ISOPTO MAXITROL Eye Drops (Dexamethasone, Neomycin, Polymyxin B) – Steroid-Responsive Ocular Inflammation Guide
ISOPTO MAXITROL® Eye Drops
1. Disclaimer
This information is provided for educational and informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. ISOPTO MAXITROL® is an ophthalmic prescription medicine containing a corticosteroid and two antibiotics; because corticosteroid-containing eye preparations can worsen or mask certain infections and may cause serious ocular complications with inappropriate or prolonged use, it should be used only according to the advice of 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.
2. Summary
ISOPTO MAXITROL® is a sterile ophthalmic suspension combining the corticosteroid dexamethasone with the antibacterial agents neomycin sulfate and polymyxin B sulfate. The formulation is intended for steroid-responsive ocular inflammation when concurrent antimicrobial treatment is considered necessary. Its principal therapeutic effect is therefore a combination of anti-inflammatory corticosteroid activity and antibacterial activity.
The formulation corresponding to the Novartis product information contains dexamethasone 0.1% (1 mg/mL), neomycin sulfate 3,500 IU/mL, and polymyxin B sulfate 6,000 IU/mL, with benzalkonium chloride 0.004% as preservative and hypromellose as part of the vehicle.
Because it contains a corticosteroid, MAXITROL must not be regarded as an ordinary antibiotic eye drop. Viral, fungal, mycobacterial and certain parasitic ocular infections are contraindications, and prolonged treatment can produce ocular hypertension, glaucoma, cataract formation, delayed healing, secondary infection, and, in susceptible eyes, corneal or scleral perforation.
3. Brand Name
ISOPTO MAXITROL® / MAXITROL®
The product is marketed in different countries under MAXITROL® and, in some markets including Egypt, as ISOPTO MAXITROL. Egyptian-market references identify the product as a 5 mL ophthalmic suspension containing dexamethasone, neomycin sulfate and polymyxin B sulfate, associated with Novartis Scientific Office.
4. Category
Ophthalmic corticosteroid–antibiotic combination
Pharmacotherapeutic group: ophthalmological anti-infectives; corticosteroids and anti-infectives in combination.
ATC code: S01CA01.
5. Active Ingredient
Each 1 mL of the Novartis formulation contains:
- Dexamethasone 1 mg (0.1%)
- Neomycin sulfate 3,500 IU/mL
- Polymyxin B sulfate 6,000 IU/mL
- Benzalkonium chloride 0.04 mg/mL (0.004%) as preservative.
The suspension also contains excipients including hypromellose, polysorbate 20, sodium chloride, purified water, and hydrochloric acid and/or sodium hydroxide for pH adjustment.
A formulation distinction is important: the current U.S. DailyMed MAXITROL suspension contains 10,000 units/mL of polymyxin B, so U.S. labeling should not be used to replace the composition of the 6,000-IU/mL Novartis formulation marketed in other jurisdictions.
6. Pharmaceutical Form & Strength
Pharmaceutical form: Sterile ophthalmic suspension.
The Novartis product information describes it as an opaque, white to pale-yellow suspension without agglomerates.
Strength per mL:
- Dexamethasone: 1 mg (0.1%)
- Neomycin sulfate: 3,500 IU
- Polymyxin B sulfate: 6,000 IU
Pack size: The current UK MAXITROL product is supplied in 8 mL and 10 mL natural LDPE bottles. A 5 mL presentation is identified in Egyptian-market listings, but pack sizes vary by jurisdiction and should not be treated as universal specifications.
7. Manufacturer & Marketing Authorization Holder
Brand/company: Novartis.
Current UK product information identifies Novartis Pharmaceuticals UK Ltd as the Marketing Authorisation Holder for the UK MAXITROL product.
For the Egyptian-market ISOPTO MAXITROL 5 mL product, available Egyptian medicine references identify Novartis Scientific Office as the associated producer/company. However, these publicly accessible market listings do not establish the precise physical manufacturing site for every Egyptian batch. The actual manufacturer and local marketing authorization details should therefore be taken from the current Egyptian carton/leaflet or the Egyptian regulatory record rather than inferred from another country's MAXITROL product.
