Used for the prevention and treatment of inflammation and to prevent eye infections after cataract surgery
Tornaza Dex 3 mg/ml + 1 mg/ml eye drops, suspension
Tobramycin/Dexamethasone
What is Tornaza Dex and what is it used for?
A combination medicinal product containing dexamethasone and tobramycin, intended for ocular use.
Dexamethasone is a corticosteroid with pronounced anti-inflammatory activity (it blocks certain substances that cause inflammation in the body). Tobramycin is an antibiotic from the so-called aminoglycoside group. It inhibits bacterial growth and reduces infections and is active against a wide range of microorganisms that cause eye infections.
It is used in adults and children over 2 years of age for the prevention and treatment of inflammation and to prevent eye infections after cataract surgery (clouding of the eye’s natural lens).
Active substances: tobramycin sulfate, equivalent to 3.0 mg of tobramycin, and 1.0 mg of dexamethasone.
Excipients: benzalkonium chloride, disodium edetate, sodium chloride, sodium sulfate (anhydrous), tyloxapol, hydroxyethylcellulose, sodium hydroxide and/or sulfuric acid (for pH adjustment), water for injections.
Do not use Tornaza Dex eye drops:
• if you are allergic to tobramycin, dexamethasone, or any of the other ingredients of this medicine. Consult your doctor if you think you may be allergic
• if you have herpes simplex of the cornea, chickenpox, or other viral diseases of the cornea and conjunctiva
• if you have eye infections caused by mycobacteria (ocular tuberculosis)
• if you have fungal eye infections or untreated parasitic eye infections.
Warnings and precautions:
Talk to your doctor or pharmacist before using Tornaza Dex eye drops:
• If allergic reactions occur while using Tornaza Dex eye drops, stop using the medicine and consult a doctor. Allergic reactions may present differently, such as localized itching or skin redness, as well as severe allergic reactions (anaphylactic reactions) or severe skin reactions. Such allergic reactions may also occur with other topical or systemic antibiotics from the same group (aminoglycosides).
• If symptoms worsen or there is a sudden relapse, please consult a doctor. Use of this product may make you more susceptible to eye infections.
• If you are taking other antibiotics, including orally, together with Tornaza Dexi, consult your doctor for advice.
• If you have or have had conditions such as myasthenia gravis (a neuromuscular disorder causing skeletal muscle weakness) or Parkinson’s disease (a progressive nervous system disorder affecting movement). These types of antibiotics may worsen muscle weakness.
• If you have diabetes, consult your doctor. Patients with diabetes have an increased risk of elevated intraocular pressure and/or cataract formation with corticosteroids.
• Consult your doctor if you experience blurred vision or other visual disturbances.
• If you use Tornaza Dex eye drops for a long time, you may become more susceptible to eye infections, develop increased intraocular pressure, or cataracts.
• Consult your doctor if you experience facial swelling and weight gain around the abdomen and waist, as these are usually the first signs of Cushing’s syndrome. Reduced adrenal gland function may develop after stopping long-term or intensive treatment with Tornaza Dex. Talk to your doctor before stopping treatment. These risks are particularly important in children and in patients treated with ritonavir or cobicistat.
• Corticosteroids can thin the cornea or sclera, cause perforation, and delay healing of eye injuries. Topical non-steroidal anti-inflammatory drugs (NSAIDs) are also known to delay healing. If you use topical NSAIDs and corticosteroids together, this may increase the likelihood of healing problems.
• Your intraocular pressure should be checked frequently. This is especially important in pediatric patients, as the risk of corticosteroid-induced intraocular pressure increase may be higher in children and may occur earlier than in adults. Consult your doctor for advice, especially regarding children.
• Consult your doctor before using this medicine if you have disorders that cause thinning of eye tissues.
• Children (over 2 years of age): The safety and efficacy of Tornaza Dexi eye drops in children under 2 years of age have not been established; therefore, use is not recommended. Tornaza Dexi eye drop suspension may be used in children over 2 years of age at the same dose as in adults.
• Elderly patients (over 65 years of age): You may use Tornaza Dexi eye drops, suspension, at the same dose as adults.
• If you wear contact lenses. Wearing contact lenses is not recommended during treatment of eye inflammation or eye infection.
Other medicines and Tornaza Dex eye drops:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Be sure to inform your doctor if you are using topical non-steroidal anti-inflammatory medicines. Concomitant use of topical steroids and topical NSAIDs may increase the risk of corneal healing problems.
Tell your doctor if you are taking ritonavir or cobicistat, as this may increase the amount of dexamethasone in your blood.
