Maxitrol® (Maxitrol®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDexamethasone + Neomycin + Polymyxin BDexamethasone + Neomycin + Polymyxin B
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  • Maxitrol®
    drops d / eye 
    Alkon-Kouvreur N.V. S.A.     Belgium
    • Dosage form: & nbspeye drops
    Composition:

    1 ml of the preparation contains:

    active substances: dexamethasone 1.0 mg; neomycin sulfate 3500 ME; polymyxin B sulfate 6000 ME;

    Excipients: benzalkonium chloride 0.04 mg; sodium chloride 8.5 mg; polysorbate 20 0.5 mg; hypromellose 5.0 mg; hydrochloric acid and / or sodium hydroxide until adjusted to pH; water purified to 1 ml.

    Description:Opaque suspension from white to light yellow color.
    Pharmacotherapeutic group:glucocorticosteroid for topical use + antibiotics (aminoglycoside and cyclic polypeptide)
    ATX: & nbsp

    S.02.C.A   Corticosteroids in combination with antimicrobials

    S.02.C.A.06   Dexamethasone in combination with antimicrobials

    Pharmacodynamics:

    Combination drug for topical application in ophthalmology.

    Neomycin has a bactericidal effect, disrupting the synthesis of the bacterial cell protein. Active with respect to Staphylococcus aureus, Corynebacterium diphteriae, Streptococcus viridans, Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, Aerobacter aerogenes and Haemophilus influenzae.

    Mechanism of action polymyxin B is mainly due to blockade of the permeability of the cytoplasmic membrane of bacterial cells. Active with respect to Pseudomonas Aeruginosa, Aerobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Koch-Weeks bacillus.

    Dexamethasone - Glucocorticosteroid. Has anti-inflammatory, antiallergic and desensitizing effects. Has an antiexudative effect. Dexamethasone effectively suppresses inflammatory processes.

    Combination of glucocorticoid with antibiotics can reduce the risk of infection.

    Pharmacokinetics:

    With topical application, systemic absorption is low.

    Indications:

    Infections of the eye and its appendages:

    - blepharitis;

    - conjunctivitis;

    - keratoconjunctivitis;

    - blepharoconjunctivitis;

    - keratitis;

    - iridocyclitis.

    Prevention of postoperative infectious complications.

    Contraindications:

    - Individual hypersensitivity to the components of the drug;

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

    - mycobacterial infection of the eyes;

    - tuberculosis diseases of the eyes;

    - Acute herpes zoster;

    - fungal diseases of the eyes;

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

    - purulent infection of the mucous membrane of the eye and eyelids caused by microorganisms resistant to the action of neomycin, a purulent corneal ulcer.

    Carefully:With glaucoma, cataract.
    Pregnancy and lactation:

    Sufficient experience in the use of the drug during pregnancy and lactation is not present.

    It is possible to use the treatment for pregnant women on prescription of the attending physician if the expected curative effect exceeds the risk of development of possible side effects.

    It is necessary to interrupt the use of the drug for the period of breastfeeding.

    Dosing and Administration:

    Locally.

    With a mild infectious process 1-2 drops in the conjunctival sac 4-6 times a day.

    In acute severe infectious process 1-2 drops in the conjunctival sac every 60 minutes, with a decrease in the frequency of instillations of the drug as the phenomena of inflammation decrease.
    Side effects:

    Local. Allergic reaction, accompanied by itching and swelling of the eyelids, hyperemia of the conjunctiva.

    Side effects due to the steroid component: increased intraocular pressure with possible subsequent development of glaucoma, optic nerve damage and visual fields (with the use of the drug for more than 10 days, monitoring of intraocular pressure is necessary); posterior subcapsular cataract, slowing down the process of wound healing.Local use of steroids in diseases that cause thinning of the cornea or sclera can lead to their perforation.

    Secondary infection. The development of secondary infection is observed after the use of combined preparations containing glucocorticosteroids in combination with antibiotics. With prolonged use of steroids, fungal infections of the cornea may develop. The appearance of non-healing ulcers on the cornea after prolonged treatment with steroid preparations may indicate the development of fungal infestation. Secondary bacterial infection may occur as a consequence of suppression of the protective reaction of the patient's body.

    Interaction:

    Interaction with other drugs is not currently known.

    In the case of use with other local ophthalmic preparations, the interval between their use should be at least 10 minutes.

    Special instructions:

    The bottle must be closed after each use.

    Shake the bottle before use.

    Pediatric Use

    Safety and effectiveness of the drug in children are not established.

    Form release / dosage:

    Eye drops.

    Packaging:

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

    For 1 bottle with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature of 8 to 30 ° C.

    Keep 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 stated on the package
    Terms of leave from pharmacies:On prescription
    Registration number:П N014557 / 01
    Date of registration:22.05.2008 / 08.05.2013
    The owner of the registration certificate:Alkon-Kouvreur N.V. S.A.Alkon-Kouvreur N.V. S.A. Belgium
    Manufacturer: & nbsp
    Representation: & nbspALKON PHARMACEUTICS LLCALKON PHARMACEUTICS LLCRussia
    Information update date: & nbsp07.01.2016
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