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Molecule

Tobramycin

Also known as tobramycin sulfate
Available on requestOrphanCold chainAntibioticsOphthalmology
Presentations
16
Brands
6
Manufacturers
5
Available from stock
0

Tobramycin is an aminoglycoside antibacterial indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. It is available as inhalation solution, eye drops and injection for ophthalmic and intravenous use. MedsAcross supplies Tobramycin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Aminoglycoside Antibacterial
ATC classification
J01GB01 Tobramycin · Aminoglycoside antibiotic, subgroup J01GBS01AA12 Tobramycin · Eye medicines, subgroup S01A, subgroup S01AA
US FDA first approval
11 June 1975
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Ophthalmic, Inhalation, Intravenous, Intramuscular, Oral
Dosage forms
Inhalation solution, Eye drops, Injection, Ophthalmic solution, Powder for injection, Inhalant, Eye ointment, Inhalation capsule
Identifiers
UNII VZ8RRZ51VKRxCUI 10627CAS 32986-56-4DrugBank DB00684Q1758380

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

TOBREX ® (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

Source: US FDA prescribing information

Dosing overview

In mild to moderate disease, apply a half-inch ribbon into the affected eye(s) 2 or 3 times per day. In severe infections, instill a half-inch ribbon into the affected eye(s) every 3 to 4 hours until improvement, following which treatment should be reduced prior to discontinuation. How to Apply TOBREX (tobramycin ophthalmic ointment) 0.3%: 1. Tilt your head back. 2. Place a finger on your cheek just under your eye and gently pull down until a ''V'' pocket is formed between your eyeball and your lower lid. 3. Place a small amount (about ½ inch) of TOBREX ® (tobramycin ophthalmic ointment) 0.3% in the ''V'' pocket. Do not let the tip of the tube touch your eye. 4. Look downward before closing your eye.

Source: US FDA prescribing information

Contraindications

TOBREX (tobramycin ophthalmic ointment) 0.3 % is contraindicated in patients with known hypersensitivity to any of its components.

Source: US FDA prescribing information

Warnings and precautions

NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction to TOBREX (tobramycin ophthalmic ointment) 0.3% occurs, discontinue use.

Source: US FDA prescribing information

Side effects

The most frequent adverse reactions to TOBREX (tobramycin ophthalmic ointment) 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with TOBREX ® (tobramycin ophthalmic ointment) 0.3%. Postmarketing Experience: Additional adverse reactions identified from postmarketing use include anaphylactic reaction, Stevens-Johnson syndrome, and erythema multiforme. The following additional adverse reactions have been reported with systemic aminoglycosides: Neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

16 presentations of Tobramycin, sorted by availability.

MedicineManufacturerRegisterAvailability
Tobramycin 3 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Tobramycin 1.2 g/30 mL powder for injectionIntravenousGeneric name—US FDAAvailable on request
Tobramycin 300 mg/5 mL inhalation solutionInhalation Cold chainGeneric name—US FDAAvailable on request
Tobramycin 3 mg/mL ophthalmic solutionOphthalmicGeneric name—US FDAAvailable on request
Tobramycin 80 mg/2 mL injectionIntramuscular, intravenousGeneric name—US FDAAvailable on request
Tobramycin 1200 mg/30 mL injectionIntramuscular, intravenousGeneric name—US FDAAvailable on request
Tobramycin 300 mg/4 mL inhalation solutionInhalation Cold chainGeneric name—US FDAAvailable on request
Tobramycin 300 mg/5 mL inhalantInhalation Cold chainGeneric name—US FDAAvailable on request
Bethkis 300 mg/4 mL inhalation solutionInhalation Cold chainChiesiUS FDAAvailable on request
Tobramycin 20 mg/2 mL injectionIntramuscular, intravenousGeneric name—US FDAAvailable on request
Kitabis Pak 300 mg/5 mL inhalation solutionInhalation Cold chainPari Respiratory EquipmentUS FDAAvailable on request
Tobi 300 mg/5 mL inhalation solutionInhalation, oral Cold chainViatris SpecialtyUS FDAAvailable on request
TOBI Podhaler 28 mg inhalation capsuleInhalation, oralViatris SpecialtyUS FDAAvailable on request
Tobramycin 2000 mg/50 mL injectionIntravenousGeneric name—US FDAAvailable on request
Tobramycin Inhalation Solution Pak 300 mg/5 mL inhalation solutionInhalation Cold chainGenericusUS FDAAvailable on request
Tobrex 0.3% eye ointmentOphthalmicNovartis PharmaceuticalsUS FDAAvailable on request

Brands by market

6 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 11 June 1975Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Tobramycin in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Tobramycin available for export from India?

Yes, on request. MedsAcross lists 16 presentations of Tobramycin and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Tobramycin have?

The catalogue lists 6 brand names for Tobramycin, including Bethkis, Kitabis Pak, Tobi, TOBI Podhaler, Tobramycin Inhalation Solution Pak, Tobrex.

Is Tobramycin approved by the US FDA?

Yes. The US FDA first approved Tobramycin on 11 June 1975, according to Drugs@FDA.

Is Tobramycin authorised in the European Union?

Yes. Tobramycin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Tobramycin need cold chain shipping?

At least one listed presentation of Tobramycin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Tobramycin in?

Tobramycin is classified under ATC code J01GB01 (Tobramycin).

References

  1. TOBREX prescribing information (Novartis Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 26 October 2026
  2. Tobi Podhaler: European public assessment report (EPAR). European Medicines Agency. Retrieved 11 May 2026
  3. Vantobra (previously Tobramycin PARI): European public assessment report (EPAR). European Medicines Agency. Retrieved 5 August 2026

Request Tobramycin for export supply

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