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Tobrex

Tobrex

Generic Name: tobramycin (Ophthalmic route)

toe-bra-MYE-sin

OverviewSide EffectsFor ProfessionalsMore…

Commonly used brand name(s)

In the U.S.

  • AKTob
  • Tobrasol
  • Tobrex

In Canada

  • Apo-Tobramycin
  • Sab-Tobramycin
  • Tomycine

Available Dosage Forms:

  • Ointment
  • Solution

Therapeutic Class: Antibiotic

Chemical Class: Aminoglycoside

Uses For Tobrex

Ophthalmic tobramycin is used in the eye to treat bacterial infections of the eye. Tobramycin works by killing bacteria.

Ophthalmic tobramycin may be used alone or with other medicines for eye infections. Either the drops or the ointment form of this medicine may be used alone during the day. In addition, both forms may be used together, with the drops being used during the day and the ointment at night.

Tobramycin ophthalmic preparations are available only with your doctor’s prescription.

Before Using Tobrex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ophthalmic tobramycin in the elderly with use in other age groups.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alcuronium
  • Atracurium
  • Cidofovir
  • Cisatracurium
  • Colistimethate Sodium
  • Decamethonium
  • Doxacurium
  • Ethacrynic Acid
  • Fazadinium
  • Furosemide
  • Gallamine
  • Hexafluorenium
  • Lysine
  • Metocurine
  • Mivacurium
  • Pancuronium
  • Pipecuronium
  • Rapacuronium
  • Rocuronium
  • Succinylcholine
  • Tacrolimus
  • Tubocurarine
  • Vancomycin
  • Vecuronium

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cisplatin
  • Cyclosporine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of tobramycin

This section provides information on the proper use of a number of products that contain tobramycin. It may not be specific to Tobrex. Please read with care.

For patients using tobramycin ophthalmic solution (eye drops):

  • The bottle is only partially full to provide proper drop control.
  • To use:
    • First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes, to allow the medicine to come into contact with the infection.
    • If you think you did not get the drop of medicine into your eye properly, use another drop.
    • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.
  • If your doctor ordered two different ophthalmic solutions to be used together, wait at least 5 minutes between the times you apply the medicines. This will help to keep the second medicine from “washing out” the first one.

For patients using tobramycin ophthalmic ointment (eye ointment):

  • To use:
    • First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1.25-cm (approximately ½-inch) strip of ointment usually is enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes and keep them closed for 1 or 2 minutes, to allow the medicine to come into contact with the infection.
    • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using tobramycin eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

To help clear up your eye infection completely, keep using tobramycin for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For ophthalmic ointment dosage forms:
    • For mild to moderate infections:
      • Adults and children—Use every eight to twelve hours.
    • For severe infections:
      • Adults and children—Use every three to four hours until improvement occurs.
  • For ophthalmic solution (eye drops) dosage forms:
    • For mild to moderate infections:
      • Adults and children—One drop every four hours.
    • For severe infections:
      • Adults and children—One drop every hour until improvement occurs.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Tobrex

If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor.

Tobrex Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  • Itching, redness, swelling, or other sign of eye or eyelid irritation not present before use of this medicine

Symptoms of overdose

  • Increased watering of the eyes
  • itching, redness, or swelling of the eyes or eyelids
  • painful irritation of the clear front part of the eye

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Burning or stinging of the eyes

Eye ointments usually cause your vision to blur for a few minutes after application.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Tobrex side effects (in more detail)

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Tobrex

Tobrex

Generic Name: tobramycin ophthalmic (TOE bra MYE sin off THAL mik)

Brand Name: Aktob, Tobralcon, Tobrasol, Tobrex

OverviewSide EffectsFor ProfessionalsMore…

What is Tobrex (tobramycin ophthalmic)?

Tobramycin ophthalmic is an antibiotic.

Tobramycin ophthalmic is used to treat bacterial infections of the eyes.

Tobramycin ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Tobrex (tobramycin ophthalmic)?

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down the tear ducts.

What should I discuss with my healthcare provider before using Tobrex (tobramycin ophthalmic)?

Do not use tobramycin ophthalmic if you have a viral or fungal infection in the eye. It is used to treat infections caused by bacteria only.

Tobramycin ophthalmic is in the FDA pregnancy category B. This means that it is unlikely to be harmful to an unborn baby. Do not use tobramycin ophthalmic without first talking to your doctor if you are pregnant.

It is not known whether tobramycin ophthalmic passes into breast milk. Do not use tobramycin ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use Tobrex (tobramycin ophthalmic)?

