Dexamethasone and tobramycin ophthalmic Uses, Side Effects & Warnings

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Generic name: dexamethasone and tobramycin (ophthalmic) [ DEX-a-METH-a-sone-and-TOE-bra-MYE-sin-off-THAL-mik ]
Brand names: Tobradex, TobraDex ST
Dosage forms: ophthalmic ointment (0.1%-0.3%), ophthalmic suspension (0.05%-0.3%; 0.1%-0.3%)
Drug class: Ophthalmic steroids with anti-infectives

Medically reviewed by Drugs.com on Nov 18, 2022. Written by Cerner Multum.

What is dexamethasone and tobramycin ophthalmic?

Dexamethasone and tobramycin ophthalmic (for the eyes) is a combination antibiotic and steroid medicine that is used to treat eye inflammation caused by uveitis, eye injury, radiation, chemical burns, or certain other conditions.

dexamethasone and tobramycin is used when there is a risk of bacterial infection in or around the eye.

Dexamethasone and tobramycin ophthalmic may also be used for purposes not listed in this medication guide.

Warnings

You should not use this medicine if you have a fungal or viral infection in your eyes (including herpes simplex).

Before taking this medicine

You should not use dexamethasone and tobramycin if you are allergic to dexamethasone or tobramycin, or if you have a fungal or viral infection in your eyes (including herpes simplex).

Tell your doctor if you have ever had:

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

How should I use dexamethasone and tobramycin ophthalmic?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not use while wearing soft contact lenses. A preservative in this medicine could permanently stain the lenses. Use the medicine at least 15 minutes before inserting your contact lenses.

Wash your hands before using eye medication.

Shake the eye drops well just before each use.

To use the eye drops: Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye and squeeze a drop into this pocket. Close your eyes for 1 or 2 minutes.

Use only the number of drops your doctor has prescribed.

To apply the ointment: Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Squeeze a ribbon of ointment from the tube into this pocket. Blink your eye gently and then keep it closed for 1 or 2 minutes. Wipe excess ointment from your eyelashes using a clean tissue.

Do not touch the tip of the eye dropper or ointment tube or place it directly on your eye. A contaminated tip can infect your eye, which could lead to serious vision problems.

If you use this medicine for longer than 10 days, you may need frequent vision tests to check the pressure inside your eyes.

Call your doctor if your symptoms do not improve after 2 days of treatment.

You should not stop using this medicine suddenly. Follow your doctor’s instructions about tapering your dose.

Store this medicine at room temperature. Do not freeze. Keep the tube tightly closed when not in use. Store the eye drops in an upright position.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Overdose symptoms may include eye redness or itching, watery eyes, and increased sensitivity to light.

What should I avoid while using dexamethasone and tobramycin ophthalmic?

Do not share dexamethasone and tobramycin with another person, even if they have the same symptoms you have.

Dexamethasone and tobramycin ophthalmic side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Dexamethasone and tobramycin may cause serious side effects. Call your doctor at once if you have:

• severe eye redness, itching, or swelling;

• blurred vision, tunnel vision, seeing halos around lights;

• pain behind your eyes, sudden vision changes;

• slow healing after eye surgery; or

• signs of eye infection–redness, severe discomfort, crusting or drainage.

Common side effects of dexamethasone and tobramycin may include:

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 other drugs will affect dexamethasone and tobramycin ophthalmic?

Medicine used in the eyes is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

More about dexamethasone / tobramycin ophthalmic

• Check interactions
• Compare alternatives
• Pricing & coupons
• Reviews (21)
• Side effects
• Dosage information
• During pregnancy
• Drug class: ophthalmic steroids with anti-infectives
• En español

Patient resources

• Advanced Reading
• Tobramycin and Dexamethasone Eye Drops
• Tobramycin and Dexamethasone Eye Ointment

Other brands

TobraDex, Tobradex ST

Professional resources

• Prescribing Information

Related treatment guides

• Conjunctivitis, Bacterial
• Keratitis
• Uveitis
• Postoperative Ocular Inflammation

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 7.01.

Dexamethasone And Tobramycin (Tobradex) – Side Effects, Interactions, Uses, Dosage, Warnings

Reviewed: June 23, 2020

Dexamethasone and tobramycin ophthalmic (for the eyes) is a combination antibiotic and steroid medicine that is used to treat eye inflammation caused by uveitis, eye injury, radiation, chemical burns, or certain other conditions.

