Tobrasone – Tobramycin and dexamethasone uses, dose and side effects


3 mg/ml / 1 mg/ml eye drops , suspension
tobramycin and dexamethasone

What Tobrasone is and what it is used for

Tobrasone eye drops contain dexamethasone, a cortisone-like substance, and tobramycin, an antibiotic that works against a wide range of organisms that can cause infection in the eye.

Tobrasone eye drops are used to prevent and treat inflammation and to prevent possible infection in the eye after cataract surgery in adults and in children who are at least 2 years old.

What you need to know before you use Tobrasone

Do not use Tobrasone eye drops

  • if you have or think you have any type of infection in the eye. The use of cortisone-like substances can make the infection worse.
  • if you have sticky discharge from the eye.
  • if you have red eyes that have not been examined by a doctor.
  • if you are allergic to tobramycin, dexamethasone, or any of the other ingredients of this medicine (listed in section 6).

If any of these conditions apply to you, ask your doctor for advice.

Warnings and precautions

If any of these conditions apply to you, talk to your doctor or pharmacist before using Tobrasone:

  • If you have a disease that causes thinning of eye tissue , such as rheumatoid arthritis , Fuchs’ dystrophy or after a cornea transplant . Corticosteroids can lead to further thinning and possible hole in the eyeball, and can slow down the healing of your eye wound.
  • Topical NSAIDs (“non-steroidal anti-inflammatory drugs”) are also known to slow or delay healing. If you use topical NSAIDs and corticosteroids at the same time, it can increase the risk of healing problems.
  • If you experience allergic reactions while using Tobrasone, stop using the eye drops and consult a doctor. Allergic reactions can vary from local itching or reddening of the skin to severe allergic reactions ( anaphylactic reaction ) or severe skin reactions. These allergic reactions can occur with other local or systemic antibiotics of the same type (the aminoglycoside type ).
  • If your symptoms get worse or come back suddenly, you should consult a doctor. You may become more susceptible to eye infections when using this product.
  • If you have diabetes , consult a doctor. The risk of increased pressure in the eye and/or the development of cataracts due to corticosteroids increases in diabetics.
  • Contact a doctor if you experience blurred vision or other visual disturbances.
  • If you use other antibiotics , including those taken by mouth, at the same time as Tobrasone, you should consult a doctor.
  • If you have or have ever had a disease such as myasthenia gravis (a neuromuscular disease that causes skeletal muscle weakness) or Parkinson’s disease (a progressive nerve disease that affects movement), consult your doctor. Antibiotics of this type can worsen muscle weakness.
  • If you use Tobrasone for a long time, you may become more sensitive to eye infections , have increased pressure in the eye(s) or develop cataracts.
  • Talk to your doctor if you develop swelling and weight gain around the trunk and face, as these are usually the first signs of a syndrome called Cushing’s syndrome. Inhibited adrenal function may develop after the end of long-term treatment or intensive treatment with Tobrasone. These risks are particularly important for children and patients treated with medicines called ritonavir or cobicistat. Therefore, talk to your doctor before ending the treatment yourself.
  • Signs and symptoms of impaired adrenal function include fatigue, dizziness when standing or difficulty standing, muscle weakness, fever, weight loss, restlessness, nausea, vomiting, diarrhea, headache, sweating, changes in mood or personality, and joint – and muscle pain.

You may still be able to use Tobrasone, but consult your doctor first.

  • The pressure in the eye ( intraocular pressure) should be checked at regular intervals. This is especially important for children under the age of 6 who are treated with products containing dexamethasone.
  • Do not give Tobrasone to children under 2 years of age as efficacy and safety have not been established in this group.

Other medicines and Tobrasone

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Tell your doctor if you use topical NSAIDs . If you use topical steroids and topical NSAIDs together , the risk of problems with eye healing may increase. Tell your doctor if you are using ritonavir or cobicistat (medicines used to treat HIV ), as this may increase the amount of dexamethasone in the blood.

If you use other eye drops or eye ointments, you must wait at least 5 minutes between the administration of the different medicines. Eye ointments should be used last.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Tobrasone is not recommended during pregnancy or breastfeeding.

Driving ability and use of machinery

If you experience temporary blurred vision after using Tobrasone eye drops , you should wait until your vision clears before driving or operating machinery .

You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.

Important information if you wear contact lenses

The use of contact lenses is not recommended during the treatment of an eye infection or eye inflammation.

Tobrasone contains benzalkonium chloride

This medicine contains 0.5 mg benzalkonium chloride per 5 ml, corresponding to 0.1 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before putting them back in.

Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you feel irritation, tingling or pain in the eye after using the medicine, consult a doctor.