Use tobramycin ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eyedrops or ointment.

To apply the eyedrops:

  • Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye, repeat the process with about 5 minutes between drops. If you are using drops in both eyes, repeat the process in the other eye.

To apply the ointment:

  • Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before applying the other medication.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye.

Do not use any eyedrop that is discolored or has particles in it.

Store tobramycin ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose or if the medication has been ingested, call an emergency room or poison control center for advice.

What should I avoid while using Tobrex (tobramycin ophthalmic)?

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye.

Use caution when driving, operating machinery, or performing other hazardous activities. Tobramycin ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with tobramycin ophthalmic. After applying the medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with tobramycin ophthalmic unless otherwise directed by your doctor.

Tobrex (tobramycin ophthalmic) side effects

Serious side effects are not expected with this medication.

Commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Tobrex side effects (in more detail)

What other drugs will affect Tobrex (tobramycin ophthalmic)?

Do not use other eye drops or medications during treatment with tobramycin ophthalmic unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with tobramycin ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Next Page → Side Effects

More Tobrex resources

  • Side Effects
  • Pregnancy Warnings
  • Support Group
  • 0 Reviews - Add your own review/rating
  • Generic Availability
  • Tobrex Prescribing Information (FDA)
  • Tobrex Advanced Consumer (Micromedex) – Includes Dosage Information
  • Tobrex drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Tobrex with other medications

  • Conjunctivitis, Bacterial

Where can I get more information?

  • Your pharmacist has additional information about tobramycin ophthalmic written for health professionals that you may read.

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Tobrex

Tobrex

Generic Name: tobramycin

Dosage Form: ophthalmic solution

For ProfessionalsSide EffectsDosageMore…

Tobrex®

(tobramycin ophthalmic solution) 0.3%

DESCRIPTION

Tobrex® (tobramycin ophthalmic solution) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.

Each mL of Tobrex® solution contains: Active: tobramycin 0.3% (3 mg). Preservative: benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and purified water. Tobrex® (tobramycin ophthalmic solution) 0.3% has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg.

Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.

The chemical structure of tobramycin is:

Molecular Weight = 467.52

Molecular Formula: C18H37N5O9

Chemical name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine.

CLINICAL PHARMACOLOGY

In Vitro Data: In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

INDICATIONS AND USAGE

Tobrex® (tobramycin ophthalmic solution) 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®. Clinical studies have shown tobramycin to be safe and effective for use in children.

CONTRAINDICATIONS

Tobrex® (tobramycin ophthalmic solution) 0.3% is contraindicated in patients with known hyper sensitivity to any of its components.

WARNINGS

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to Tobrex® (tobramycin ophthalmic solution) 0.3% occurs, discontinue use.

PRECAUTIONS

General

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.

Information For Patients

Do not touch dropper tip to any surface, as this may contaminate the solution.

Pregnancy Category B

Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Because of the potential for adverse reactions in nursing infants from Tobrex®, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 months has not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

The most frequent adverse reactions to Tobrex® Ophthalmic Solution 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®. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from Tobrex® (tobramycin ophthalmic solution) 0.3% therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

OVERDOSAGE

Clinically apparent signs and symptoms of an overdose of Tobrex® (tobramycin ophthalmic solution) 0.3% (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

DOSAGE AND ADMINISTRATION

In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.

HOW SUPPLIED

5 mL sterile solution is packaged in a 8 mL low density polyethylene white DROP-TAINER® bottle and natural dispensing plug and white polypropylene closure (NDC 0065-0643-05) containing tobramycin 0.3% (3 mg/mL).

Storage: Store at 2° – 25°C (36° – 77°F).

Rx Only

© 2000-2003, 2012 Novartis

Revised: June 2012

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Printed in USA

9008199-0712

PRINCIPAL DISPLAY PANEL

NDC 0065-0643-05

Alcon®

Tobrex®

(tobramycin ophthalmic solution) 0.3%

5mL Sterile

Tobrex  

tobramycin solution

Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0065-0643
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOBRAMYCIN (TOBRAMYCIN) TOBRAMYCIN 3 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
BORIC ACID  
SODIUM SULFATE  
SODIUM CHLORIDE  
TYLOXAPOL  
SODIUM HYDROXIDE  
SULFURIC ACID  
WATER  
Packaging
# Item Code Package Description
1 NDC:0065-0643-05 5 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050541 03/15/1981
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Operations
Alcon Laboratories, Inc. 008018525 MANUFACTURE(0065-0643)

Revised: 11/2012   Alcon Laboratories, Inc.

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