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COMBINED-Duo eye/ear drops 5 ml




The instruction for medical use

of KOMBINIL-DUO medicine

the Trade name
of Kombinil-Duo

the International unlicensed name
Is not present

the Dosage form
of the Drop eye and ear

the Structure
of 1 ml of drug contains
active agents: ciprofloxacin a hydrochloride, it is equivalent to ciprofloxacin of 3.0 mg, dexamethasone of 1.0 mg
excipients: a benzalkoniya chloride, dinatrium edetat, hydroksipropilbetatsiklodekstrin, Mannitolum, Acidum hydrochloricum, water for injections.

The description
Transparent solution from colourless till light yellow color

Pharmacotherapeutic group
Drugs for treatment of ophthalmologic and otological diseases. Glucocorticoids in a combination with antimicrobial drugs. Dexamethasone in a combination with antimicrobial drugs.
The ATX S03CA01 code

the Pharmacological

Pharmacokinetics At properties use in ophthalmology ciprofloxacin well gets into various tissues of an eye, except for a crystalline lens. Cmax arises within 30 minutes, the highest concentration is observed in moisture of an anterior chamber. The system reabsorption is observed. However the concentration of medicinal substance reached in blood is much lower than a limit of detection and has no clinical importance.
Dexamethasone after instillation in a conjunctival sac well gets into an epithelium of a cornea and a conjunctiva, at the same time in watery moisture of an eye therapeutic concentration are reached, at inflammation or injury of a mucous membrane the speed of a penetration increases.
At use in otorhinolaryngological practice at introduction of the fixed combination of ciprofloxacin and dexamethasone to acoustical pass the maximum serumal concentration for ciprofloxacin makes 1.55 ng/l, and for dexamethasone 0.86 ng/l. Time of semi-removal of drugs – 2.9 hours and 2.8 hours respectively.
Being a part of drug as an auxiliary component hydroksipropilbetatsiklodekstrin promotes long preservation of active agent on the front surface of an eye, increasing thereby efficiency and duration of effect of drug.
A pharmacodynamics
of Kombinil-Duo it is intended for local use in ophthalmologic and otorhinolaryngological practice. The therapeutic effect of Kombinil-Duo is caused by antimicrobic effect of ciprofloxacin and anti-inflammatory effect of dexamethasone.
Ciprofloxacin – antimicrobial drug from group of ftorkhinolon, possesses a wide range of antibacterial action, renders bactericidal effect. Drug inhibits DNK-girazu enzyme of bacteria owing to what DNA replication and synthesis of cellular proteins of bacteria is broken. Ciprofloxacin affects both the breeding microorganisms, and on being in a rest stage.
The range of antibacterial effect of ciprofloxacin includes gram-negative microorganisms: Esherichia coli, Salmonella spp., Shigella spp., Proteus spp. (indolpositive and indolnegative), Morganella morganii, Citrobacter spp., Klebsiell 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.
Also gram-positive microorganisms are sensitive to ciprofloxacin: staphylococcus spp., Streptococcus pyogenes, St. agalactiae, Corynebacterium diphtheriae, Listeria monocitogenes. Drug malotoksichen.
Dexamethasone – the synthetic glucocorticosteroid which is mainly used as the anti-inflammatory and immunosuppressive agent. At topical administration the therapeutic activity of dexamethasone is caused by anti-inflammatory, antiallergic and anti-proliferative action. It reduces permeability and proliferation of capillaries, local exudation, cellular infiltration, phagocytal activity, adjournment of collagen and activity of fibroblasts, formation of cicatricial fabric oppresses. Thus, dexamethasone reduces the main symptoms of inflammation – hyperaemia, pain swelled also a local hyperthermia.

For short-term therapy
Bacterial inflammatory diseases of an eye and its appendages:
– acute and subacute conjunctivitis
– a keratitis
– a front uveitis
– blepharitis and other inflammatory diseases a century
– prevention and treatment of infectious complications after wounds of an eye and its appendages and at eyeball surgeries.
Bacterial inflammatory diseases of an ear:
– acute external otitis at adults and children
– acute average otitis with granulations and an otorrhea in the presence of the shunt of a tympanic membrane.

Route of administration and doses
Bacterial inflammatory diseases of an eye and its appendages:
1-2 drops dig in in a conjunctival sac each four-six hours. The first 24-48 hours of instillation can be made each two hours
the Course of treatment:
– in acute bacterial conjunctivitis, blefarita – from 5 to 14 days
– in a keratitis – 2-4 weeks
– for prevention of inflammatory diseases after surgical interventions with perforation of an eyeball – from 5 days to 1 month.
If drug is used more than 10 days, it is necessary to carry out monitoring of intraocular pressure of the patient.
Bacterial inflammatory diseases of an ear:
4 drops in an external ear canal of the affected ear twice a day within 7 days. It is not necessary to change position of the head within 60 seconds for full penetration of drug into an ear canal.