This medicine is used when there is a risk of bacterial infection in or around the eye.

Dexamethasone and tobramycin ophthalmic may also be used for purposes not listed in this medication guide.

uses

What is Dexamethasone And Tobramycin (Tobradex) used for?

• Uveitis
• Bacterial Conjunctivitis
• Keratitis
• Visual Defect/Disturbance
• Infectious Posterior Uveitis
• Herpes Simplex Iridocyclitis
• Herpes Zoster Iridocyclitis
• Infectious Anterior Uveitis
• Syphilitic Uveitis
• Uveitis (Anterior)
• Panuveitis
• Uveitis (Posterior)

warnings

What is the most important information I should know about Dexamethasone And Tobramycin (Tobradex)?

You should not use this medicine if you are allergic to dexamethasone or tobramycin, or if you have a fungal or viral infection in your eyes (including herpes simplex).

Tell your doctor if you have ever had:

• glaucoma; or
• cataracts, or if you need cataract surgery.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Side Effects

What are the side effects of Dexamethasone And Tobramycin (Tobradex)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe eye redness, itching, or swelling;
• blurred vision, tunnel vision, seeing halos around lights;
• pain behind your eyes, sudden vision changes;
• slow healing after eye surgery; or
• signs of eye infection–redness, severe discomfort, crusting or drainage.

Common side effects may include:

• minor burning or stinging.

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.

Pregnancy & Breastfeeding

Can I take Dexamethasone And Tobramycin (Tobradex) if I’m pregnant or breastfeeding?

C

Risk cannot be ruled out

Based on FDA pregnancy categories

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Interactions

What drugs and food should I avoid while taking Dexamethasone And Tobramycin (Tobradex)?

Do not share this medicine with another person, even if they have the same symptoms you have.

Dosage Guidelines & Tips

How to take Dexamethasone And Tobramycin (Tobradex)?

Use Dexamethasone And Tobramycin (Tobradex) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

What should I do if I missed a dose of Dexamethasone And Tobramycin (Tobradex)?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Overdose Signs

What happens if I overdose on Dexamethasone And Tobramycin (Tobradex)?

Overdose symptoms may include eye redness or itching, watery eyes, and increased sensitivity to light.

If you think you or someone else may have overdosed on: Dexamethasone And Tobramycin (Tobradex),  call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn’t breathing after taking Dexamethasone And Tobramycin (Tobradex), call 911

911

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Medical Disclaimer

Drugs A-Z provides drug information from Everyday Health and our partners, as well as ratings from our members, all in one place. Cerner Multum™ provides the data within some of the Overview, Uses, Warnings, Side Effects, Pregnancy, Interactions, Dosage, Overdose, and Images sections. The information within all other sections is proprietary to Everyday Health. 

Dexamethasone + Tobramycin – description of the substance, pharmacology, use, contraindications, formula

Contents

• Russian name

• English name

• Latin name

• Pharmacological group of the substance Dexamethasone + Tobramycin

• Nosological classification

• pharmachologic effect

• Pharmacology

• Application of the substance Dexamethasone + Tobramycin

• Contraindications

• Use during pregnancy and lactation

• Side effects of the substance Dexamethasone + Tobramycin

• Interaction

• Overdose

• Dosage and administration

• Precautionary measures

• Information sources

• Trade names with the active substance Dexamethasone + Tobramycin

Russian name

Dexamethasone + Tobramycin

English name

Dexamethasone + Tobramycin

Latin name

Dexamethasonum + Tobramycinum (genus Dexamethasoni + Tobramycini)

Pharmacological group of the substance Dexamethasone + Tobramycin

Glucocorticosteroids in combinations

Ophthalmic agents in combinations

Nosological classification

ICD-10 code list

• h20 Conjunctivitis

• h26. 8 Other forms of keratitis

• h30.9 Iridocyclitis, unspecified

• H59 Disorders of the eye and adnexa following medical procedures

• T26.1 Thermal burn of cornea and conjunctival sac

• T26. 6 Chemical burn of cornea and conjunctival sac

Pharmacological action

Pharmacological action –

anti-inflammatory , antibacterial .