8. Mechanism of Action
ISOPTO MAXITROL has a dual therapeutic action.
Dexamethasone is a synthetic glucocorticoid that suppresses multiple components of the inflammatory response, thereby reducing ocular inflammation, edema and associated symptoms. It does not by itself eradicate the underlying infection and may suppress local immune defenses.
Neomycin is an aminoglycoside antibiotic. It acts primarily by interfering with bacterial protein synthesis through effects on the bacterial ribosome.
Polymyxin B is a cyclic lipopeptide that interacts with the cell membranes of susceptible Gram-negative bacteria, disrupting membrane integrity and producing a bactericidal effect.
The combination is useful when an ocular inflammatory condition requires corticosteroid treatment and an antibacterial component is concurrently judged necessary.
9. Spectrum of Activity
The antibacterial components provide activity against a range of susceptible Gram-positive and Gram-negative organisms, but susceptibility varies by species and resistance pattern.
The Novartis product information specifically lists susceptibility to organisms including Staphylococcus aureus, Corynebacterium species, Streptococcus viridans, Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, Aerobacter/Enterobacter-related organisms, Haemophilus influenzae, Pseudomonas aeruginosa, and Koch-Weeks bacillus, with polymyxin B particularly active against susceptible Gram-negative organisms.
More recent product information emphasizes that acquired resistance may vary geographically and over time. The combination should therefore not be regarded as providing universal antibacterial coverage. Some organisms may be resistant or inadequately covered, and microbiological assessment may be necessary in significant or persistent infections. The current UK SmPC identifies organisms with established or potential resistance and indicates that susceptibility cannot be assumed for organisms such as MRSA, certain streptococci and enterococci.
10. Pharmacokinetics
Following topical administration into the conjunctival sac, dexamethasone penetrates the eye and reaches the aqueous humor. Some systemic absorption can occur, although systemic exposure is generally much lower than with systemic corticosteroid administration.
Neomycin has limited systemic absorption after topical ocular use, but ocular penetration can increase when the corneal epithelium is damaged. Systemically absorbed neomycin is principally eliminated unchanged.
Polymyxin B has very limited systemic absorption after ocular administration; the Novartis product information reports systemic absorption as undetectable after ocular administration.
MAXITROL eye drops have not been specifically studied in patients with renal or hepatic impairment. However, because systemic absorption of the active substances after topical administration is low, the current UK SmPC states that dose adjustment is not necessary in these populations.
11. Indications
MAXITROL eye drops, suspension is indicated for the short-term treatment of steroid-responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease.
The medicine is therefore intended for selected ocular inflammatory conditions in which an ophthalmic corticosteroid is appropriate and antibacterial coverage is also considered necessary.
The medicine is not intended for indiscriminate treatment of red eye. A corticosteroid can worsen certain infections or suppress their clinical manifestations, so the underlying ocular condition should be appropriately evaluated before treatment.
12. Administration
The Novartis formulation is administered topically into the conjunctival sac.
The current UK SmPC states:
Adults, children and elderly patients:
Apply one or two drops to each affected eye up to six times daily or, more frequently if required.
The Novartis product information for the corresponding formulation further describes 1–2 drops topically in the conjunctival sac(s); in mild disease, drops may be used up to 4–6 times daily, while in severe disease they may initially be used hourly, followed by tapering as the inflammation subsides.
Exact dosing frequency and duration should be determined by the prescribing ophthalmologist according to the severity and nature of the condition.
Shake the bottle well before each use because the product is a suspension.
The dropper tip should not touch the eye, eyelids, fingers or other surfaces. After instillation, gently closing the eye or applying nasolacrimal occlusion is recommended and may reduce systemic absorption. When more than one ophthalmic medicine is used, separate the preparations by at least 5 minutes, with eye ointments applied last.
