Tobropt, eye drops 0.3% 5 ml

The antibiotic tobramycin in the preparation belongs to the broad-spectrum substances of the aminoglycoside group. It has bacteriostatic action (by blocking 30S ribosome subunit, disrupting protein synthesis of the bacteria).

The main activity of the drug is shown against coagulase-negative, coagulase-positive staphylococcal flora, penicillin-resistant strains (including Staphylococcusepidermidis, Staphylococcus aureus) and several types of streptococci (including group A beta-haemolytic strains, some non-haemolytic strains, Streptococcuspneumoniae). In addition, it acts on Pseudomonasaeruginosa, indole-positive and indole-negative Proteus species (including Proteusmirabilis, Proteusvulgaris), Haemophilusinfluenzae, Haemophilusaegyptius, Escherichiacoli, Klebsiellapneumoniae, Enterobacteraerogenes, Moraxellalacunata, Morganellamorganii, Neisseriaspp, Acinetobactercalcoaceticus. At the same time, some gentamicin-resistant strains retain high sensitivity to tobramycin. It is ineffective against group D streptococci.

Pharmacokinetics

It penetrates well through the blood-ophthalmic barrier. Systemic absorption when instilled into the conjunctival sac is insignificant. When injection into the conjunctival sac is detected at therapeutic concentrations in the corneal stroma, anterior chamber moisture, the vitreous body within 6 hours. Aminoglycosides are not metabolized, excreted by the kidneys.

Indications

Infections of the eye and its appendages:

blepharitis,
conjunctivitis,
keratoconjunctivitis,
blepharoconjunctivitis,
keratitis,
endophthalmitis,
dacryocystitis,
meibomite (barley).

Prevention of postoperative infectious complications in ophthalmology.

Pharmacological effect

The antibiotic tobramycin in the drug belongs to the broad-spectrum substances of the aminoglycoside group. It has a bacteriostatic effect (blocking the 30S ribosomal subunit, disrupting bacterial protein synthesis).

The main activity of the drug is manifested against coagulase-negative, coagulase-positive staphylococcal flora, penicillin-resistant strains (including Staphylococcus epidermidis, Staphylococcusaureus) and several types of streptococci (including beta-hemolytic strains of group A, some non-hemolytic strains, Streptococcus pneumoniae). In addition, it acts on Pseudomonasaeruginosa, indole-positive and indole-negative Proteus species (including Proteusmirabilis, Proteusvulgaris), Haemophilusinfluenzae, Haemophilusaegyptius, Escherichiacoli, Klebsiellapneumoniae, Enterobacteraerogenes, Moraxellalacunata, Morganellamorganii, Neisseriaspp, Acinetobacter calcoaceticus. At the same time, some gentamicin-resistant strains remain highly sensitive to tobramycin. Ineffective against group D streptococci.

Pharmacokinetics

Penetrates well through the blood-ophthalmic barrier. Systemic absorption when installed in the conjunctival sac is negligible. When instilled into the conjunctival sac, they are found in therapeutic concentrations in the corneal stroma, anterior chamber moisture, and vitreous humor within 6 hours. Aminoglycosides are not metabolized and are excreted by the kidneys.

Special instructions

Tobropt is for topical use only.
The bottle must be closed after each use.

Do not touch the tip of the pipette to your eye to maintain the sterility of the solution.
Long-term use of the drug Tobropt, as in the case of the use of other antibiotics, can lead to increased growth of resistant microorganisms (including fungi). It is recommended to perform a culture after completion of treatment if the clinical result is unsatisfactory.

During the treatment period, you should not wear soft contact lenses. Rigid contact lenses should be removed while using the drug; they can be put on 15 minutes after instilling the drops.
The use of the drug should be discontinued if allergic reactions develop.
Shake the contents of the bottle before use.

Impact on the ability to drive vehicles and work with special equipment
The use of the drug Tobropt does not cause increased fatigue and visual impairment, and therefore does not affect the ability to drive vehicles or operate machinery. Patients who temporarily lose clarity of vision after application are not recommended to drive a car or operate complex equipment immediately after instilling the drug.

Active ingredient

Tobramycin

Composition

1 ml eye drops contains:

active ingredient:

tobramycin – 3 mg

excipients:

boric acid,

sodium chloride,

sodium sulfate anhydrous,

tyloxapol, benzalkonium chloride,

1 M sodium hydroxide solution or 0.5 M sulfuric acid solution,

purified water.

Pregnancy

The use of the drug during pregnancy and lactation (breastfeeding) is contraindicated.

Use in children

Contraindicated in children and adolescents under 18 years of age.

Contraindications

Hypersensitivity to the components of the drug Tobropt,
age up to 18 years,
pregnancy, lactation.

Side Effects

When using the drug, allergic reactions may occur:
in 15% of cases: burning, paresthesia, itching of the conjunctiva;
in 1-5%: hyperemia of the mucous membrane of the eye, sensation of a foreign body in the eye, lacrimation;
less than 1%: blepharitis, keratitis, eyelid edema, eye pain, chemosis, crystal deposition, corneal ulceration.

Interaction

It is possible to increase systemic side effects (nephrotoxic, ototoxic effects, disorders of mineral metabolism and hematopoiesis) in case of simultaneous administration of the drug Tobropt with systemic antibiotics from the aminoglycoside group.

Overdose

Symptoms: punctate keratitis, erythema, increased lacrimation, itching and swelling of the eyelid.

Treatment: carry out symptomatic therapy.

Storage conditions

In a dry place, protected from light, at a temperature of 15–25 °C

Shelf life

3 years

Manufacturer

K.O.Rompharm Company S.R.L., Romania