Tobramycin eent

T

Class: Antibacterials
CAS Number: 32986-56-4
Brands: AK-Tob, TobraDex, Tobrex, Zylet

Introduction

Antibacterial; aminoglycoside antibiotic produced by Streptomyces tenebrarius.1 2 a d e

Uses for Tobramycin Bacterial Ophthalmic Infections

Treatment of superficial infections of the eye caused by susceptible bacteria.1 2 d e

Used alone or in fixed combination with topical corticosteroids (e.g., dexamethasone, loteprednol etabonate) when such combination therapy is indicated.3 4 5 (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Tobramycin Dosage and Administration General

Monitor for bacterial response during therapy.d e

A 5- to 7-day course of anti-infective therapy usually is adequate for the treatment of mild bacterial conjunctivitis.6

Administration Ophthalmic Administration

Apply topically to the eye(s) as an ophthalmic ointment, solution, or suspension.1 2 3 4 5 e For ophthalmic use only.b e

Not for injection;1 2 3 4 5 e do not inject subconjunctivally or directly into the anterior chamber of the eye.1 2 5 b c

Shake suspension vigorously prior to use.3 5

Do not administer suspensions containing benzalkonium chloride while wearing soft contact lenses.5 b (See Advice to Patients.)

Avoid contamination of preparation container.1 2 3 4 5 e

Dosage Pediatric Patients Bacterial Ophthalmic Infections Tobramycin 0.3% Ophthalmic Ointment

Children ?2 months of age, mild-to-moderate infections: Apply a 1.25-cm ribbon to the affected eye(s) 2–3 times daily.d

Children ?2 months of age, severe infections: Apply a 1.25-cm ribbon to the affected eye(s) every 3–4 hours.d Decrease dosing frequency when improvement occurs.d

Ophthalmic Solution

Children ?2 months of age, mild-to-moderate infections: 1 or 2 drops into the affected eye(s) every 4 hours.e

Children ?2 months of age, severe infections: 2 drops into the affected eye(s) every hour.e Decrease dosing frequency when improvement occurs.e

Tobramycin 0.3% and Dexamethasone 0.1% Ophthalmic Ointment

Children ?2 years of age: Apply a 1.25-cm ribbon into the conjunctival sac of affected eye(s) up to 3 or 4 times daily.c

Ophthalmic Suspension

Children ?2 years of age: Initial 24–48 hours, 1 or 2 drops into the affected eye(s) every 2 hours.b Thereafter, 1 or 2 drops every 4–6 hours.b Decrease dosing frequency when improvement occurs.b Do not discontinue prematurely.b

Adults Bacterial Ophthalmic Infections Tobramycin 0.3% Ophthalmic Ointment

Mild-to-moderate infections: Apply a 1.25-cm ribbon to the affected eye(s) 2–3 times daily.d

Severe infections: Apply a 1.25-cm ribbon to the affected eye(s) every 3–4 hours.d Decrease dosing frequency when improvement occurs.d

Ophthalmic Solution

Mild-to-moderate infections: 1 or 2 drops into the affected eye(s) every 4 hours.e

Severe infections: 2 drops into the affected eye(s) every hour.e Decrease dosing frequency when improvement occurs.e

Tobramycin 0.3% and Dexamethasone 0.1% Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of affected eye(s) up to 3 or 4 times daily.c

Ophthalmic Suspension

Initial 24–48 hours: 1 or 2 drops into the conjunctival sac of the affected eye(s) every 2 hours.b Thereafter, 1 or 2 drops every 4–6 hours.b Decrease dosing frequency when improvement occurs.b Do not discontinue prematurely.b

Tobramycin 0.3% and Loteprednol Etabonate 0.5% Ophthalmic Suspension

Initial 24–48 hours: 1 or 2 drops into the conjunctival sac of affected eye(s) every 1–2 hours.5 Thereafter, 1 or 2 drops every 4–6 hours.5 Decrease dosing frequency when improvement occurs.5 Do not discontinue prematurely.5

Cautions for Tobramycin Contraindications

Known hypersensitivity to tobramycin or any ingredient in the formulation.1 2 5 b c e

Warnings/Precautions Sensitivity Reactions

Hypersensitivity reported.1 2 5 b c If hypersensitivity occurs, discontinue the drug.1 2 5 b c e

Cross-allergenicity occurs among the aminoglycosides.1 2 5 b c e

General Precautions Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.1 2 5 b c e If superinfection occurs, discontinue the drug and institute appropriate therapy.1 2 5 c e

Infection Complications

Ophthalmic ointments may delay corneal healing.c d

Use of Fixed Combinations Containing Corticosteroids

Concomitant topical corticosteroids may mask clinical signs of bacterial, fungal, or viral infections, prevent recognition of ineffectiveness of the antibiotic, or may suppress hypersensitivity reactions to ingredients in the formulation.3 4 5

When tobramycin is used in fixed combination with a corticosteroid, consider the cautions, precautions, and contraindications associated with EENT corticosteroids.3 4 5

Specific Populations Pregnancy

Category B.1 2 e

In fixed combination with dexamethasone or loteprednol etabonate: Category C.5 b c

Lactation

Discontinue nursing or the drug.1 2 e

Pediatric Use

Safety and efficacy of tobramycin ophthalmic ointment or ophthalmic solution not established in children <2 months of age.1 d e

Safety and efficacy of tobramycin in fixed combination with dexamethasone (ophthalmic ointment or ophthalmic suspension) not established in children <2 years of age.3 4 b c

Safety and efficacy of loteprednol etabonate in fixed combination with tobramycin ophthalmic suspension not established.5

Geriatric Use

No overall differences in safety and efficacy observed between geriatric and younger adults.1 5 b c d e

