Tobrosoot® (Tobrosopt)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTobramycinTobramycin
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  • Tobrosoot®
    drops d / eye 
    Warsaw Pharmaceutical Plant Polfa, JSC     Poland
    • Dosage form: & nbspeye drops
    Composition:
    Active substance: Tevomycin 3.0 mg.
    Excipients: boric acid 13.0 mg, sodium chloride 2.5 mg, sodium sulfate anhydrous 2.0 mg, benzalkonium chloride solution 50% 0.2 mg, purified water up to 1 ml.

    Description:
    Colorless or light yellow transparent liquid.

    Pharmacotherapeutic group:Antibiotic - aminoglycoside.
    ATX: & nbsp

    J.01.G.B   Other aminoglycosides

    J.01.G.B.01   Tobramycin

    Pharmacodynamics:
    Tobramycin is an antibiotic from the aminoglycoside group that exhibits in vitro activity against sensitive strains of the following bacteria: Pseudomonas aeruginosa,
    Escherichia coli,
    Klebsiella pneumoniae,
    Enterobacter aerogenes,
    Proteus mirabilis (indolpositive and indolotricative strains),
    Proteus species,
    Haemophilus influenzae and H. aegyptius,
    Moraxella lacunata,
    Acinetobacter calcoaceticus (Herellea vaginacola), some strains of Neisseria spp.,
    Staphylococcus - S. aureus and S. epidermidis (coagulase-positive and coagulase-negative strains),
    including strains resistant to penicillin, some bacteria of the genus Streptococcus (resistant species may appear).
    It has been established that in some cases microorganisms resistant to gentamicin remain sensitive to tobramycin.

    Pharmacokinetics:
    After instillation into the conjunctival sac, only a small amount of tobramycin penetrates the cornea.

    Indications:
    Indications for use
    Treatment of external infections of the eye and its appendages caused by strains of bacteria sensitive to tobramycin, especially strains resistant to most other antibiotics, mainly Pseudomonas aeruginosa.

    Contraindications:
    Hypersensitivity to tobramycin or any of the components of the drug; children age up to 2 months.

    Carefully:
    The drug is not intended for intraocular injection.
    Prolonged local application of tobramycin can lead to excessive development of resistant microorganisms, including fungi.Therefore, it is recommended to carry out bacterial culture before the beginning of treatment and after its completion in case of unsatisfactory effectiveness. If a secondary infection is found, appropriate treatment is necessary.
    Some patients may experience a hypersensitivity reaction (allergy) in the form of edema, tingling, congestion hyperemia. In this case, it is necessary to stop using the medication and consult a doctor.

    Pregnancy and lactation:
    Before using the drug, you should consult your doctor.
    The drug can be used during pregnancy only under the supervision of a doctor and only if the doctor considers the treatment necessary.
    It is impossible to exclude the appearance of undesirable effects in children who are breast-feeding mothers who use tobramycin in the form of eye drops. For this reason, taking into account the need for the use of the drug by a woman during breastfeeding, breastfeeding should be discontinued.

    Dosing and Administration:
    Infections with mild course: usually 1 or 2 drops in the conjunctival sac every 4 hours.
    Infections with severe course: usually 2 drops in the conjunctival sac at intervals of one hour until the improvement is achieved, after which, before the drug is discontinued, the dose should be gradually reduced.
    The duration of treatment with the drug is usually 6-8 days.
    Tobramycin can be used in the treatment of eye (eye) infections in children.
    Method of administration
    The drug is intended for topical use only - in the conjunctival sac.
    When using the drug, avoid touching the tip of the drip feeder with any surface to avoid microbial contamination.
    Before instillation of the drug should be thoroughly washed hands. Remove the lid and inject the medication into the conjunctival sac. If the drop does not hit the conjunctival sac, the next drop should be dripped. Carefully close eyelids without blinking or opening your eyes for about 2 minutes to allow the drug to absorb. Then wash your hands to remove the remnants of the drug and close the bottle.

    Side effects:
    Undesirable effects are characteristic of antibiotics from the aminoglycoside group and include local toxic effects and reactionshypersensitivity (swelling, tingling, congestion hyperemia).

    Overdose:
    When an overdose of the drug can develop clinical symptoms: spot keratitis, hyperemia, increased lacrimation, edema, itchy eyelids. In case of an overdose, it is necessary to wash the eyes (eye) with a sterile warm isotonic (0.9%) sodium chloride solution.

    Interaction:
    In case of simultaneous topical application of tobramycin and other aminoglycosides of systemic action to ensure maintenance of the necessary therapeutic concentrations, it is necessary to control their total concentration in the blood serum.
    In the case of parallel application of other ophthalmic drugs, an interval of at least 10 minutes between the instillation of the two drugs should be observed.

    Special instructions:
    The drug product TobroSpt® contains as a preservative benzalkonium chloride, so patients who wear soft (hydrophilic) contact lenses should remove them before instilling eye drops and wait at least 15 minutes before inserting them again. Benzalkonium chloride may cause eye irritation and discoloration of contact lenses.

    Effect on the ability to drive transp. cf. and fur:
    During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:
    Eye drops 0,3%

    Packaging:

    5 ml are packed in a polyethylene bottle with a dropper, closed with a cover with a warranty ring. One bottle together with the instruction for use is placed in a cardboard box.

    Storage conditions:
    Store at a temperature not exceeding 25 ° C.
    Keep out of the reach of children.

    Shelf life:
    2 years.
    Shelf life after autopsy - 4 weeks.
    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001888
    Date of registration:02.11.2012
    The owner of the registration certificate:Warsaw Pharmaceutical Plant Polfa, JSCWarsaw Pharmaceutical Plant Polfa, JSC Poland
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp12.09.2015
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