxicity and neurotoxicity. Although systemic exposure from ophthalmic TOBREX is usually low, additional caution is required when topical tobramycin is used at the same time as systemic aminoglycosides. ([Novartis][2])
Aminoglycosides may aggravate neuromuscular weakness. Particular caution is advised in patients with disorders such as myasthenia gravis or Parkinson's disease. ([Novartis][2])
Contact-lens wear is not recommended during treatment of an active eye infection. Preserved TOBREX eye drops containing benzalkonium chloride should not be instilled while soft contact lenses are in place. Where lens use is specifically permitted by the clinician, lenses should be removed before administration and not reinserted for at least 15 minutes. Benzalkonium chloride may irritate the eye and can be absorbed by soft contact lenses. ([Novartis][2])
Some professional product information also warns that ophthalmic antibiotic solutions or ointments may delay corneal wound healing.
16- Drug Interactions
No clinically significant drug interactions have been identified with topical ocular administration of TOBREX, and specific interaction studies with TOBREX have not been performed. ([Novartis][2])
Because systemic aminoglycosides can cause clinically important toxicity, caution is appropriate when ophthalmic tobramycin is used concomitantly with a systemic aminoglycoside. Where both are used, monitoring of total serum aminoglycoside concentrations may be appropriate to help ensure suitable systemic exposure. ([Novartis][2])
When several topical ophthalmic medicines are being used, they should generally be administered at least 5 minutes apart. Ophthalmic ointments should be administered last. Some formulation-specific product information specifies an interval of 5–10 minutes between different eye drops. ([Novartis][2])
17- Side Effects
The most commonly reported effects are local ocular reactions.
Common reactions may include:
- Ocular discomfort.
- Ocular redness/hyperemia.
Uncommon reactions include:
- Keratitis or inflammation of the ocular surface.
- Corneal abrasion or damage.
- Blurred or impaired vision.
- Eyelid redness or swelling.
- Conjunctival swelling.
- Eye pain.
- Dry eye.
- Eye discharge.
- Eye itching.
- Foreign-body sensation.
- Increased lacrimation.
- Headache.
- Hypersensitivity, urticaria or dermatitis.
Temporary blurred vision is particularly possible after ophthalmic ointment administration.
Post-marketing reactions of unknown frequency include severe hypersensitivity/anaphylactic reactions, eye allergy or irritation, rash, erythema multiforme and Stevens-Johnson syndrome. ([Novartis][2])
Any severe allergic reaction, marked deterioration of the eye condition or serious skin reaction requires prompt medical assessment.
18- Use in Special Populations
Children
Pediatric age recommendations are product- and market-specific.
Current Novartis European product information for TOBREX eye drops permits use in children 1 year of age and older at the same dosage as adults and states that safety and efficacy have not been established in children younger than 1 year. ([Novartis][2])
The reviewed TOBREX 2X labeling likewise states that the medicine is not intended for children under 1 year of age. ([Mohpublic][1])
However, U.S. labeling for some tobramycin ophthalmic products states that safety and effectiveness have not been established in pediatric patients below 2 months of age. The minimum approved age should therefore not be assumed to be identical in every country or for every product; the locally approved labeling for the specific formulation should be followed. ([DailyMed][3])
Pregnancy
Human data following topical ophthalmic use are limited. Because systemic exposure is expected to be low but fetal risk cannot be completely excluded, current product information generally recommends use during pregnancy only when clearly needed or when the expected maternal benefit justifies the potential fetal risk. Current Novartis product information states that TOBREX should be used during pregnancy only when absolutely necessary. ([Novartis][2])
Breast-feeding
Recommendations vary somewhat between national product information. Some European information advises against routine use during breastfeeding, whereas current Novartis product information states that a decision should be made whether to continue or discontinue breast-feeding or to continue or discontinue treatment, taking into account the benefit of breast-feeding for the child and the benefit of treatment for the mother. Clinical advice should therefore be obtained before use while breastfeeding. ([Novartis][2])
Elderly
No routine age-related dosage adjustment is generally required.
Renal or hepatic impairment
Specific studies are limited. Because systemic absorption after topical ophthalmic use is low, routine dosage adjustment is generally not expected solely because of renal or hepatic impairment; however, additional caution is appropriate when systemic aminoglycosides are also being administered. Current Novartis information notes that safety and efficacy have not been established specifically in patients with renal or hepatic impairment and recommends attention to total serum aminoglycoside concentrations when systemic aminoglycosides are administered concurrently. ([Novartis][2])
Fertility
Adequate studies evaluating the effect of topical ophthalmic TOBREX on human fertility have not been performed. ([Novartis][2])
19- Storage Conditions
Storage instructions are formulation- and country-specific, and the conditions printed on the actual Egyptian product should take precedence.
For conventional TOBREX eye drops and ointment, current European product information reviewed specifies do not store above 25°C, do not freeze, keep the container tightly closed and protect it from light. The eye drops should be discarded four weeks after first opening. Current Novartis information for the eye drops likewise specifies storage below 25°C and a four-week in-use shelf life. ([Novartis][2])
Official TOBREX 2X information reviewed specifies storage below 30°C and disposal of the bottle 28 days after opening. ([Mohpublic][1])
Post-opening instructions for the ointment can differ between markets, so its local package insert should be followed rather than automatically applying the eye-drop rule.
