Combinil (Kombinil)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspdrops eye and ear
Composition:

1 ml of the preparation contains:

Active substance:

Ciprofloxacin hydrochloride, in terms of ciprofloxacin 3.0 mg,

Dexamethasone 1.0 mg.

Excipients:

benzalkonium chloride 0.1 mg, disodium edetate 1 mg, hydroxypropyl betacyclodextrin 20.4 mg, mannitol 42 mg, hydrochloric acid to pH 4.0, water for injection up to 1 ml.

Description:Transparent solution from colorless to light yellow color.
Pharmacotherapeutic group:Glucocorticosteroid for topical use + antimicrobial agent
ATX: & nbsp
  • Dexamethasone in combination with antimicrobials
    • Pharmacodynamics:

    Combinil® is intended for topical use in ophthalmic and otorhinolaryngological practice. The therapeutic effect of Combinil® is due to the antimicrobial effect of ciprofloxacin and the anti-inflammatory effect of dexamethasone.

    Ciprofloxacin is a protivomicrobial drug from the group of fluoroquinolones, has a broad spectrum of antibacterial action, has a bactericidal effect. The drug inhibits the DNA enzyme enzyme of bacteria, as a result of which DNA replication and the synthesis of bacterial cell proteins are disrupted. Ciprofloxacin It acts both on multiplying microorganisms, and on those in rest.

    The antibacterial spectrum of ciprofloxacin includes Gram-negative microorganisms: Esherichia coli, Salmonella spp., Shigella spp., Proteus spp.

    (indolpositive and endothelial), Morganella morganii, Citrobacter spp., Klebsiella spp., Enterobacter spp., Vibrio spp., Campylobacter spp., Hafnia spp., Providencia stuartii, Haemophilus influenzae, Pasteurella multocida, Pseudomonas spp., Gardnerella spp., Legionella pneumophila, Neisseria spp., Moraxella catarrhalis, Acinetobacter spp ,, Brucella spp., Chlamidia spp.

    Gram-positive microorganisms are also sensitive to ciprofloxacin: Staphylococcus spp., Streptococcus pyogenes, St. agalactiae, Corynebacterium diphtheriae, Listeria monocitogenes. The drug is low toxicity.

    Dexamethasone is a synthetic glucocorticosteroid, mainly used as an anti-inflammatory and immunosuppressive agent. With topical application, the therapeutic activity of dexamethasone is due to anti-inflammatory, antiallergic and antiproliferative action. It reduces the permeability and capillary proliferation, local exudation, cellular infiltration, phagocytic activity, collagen deposition and fibroblast activity, inhibits the formation of scar tissue. In this way, dexamethasone reduces the main symptoms of inflammation.

    Pharmacokinetics:

    When used in ophthalmology ciprofloxacin well penetrates into various tissues of the eye, with the exception of the lens. FROMmax occurs within 30 minutes, the highest concentration is observed in the moisture of the anterior chamber. Systemic reabsorption is observed. However, the drug concentration achieved in the blood is well below the detection limit and is not clinically relevant.

    Dexamethasone after digestion into the conjunctival sac penetrates well into the epithelium of the cornea and conjunctiva; while in the aqueous humor of the eye, therapeutic concentrations are achieved; with inflammation or damage to the mucous membrane, the penetration rate increases.

    When used in otorhinolaryngological practice with the introduction of a fixed combination of ciprofloxacin and dexamethasone in the auditory meatus, the maximum serum concentration for ciprofloxacin is 1.55 ng / l, and for dexamethasone 0.86 ng / l. Time, half-life of drugs - 2.9 hours and 2.8 hours, respectively.

    The hydroxypropyl betacyclodextrin included in the preparation as an auxiliary component contributes to the long-term retention of the active substance on the anterior surface of the eye; thereby increasing the effectiveness and duration of the drug.

    Indications:

    Bacterial inflammatory diseases of the eye and its appendages:

    - acute and subacute conjunctivitis;

    - keratitis;

    - anterior uveitis;

    - blepharitis and other inflammatory diseases of the eyelids;

    - prevention and treatment of infectious complications after wounds of the eye and its appendages and in operations on the eyeball.

    Bacterial inflammatory diseases of the ear:

    - acute otitis externa;

    - acute otitis media with a shunt of the tympanic membrane;

    - Acute otitis media with granulations and otorei with a shunt of the tympanic membrane.

    Contraindications:

    - Hypersensitivity to the active substance of the drug or to any of the auxiliary ingredients that make up this drug form of the drug;

    - herpetic keratitis and other viral lesions of the cornea and conjunctiva;

    - tuberculosis of the eye;

    - fungal lesions of the eyes;

    - viral infections of the ear canal;

    - perforation of the tympanic membrane;

    - children's age till 18 years;

    - pregnancy;

    - the period of lactation.