Common Adverse Effects

Itching and edema of the eyelid, conjunctival erythema.1 2 5 b

Tobramycin Pharmacokinetics Absorption Bioavailability

Not known if absorbed into the vitreous humor following topical instillation; absorption greatest when the cornea is abraded.a

Stability Storage Ophthalmic Ointment

Tobramycin alone and tobramycin in fixed combination with dexamethasone: 8–27°C.2 c

Solution

Tobramycin: 8–27°C.e

Suspension

Tobramycin in fixed combination with dexamethasone: Upright container at 8–27°C.b

Loteprednol etabonate in fixed combination with tobramycin: Upright container at 15–25°C; do not freeze.5

Actions and SpectrumActions

Usually bactericidal.a

Exact mechanism of action not fully elucidated; appears to inhibit protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.a

Spectrum of activity of tobramycin includes many aerobic gram-negative bacteria and some aerobic gram-positive bacteria.1 2

Inactive against Chlamydia, fungi, viruses, and most anaerobic bacteria.a

Gram-positive aerobes: Active against Staphylococcus aureus, S. epidermidis, and some streptococci.1 2 3 4 5 e

Gram-negative aerobes: Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, some Neisseria, Moraxella lacunata, Proteus, and Pseudomonas aeruginosa.1 2 3 4 5 e

Partial cross-resistance occurs between tobramycin and other aminoglycosides.a

Advice to Patients

Importance of discontinuing therapy and consulting clinician if condition persists or deteriorates or signs of sensitivity occur.1 2 3 4 5

Importance of learning and adhering to proper administration techniques to avoid contamination of the product.1 2 3 4 5 e

Importance of not wearing contact lenses if signs and symptoms of bacterial ocular infection occur.1 b c e When using an ophthalmic preparation that contains benzalkonium chloride, importance of not wearing soft contact lenses.5

Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 2 3 4 5

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2 3 4 5

Importance of informing patients of other important precautionary information.1 2 3 4 5 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Tobramycin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

0.3%

Tobrex (with chlorobutanol)

Alcon

Solution

0.3%*

AK-Tob (with benzalkonium chloride)

Akorn

Tobramycin

Bausch & Lomb, Falcon

Tobrex (with benzalkonium chloride)

Alcon

Tobramycin and Dexamethasone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

0.3% Tobramycin and Dexamethasone 0.1%

TobraDex (with chlorobutanol)

Alcon

Suspension

0.3% Tobramycin and Dexamethasone 0.1%

TobraDex (with benzalkonium chloride)

Alcon

Other Tobramycin Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Suspension

0.3% with Loteprednol Etabonate 0.5%

Zylet (with benzalkonium chloride and povidone)

Bausch & Lomb

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

TobraDex 0.3-0.1% Ointment (ALCON VISION): 3/$139.99 or 10/$400.95

TobraDex 0.3-0.1% Suspension (ALCON VISION): 2/$61.99 or 7/$159.97

TobraDex 0.3-0.1% Suspension (ALCON VISION): 5/$112.99 or 15/$320.96

Tobramycin Sulfate 0.3% Solution (BAUSCH &amp; LOMB): 5/$15.99 or 10/$22.98

Tobramycin-Dexamethasone 0.3-0.1% Suspension (FALCON PHARMACEUTICALS): 10/$129.98 or 30/$359.96

Tobramycin-Dexamethasone 0.3-0.1% Suspension (FALCON PHARMACEUTICALS): 5/$69.99 or 15/$179.98

Tobrex 0.3% Ointment (ALCON VISION): 3/$84.99 or 10/$227.98

Tobrex 0.3% Solution (ALCON VISION): 5/$66.56 or 15/$185.2

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Falcon Pharmaceuticals. Tobramycin ophthalmic solution USP, 0.3% prescribing information. Ft. Worth, TX; 2003 Nov.

2. Alcon. Tobrex (tobramycin 0.3%) Ophthalmic ointment prescribing information. In: Physicians’ desk reference for ophthalmic medicines. 30th ed. Montevale, NJ; Medical Economics Company. 2002:220-1.

3. Alcon. Tobradex (tobramycin and dexamethasone) ophthalmic suspension information. In: Physicians’ desk reference for ophthalmic medicines. 32nd ed. Montevale, NJ; Thompson Healthcare Inc; 2004:209-10.

4. Alcon. Tobradex (tobramycin and dexamethasone) Ophthalmic ointment sterile prescribing information. In: Physicians’ desk reference for ophthalmic medicines. 32nd ed. Montevale, NJ; Thompson Healthcare Inc; 2004:210-11.

5. Bausch & Lomb Pharmaceuticals, Inc. Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%) ophthalmic suspension prescribing information. Tampa, FL; 2004 Dec.

6. American Academy of Ophthalmology. Preferred Practice Pattern: Conjunctivitis. 2003. From the American Academy of Ophthalmology website () Accessed 11 May 2006.

a. AHFS drug information 2008. McEvoy GK, ed. Tobramycin. Bethesda, MD: American Society of Health-System Pharmacists; 2008: 2756-7.

b. Alcon Laboratories, Inc. Tobradex (tobramycin and dexamethasone ophthalmic suspension) prescribing information. Fort Worth, TX; 2006 May.

c. Alcon Laboratories, Inc. Tobradex (tobramycin and dexamethasone ophthalmic ointment) prescribing information. Fort Worth, TX; 2003 Oct.

d. Alcon Laboratories, Inc. Tobrex (tobramycin ophthalmic ointment) 0.3% prescribing information. Fort Worth, TX; 2003 Oct.

e. Alcon Laboratories, Inc. Tobrex (tobramycin ophthalmic solution) 0.3% prescribing information. Fort Worth, TX; 2003 Sept.

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