Keep all medicines out of the sight and reach of children.
20- Additional Sections
Overdose
A clinically serious overdose is not generally expected from excessive topical use or accidental ingestion of the contents of a single ophthalmic container, although excessive local irritation may occur.
A topical ocular overdose may be rinsed from the eye with lukewarm water. ([Novartis][2])
Driving and Use of Machinery
TOBREX may temporarily cause blurred vision after administration, especially with ointment. Patients should not drive or operate machinery until vision has returned to normal. ([Novartis][2])
Antimicrobial Resistance
Unnecessary or prolonged antibiotic use increases the risk of selection of resistant organisms and superinfection. TOBREX should therefore be used for suspected or confirmed susceptible bacterial infection and for the prescribed duration.
Contamination Prevention
Do not allow the bottle or tube tip to touch the eye, eyelid or any other surface. Keep the container tightly closed when not in use. ([Novartis][2])
21- Frequently Asked Questions (FAQ)
Is TOBREX a steroid?
No. TOBREX contains tobramycin, an aminoglycoside antibiotic. It does not contain a corticosteroid.
Does TOBREX treat every red eye or conjunctivitis?
No. It is intended for infections caused by bacteria susceptible to tobramycin. Viral, fungal, allergic and non-infectious causes of red eye do not benefit from tobramycin antibiotic therapy.
Are TOBREX regular eye drops and TOBREX 2X the same?
They contain the same concentration of tobramycin, 3 mg/mL, but the formulations and approved dosing schedules differ. Conventional drops may be prescribed every four hours, whereas the reviewed TOBREX 2X labeling uses a twice-daily maintenance schedule. The products should therefore be used according to their own package instructions. ([Novartis][2])
Can contact lenses be worn while using TOBREX?
Contact-lens wear is generally not recommended during an active ocular infection. Preserved eye drops should not be instilled while lenses are in place. If a healthcare professional permits continued lens use, remove them before the drops and wait at least 15 minutes before reinsertion. ([Novartis][2])
Can TOBREX be used in children?
Yes, but the approved minimum age varies between products and regulatory markets. Current Novartis European information for TOBREX eye drops supports use in children 1 year of age and older, and the reviewed TOBREX 2X labeling also excludes children under 1 year. In contrast, U.S. labeling for some tobramycin ophthalmic products states that safety and effectiveness have not been established below 2 months of age. The locally approved labeling for the exact product should therefore be followed. ([Novartis][2])
How long should TOBREX be used?
Treatment duration depends on the infection, severity, clinical response and formulation. The prescribing clinician should determine the course. TOBREX 2X labeling reviewed specifies a course of one week, while current Novartis product information for conventional TOBREX eye drops states that treatment is usually 7–10 days. ([Mohpublic][1])
What should be done if a dose is missed?
Use the next dose as scheduled. If it is almost time for the next dose, skip the missed dose rather than using a double dose.
When should medical reassessment be sought?
Medical reassessment is appropriate if symptoms worsen, recur, fail to improve as expected, or if significant eye pain, visual deterioration, severe swelling, marked hypersensitivity or a serious skin reaction develops.
22- References
- Novartis Poland — TOBREX 3 mg/mL Eye Drops, Summary of Product Characteristics, version 09/2025; Patient Information Leaflet, version 02/2026. This was used as the principal current Novartis reference for conventional TOBREX eye drops, including dosage, microbiology, pharmacokinetics, interactions, pediatric use and special-population information. ([Novartis][4])
- Malta Medicines Authority — TOBREX 3 mg/mL Eye Drops and 3 mg/g Eye Ointment. Authorized product information used for formulation, ointment dosing, precautions, adverse effects and storage information.
- Medsafe, New Zealand — TOBREX Eye Drops 0.3% and Eye Ointment 0.3%, New Zealand Data Sheet. Used for cross-checking formulation-specific dosing, warnings and other professional product information.
- Israel Ministry of Health — TOBREX 2X Eye Drops 3 mg/mL, official patient package insert. The reviewed leaflet specifies the TOBREX 2X formulation, twice-daily regimen, severe-infection dosing, pediatric restriction, contact-lens precautions, excipients and storage conditions. It states that the leaflet was checked and approved in January 2016. ([Mohpublic][1])
- U.S. DailyMed — Tobramycin ophthalmic labeling. Used for cross-checking U.S. pediatric labeling and other product-specific information; some U.S. ophthalmic tobramycin labels state that safety and effectiveness below 2 months of age have not been established. ([DailyMed][3])
- Therapeutic Goods Administration, Australia — TOBREX 3 mg/mL eye-drop and 3 mg/g eye-ointment registrations.
- Health Canada Drug Product Database — TOBREX 0.3% ophthalmic product information.
- Egyptian market listings — TOBREX 0.3% eye drops 5 mL, TOBREX 2X 0.3% eye drops 5 mL and TOBREX 0.3% eye ointment 3.5 g. These sources support evidence of commercial presentations reported in Egypt but should not replace current official Egyptian regulatory documentation.