Pregnancy, breastfeeding, and fertility:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Tornaza Dex eye drops are not recommended during pregnancy and lactation, except in cases of absolute necessity.
Effects on ability to drive and use machines:
Immediately after using Tornaza Dex eye drops, short-term blurred vision may occur. If you experience temporary blurred vision after using Tornaza Dex eye drops, do not drive or use machines until your vision has returned to normal.
Tornaza Dex eye drops contain benzalkonium chloride:
This medicine contains 0.1 mg of benzalkonium chloride per ml. Benzalkonium chloride, used as a preservative in Tornaza Dex, may cause eye irritation and discoloration of soft contact lenses. If you wear soft contact lenses, remove them before using Tornaza Dex and wait at least 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have “dry eye” or corneal damage (the transparent front layer of the eye). If you experience unusual sensations in the eye, such as burning or pain after using this medicine, consult your doctor.
Method of use:
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Do not exceed the recommended dose prescribed by your doctor.
Recommended dose:
The recommended daily dose for adults and children over 2 years of age is one or two drops into the affected eye(s) every 4–6 hours. During the first 24–48 hours, your doctor may increase the dose to 1 drop every 2 hours. The frequency of administration and duration of treatment are determined by the treating physician.
The recommended daily dose for severe infections is one or two drops into the affected eye(s) every hour until inflammation is controlled, then gradually reduced to one or two drops every two hours over the next 3 days.
If you have scheduled cataract surgery, contact your doctor for detailed instructions.
Instructions for use:
Tornaza eye drops are for ocular use only.
fore first use, make sure the tamper-evident seal between the cap and bottle is intact. Shake the bottle vigorously. Wash your hands and remove the cap.
Tilt your head back and pull the lower eyelid down. This creates a “pocket” between the eyelid and the eye. The drop should fall into this space.
Hold the bottle upside down. Bring the tip close to the eye. Use a mirror if it helps.
Be careful not to touch the eye, eyelids, or other surfaces with the bottle tip. Gently press the bottom of the bottle to release a drop of Tornaza Dexi. A small amount of pressure is sufficient.
After applying Tornaza Dexi, close your eye and press gently with a finger on the corner of the eye near the nose for at least 1 minute. This helps prevent Tornaza Dexi from entering or draining into the nose.
If you need to apply drops to both eyes, repeat all steps for the other eye.
If the drop does not enter the eye, try again.
If you use other eye drops or eye ointments, wait at least 5 minutes between applications. Eye ointments should be applied last.
If you use more Tornaza Dex eye drops than you should:
Rinse your eyes thoroughly with warm water. If you have recently had eye surgery, consult your doctor for detailed instructions. Do not apply more drops until it is time for your next regular dose.
you forget to use Tornaza Dex eye drops:
Continue with the next dose according to your usual schedule. If it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
Possible side effects:
Rare:
Eye-related effects: increased pressure in the eye(s), eye pain, eye itching, eye discomfort, eye irritation, eyelid itching, inflammation of the eye surface (with nodules), eye allergy, blurred vision, dry eye, redness.
General effects: reduced sense of taste.
Frequency unknown:
Eye effects: eyelid swelling, eyelid redness, pupil dilation, increased tearing.
General effects: severe allergic reaction (hypersensitivity), dizziness, headache, nausea, stomach discomfort, rash, severe skin reactions (erythema multiforme), facial swelling, itching.
Effects related to hormonal disorders: excessive hair growth on the body (especially in women), muscle weakness and loss of muscle mass, purple stretch marks on the skin, high blood pressure, irregular or missed menstruation, changes in protein and calcium levels in the body, growth retardation in children and adolescents, swelling and weight gain in the trunk and face (Cushing’s syndrome).
Storage conditions:
- Keep out of the reach of children.
- Store at a temperature not exceeding 25°C.
- Store in the original package.
- Shelf life after first opening is 28 days. Discard the bottle 4 weeks after opening to avoid possible infections and contamination.
- Do not use this medicine after the expiry date stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.
- Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures help protect the environment.
Marketing authorization holder
Antibiotic Razgrad AD
68 Aprilisko Vastanie Blvd., Office 201
7200 Razgrad
Bulgaria
Manufacturer
Balkanpharma-Razgrad AD
68 Aprilisko Vastanie Blvd.
7200 Razgrad
Bulgaria
Local representative of the marketing authorization holder:
Medexport LLC,
264 Omar Khizanishvili St.,
Gldani District, 0167, Georgia.