Pharmacology

Mechanism of action

Dexamethasone in the combination of dexamethasone + tobramycin suppresses the inflammatory response to various factors and can stop or slow down the repair process. Because dexamethasone can suppress the body’s defense mechanisms against infection, a concomitant antimicrobial agent may be used in clinically significant immunosuppression.

Tobramycin as part of a combination of dexamethasone + tobramycin is an antibacterial drug of the aminoglycoside group. It inhibits bacterial growth by inhibiting protein synthesis. Tobramycin is included in the combination to provide action against susceptible bacteria.

Pharmacokinetics

In a multicentre, randomized, double-blind, single-dose, parallel-group pharmacokinetic study in males and females undergoing cataract surgery, dexamethasone concentrations after administration of a combination of dexamethasone + tobramycin eye drops were similar at different concentrations. research institutes in medicinal form. From _max in the aqueous humor of the eye reached 33.7 ng / ml 2 hours after a single application.

Data on the extent of systemic absorption of dexamethasone or tobramycin from eye drops are not available. After repeated (4 times a day for 2 days) bilateral ophthalmic use of a combination of dexamethasone + tobramycin in healthy male and female volunteers, C _max dexamethasone in plasma was less than 1 ng / ml and was observed within 2 hours after application in all test subjects.

Microbiology

Tobramycin in the combination dexamethasone + tobramycin provides action against susceptible bacteria. In vitro studies”> in vitro showed that tobramycin is active against susceptible isolates of Staphylococcus aureus (including penicillin-resistant isolates), Staphylococcus epidermidis (including penicillin-resistant isolates), streptococci, including some groups A , other beta-hemolytic species, some non-hemolytic species, as well as in relation to some other strains, in particular Streptococcus pneumoniae, Acinetobacter calcoaceticus, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Haemophilus aegypticus, Klebsiella pneumoniae, Moraxella lacunata, Morganella morganii, Neisseria perflava, Neisseria sicca, Proteus mirabilis, Proteus vulgaris, Pseudomonas a eruginosa.

In vitro bacteriological studies”> in vitro show that in some cases bacteria resistant to gentamicin are susceptible to tobramycin.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenic or mutagenic potential has been studied.

In studies of SC administration of tobramycin to rats at doses of 50 and 100 mg/kg/day (equivalent to doses of 8 and 16 mg/kg/day in humans, which is at least 2 orders of magnitude higher than the dose for topical ophthalmic application), there was no fertility disorders were noted.

Use of the substance Dexamethasone + Tobramycin

Inflammatory diseases of the eye, in which the use of corticosteroids is indicated, as well as in the presence of superficial bacterial eye infection or the risk of its development (inflammatory diseases of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eyeball, chronic anterior uveitis and damage to the cornea as a result of chemical, radiation and thermal burns or penetration of foreign bodies).

Contraindications

Hypersensitivity to any of the components of the combination; viral diseases of the cornea and conjunctiva, including epithelial keratitis caused by the herpes simplex virus (dendritic keratitis), post-vaccination keratitis and chicken pox, as well as mycobacterial infection of the eye and fungal diseases of the eye structures.

Pregnancy and Lactation Use

FDA Fetal Category – C.

There are no adequate and well-controlled studies in pregnant women. The combination dexamethasone + tobramycin eye drops should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

GCS have been shown to be teratogenic in animal studies. Ocular application of dexamethasone 0.1% resulted in 15.6% and 32.3% of cases of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality have been observed in rats on chronic dexamethasone therapy.

Reproduction studies have been performed in rats and rabbits using tobramycin at doses up to 100 mg/kg/day (equivalent to human doses of 16 and 32 mg/kg/day, respectively). These studies did not reveal evidence of impaired fertility or harm to the fetus.

Systemic corticosteroids appear in human milk and may suppress growth, interfere with the production of endogenous corticosteroids, or cause other undesirable effects. It is not known whether topical application of corticosteroids can lead to systemic absorption sufficient to detect them in the milk of a nursing woman. Caution should be exercised when prescribing dexamethasone + tobramycin combination eye drops to a nursing woman.

Side effects of the substance Dexamethasone + Tobramycin

When using combined steroid / antibacterial drugs, adverse reactions occurred that can be attributed to the action of the steroid component, the antibacterial component, or their combination. There is no exact data on the frequency of occurrence of such cases.

