Active substanceDexamethasone + TobramycinDexamethasone + Tobramycin
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  • DexaTeach
    drops d / eye 
    ROMFARMA, OOO     Russia
  • Tebridex®
    drops d / eye 
  • Tebridex®
    ointment d / eye 
  • Tebronez
    drops d / eye 
  • Dosage form: & nbspeye drops
    Composition:

    Per 1 ml:

    active substances: tobramycin 3 mg, dexamethasone 1 mg;

    Excipients: benzalkonium chloride, a solution equivalent to benzalkonium chloride 0.1 mg; disodium edetate 0.1 mg; sodium chloride 3.0 mg; sodium sulfate anhydrous 12.0 mg; tyloxapol 0.5 mg; Hyethellosis (hydroxyethylcellulose) 2.5 mg; sulfuric acid and / or sodium hydroxide to adjust the pH; water purified to 1.0 ml.

    Description:

    Suspension from white to almost white.

    Pharmacotherapeutic group:glucocorticosteroid for topical use + antibiotic-aminoglycoside
    ATX: & nbsp

    S.01.C.A   Corticosteroids in combination with antimicrobials

    S.01.C.A.01   Dexamethasone in combination with antimicrobials

    Pharmacodynamics:

    Combined drug.

    Tobramycin - a broad-spectrum antibiotic from the aminoglycoside group. Violates protein synthesis and permeability of the cytoplasmic membrane of the microbial cell.

    It is active against gram-positive and gram-negative microorganisms: staphylococci (including Staphylococcus aureus, Staphylococcus epidermidis), including strains resistant to methicillin; streptococci, including some beta-hemolytic species of group A, nonhemolytic species and some strains Streptococcus pneumonie; Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter spp, Proteus mirabilis, Morganella morganii, Citrobacter spp, Haemophilus influenzae, Moraxella spp, Acinetobacter spp, Serratia marcescens.

    Dexamethasone - synthetic fluorinated glucocorticoid, does not have mineralocorticoid activity. Has a pronounced anti-inflammatory, antiallergic and desensitizing effect. Dexamethasone actively suppresses inflammatory processes, suppressing eosinophilic ejection of inflammatory mediators, migration of mast cells and decreasing capillary permeability, vasodilation.

    The combination of a glucocorticosteroid with an antibiotic (tobramycin) can reduce the risk of infection.

    Pharmacokinetics:

    With topical application of Tevadex®, systemic absorption of dexamethasone is low. The maximum concentration (CmOh) of dexamethasone in blood plasma is from 220 to 888 pg / ml (about 555 ±217 pg / ml) after using 1 drop of Teborex® in each eye 4 times a day for 2 days.About 77-84% of dexamethasone entering the systemic circulation is associated with plasma proteins. T1/2 averages 3-4 hours. It is excreted by metabolism, about 60% in the form of 6-β-hydroxydexamethasone in urine.

    With topical application of Tevorex®, systemic absorption of tobramycin is low. The concentration of tobramycin in the blood plasma after using 1 drop of Tevadex® in each eye 4 times a day for 2 days was below the detection threshold in 9 of 12 patients. The maximum measurable concentration (CmOh) of tobramycin in the blood plasma was 247 ng / ml, which is eight times lower than the concentration threshold associated with nephrotoxicity. It is excreted by the kidneys, mostly unchanged.

    Indications:

    Inflammatory diseases of the eye and its appendages caused by pathogens that are sensitive to the drug:

    - blepharitis;

    - conjunctivitis;

    - keratoconjunctivitis;

    - blepharoconjunctivitis;

    - keratitis;

    - iridocyclitis.

    Prevention and treatment of inflammatory phenomena in the postoperative period after cataract extraction.

    Contraindications:

    - Individual hypersensitivity to the components of the drug;

    - viral diseases of the eyes (including keratitis caused by Herpes simplex, chickenpox);

    - mycobacterial infections of the eyes;

    - fungal diseases of the eyes;

    - purulent eye diseases;

    - condition after removal of the foreign body of the cornea;

    - the period of breastfeeding;

    - children under 12 years.

    Pregnancy and lactation:

    Sufficient experience in the use of the drug during pregnancy is not present. It is possible to use the treatment for pregnant women on prescription of the attending physician if the expected curative effect for the mother exceeds the risk of development of possible side effects in the fetus.

    Teratogenic effect

    Studies in animals have revealed nephrotoxicity and ototoxicity in the fetus when high doses of tobramycin are prescribed. Anomalies of fetal development in cases of chronic administration of high doses of dexamethasone have been revealed.

    Dosing and Administration:

    Locally. Shake the bottle before use!

    Children over 12 years and adults Bury 1-2 drops in the conjunctival sac every 4-6 hours.

