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Tobramycin (ophthalmic): Drug information

Tobramycin (ophthalmic): Drug information
(For additional information see "Tobramycin (ophthalmic): Patient drug information" and see "Tobramycin (ophthalmic): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Tobrex
Brand Names: Canada
  • Crown Ak-Tobra;
  • SANDOZ Tobramycin;
  • Tobrex
Pharmacologic Category
  • Antibiotic, Aminoglycoside;
  • Antibiotic, Ophthalmic
Dosing: Adult
Ocular infections

Ocular infections: Ophthalmic:

Ointment: Apply half-inch ribbon into affected eye(s) 2 or 3 times daily for mild to moderate infections; for severe infections, apply every 3 to 4 hours until improvement (then reduce prior to discontinuation).

Solution: Instill 1 to 2 drops into affected eye(s) every 4 hours for mild to moderate infections; for severe infections, instill 2 drops every hour until improvement (then reduce prior to discontinuation).

Viscous solution (Tobrexan [Canadian product]): Instill 1 drop into affected eye(s) 2 times daily for 7 days for mild to moderate infections; for severe infections, instill 1 drop 4 times daily on day 1 and then 2 times daily for duration of treatment period.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Tobramycin (ophthalmic): Pediatric drug information")

Ocular infections

Ocular infections: Ophthalmic: Infants ≥2 months, Children, and Adolescents:

Ointment:

Mild to moderate infections: Apply 1/2 inch ribbon into the affected eye(s) 2 to 3 times daily

Severe infections: Apply 1/2 inch ribbon into the affected eye(s) every 3 to 4 hours initially until improvement, then reduce to less frequent intervals prior to discontinuation

Solution:

Mild to moderate infections: Instill 1 to 2 drops into the affected eye(s) every 4 hours

Severe infections: Instill 2 drops into the affected eye(s) every hour initially until improvement, then reduce to less frequent intervals prior to discontinuation

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

<1%:

Hypersensitivity: Hypersensitivity reaction

Ophthalmic: Conjunctival erythema, eyelid edema, eyelid pruritus, ocular toxicity (localized)

Postmarketing:

Dermatologic: Erythema multiforme, Stevens-Johnson syndrome

Hypersensitivity: Anaphylaxis

Contraindications

Hypersensitivity to tobramycin or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Known hypersensitivity to any aminoglycoside

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Sensitivity varying from local to generalized effects (eg, erythema, pruritus, urticaria, skin rash, anaphylaxis, anaphylactoid reaction, bullous reaction) to topically applied aminoglycosides and cross sensitivity to other aminoglycosides antibiotics may occur; discontinue use if hypersensitivity develops.

• Superinfection: Prolonged use may lead to overgrowth of nonsusceptible organisms, including fungi. If superinfection is suspected, institute appropriate alternative therapy.

Special populations:

• Contact lens wearers: Some products may contain benzalkonium chloride or benzododecinium bromide which may be absorbed by soft contact lenses; contact lenses should not be worn during treatment of ophthalmologic infections.

Other warnings/precautions:

• Appropriate use: For topical application to the eye only; not for injection. To avoid contamination, do not touch tip of container to any surface.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Ointment, Ophthalmic:

Tobrex: 0.3% (3.5 g [DSC])

Tobrex: 0.3% (3.5 g) [contains chlorobutanol (chlorobutol)]

Solution, Ophthalmic:

Tobrex: 0.3% (5 mL [DSC])

Generic: 0.3% (5 mL)

Generic Equivalent Available: US

May be product dependent

Pricing: US

Ointment (Tobrex Ophthalmic)

0.3% (per gram): $84.81

Solution (Tobramycin Ophthalmic)

0.3% (per mL): $1.25 - $6.80

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, Ophthalmic:

Tobrex: 0.3% (3.5 g) [contains chlorobutanol (chlorobutol)]

Solution, Ophthalmic:

Crown Ak-Tobra: 0.3% (5 mL)

Tobrex: 0.3% (5 mL) [contains benzalkonium chloride]

Generic: 0.3% (5 mL)

Administration: Adult

For topical ophthalmic use only; not for injection into the eye. Contact lenses should not be worn during treatment of ophthalmic infections. Avoid contaminating the applicator tip with affected eye(s).

Ointment: Apply into conjunctival sac(s) of eye; patient should look downward before closing eye.

Administration: Pediatric

For topical ophthalmic use only; not for injection into the eye. Contact lenses should not be worn during treatment of ophthalmic infections. Avoid contact of tube or bottle tip with skin or eye.

Ointment: Apply into conjunctival sac(s) of eye; patient should look downward before closing eye

Solution: Apply gentle pressure to lacrimal sac during and immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration, to decrease systemic absorption of ophthalmic drops (Ref).

Use: Labeled Indications

Ocular infections: Treatment of external infections of the eye and its adnexa caused by susceptible bacteria.

Medication Safety Issues
Sound-alike/look-alike issues:

Tobramycin may be confused with Trobicin, vancomycin

Tobrex may be confused with TobraDex

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. The amount of tobramycin available systemically following topical application of the ophthalmic drops is undetectable (<0.2 mcg/mL) (Filatov 1994). If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease systemic absorption (Samples 1988).