13. Method of Preparation
No reconstitution or dilution is required.
ISOPTO MAXITROL is supplied as a ready-to-use sterile ophthalmic suspension. Shake the bottle thoroughly before use to redistribute the suspended ingredients. Keep the bottle tightly closed when not in use and avoid contaminating the dropper tip.
14. Contraindications
MAXITROL should not be used in patients with:
- Hypersensitivity to dexamethasone, neomycin, polymyxin B, or any excipient.
- Herpes simplex keratitis.
- Vaccinia, varicella, or other viral infection of the cornea or conjunctiva.
- Fungal diseases of ocular structures or untreated parasitic eye infections.
- Mycobacterial ocular infections.
The medicine should not be used simply to suppress unexplained ocular redness, because corticosteroids can mask or aggravate serious ocular infections.
15. Warnings & Precautions
Prolonged or intensive ophthalmic corticosteroid treatment may cause increased intraocular pressure and/or glaucoma, with possible optic-nerve damage, reduced visual acuity, visual-field defects, and posterior subcapsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure should be checked routinely and frequently. This is particularly important in pediatric patients because corticosteroid-induced ocular hypertension may occur earlier and may be more pronounced in children.
Topical corticosteroids may slow corneal wound healing. The combination of topical corticosteroids with topical NSAIDs may further increase the potential for corneal-healing problems. In conditions associated with corneal or scleral thinning, corticosteroid treatment may increase the risk of perforation.
Prolonged use may lead to overgrowth of non-susceptible bacterial strains or fungi. If superinfection occurs, appropriate treatment should be initiated.
Neomycin may produce hypersensitivity or allergic sensitization. Cross-sensitivity with other aminoglycosides can occur, and reactions may range from local effects to generalized hypersensitivity reactions, including anaphylactic or bullous reactions. If serious hypersensitivity occurs, treatment should be discontinued.
Patients using ophthalmic preparations containing neomycin sulfate should consult a physician if ocular pain, redness, swelling, or irritation worsens or persists.
Serious neurotoxic, ototoxic and nephrotoxic reactions have occurred with systemic neomycin and, in some circumstances, with systemic polymyxin B. Although these effects have not been reported following topical ocular use of MAXITROL, caution is advised when it is used concomitantly with systemic aminoglycoside or polymyxin B therapy.
Corticosteroid treatment may also cause or contribute to visual disturbances, including blurred vision. Patients presenting with persistent visual disturbance should be evaluated for possible causes such as cataract, glaucoma, or other corticosteroid-associated ocular conditions.
The product contains benzalkonium chloride, which may be absorbed by soft contact lenses and may change their colour. Benzalkonium chloride may also cause eye irritation, symptoms of dry eye, and effects on the tear film and corneal surface, particularly with prolonged use or in patients with compromised corneas.
Contact-lens wear is discouraged during treatment of an ocular infection. If contact lenses are specifically permitted, they should be removed before administration and not reinserted for at least 15 minutes after instillation.
16. Drug Interactions
No formal interaction studies have been performed with MAXITROL eye drops. Important clinically relevant interactions and precautions include:
- Topical NSAIDs: concurrent use of topical corticosteroids and topical non-steroidal anti-inflammatory drugs may increase the risk of delayed or impaired corneal healing.
- Systemic aminoglycosides or polymyxin B: caution is advised because systemic neomycin or polymyxin B exposure may be associated with nephrotoxicity, ototoxicity or neurotoxicity.
- Antidiabetic medicines: corticosteroids may reduce the hypoglycaemic effect of glucose-lowering medicines, so an increased need for hypoglycaemic treatment may need to be considered in diabetic patients.
17. Side Effects
In clinical trials with MAXITROL eye drops and MAXITROL eye ointment, the most common adverse reactions were ocular discomfort, keratitis, and eye irritation, occurring in 0.7% to 0.9% of patients.