    In the first 24-48 hours, the dose can be increased to 1-2 drops in the conjunctival sac every 2 hours, followed by a decrease in the frequency of instillations of the drug as the phenomena of inflammation decrease.

    In acute severe infectious process: 1-2 drops in the conjunctival sac every 60 minutes until the severity of the condition decreases. Then reduce the frequency of instillations of the drug to 1-2 drops in the conjunctival sac every 2 hours for 3 days. Then 1-2 drops into the conjunctival sac every 4 hours for 5-8 days. If necessary, continue instillation: 1-2 drops in the conjunctival sac for 5-8 days.

    For the prevention of inflammatory phenomena in the postoperative period: 1 drop in the conjunctival sac 4 times a day, starting from the day of surgery up to 24 days. Therapy can be started before surgery: 1 drop in the conjunctival sac 4 times a day for 1 day before surgery, 1 drop per day of the operation, then 1 drop in the conjunctival sac 4 times a day for 23 days. If necessary, the frequency of instillations of the drug can be increased to 1-2 drops in the conjunctival sac every 2 hours for the first 2 days after surgery.

    After applying the drug to reduce the risk of systemic side effects, it is recommended to lightly press the finger on the projection area of ​​lacrimal sacs at the inner corner of the eye within 1-2 minutes after instillation of the drug - this reduces the systemic absorption of the drug.

    You can combine the use of ointments and drops of Tevodex®: ointment - in the evening before going to bed, drops - during the day (with the frequency of use of the drug 3-4 times a day).

    Side effects:

    Local. In 1-10% of cases: a feeling of discomfort in the eyes, pain and irritation of the eyes. In 0.1-1% of cases: hypersensitivity and allergic reactions, increased intraocular pressure, keratitis (including acupressure), conjunctival hyperemia, pruritus, erythema eyelids, blurred vision, sensation of foreign body in the eye, edema of the eyelids and conjunctiva, syndrome " dry eye ", increased lacrimation. The frequency is unknown: the development of glaucoma, cataracts, decreased visual acuity, mydriasis, photophobia.

    System. In 0.1-1% of cases: headache, dysgeusia, laryngospasm, rhinorrhea.

    With prolonged use (more than 24 days) or an increase in the frequency of instillations of glucocorticosteroids, there may be: increased intraocular pressure with possible subsequent development of steroid glaucoma; posterior subcapsular cataract, slowing down the process of wound healing (with diseases that cause thinning of the cornea, its perforation is possible).

    Secondary infection. Secondary bacterial infection may occur as a consequence of local immunosuppressive effects of glucocorticosteroids. Fungal infection of the cornea tends to occur especially often with prolonged use of glucocorticosteroids. The appearance of non-healing ulcers on the cornea after prolonged treatment with glucocorticosteroids may indicate the development of a fungal infection. In acute purulent diseases of the eye, glucocorticosteroids can mask or strengthen the existing infectious process.

    Overdose:

    Symptoms: hyperemia of the conjunctiva, spot keratitis, erythema, increased lacrimation, edema and itching of the eyelids.

    Wash eyes with warm water, symptomatic treatment.

    Interaction:

    In case of use with other local ophthalmic preparations, the interval between their use should be at least 5 minutes.

    Special instructions:

    The drug contains a preservative benzalkonium chloride, which can be absorbed by contact lenses. Before using the drug, contact lenses should be removed and installed back no earlier than 20 minutes after using the drug.

    If the duration of therapy is more than 2 weeks, the condition of the cornea should be monitored.

    In the case of the appointment of tobramycin topically at the same time as systemic aminoglycoside antibiotics, the overall blood picture should be monitored.

    Do not touch the tip of the dropper bottle to any surface to avoid contamination of the dropper and its contents.

    The bottle must be closed after each use.

    Use in children

    Tevendex® eye drops can be used in pediatrics in children from the age of 12.

    Duration of treatment should not exceed 7 days.
    Effect on the ability to drive transp. cf. and fur:

    If the patient after the application of the drug temporarily reduces the clarity of vision, until it is restored, it is not recommended to drive and engage in activities that require increased attention.

    Form release / dosage:

    Eye drops.

    Packaging:

    5 ml per bottle-dropper "Droptainertm "of low density polyethylene.

    For 1 bottle with instructions for use in a pack of cardboard.

    Storage conditions:

    At a temperature of 8 to 27 ° C, in an upright position, out of the reach of children.

    Shelf life:

    2 years.

    Use within 4 weeks after opening the vial.

    Do not use after the expiry date printed on the package

    Terms of leave from pharmacies:On prescription
    Registration number:П N016323 / 02
    Date of registration:23.07.2010
    The owner of the registration certificate:ALKON PHARMACEUTICS, LLC ALKON PHARMACEUTICS, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspALKON PHARMACEUTICS LLCALKON PHARMACEUTICS LLCRussia
    Information update date: & nbsp07.01.2016
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