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Tobramycin

Bramitob, Tobi, Tobrasix, Tobrex · ATC code J01GB01

Also known as: Tobramisin · Brand names: Bramitob, Tobi, Tobrasix, Tobrex, Gernebcin, Tobramaxin, Tobramycin Aliud, Tobramycin Aristo, Tobramycin Infectopharm, Tobramycin Sun, Tobramycin Teva, Tobramycin Zentiva, Tobrazid, Airfibro, Kfibrogen …

Key facts
Active substance
Tobramycin
Drug class
Aminoglycoside antibiotic
ATC code
J01GB01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Tobramycin is an aminoglycoside antibiotic, here as an inhalation solution (TOBI). Per the US prescribing information, it is used to manage cystic fibrosis with Pseudomonas aeruginosa in patients aged 6 years and older.

What it is used for

  • Management of cystic fibrosis patients with Pseudomonas aeruginosa, adults and children 6 years of age and older
  • Not established under 6 years, with FEV₁ < 25% or > 75% predicted, or with Burkholderia cepacia colonization

Dosing

  • One 300 mg ampoule inhaled twice daily for 28 days, then 28 days off, in repeating cycles; not adjusted by weight
  • Doses as close to 12 hours apart as possible, not less than 6 hours apart; a missed dose can be taken up to 6 hours before the next one
  • Inhaled over about 15 minutes with the PARI LC PLUS nebulizer; do not dilute or mix with dornase alfa or other medicines
  • For oral inhalation only; patients on multiple therapies take their other medicines before TOBI

Contraindications

  • Known hypersensitivity to any aminoglycoside

Important warnings

  • Bronchospasm with inhalation
  • Ototoxicity (auditory and vestibular); tinnitus may be an early sign; hearing loss reported after marketing; higher risk with certain mitochondrial DNA variants
  • Nephrotoxicity, associated with aminoglycosides as a class; monitor in renal dysfunction
  • Neuromuscular disorders: may aggravate muscle weakness, e.g. in myasthenia gravis or Parkinson's disease
  • Embryo-fetal toxicity; avoid concomitant systemic aminoglycosides

Side effects

  • Voice alteration (12.8% vs. 6.5% with placebo) and tinnitus were the only reactions significantly more frequent than with placebo
  • Also reported: cough, pharyngitis, increased sputum, dyspnea, hemoptysis, taste perversion, rash
  • Serious: bronchospasm, hearing loss, nephrotoxicity

Interactions

  • Other drugs with neurotoxic, nephrotoxic or ototoxic potential: avoid
  • Ethacrynic acid, furosemide, urea or intravenous mannitol: should not be given concomitantly

Pregnancy and breastfeeding

  • Aminoglycosides can cause fetal harm (congenital deafness reported with streptomycin); systemic absorption after inhalation is expected to be minimal

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • BramitobChiesi Pharmaceuticals Gmbh · 1 register entry
  • TobiViatris Healthcare Limited · 1 register entry
  • TobrasixInfectopharm Arzneimittel Und Consilium Gmbh, De, Heppenheim · 1 register entry
  • TobrexNovartis Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • BramitobChiesi Gmbh · 1 register entry
  • GernebcinInfectopharm Arzneimittel Und Consilium Gmbh, De, Heppenheim · 1 register entry
  • TobiViatris Healthcare Gmbh · 1 register entry
  • TobramaxinNovartis Pharma Gmbh · 1 register entry
  • Tobramycin AliudAliud Pharma Gmbh · 1 register entry
  • Tobramycin AristoAristo Pharma Gmbh (Art 57) · 1 register entry
  • Tobramycin InfectopharmInfectopharm Arzneimittel Und Consilium Gmbh, De, Heppenheim · 1 register entry
  • Tobramycin SunSun Pharmaceuticals Germany Gmbh · 1 register entry
  • Tobramycin TevaTeva Gmbh · 1 register entry
  • Tobramycin ZentivaZentiva Pharma Gmbh · 1 register entry
  • TobrazidInfectopharm Arzneimittel Und Consilium Gmbh, De, Heppenheim · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • AirfibroPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • KfibrogenGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 1 register entry
  • TobelNOBEL İLAÇ SAN. VE TİC. A.Ş. · 8 register entries
  • TobiVİATRİS İLAÇLARI LİMİTED ŞİRKETİ · 1 register entry
  • ToblairVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • BethkisChiesi USA, Inc. · 1 register entry
  • Kitabis PakPari Respiratory Equipment, Inc. · 1 register entry
  • TobiViatris Specialty LLC · 1 register entry
  • TOBI PodhalerViatris Specialty LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 28 more European countries
Belgium
Obracin, Tobi, Tobrex
Bulgaria
Tобрекс, Тобрамизил, Тобрамицин Виа Фарма, Тобримед, Тобрин
Croatia
Bramitob, Tobrex
Cyprus
Bramitob, Ikobel, Tobi, Tobrex
Czechia
Bramitob, Tobramycin Vioser, Tobrex
Denmark
Nebcina, Tobi, Tobramycin Sun, Tobramycin Teva
Estonia
Tobramycin Via Pharma, Tobrex
Finland
Tobi
France
Nebcine, Tobi, Tobrabact, Tobramycine Medac, Tobramycine Sun, Tobramycine Zentiva, Tobrex
Greece
Bramitob, Eyetobrin, Ikobel, Tobi, Tobramycin Vioser, Tobrex
Hungary
Bramitob, Brulamycin, Tobi, Tobramycin Via Pharma, Tobrex
Iceland
Tobi Podhaler, Vantobra
Ireland
Bramitob, Tobi, Tobramycin Pfizer Healthcare Ireland, Tymbrineb
Italy
Bramicil, Bramitob, Iridina Antibiotico, Mitobrin, Nebicina Flaconcino, Ocupix, Paidomicina, Tobral, Tobramicina, Tobrastill, Tobrineb
Latvia
Bramitob, Tobramycin Via Pharma, Tobrex
Liechtenstein
Tobi Podhaler, Vantobra
Lithuania
Bramitob, Tobramycin Via Pharma, Tobrex, Tobrin
Luxembourg
Obracin, Tobi, Tobrex
Malta
Tobi, Tobrex
Netherlands
Bramitob, Obracin, Tobi, Tobrabact, Tobramycine Aristo, Tobramycine Cf, Tobramycine Steri-Neb Teva Nederland, Tobramycine Sun, Tobrex
Norway
Bramitob, Nebcina, Tobi, Vantobra
Poland
Bramitob, Tobramycin Via Pharma, Tobramycyna Sun, Tobrex
Portugal
Bramitob, Tobi, Tobramicina Accord, Tobramicina Altan, Tobramicina Labesfal, Tobramicina Medichem, Tobramicina Teva, Tobrex, Ursitan
Romania
Tobi, Tobramicină Sun, Tobramycin Via Pharma, Tobrex, Tobrom
Slovakia
Bramitob, Tobrex
Slovenia
Tobrex
Spain
Bramitob, Tobrabact, Tobramicina Accord, Tobramicina Altan, Tobramicina Normon, Tobramicina Sun, Tobrex, Ursitan
Sweden
Bramitob, Nebcina, Tobi, Tobramycin Eql Pharma

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. TOBI (Viatris Specialty LLC) – Prescribing Information, 2025-11-15. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6a3c3871-1d3a-44d6-8be3-526b30123ef7
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC J01GB.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.