Other reported reactions include:
- Hypersensitivity
- Headache
- Keratitis
- Increased intraocular pressure
- Eye itching
- Ocular discomfort
- Eye irritation
- Ulcerative keratitis
- Corneal thinning
- Blurred vision
- Photophobia
- Mydriasis
- Eyelid ptosis
- Eye pain
- Eye swelling
- Foreign-body sensation in the eyes
- Ocular hyperaemia
- Increased lacrimation
- Stevens–Johnson syndrome
- Adrenal suppression
- Cushing's syndrome
In the current UK SmPC, keratitis, increased intraocular pressure, eye pruritus, ocular discomfort and eye irritation are classified as uncommon adverse reactions, while several other reactions are listed with frequency not known.
With prolonged corticosteroid exposure, glaucoma, optic-nerve damage, cataract formation, delayed corneal healing and corneal thinning/perforation may occur.
18. Use in Special Populations
Children: The current UK SmPC permits the same dosing regimen for children and adults, including the elderly: one or two drops in each affected eye up to six times daily, or more frequently if required. However, children may be more susceptible to corticosteroid-induced increases in intraocular pressure, which may occur earlier than in adults. Prolonged treatment therefore requires particular ophthalmic monitoring.
Elderly: No specific dosage adjustment is required solely because of age. The usual corticosteroid-related precautions remain applicable.
Renal or hepatic impairment: MAXITROL has not been studied specifically in these populations. However, due to low systemic absorption after topical administration, the current product information states that dose adjustment is not necessary.
Pregnancy: There are no or limited clinical data on the use of MAXITROL eye drops during pregnancy. The product is not recommended during pregnancy. Aminoglycosides such as neomycin cross the placenta after intravenous administration, and prolonged or repeated corticosteroid exposure during pregnancy has been associated with potential fetal risks.
Breastfeeding: It is unknown whether topical ophthalmic dexamethasone, neomycin or polymyxin B is excreted into human milk. Because systemic corticosteroids and aminoglycosides may be distributed into milk, a risk to the breastfed child cannot be excluded. A decision should therefore be made between continuing/discontinuing breastfeeding and continuing/discontinuing therapy, taking into account the benefits of breastfeeding and the benefits of treatment.
Driving and operating machinery: MAXITROL has no or negligible influence on the ability to drive or use machines. However, temporary blurred vision or other visual disturbances may occur after instillation. Patients should wait until vision clears before driving or operating machinery.
19. Storage Conditions
For the current Novartis/UK MAXITROL eye-drop formulation:
- Do not store above 25°C.
- Do not refrigerate.
- Keep the bottle tightly closed.
- Keep away from direct sunlight.
- Keep out of the sight and reach of children.
- Do not use after the expiry date printed on the package.
- Discard the bottle 28 days (4 weeks) after first opening.
The exact storage statement on the Egyptian package should take precedence if it differs because storage requirements can vary by registered market presentation.
20. Additional Sections
Prescription Status
MAXITROL is a prescription-only medicine in the United Kingdom and should be used under appropriate medical supervision.
Contact Lenses
Contact-lens use is discouraged during treatment of an ocular infection. The benzalkonium chloride preservative may irritate the eye and may be absorbed by soft contact lenses, potentially changing their colour. If lens use is specifically permitted, remove lenses before administration and wait at least 15 minutes before reinsertion.
Overdose
No case of overdose has been reported. Signs and symptoms of excessive use may resemble adverse ocular reactions such as punctate keratitis, erythema, increased lacrimation, edema and eyelid itching.
Because of the topical nature of the preparation, no toxic effects are expected from administration to the eye at the recommended dose or from accidental ingestion of the contents of a bottle. A topical ophthalmic overdose may be flushed from the eye(s) with lukewarm water.
Contamination Prevention
Do not allow the dispenser tip to touch the eye, eyelids, fingers or other surfaces. This helps prevent contamination of the sterile suspension. Shake the bottle well before use and keep the container tightly closed afterward.
