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: & nbspointment eye
    Composition:

    1 g of ointment contains:

    active substances: tobramycin 3 mg, dexamethasone 1 mg;

    Excipients: chlorobutanol (chlorobutanol anhydrous), paraffin liquid (mineral oil), white petrolatum.

    Description:

    Homogeneous ointment is white or 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, structure 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 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-r-hydroxydexamethasone with 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's age till 18 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.

    A strip of ointment 1.5 cm long is placed in the conjunctival sac 3-4 times a day with a decrease in the frequency of application of the drug as the phenomena of inflammation decrease.

    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, foreign body sensation in the eye, edema of the eyelids and conjunctiva, dry eye syndrome, increased lachrymation. 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 steroid drugs, 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:

    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 tube with any surface to avoid contamination of the tip of the tube and its contents.

    The tube must be closed after each use.

    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:Ointment eye.
    Packaging:

    In an aluminum tube of 3.5 grams with a plastic screw cap.

    One tube with instructions for use in a pack of cardboard.

    Storage conditions:

    At a temperature of 8 to 27 ° C, out of the reach of children.

    Shelf life:2 years.
    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N016323 / 01
    Date of registration:20.07.2010 / 23.04.2012
    Date of cancellation:2017-01-09
    The owner of the registration certificate:ALKON PHARMACEUTICS, LLC ALKON PHARMACEUTICS, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspALKON PHARMACEUTICS LLCALKON PHARMACEUTICS LLCRussia
    Information update date: & nbsp09.01.2016
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