    Pregnancy and lactation:The use is contraindicated.
    Dosing and Administration:

    Bacterial inflammatory diseases of the eye and its appendages:

    1-2 drops are instilled in the conjunctival sac every four to six hours. The first 24-48 hours of instillation can be done every two hours.

    A course of treatment:

    • with acute bacterial conjunctivitis, blepharitis - from 5 to 14 days,
    • with keratitis - 2 - 4 weeks,
    • for the prevention of inflammatory diseases after surgery with perforation of the eyeball - from 5 days to 1 month.

    If the drug is used for more than 10 days, the patient's intraocular pressure should be monitored.

    Bacterial inflammatory diseases of the ear:

    4 drops into the external auditory canal of the affected ear twice a day for 7 days. Do not change the position of the head for 60 seconds to completely penetrate the canal into the auditory canal.

    Before applying ear drops, the external auditory canal should be sanitized (rinse and drain the external ear canal).

    Before instillation of the drug in the external ear canal, it should be warmed to body temperature, holding the bottle in the hands for 1-2 minutes.

    You need to lie sideways or tilt your head to ease instillation. To drip into the external ear canal specified number of drops.Allow the drops to drain into the external ear canal, pulling the earlobe down and back. Hold the head in the inverted position for about 2 minutes. You can put in the outer ear canal wool turunda.

    Side effects:Corneal infiltrates, burning, redness, pruritus, conjunctivitis, keratitis, periocular edema, facial edema, foreign body sensation in the eye, photophobia, blurred vision, dry eyes, eyelid edema, conjunctival hyperemia, glaucoma and optic nerve damage, decreased visual acuity and narrowing of the visual fields, cataract formation, secondary infection (fungal and bacterial), thinning of the cornea and / or perforation of the eyeball, delayed wound healing, discomfort and earache, itching in the ear, ear congestion, taste perversions, cutaneous rash.
    Overdose:Overdosage of the drug may manifest itself following local symptoms: the emergence of point keratitis, erythema, increased tear, edema and itching of the eyelids. There is no specific antidote. Rinse the eyes with water, cancel the drug and prescribe symptomatic therapy. There are no data on systemic manifestations of an overdose.
    Interaction:

    Systemic absorption with local application is insignificant, therefore the probability of occurrence of medicinal interactions is extremely small.

    Inducers, inhibitors and substrates of hepatic enzymes: drugs that induce cytochrome P450 3A4 (CUR3A4) activity (barbiturates, phenytoin, carbamazepine, rifampicin) can enhance the metabolism of corticosteroids. Drugs that induce the activity of CUR3A4 (ketococcazole, macrolides) can potentially cause an increase in the level of corticosteroids in the plasma. Dexamethasone is a moderate inductor CUR3A4. Joint reception with drugs metabolized by CUR3A4 (erythromycin) can increase their clearance, reducing their concentration in the plasma. When ciprofloxacin is combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole) synergy is usually observed; can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp .; with mezlocillin and other beta-lactam antibiotics - with streptococcal infections; with isoxazolylpenicillins and vancomycin - with staphylococcal infections; with metronidazole and clindamycin - with anaerobic infections.

    Special instructions:

    Bacterial inflammatory diseases of the eye and its appendages:

    Prolonged use can lead to an increase in intraocular pressure with subsequent damage to the optic nerve, a decrease in the severity and narrowing of the visual fields, as well as the formation of posterior subcapsular cataract. When using Combinil® for more than 10 days, it is necessary to monitor the intraocular pressure.

    In acute purulent eye infections, glucocorticoids can worsen or mask the symptoms of the disease. Prolonged use of the drug may reduce the immune response and lead to the development of secondary infection of the eye. Patients using contact lenses should be removed before instillation of the drug and reapply only after 20 minutes, since the preservative contained in the preparation may have an adverse effect on the eye tissue.

    After application of the drug, it is possible to reduce the clarity of visual perception, so immediately after instillation, it is not recommended to drive and engage in activities requiring increased attention and speed of psychomotor reactions.

    The bottle must be closed after each use.Do not touch the tip of the pipette to the eye.

    Storage at a low temperature can cause precipitation of the precipitate, which dissolves at room temperature. The bottle should not be stored in the refrigerator.

    Form release / dosage:
    Eye and ear drops.
    Packaging:

    5 ml in a plastic dropper bottle with a screw cap or in a plastic bottle sealed with a stopper capper, closed with a plastic screw cap with the control of the first autopsy.

    Each bottle-dropper or plastic bottle together with the instruction for use is placed in a cardboard box.

    Storage conditions:At a temperature of 15 - 25 ° C in the dark place. Do not store in the refrigerator. Keep out of the reach of children.
    Shelf life:3 years. Drops should be used within 45 days after opening the vial. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-006467/09
    Date of registration:13.08.2009 / 28.10.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Promed Exports Pvt. Ltd.Promed Exports Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSENTISS RUSS LLCSENTISS RUSS LLCRussia
    Information update date: & nbsp31.01.2018
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