Important Formulation Note
MAXITROL is not compositionally identical in every market. The Novartis formulation documented above contains 6,000 IU/mL polymyxin B, while the current U.S. DailyMed formulation contains 10,000 units/mL. Drug information should therefore always be matched to the exact marketed product and jurisdiction.
21. Frequently Asked Questions (FAQ)
What is ISOPTO MAXITROL used for?
It is used for the short-term treatment of steroid-responsive ocular conditions when prophylactic antibiotic treatment is also required, after fungal and viral disease have been excluded.
Is MAXITROL simply an antibiotic eye drop?
No. It contains two antibiotics plus the corticosteroid dexamethasone. The corticosteroid component makes its safety profile and contraindications substantially different from those of an antibiotic-only eye drop.
Does MAXITROL treat viral eye infections?
No. It is contraindicated in conditions such as herpes simplex keratitis, vaccinia, varicella and other specified viral infections of the cornea or conjunctiva. Corticosteroids can worsen or mask certain infections.
Does it need to be shaken?
Yes. It is an ophthalmic suspension and should be shaken well before administration.
Can MAXITROL be used with contact lenses?
Contact-lens wear is discouraged during treatment of an ocular infection. If a clinician specifically permits lens use, lenses should be removed before application and replaced after at least 15 minutes.
How long can the opened bottle be kept?
The bottle should be discarded 28 days (4 weeks) after first opening, even if some suspension remains.
Can MAXITROL raise eye pressure?
Yes. Ophthalmic corticosteroids can increase intraocular pressure and may cause steroid-induced glaucoma, particularly with prolonged treatment or in susceptible patients. The current SmPC classifies increased intraocular pressure as an uncommon adverse reaction.
Can it be used during pregnancy?
MAXITROL is not recommended during pregnancy because clinical data are limited and corticosteroid and aminoglycoside exposure may present potential risks. A physician should make the individual benefit-risk decision.
What should be done if vision becomes blurred immediately after using it?
Temporary blurred vision can occur after instillation. The patient should wait until vision clears before driving or operating machinery. Persistent or significant visual disturbance should be medically assessed.
22. References
- Novartis. MAXITROL® Sterile Ophthalmic Suspension — Product Information. Novartis Singapore. The document specifies the 1 mg/mL dexamethasone, 3,500 IU/mL neomycin sulfate and 6,000 IU/mL polymyxin B sulfate formulation, together with indications, dosing, contraindications, precautions and pharmacological information.
- Electronic Medicines Compendium (emc). MAXITROL Eye Drops — Summary of Product Characteristics. Current product information, last updated on 4 September 2025, with the text revision dated 21 August 2025. It provides current clinical information on composition, indication, posology, contraindications, warnings, interactions, adverse effects, special populations, storage, pack size and marketing authorization.
- Electronic Medicines Compendium (emc). MAXITROL Eye Drops — Patient Information Leaflet. Last updated 29 August 2025. Provides current patient-use and storage information.
- DailyMed / U.S. National Library of Medicine. MAXITROL ophthalmic suspension. Current U.S. labeling. It is useful for U.S. safety and administration information, but the U.S. formulation differs in polymyxin B concentration from the Novartis 6,000-IU/mL formulation described above.
- Egyptian-market medicine references for ISOPTO MAXITROL 5 mL. These sources identify the Egyptian-market presentation as a 5 mL product containing dexamethasone, neomycin sulfate and polymyxin B sulfate and associate it with Novartis/Novartis Scientific Office. They are used only for market-identification information, not as the primary source for clinical safety claims.
Final accuracy note
MAXITROL formulations and labeling are jurisdiction-specific. The Novartis formulation documented here contains 6,000 IU/mL polymyxin B and 3,500 IU/mL neomycin, whereas the current U.S. formulation contains 10,000 units/mL polymyxin B. The clinical information above is therefore anchored to the Novartis 6,000-IU/mL formulation, while current UK SmPC information is used where it provides the most up-to-date clinical and regulatory details.