Breastfeeding Considerations

The amount of tobramycin available systemically following topical application of the ophthalmic drops is undetectable (<0.2 mcg/mL) (Filatov 1994). If ophthalmic agents are needed in lactating women, the minimum effective dose should be used in combination with punctal occlusion to decrease systemic absorption (Samples 1988).

Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.

Mechanism of Action

Interferes with bacterial protein synthesis by binding to 30S ribosomal subunit resulting in a defective bacterial cell membrane

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Systemic absorption: Undetectable (<0.2 mcg/mL) (Filatov 1994); tear film exposure and time above MIC90 are significantly greater with viscous ophthalmic solution [Canadian product] (Tobrexan Canadian product labeling).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Tobrex | Tobrin;
  • (AR) Argentina: Bideon Biotic | Bio eyes biotic | Fotex | Gotabiotic | Klonamicin | Oftalbrax | Radina | Tobra-M | Tobragan | Tobral | Tobralep | Tobraler | Tobramicina Atlas | Tobramicina dorf | Tobramicina tetrafarm | Tobranet | Tobrex | Xao-t | Xibrax;
  • (AT) Austria: Tobrex;
  • (AU) Australia: Tobrex;
  • (BD) Bangladesh: Cinarex | Eytob | Gentob | Intobac | T-mycin | Tobcin | Tobi | Tobirax | Tobrabac | Tobracin | Tobramin | Tobrel | Tobrex | Tomycin;
  • (BE) Belgium: Tobrex;
  • (BF) Burkina Faso: Tobrex;
  • (BG) Bulgaria: Tobramysil | Tobrex | Tobrex 2x | Tobrin | Tobrom;
  • (BR) Brazil: Tobracin | Tobracular | Tobragan | Tobralox | Tobramicina | Tobranom | Tobrex | Toflamixina;
  • (CH) Switzerland: Tobrex;
  • (CL) Chile: Notrix | Tobragan | Tobrex | Tobrin | Trazil | Xolof;
  • (CN) China: Eyebrex | Jia nuo tai | Tobrex | Xin tuo ming;
  • (CO) Colombia: Ocumicin | Oftalmotrisol tobramicina | Oftitob | Tobragan | Tobramicina | Tobramisol | Tobramixin | Tobraoftal | Tobravision | Tobrex | Tobroptic simple;
  • (CZ) Czech Republic: Brulamycin | Tobrex | Tobrex LA;
  • (DE) Germany: Tobramaxin;
  • (DO) Dominican Republic: Obicin | Obry | Poentobral | Tobramicina | Tobrex | Tobrimin | Tosobrel | Trazil ofteno | Trazil ungena | Xolof;
  • (EC) Ecuador: Oxialbrex | Poentobral | Tobral | Tobravision | Tobrex | Xolof;
  • (EE) Estonia: Tobrex | Tobrex 2x;
  • (EG) Egypt: Avazir | T grand | Thalmotobrin | Tobractiva | Tobral | Tobralex | Tobrex | Tobrex 2x | Tobrin;
  • (ES) Spain: Tobrabact | Tobrex | Tobrexan;
  • (ET) Ethiopia: Tobacin | Tobrastill;
  • (FI) Finland: Tobrex;
  • (FR) France: Tobrex | Tobrex l.p.;
  • (GB) United Kingdom: Tobralex | Tobravisc;
  • (GR) Greece: Colther | Eyebrex | Eyetobrin | Ikobel | Thilo micine | Tobrex;
  • (HK) Hong Kong: Kamin | Ocle | Ocusyn | Tobra | Tobrastill | Tobrex | Toracin;
  • (HR) Croatia: Tobrex;
  • (HU) Hungary: Brulamycin | Tobrex;
  • (ID) Indonesia: Bralifex | Cendo Tobro | Isotic tobryne | Tobrex;
  • (IL) Israel: Tobrex;
  • (IN) India: Eyebrex | Gb-Cin | Ibrex | Itocin | Kindercin | Nebracin | Obra | Obrin | Ocutob | Optob | Switob | Toba | Tobaren | Tobasafe | Tobastar | Tobazon | Tobcin | Tobrabact | Tobracad | Tobracid | Tobracin | Tobrafil | Tobrop | Tocin | Tojawa | Tozen | Tromacyn | Vanmycetin-t | Zentob;
  • (IT) Italy: Mitobrin | Ocupix | Paidomicina | Rocotob | Timorreb | Tobrabact | Tobral | Tobral oto | Tobramicina doc generici | Tobramicina eg | Tobrastil;
  • (JO) Jordan: Ikobel | Tobracin | Tobrastill | Tobrex;
  • (JP) Japan: Tobracin | Tobracin eli lilly | Tobracin nidek;
  • (KE) Kenya: Alemtob | Bracin | Ocutob;
