Composition, form of production and packaging
Eye drops 0.3% 1 ml
tobramycin (in the form of sulphate) 3 mg
Excipients: benzalkonium chloride 100 mcg, hypromellose 2.5 mg, disodium edetate 1 mg, sodium chloride 9 mg, hydrochloric acid or sodium hydroxide (up to pH 7.5), water d / and up to 1 ml.
5 ml - a bottle-droppers (1) with a dispenser - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
A broad-spectrum antibiotic from the aminoglycoside group. At low concentrations, it acts bacteriostatically (blocks the 30S subunit of the ribosome and breaks down the synthesis of the protein), and at higher bactericidal levels (it breaks the protein synthesis and permeability of the cytoplasmic membrane of the microbial cell, causing its death). In vitro is active against Staphylococcus spp., Including Staphylococcus aureus and Staphylococcus epidermidis (coagulase-positive and coagulase-isolating), including penicillin-resistant strains; for Streptococcus spp., including some hemolytic Streptococcus spp. group A, some non-hemolytic species and some Streptococcus pneumoniae; Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most strains of Proteus vulgaris, Haemophilus influenzae and Haemophilus aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria spp. Some gentamycin resistant strains retain high sensitivity to tobramycin. Ineffective against most strains of streptococcus group D.
With topical application, systemic absorption is low. Tobramycin poorly penetrates the cornea, and its concentration in aqueous humor after topical application of 0.3% solution is not determined. Increasing the frequency of application can increase the concentration of tobramycin in aqueous humor.
Infections of the eye and its appendages: blepharitis, blepharoconjunctivitis, dacryocystitis, meibomite, conjunctivitis, keratoconjunctivitis, keratitis, endophthalmitis, iridocyclitis caused by drug-susceptible pathogens.
Prevention of infectious complications after ophthalmologic surgical interventions.
For mild and moderate severity of the disease, instill 1-2 drops in the affected eye every four hours for 7-10 days. In severe infections, instill two drops in the eye every hour until the inflammation phenomenon decreases. To prevent infectious complications after ophthalmic operations, the drug is instilled 3-4 times a day for a month after the operation.
Lachrymation, burning, itching and pain in the eye, photophobia, eyelid edema, conjunctival hyperemia, chemosis, pinpoint erosion of the corneal epithelium, allergic conjunctivitis, blepharitis and contact dermatitis.
Hypersensitivity to the components of the drug, the period of breastfeeding, children under 2 months.
PREGNANCY AND LACTATION
In studies of the effect on fetal development, no adverse effect on the fetus or course of pregnancy was found in animals. However, given the lack of sufficient experience in the use of the drug Dilaterol В® in pregnancy, the appointment of the drug in this category is possible only if the intended benefit to the mother exceeds the potential risk to the fetus. Breastfeeding for the period of treatment is recommended to be discontinued, since there is a risk of development of adverse reactions in the child caused by the use of tobramycin.
APPLICATION FOR CHILDREN
Contraindicated in childhood up to 2 months.
Long-term use of eye drops Dilaterol В® , as in the case of the use of other antibiotics, can lead to increased growth of non-susceptible microorganisms (including fungi). It is recommended to carry out bacteriological examination of the microflora of the eye before and after the end of treatment, if the clinical result is unsatisfactory.
It is unacceptable to wear contact lenses during treatment with the drug.
Impact on the ability to drive vehicles and manage mechanisms
If, after the application of droplets in patients, vision loss is temporarily reduced, it is not recommended to drive vehicles and engage in activities requiring increased attention and response before recovery.
Symptoms: itching and edema of the eyelids, acuminate keratitis, erythema eyelids, increased lacrimation. The total amount of tobramycin contained in one bottle of eye drops is too low to cause toxic reactions even after accidental ingestion.
After topical application of an excessive dose of eye drops Dilaterol В® , the eyes should be washed with clean water at room temperature.
In the case of simultaneous use of eye drops Dilaterol В® with systemic antibiotics from the aminoglycoside group, it is possible to intensify systemic side effects (nephrotoxic, ototoxic effect, disturbance of mineral metabolism and hemopoiesis).
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The preparation should be stored at a temperature of no higher than 30 В° C in a place protected from light. Do not freeze. Keep out of the reach of children.
Shelf life - 2 years. After opening the vial, the drug should be used within 30 days.
Do not use after the expiration date printed on the package.