Optidex T Eye drops 5 ml

Optidex T Eye drops 5 ml

Each ml of eye drop suspension contains:
Tobramycin — 3 mg (0.3%).
Dexamethasone — 1 mg (0.1%).
Excipients:
Benzalkonium chloride — 0.06 mg (0.006% as a preservative), hydroxypropyl methylcellulose (hypromellose), purified water.

Product Description:

• Optidex T is a combination ophthalmic product for topical use, providing pronounced anti-inflammatory and antibacterial effects.
• Mechanism of Action: Dexamethasone:
  A synthetic glucocorticosteroid with potent anti-inflammatory, antiallergic, and desensitizing activity (approximately 25 times more potent than hydrocortisone).
  Reduces edema, hyperemia, and inflammatory exudation.
• Tobramycin: A broad-spectrum aminoglycoside antibiotic. Inhibits bacterial protein synthesis, leading to bacterial cell death.
• Spectrum of Activity: Tobramycin is active against a wide range of Gram-positive and Gram-negative microorganisms: Staphylococci (including S. aureus and S. epidermidis, as well as penicillin-resistant strains), Streptococci (including S. pneumoniae and beta-hemolytic species), Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most strains of Proteus vulgaris, Haemophilus influenzae, Moraxella lacunata, Acinetobacter calcoaceticus, and certain Neisseria species.
• Pharmacokinetics: Systemic absorption following topical ocular administration is low; however, active components penetrate well into ocular tissues and the anterior chamber.

Indications for Use:

• Steroid-responsive inflammatory ocular conditions where prophylactic antibacterial treatment is also indicated (after excluding viral and fungal infections).
• Inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (blepharitis, conjunctivitis, keratoconjunctivitis).
• Chronic anterior uveitis.
• Corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
• Postoperative management of cataract, glaucoma, and strabismus surgeries to prevent and treat inflammation.

Method of Administration and Dosage:

• Method of Administration: Topical ocular use. Instill into the conjunctival sac of the affected eye(s). Shake the bottle well before use.
• Dosage Regime:
  Instill 1 to 2 drops into the conjunctival sac every 4 to 6 hours.
  During the initial 24 to 48 hours in severe cases, the dosage may be increased to 1 to 2 drops every 2 hours, with frequency decreased gradually as inflammation improves.
• Do not discontinue treatment prematurely to avoid relapse of infection.
• Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Contraindications:

• Hypersensitivity to tobramycin, dexamethasone, or any of the excipients.
• Viral diseases of the cornea and conjunctiva (including epithelial herpetic keratitis / dendritic keratitis, vaccinia, chickenpox).
• Mycobacterial infections of the eye (such as ocular tuberculosis).
• Fungal infections of ocular structures.
• Use following uncomplicated removal of a corneal foreign body.
• Glaucoma.

Precautions:

• Topical Ocular Use Only: Not for intraocular injection or parenteral use.
• Duration of Use and IOP: Prolonged use of corticosteroids may result in ocular hypertension/glaucoma with damage to the optic nerve and visual disturbances. Intraocular pressure (IOP) should be monitored routinely if the product is used for more than 10 days.
• Secondary Infections: Prolonged corticosteroid use may suppress the host response and increase the hazard of secondary ocular infections (including fungal infections) or mask acute infections.
• Superinfection: Prolonged use of tobramycin may result in the overgrowth of non-susceptible organisms, including fungi.
• Contact Lenses: Wearing contact lenses is not recommended during treatment with eye drops containing benzalkonium chloride.

Adverse Reactions / Side Effects:

Local Reactions:
Ocular allergic reactions (itching, eyelid swelling, conjunctival erythema), transient ocular discomfort, burning, or tearing upon instillation.
Ophthalmic Complications:
Increased intraocular pressure, glaucoma, optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing.

Pregnancy and Lactation:

• There are no adequate and well-controlled studies in pregnant women.
• Use during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
• It is unknown whether topical ophthalmic administration of corticosteroids or tobramycin results in sufficient systemic absorption to produce detectable quantities in human milk. 
• Caution should be exercised when administering to nursing mothers (temporary discontinuation of breastfeeding may be considered).

Storage Conditions:

Store at 15–25°C.
Discard bottle 1 month after opening.
Keep out of reach of children.

Packaging:

5 ml eye drop suspension in a dropper bottle with a dispenser.
1 bottle together with a patient instruction leaflet in a cardboard box.