  • (KR) Korea, Republic of: Aitocin | Bitobra | Eyetobra | Eyetocin | Huons tobramycin | Mp tovramycin | Ocle | Ocuracin | Optimai | Optimy | Retobra | Ritobra | Tob | Tob i | Tob m | Tobacin | Tobaeyen | Tobca | Toberan | Tobeye | Tobian | Tobin | Tobistar | Tobra | Tobrabact | Tobracin | Tobramax | Tobramin | Tobran | Tobrased | Tobrex | Toeyecin | Toma | Tomacin | Toracin | Toramicin | Toraone | Torasin | Toravin | Trona | Tronamycin | Union topracin;
  • (KW) Kuwait: Tobrex | Tobrin;
  • (LB) Lebanon: Eyetobrin | Tobracin | Tobrastill | Tobrex;
  • (LT) Lithuania: Brulamycin | Tobrex | Tobrin;
  • (LU) Luxembourg: Tobrex;
  • (LV) Latvia: Brulamycin | Tobrex;
  • (MA) Morocco: Tobrex;
  • (MX) Mexico: Bircel | Contycol | Eyebrex | Isenia | Marunol | Micitrex | Obry | Tobramicina | Tobramicina grin | Tobrex | Trazil | Trazil ofteno | Trazil ungena | Verbram;
  • (MY) Malaysia: Tobrex;
  • (NG) Nigeria: Tobralin;
  • (NL) Netherlands: Tobrabact | Tobrex | Tobrex B.I.D.;
  • (NO) Norway: Tobrex;
  • (NZ) New Zealand: Tobrex;
  • (PE) Peru: Gotabiotic | Tobragan | Tobramicina | Tobramicina wasser | Tobramixin | Tobrazol | Tobrex | Trazil ofteno | Trazil ungena | Unitob;
  • (PH) Philippines: Celsus Tobramycin | Eotob | Ramitop | Sensomed Tobramycin | T-mycin | Tobra V | Tobrabact | Tobralcin | Tobramex | Tobrex | Tomracin;
  • (PK) Pakistan: Bracin | Brexil | Bromycin | Brulacil | Brulamycin | Eyebrex | Nebra | Neobrex | Obrex | Ocucid | Ocutob | Ophth-Tobra | Optibrex | Orbacin | Orcy | Ototob | Revicure | Santobrex | Tobarin | Tobra | Tobracin | Tobralux | Tobraxia | Tobrex | Toma | Tozen;
  • (PL) Poland: Brulamycin | Tobrex | Tobrexan | Tobrosopt;
  • (PR) Puerto Rico: Aktob | Tobrex | Tomycine;
  • (PT) Portugal: Tobrex | Tobridavi;
  • (PY) Paraguay: Citol tobramicina | Oftalmol t | Tobrex | Tolbet | Xolof;
  • (RO) Romania: Brulamycin | Ikobel;
  • (RU) Russian Federation: Alemtob | Brulamycin | Dilaterol | Tobrex | Tobrex 2x | Tobriss | Tobropt | Tobrosopt;
  • (SA) Saudi Arabia: Tobracin | Tobrex;
  • (SE) Sweden: Tobrex;
  • (SG) Singapore: Tobra | Tobrex;
  • (SI) Slovenia: Tobrex;
  • (SK) Slovakia: Brulamycin | Tobravisc | Tobrex;
  • (TH) Thailand: Brulamycin | Tobrabact | Tobrex;
  • (TN) Tunisia: Tobracol | Tobrex;
  • (TR) Turkey: Obramis | Oftamycin | Thilomaxine | Tobrased | Tobrex;
  • (TW) Taiwan: Biomicin | Kamin | Tobacin | Tobra | Tobrex | Tocin;
  • (UA) Ukraine: Brulamycin | Tobramycin pharmex | Tobrex | Tobrex 2x | Tobrin | Tobrocim next;
  • (UG) Uganda: Tobrin;
  • (UY) Uruguay: Belpar | Beyonas tobra | Bioptic | Coxel | Gotabiotic | Tobrabiotic | Tobramicina | Tobramin | Tobrex | Toflamixina | Trazil ofteno | Xolof;
  • (VE) Venezuela, Bolivarian Republic of: Poentobral | Tobramicina | Tobranax | Tobrasol | Tobrex | Tomycin | Trazil;
  • (ZA) South Africa: Tobrex | Toryn;
  • (ZM) Zambia: Optob | Tobrex
  1. Filatov V, Alexandrakis G, Rainey PM, Perazella MA, Gloor P. No detectable systemic absorption of topically administered ophthalmic tobramycin. Am J Ophthalmol. 1994;117(3):402-403. [PubMed 8129019]
  2. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623. [PubMed 2903673]
  3. Tobrex ointment (tobramycin ophthalmic) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2021.
  4. Tobrex ointment and solution (tobramycin ophthalmic) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; February 2020.
  5. Tobrex solution (tobramycin ophthalmic) [prescribing information]. Fort Worth, TX: Alcon Laboratories Inc; May 2021.
  6. Tobrexan viscous solution (tobramycin ophthalmic) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; October 2017.
  7. Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol. 1993;37(6):435-456. [PubMed 8100087]
  8. Zimmerman TJ, Kooner KS, Kandarakis AS, Ziegler LP. Improving the therapeutic index of topically applied ocular drugs. Arch Ophthalmol. 1984;102(4):551-553. [PubMed 6704011]
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