Side effects
Very often
– passing burning in an eye, discomfort, formation of a white deposit – usually at prolonged use of drug in a high dose, superinfection.
– gripes, reddening, an itching of eyes, misting of sight, passing discomfort
delay of healing of wounds, thinning of a cornea, consecutive infection – fungal/bacterial
is not frequent
– conjunctivitis, a keratitis, periokulyarny swelled, the century, a face edema, feeling of a foreign body in an eye, photophobia, misting of sight, dryness of an eye, injury of an optic nerve, flavoring perversions swelled.
– corneal infiltrates, dizziness, allergic reactions, skin rash, hypersensitivity, discomfort and ear pain, an itching of an ear, congestion of an ear,
It is very rare
– decrease in visual acuity and narrowing of fields of vision, forming of a cataract, at prolonged use the increase in intraocular pressure and glaucoma is possible, when thinning a cornea there is a danger of perforation of an eyeball.

– hypersensitivity to active ingredient of drug or to any auxiliary ingredients which are a part of this dosage form of drug
– a herpetic keratitis and other virus defeats of a cornea and conjunctiva
– tuberculosis of eyes
– fungal infections of eyes
– viral infections of acoustical pass
– perforation of a tympanic membrane
– children’s age up to 18 years
– pregnancy and the period of a lactation

Medicinal interactions
System absorption at topical administration is insignificant therefore the probability of emergence of medicinal interactions is extremely small. Inductors, inhibitors and substrates of liver enzymes: the drugs inducing activity of P450 3A4 cytochrome (CYP 3A4) (barbiturates, Phenytoinum, carbamazepine, rifampicin) can strengthen metabolism of corticosteroids. The drugs inducing activity of CYP3A4 (ketokonazol, macroleads) can potentially cause increase in level of corticosteroids in plasma. Dexamethasone is the moderate inductor CYP3A4. Joint reception with the drugs metaboliziruyemy by means of CYP3A4 (erythromycin) can increase their clearance, reducing their concentration in plasma. At a ciprofloxacin combination to other antimicrobial medicines (beta laktamnye antibiotics, aminoglycosides, clindamycin, metronidazole) synergism is usually observed, it can successfully be applied in a combination with azlotsilliny and a ceftazidime in the infections caused by Pseudomonas spp., with mezlotsilliny, azlotsilliny and others beta laktamnymi antibiotics
– in streptococcal infections, with izoksazolilpenitsillina and Vancomycinum
– in staphylococcal infections, with metronidazole and clindamycin
– in mephitic gangrenes.

Long use can lead special instructions to increase in intraocular pressure with the subsequent injury of an optic nerve, decrease in sharpness and fields of vision and also to forming of a back subkapsulyarny cataract. When using drug Kombinil-Duo more than 10 days it is necessary to control intraocular pressure.
In acute purulent infections of eyes the corticosteroids can worsen or mask disease symptoms.
The patients using contact lenses have to use the drug Kombinil-Duo only at the removed lenses and can dress them in 20 minutes after burying drug. Right after burying drug the decrease in clearness of sight and delay of mental reactions is possible therefore during treatment it is necessary to abstain from occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
The bottle needs to be closed after each use. It is not necessary to touch with a pipette tip an eye.
Bacterial inflammatory diseases of an ear: Before use of ear drops it is necessary to carry out sanitation of external acoustical pass (to wash out and drain external acoustical pass).
Before burying drug in external acoustical pass it is necessary to warm it to body temperature, having taken in hands within 1-2 minutes.
It is necessary to lay down on one side or to throw back the head to facilitate burying. To dig the specified quantity of drops in external acoustical pass, to allow drops to flow down in external acoustical pass, having delayed an ear lobe down and back. To keep the head in the thrown-back situation about 2 minutes. It is possible to place a cotton turunda in external acoustical pass.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
to Patients at whom after applique the sight clearness is temporarily lost is not recommended to drive or work with a difficult technique, machines or any difficult equipment demanding sight clearness right after burying.

Symptoms: developing of a dot keratitis, an erythema, the raised slezootdeleniye, hypostasis and itching a century.
Treatment: there is no specific antidote. It is necessary to wash eyes with water, to cancel drug and to appoint symptomatic therapy.

The form of release and packing
of the Drop eye and ear
On 5 ml of drug spill in a plastic bottle dropper with the screw-on cap or in the plastic bottle corked by a stopper dropper, closed by the plastic screw-on cap with control of the first opening.
On a bottle paste the label self-adhesive. On 1 bottle dropper or a plastic bottle together with the instruction for medical use in the state and Russian languages place in a cardboard pack.

To Store storage conditions in the place protected from light at a temperature of 15 – 25 °C.
To store out of children’s reach!

A period of storage
3 years
the use Period after opening of a bottle of 45 days.
Not to use after the expiry date specified on packing!

Prescription status
According to the prescription

of Proizvoditel SENTISS FARM Pvt. Ltd.
212/D-1, Greene Park, New Delhi, India
At the plant: Villidzh Khera Nikhla, Tekhsil Nalagarkh, Region of Solan, Himachal Pradesh 174,101, India

Name and country of the owner of the registration certificate
of SENTISS FARMA of Pvt. Ltd., India

the Address of the organization accepting claims from consumers on quality of products and responsible for post-registration observations of safety of medicine in the territory of the Republic of KazahstanRespublika Kazakhstan, 050000, Almaty, Bogenbay St. of the Batyr 132, office 309 Ph./fax: +7 (7272) 96-45-99Email:

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