Dexatobrin Sterile eye ointment 5 g

Dexatobrin Sterile eye ointment 5 g

Composition:

Dexamethasone 1 mg

Tobramycin 3 mg

Inactive ingredients: 

Chlorobutanol, mineral oil, petrolatum base

Properties:

Dexatobrin® contains dexamethasone, a corticosteroid, and tobramycin, an aminoglycoside antibiotic. 

Dexamethasone blocks some substances that inflame the body. Tobramycin blocks bacterial growth and reduces infections. Together, they treat the eye.

Indications:

Dexatobrin® is used to treat inflammatory conditions of the eye where there is or may also be an eye infection.

• Chronic inflammation of the uvea
• Eye injuries caused by chemicals, radiation or heat burns
• Eye injuries caused by foreign objects
• Antibacterial drugs like Dexatobrin® treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, Dexatobrin® should be used exactly  as directed.

Directions for use:

• Usual adult dose:

Apply one-half inch ribbon into the conjunctival sac of the affected eye(s) up to 3 or 4 times a day. Dexatobrin® ointment may be used with Dexatobrin® suspension at bedtime.

-Wash your hands.

-Tilt your head back.

-Place a finger on your cheek just under your eye and gently pull down until a “v” pocket is formed between your eyeball and lower eyelid.

-Place a small amount of Dexatobrin® in the “v” pocket. Do not let the tip of the tube  touch your eye, to avoid contaminating the ointment.

-Look down before closing your eye.

-Replace the cap of the tube.

• If your doctor has prescribed other eye drop or ointment medicines to be used along with Dexatobrin®, apply each medicine at least 5 minutes apart. Eye ointments should be administered last.
• If you apply too much Dexatobrin®, rinse it out with warm water. Do not apply more  Dexatobrin® until it is time for your next regular dose.

• If you forget to take Dexatobrin®, take it as soon as you remember. 
• Do not use a double dose to make up the missed dose.

Side effects:

Common:

• Eyelid redness or swelling
• Increased tearing
• Pupil dilation
• Dry eye
• Eye allergy
• Eye irritation, pain, itching, inflammation, discomfort or redness
• Blurred vision
• Upset stomach, nausea or metallic taste in the mouth
• Dizziness
• Headache
• Abdominal discomfort
• Skin itching or rash
• Eyelid drooping

Rare:

Allergic reaction: swelling of the face, lips or tongue; difficulty breathing; hives; skin  redness, serious skin reactions (erythema multiforme), itching or blisters, infection, increased eye pressure and/or glaucoma, vision problems, or cataracts.

Contraindications:

• Are allergic (hypersensitive) to tobramycin, dexamethasone or any of the other ingredients of Dexatobrin® 
• Are allergic to other aminoglycoside antibiotics.
• Have herpes simplex keratitis 
• Have smallpox, chickenpox or any other viral infection of the eye.
• Have a fungal infection of the eye.
• Have a parasitic infection of the eye.
• Have a mycobacterial infection of the eye, including tuberculosis.
• Have an active untreated eye infection.
• Recently had a simple removal of an object from the eye.

Warnings and precautions:

• Inform your doctor if:

-you have used other corticosteroids before in the past;

-you develop an allergic reaction. Signs may include skin redness, itching and rash. You should stop taking Dexatobrin®;

-you are taking another aminoglycoside antibiotic;

-you have or if you have ever had conditions such as myasthenia gravis or Parkinson’s disease. Antibiotics of this kind may worsen muscle weakness;

-you develop an eye infection or your infection gets worse. You should stop taking Dexatobrin®;

-you have problems with your metabolism;

-you experience swelling and  weight gain around the trunk and in the face as these are usually the first signs of problems with your metabolism;

-you are taking a nonsteroidal anti-inflammatory drug (NSAID). Taking Dexatobrin® and an NSAID at the same time may slow healing of the eye;

-you have diabetes. You may be at a higher risk of developing increased pressure in the eyes, vision problems or cataracts;

-you have a disease causing thinning of the eye. Small tears (perforations) have occurred;

-you wear contact lenses. Contact lens wear is not recommended during treatment of eye inflammation or an eye infection;

-you are pregnant, may be pregnant or planning to become pregnant;

-you are breastfeeding or planning to breastfeed;

-you are under 18 years of age; •Dexatobrin® has not been tested in children under 18 years of age.

• Taking Dexatobrin® for a long time increases the risk of developing:

– High eye pressure

– Glaucoma

– Vision problems

– Cataracts

– An eye infection

– Problems with your metabolism

• If you take Dexatobrin® for a long time, your doctor should check your eye pressure regularly.
• Your vision may become blurry right after using Dexatobrin®. Do not drive or use machines until your vision clears.
• Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines, including:

-Nonsteroidal anti-inflammatory drugs (NSAIDs).

-Ritonavir or cobicistat (medicines used in the treatment of HIV).

• Keep out of reach and sight of children.

Storage:

Store at a temperature not exceeding 25°C

Package:

Carton box holds a tube 5 g and an insert leaflet