How to use Tobrasone

Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure. Only use Tobrasone drops in the eye(s).

Recommended dose

The recommended dose is one drop in the affected eye(s) every 4 to 6 hours during the waking part of the day. During the first 48 hours, your doctor may increase the dose by one to one drop every two hours.

Do not use longer than 24 days.

Use for children

Tobrasone can be used in children 2 years of age and older at the same dose as for adults.

Instructions for use

  • Wash your hands before you start.
  • Shake the bottle well. 
  • Remove the screw cap. Remove the loose plastic ring from the screw cap on the bottle when it is first opened.
  • Hold the bottle between your thumb and middle finger with the tip down.
  • Tilt your head back
  • Gently pull down the lower eyelid with a finger so that a pocket is formed between the eyelid and the eye (the drop should end up here, see Figure 1).
  • Place the dropper tip of the bottle close to the eye. Looking in a mirror can help you.
  • Do not touch the eye or eyelid , surrounding tissue or other surfaces with the dropper tip. It can contaminate the drops.
  • Press lightly on the bottom of the bottle to release a drop (see figure 2)
  • Do not squeeze the bottle , but a light pressure at the bottom is all that is needed.
  • After using Tobrasone, keep the eyelid closed while pressing gently with a finger on the inner corner of the eye near the nose for at least 1 minute (see Figure 3). It helps limit the amount of medicine that gets out into the rest of the body.
  • If you are using the drops in both eyes, repeat the steps for the other eye. Screw the cap on the bottle tightly immediately after use.
  • If a drop misses the eye, try again.
  • If you forget a dose , do not worry, but take a dose as soon as possible. Do not take a double dose to make up for a missed dose .
  • If you have used a larger amount of Tobrasone than you should , the medicine can be washed out with lukewarm water. If you have recently had eye surgery, contact your doctor for detailed instructions.

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.

If you have any further questions about the use of this medicine, contact your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them. The following side effects have been seen with Tobrasone:

Stop taking this medicine and see a doctor immediately if you notice any of the following possible side effects;

  • itchy rash or hives
  • swelling of the face, lips, tongue or other parts of the body
  • shortness of breath/wheezing
  • severe skin reactions such as blisters which may be accompanied by a sore throat, fever or headache

The following side effects have also occurred with Tobrasone:

Uncommon side effects : may affect up to 1 in 100 users

  • Effects in the eye: increased pressure in the eye(s), eye irritation, eye pain, eye itching, watery eyes, eye discomfort.
  • General side effects: headache, runny nose, feeling of tightness in the throat.

Rare side effects : may occur in up to 1 in 1,000 users

  • Effects in the eye: redness , blurred vision, dry eyes, eye allergy, inflammation of the surface of the eye.
  • General side effects: bad taste in the mouth.

Has been reported: occurring in an unknown number of users

  • Effects in the eye: increased pupil size, redness of the eyelids, swollen eyelid, increased tear production.
  • General side effects: dizziness, nausea, stomach discomfort, rash, facial swelling, itching .

Hormonal problems: extra hair growth on the body (especially in women), muscle weakness and atrophy, purple stretch marks in the skin, high blood pressure , irregular or no menstruation, changes in protein and calcium levels in the body, growth retardation in children and adolescents, and swelling and weight gain on the body and in the face (called Cushing’s syndrome, see section 2 “Warnings and precautions”).

If you use Tobrasone for more than 24 days , it may cause you to get an infection and wound healing may also be slower.

How Tobrasone should be stored

  • Keep this medicine out of the sight and reach of children.
  • No special temperature instructions.
  • Keep the bottle tightly closed.
  • Use before the expiry date which is stated on the bottle and carton after EXP. The expiration date is the last day of the specified month.
  • The contents of an opened bottle are stable for 4 weeks . After that, the medicine should not be used anymore to avoid infection .
  • Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
  • You should not pass this medicine on to others . It can harm them, even if they show signs of illness similar to yours.

Contents of the packaging and other information

Contents declaration

  • The active substances are tobramycin 3 mg/ml and dexamethasone 1 mg/ml.
  • Other ingredients are disodium edetate, tyloxapol, sodium chloride, sodium sulfate, hydroxyethyl cellulose, benzalkonium chloride, sulfuric acid and/or sodium hydroxide (to adjust acidity) and purified water.

Appearance and package sizes of the medicine

Tobrasone eye drops are a white to off-white suspension packaged in a 5 ml plastic bottle with a screw cap.

Marketing Authorisation Holder 


Alcon-Couvreur NV

Rijksweg 14

2870 Puurs


Siegfried El Masnou, SA Camil Fabra 58

El Masnou

08320 Barcelona


Novartis Farmacéutica, SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona


Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg


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