Prevention and treatment of inflammation and prevention of infection after surgical removal of cataracts in adults and children aged 2 years and older.
Composition:
1 ml eye drops contains 3 mg tobramycin and 1 mg dexamethasone. Drops contain benzalkonium chloride.
Action:
Combined preparation containing Dexamethasone - a corticosteroid with anti-inflammatory action and tobramycin - an aminoglycoside antibiotic with a strong and rapid bactericidal effect on both Gram-positive bacteria (Staphylococcus aureus (sensitive or resistant to methicillin),S. epidermidis (sensitive or resistant to methicillin), other speciesstaphylococcus coagulase-negative,Streptococcus pneumoniae (sensitive or resistant to penicillin), other speciesStreptococcus) as well as Gram-negative (Acinetobacter spp., Citrobacter spp., Enterobacter spp., E. coli, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella spp., Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens). After topical administration, systemic exposure to dexamethasone and tobramycin is low.
Contraindications:
Hypersensitivity to tobramycin, dexamethasone or to any of the excipients. acute superficial keratitis caused by herpesvirus, cowpox virus, chickenpox or other viral diseases of the cornea and conjunctiva. Uncomplicated removal of the foreign body from the cornea. Tuberculosis of the eye caused byMycobacteriae, including acid-like sticks, such asMycobacterium tuberculosis, Mycobacterium leprae orMycobacterium avium. Fungal infection of the eye. Untreated, purulent ocular infection.
Precautions:
Long-term use of the preparation (ie, over 24 days) or an increased frequency of its administration may lead to an increase in intraocular pressure / glaucoma, and consequent to damage to the optic nerve, reduced visual acuity and reduced visual field. It can also lead to the posterior subcapsular cataract. In sensitive patients, intraocular pressure may increase even after using the drug at the recommended doses. Regular monitoring of intraocular pressure is recommended; this is particularly important in children (in children under 6 years, the risk of developing ocular hypertension may be higher and the response to corticosteroids may be faster). Frequency of administration and duration of treatment should be carefully planned and intraocular pressure should be monitored from the beginning of treatment, taking into account the risk of earlier and higher elevation of intraocular pressure induced by corticosteroids in children. After the use of combined preparations containing steroids and antibacterial agents, secondary infections developed. Long-term use of steroids is particularly predisposed to fungal infections of the cornea. Therefore, in the case of persistent corneal ulceration that has occurred after steroid treatment, the possibility of fungal infection should always be considered. Secondary eye infection also occurs as a result of impairment of the patient's resistance. Treatment with corticosteroids may mask or exacerbate acute purulent infections. Local presence of steroids in the diseases that cause thinning of the cornea or sclera has reported the occurrence of perforation. If hypersensitivity occurs, the preparation should be discontinued and appropriate treatment should be given. Topical corticosteroids may delay corneal healing. The preparation contains benzalkonium chloride, which may cause eye irritation and change the color of soft contact lenses. Before applying the product, soft (hydrophilic) contact lenses should be removed and wait at least 15 minutes before putting them back on. Patients should not use contact lenses when eye infections occur. The safety and efficacy of the preparation in children under the age of 2 years has not been determined and no data are available on this subject.
Pregnancy and lactation:
The safety of the preparation in pregnant and breast-feeding women has not been established. The preparation may be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.When administered to the eye, the systemic exposure to the active substances is low, as are the risks associated with it, but these should be taken into account when prescribing to breast-feeding women. Consideration should be given to discontinuing breast-feeding while the preparation is being used.
Side effects:
Common: discomfort in the eye (transient burning or stinging after administration of the preparation). Uncommon: pruritus, increased intraocular pressure, ocular congestion, punctate keratitis, erythema, increased tearing, swelling and eyelid pruritus.
Dosage:
Adults, adolescents and children from 2 years: 1-2 drops into the conjunctival sac (conjunctival sacs) of the infected eye (eyes) every 4-6 h. In the first 24-48 h the dose can be increased to 1-2 drops every 2 h. Gradually reduce the frequency of use as the symptoms subside. Use caution and do not stop treatment prematurely. In severe cases, 1-2 drops are used in the conjunctival sac (conjunctival sac) of the infected eye (eyes) every 1 hour, for improvement. Gradually, the preparation is used less and less frequently - up to 1-2 drops every 2 hours for a period of 3 days. Then apply 1-2 drops every 4 h for 5-8 days, finally 1-2 drops daily for 5-8 days, if the doctor deems it necessary. After cataract surgery, 1-2 drops 4 times a day are used, starting from the day after surgery for up to 24 days. The preparation can be used the day before the procedure, in a dose of 1 drop 4 times a day, and then 1 drop after the treatment and then 1 drop 4 times a day for the Next 23 days. If necessary, the preparation can be used more often - up to a dose of 1 drop every 2 hours for the first 2 days of treatment. After instillation, it is recommended to gently close the eyelid and compress the nasolabial tract. In the case of simultaneous use of other drugs administered topically to the eye, it should be kept for 10-15 minutes. intervals between administrations of subsequent preparations.