Tobradex

DRUG DESCRIPTION

TOBRADEX®(tobramycin and dexamethasone ophthalmic suspension) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use.

The chemical structures for tobramycin and dexamethasone are presented below:

Tobramycin Structural Formula Illustration

Tobramycin

Empirical Formula: C18H37N5O9
Chemical Name: O-3-Amino-3-deoxy-?-D-glucopyranosyl-(1 ? 4)-O-[2,6-diamino-2,3,6-trideoxy-?-D-ribo-hexopyranosyl-(1 ? 6)]-2-deoxy-L-streptamine

Dexamethasone

Empirical Formula :C22H29FO5
Chemical Name: 9-Fluoro-11?,17,21-trihydroxy-16?-methylpregna-1,4-diene- 3,20-dione

Each mL of TOBRADEX® (tobramycin and dexamethasone ophthalmic suspension) contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg). Preservative: benzalkonium chloride 0.01%. Inactives: tyloxapol, edetate disodium, sodium chloride, hydroxyethyl cellulose, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH) and purified water.

What are the possible side effects of tobramycin and dexamethasone ophthalmic (Tobradex)?

Serious side effects are not expected to occur with the use of this medication.

Some 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...

Read All Potential Side Effects and See Pictures of Tobradex »

What are the precautions when taking tobramycin and dexamethasone (Tobradex)?

Before using tobramycin with dexamethasone, tell your doctor or pharmacist if you are allergic to either drug; or to other aminoglycoside antibiotics (e.g., gentamicin); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma).

Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when...

Read All Potential Precautions of Tobradex »


Tobradex Consumer (continued)

SIDE EFFECTS: Eye redness, eye discomfort, and eyelid itching/swelling may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged/repeated periods may result in a new fungal eye infection and may increase your risk for other eye problems (e.g., glaucoma, cataracts). Do not use this medication for longer than prescribed. Tell your doctor immediately if you notice any of the following: new or worsening eye symptoms (e.g., discharge, swelling), vision changes, eye pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using tobramycin with dexamethasone, tell your doctor or pharmacist if you are allergic to either drug; or to other aminoglycoside antibiotics (e.g., gentamicin); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma).

Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.


Tobradex Patient Information Including Side Effects

Brand Names: Tobradex

Generic Name: tobramycin and dexamethasone ophthalmic (Pronunciation: TOE bra MYE sin and DEX a METH a sone off THAL mik)

  • What is tobramycin and dexamethasone ophthalmic (Tobradex)?
  • What are the possible side effects of tobramycin and dexamethasone ophthalmic (Tobradex)?
  • What is the most important information I should know about tobramycin and dexamethasone ophthalmic (Tobradex)?
  • What should I discuss with my doctor before using tobramycin and dexamethasone ophthalmic (Tobradex)?
  • How should I use tobramycin and dexamethasone ophthalmic (Tobradex)?
  • What happens if I miss a dose (Tobradex)?
  • What happens if I overdose (Tobradex)?
  • What should I avoid while using tobramycin and dexamethasone ophthalmic (Tobradex)?
  • What other drugs will affect tobramycin and dexamethasone ophthalmic (Tobradex)?
  • Where can I get more information?

What is tobramycin and dexamethasone ophthalmic (Tobradex)?

Tobramycin is an antibiotic. It is used to treat bacterial infections.

Dexamethasone is a steroid. Dexamethasone ophthalmic is used to treat the swelling associated with bacterial infections of the eye.

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

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

What are the possible side effects of tobramycin and dexamethasone ophthalmic (Tobradex)?

Serious side effects are not expected to occur with the use of this medication.

Some 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.

What is the most important information I should know about tobramycin and dexamethasone ophthalmic (Tobradex)?

Contact your doctor if the symptoms begin to get worse or if you do not see any improvement in the condition after a few days.

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 your tear duct.

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