The most common adverse reactions to the combination of dexamethasone + tobramycin eye drops are hypersensitivity and local ophthalmotoxicity, including eye pain, eyelid itching, eyelid edema, and conjunctival hyperemia. These reactions occur in less than 4% of patients. Similar reactions may occur with topical application of other aminoglycoside antibiotics.

Reactions caused by the steroid component include an increase in IOP with the possible development of glaucoma and infrequent damage to the optic nerve, subcapsular cataract, impaired repair processes.

Secondary infection. The development of a secondary infection occurred after the use of combinations containing corticosteroids and antimicrobial drugs. Fungal infections of the cornea are especially prone to develop with prolonged use of corticosteroids. The possibility of fungal invasion should be considered in any persistent corneal ulcer treated with steroids. A secondary bacterial eye infection may also develop after suppression of the body’s immune response.

Other adverse reactions that occurred with a frequency of 0.5 to 1% included headache and increased blood pressure.

Interaction

When combined with other local ophthalmic drugs, the interval between their use should be at least 5 minutes.

When prescribing topically tobramycin concomitantly with systemic aminoglycoside antibiotics, the overall blood picture should be monitored.

Overdose

Symptoms: irritation of the mucous membrane of the eye, itching, lacrimation, swelling of the eyelids, conjunctival hyperemia.

Treatment: wash eyes with warm water and treat symptomatically.

Dosage and administration

Locally, in the conjunctival sac. During the first 24-48 hours, the dosage may be increased to one drop every 2 hours. The frequency of administration should be reduced gradually, as the clinical picture improves and symptoms regress. Care must be taken to ensure that the patient does not stop therapy prematurely.

Precautions

Increased IOP

Long-term use of corticosteroids can lead to the development of glaucoma with damage to the optic nerve, visual acuity and visual field defects. If the combination dexamethasone + tobramycin is used for 10 days or longer, it is strictly necessary to monitor the patient’s IOP.

Sensitivity to aminoglycosides

Hypersensitivity reactions may occur with topical aminoglycosides.

Cataract

Prolonged use of corticosteroids can lead to the formation of posterior subcapsular cataracts.

Slowing down repair processes

The use of corticosteroids after cataract surgery can slow down the healing process and increase the incidence of vesicles. In diseases that cause thinning of the cornea or sclera, there are known cases of perforation when local corticosteroids are used. The initial prescription and extension of the combination of dexamethasone + tobramycin should be carried out by a physician only after examining the patient using magnification, for example, biomicroscopy with a slit lamp, and, if necessary, after staining with fluorescein.

Bacterial infections

Long-term use of corticosteroids can suppress the body’s immune response and thus increase the likelihood of developing secondary eye infections. In acute purulent conditions, corticosteroids can mask the infection or accelerate the development and spread of already existing foci of infection. If signs and clinical symptoms do not regress 2 days after the start of the combination of dexamethasone + tobramycin, the patient should be re-examined.

Viral infections

The use of corticosteroids in patients with a history of herpes simplex virus infection requires increased caution on the part of the physician. The use of ophthalmic corticosteroids can prolong the course and aggravate the severity of many viral infections of the eye (including those caused by the herpes simplex virus).

Fungal infections

Fungal infections of the cornea are especially prone to develop with prolonged local use of corticosteroids. The possibility of fungal invasion must be considered in any persistent corneal ulcer in patients who have used or are using corticosteroids.

Simultaneous use with systemic aminoglycosides

When using a combination of dexamethasone + tobramycin in conjunction with systemic aminoglycoside antibiotics, it is necessary to carefully monitor the total concentration of drugs in the blood serum.

Special patient groups

Children. The safety and efficacy of dexamethasone + tobramycin in children under 2 years of age have not been established.

Old age. No differences were observed in the safety and efficacy of the combination of dexamethasone + tobramycin in elderly and younger patients. Dexamethasone + Tobramycin

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Dosage
All dosages 0.1%+0.3% 1mg/ml+3mg/ml No dosage

Manufacturer
All manufacturers K.O. Rompharm Company S.R.L. Kadila Pharmaceuticals Ltd. Sun Pharmaceutical Medica Ltd. s.a. Alcon-Couvrere n.v.

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Tobradex instructions for use: indications, contraindications, side effects – description of Tobradex eye drops 3 mg + 1 mg / 1 g: vial-drip. 5 ml (9989)