TobraDex
TobraDex (Tobramycin, Dexamethasone) Novartis Eye Drops are a 5 mL sterile ophthalmic suspension used for inflammation, bacterial infections, and corneal injuries.
Dexamethasone is one of the most potent corticosteroids. It inhibits multiple inflammatory cytokines and produces multiple glucocorticoid and mineralocorticoid effects. Tobramycin is an antibacterial drug. It inhibits the growth of bacteria by inhibiting protein synthesis.
Topical corticosteroids are effective in acute inflammatory conditions of the conjunctiva, sclera, cornea, lids, iris, and anterior segment of the globe, as well as in ocular allergic conditions.
Package Contains: Each pack of TobraDex contains 5ml eye drops in a dropper bottle & a leaflet.
Composition: Each ml contains Tobramycin 3mg, Dexamethasone 1mg.
(Manufacturer’s Specs)
Indication: Tobradex Eye Drops is indicated for the prevention and treatment of inflammation and the prevention of infection associated with cataract surgery in adults and children aged 2 years and older.
Ocular steroids are indicated in inflammatory conditions of the bulbar conjunctiva, cornea, and anterior segment of the globe, where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.
They are also indicated by radiation or thermal burns or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated that potentially dangerous numbers of bacteria will be present in the eye.
Method of Administration: One or two drops instilled into the conjunctival sac(s) every 4 to 6 hours. During the initial 24 to 48 hours, the dose may be increased to one or two drops every two hours. Frequency should be decreased gradually as warranted by the improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. The 5 to 8 last days, if considered necessary.
In severe disease, one or two drops are instilled every hour until inflammation is controlled, and gradually decrease frequency to one or two drops every two hours during 3 days, thereafter, one to two drops every 4 hours during 5 to 8 days, and finally one to two drops every day during the 5 to 8 last days, if considered necessary.
The dose is one drop instilled four times a day, from the day after surgery for up to 24 days. Treatment can be started the day before surgery with one drop four times a day, continuing with one drop after surgery, and then four times a day for up to 23 days. If needed, the frequency can be increased up to one drop every two hours for the first two days of therapy. It is advisable to monitor intraocular pressure routinely.
Contraindications:
- Hypersensitivity to the active substances or to any of the excipients.
- Herpes simplex Keratitis.
- Vaccinia, varicella, and other viral infections of comes or conjunctiva.
- Fungal diseases of ocular structures of untreated parasitic eye infections.
- Mycobacterial ocular infections.
Side effects: The following adverse reactions have been reported during clinical trials with Tobradex Eye Drops are classified according to the subsequent convention: very common, common, uncommon, rare to very rare. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
- Eye disorders Uncommon: intraocular pressure increased, eye pain, eye pruritus, ocular discomfort, eye irritation Rare: keratitis, eye allergy, vision blurred, dry eye, ocular hyperaemia.
- Gastrointestinal disorders, Rare: dysgeusia.
- Immune system disorders: anaphylactic reaction, hypersensitivity.
- Nervous system disorders: dizziness, headache.
- Eye disorders: eyelid oedema, erythema of the eyelid, mydriasis, lacrimation increased.
- Gastrointestinal disorders: nausea, abdominal discomfort.
- Skin and subcutaneous tissue disorders: erythema multiforme, rash, swelling face, and pruritus.
Warnings & Precautions for Use: Gently closing the eyelid after instillation. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic side effects. Sensitivity to topically may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as itching, urticarial, and skin rash.
If hypersensitivity develops during use of this medicine, treatment should be discontinued. Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral, fungal, or parasitic infections and mask the clinical signs of infection. If fungal infection occurs, corticosteroid therapy should be discontinued. Prolonged use of antibiotics such as tobramycin may result in overgrowth of non-susceptible organisms, including fungi.
If superinfection occurs, appropriate therapy should be initiated. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Contact lens wear is not recommended during treatment of an ocular inflammation or infection. In case patients are allowed to wear contact lenses, they must be instructed to remove contact lenses before application of Tobradex Eye Drops and wait at least 15 minutes before reinsertion.
Pregnancy & Lactation: Tobramycin does cross the placenta into the fetus after intravenous dosing in pregnant women. Tobramycin is not expected to cause ototoxicity from in utero exposure. Prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation.
It is unknown whether tobramycin and dexamethasone are excreted in human milk following topical ocular administration. A risk to the breastfed child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue therapy, taking into account the benefit of therapy for the woman.
Instructions: Discard 1 month after first opening. SHAKE WELL BEFORE USE. Do not store above 30°C. Keep out of reach of children. Instill as directed by the physician. Read enclosed insert. For ocular use only. To prevent contamination of the dropper tip and eye drops, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. 
Manufactured & Buy Online:
TobraDex Eye Drops are manufactured by: Alcon-Couvreur NV, Belgium.
This is the link to the manufacturer: https://www.alcon.com
Its sole agent is: Novartis Pharma (Pakistan) Limited.
This is the link to the sole agent: https://www.novartis.com
Buy Online: https://www.dvago.pk