Combined eye / ear drops, 5 ml

Infectious and 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 injuries of the eye and its appendages and during operations on the eyeball.

Infectious and inflammatory ear diseases:

• acute otitis externa;

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

• acute otitis media with granulations and otorrhea in the presence of a tympanic membrane shunt.

In case of infectious and inflammatory diseases of the eye and its appendages, 1-2 drops are instilled into the conjunctival sac every 4-6 hours.The first 24-48 hours of instillation can be performed every 2 hours.

The course of treatment for 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. In case of infectious and inflammatory diseases of the ear, 4 drops are instilled into the external auditory canal of the affected ear 2 times / day for 7 days. You should not change the position of the head within 60 seconds for complete penetration of the drug into the auditory canal.

Eye and ear drops in the form of a clear solution from colorless to light yellow.

1 ml

ciprofloxacin (in the form of hydrochloride) 3 mg

dexamethasone 1 mg

Excipients: benzalkonium chloride, disodium edetate, hydroxypropyl betadex (hydroxypropyl betacyclodextrin), hydrochloric acid, mannitol, water d / i.

• Herpetic keratitis and other viral lesions of the cornea and conjunctiva;

• tuberculosis of the eyes;

• fungal lesions of the eyes;

• viral infections of the ear canal;

• perforation of the tympanic membrane;

• children under 18 years of age;

• pregnancy;

• lactation period (breastfeeding);

• hypersensitivity to active ingredients or to any of the auxiliary ingredients of the drug.

pharmachologic effect

A drug with antibacterial and anti-inflammatory action for topical use in ophthalmology and ENT practice. The therapeutic effect of CombinilЃ-Duo is due to the antibacterial effect of ciprofloxacin and the anti-inflammatory effect of dexamethasone. Ciprofloxacin is an antibacterial drug from the group of fluoroquinolones, has a broad spectrum of action, has a bactericidal effect. The drug inhibits the enzyme DNA gyrase of bacteria, as a result of which DNA replication and the synthesis of bacterial cellular proteins are disrupted. Ciprofloxacin acts both on multiplying microorganisms and on those in the resting stage. Active against gram-negative microorganisms: Esherichia coli, Salmonella spp., Shigella spp., Proteus spp. (indole-positive and indole-negative), 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 catetoppar. , Chlamydia spp .; gram-positive microorganisms: Staphylococcus spp., Streptococcus pyogenes, Streptococcus agalactiae, Corynebacterium diphtheriae, Listeria monocytogenes. Dexamethasone is a synthetic GCS. When applied topically, the therapeutic activity of dexamethasone is due to its anti-inflammatory, antiallergic and antiproliferative action. It reduces capillary permeability and proliferation, local exudation, cell infiltration, phagocytic activity, collagen deposition and fibroblast activity, inhibits the formation of scar tissue. Thus,dexamethasone reduces the main symptoms of inflammation.

Pharmacokinetics

When used in ophthalmology, ciprofloxacin penetrates well into various tissues of the eye, with the exception of the lens. Cmax occurs within 30 minutes, the highest concentration is observed in the moisture of the anterior chamber. Systemic reabsorption is observed. However, the concentration of a drug substance reached in the blood is well below the detection limit and has no clinical significance. Dexamethasone, after instillation into the conjunctival sac, penetrates well into the corneal epithelium and conjunctiva; while in the aqueous humor of the eye, therapeutic concentrations are achieved; with inflammation or damage to the mucous membrane, the rate of penetration increases. When used in otorhinolaryngological practice, with the introduction of a fixed combination of ciprofloxacin and dexamethasone into the ear canal, Cmax for ciprofloxacin is 1.55 ng / l, and for dexamethasone 0.86 ng / l. T1 / 2 of ciprofloxacin - 2.9 h, dexamethasone - 2.8 h. Hydroxypropyl betacyclodextrin, which is part of the drug as an auxiliary component, promotes long-term preservation of the active substance on the anterior surface of the eye, thereby increasing the effectiveness and duration of the drug.

Side effect

From the side of the organ of vision: horny infiltrates, burning, redness, itchy eyes, conjunctivitis, keratitis, periocular edema, foreign body sensation in the eye, photophobia, blurred vision, dry eyes, eyelid edema, conjunctival hyperemia, glaucoma and damage to the optic nerve, decreased acuity vision and narrowing of visual fields, cataract formation, secondary infection (fungal and bacterial), thinning of the cornea and / or perforation of the eyeball. From the side of the organ of hearing: discomfort and pain in the ear, itching in the ear, ear congestion. Others: facial edema, delayed wound healing, gustatory perversion, skin rash.

Application during pregnancy and lactation

The use of the drug during pregnancy and lactation is contraindicated.

special instructions

Prolonged use of eye drops can lead to an increase in intraocular pressure with subsequent damage to the optic nerve, a decrease in visual acuity and fields, as well as the formation of a posterior subcapsular cataract. When using the drug CombinilЃ-Duo for more than 10 days, it is necessary to control the intraocular pressure. In acute purulent eye infections, corticosteroids may worsen or mask symptoms. Long-term use of the drug can reduce the immune response and lead to the development of a secondary infection of the eye. Patients using contact lenses should remove them before instilling the drug and put them back on only after 20 minutes, since the preservative contained in the drug can have an adverse effect on the eye tissue. The bottle must be closed after each use.Do not touch the eye with the pipette tip. Before using ear drops, you should sanitize the external auditory canal (rinse and dry the external auditory canal). Before instilling the drug into the external auditory canal, you should warm it up to body temperature by holding it in your hands for 1-2 minutes. It is necessary to lie on one side or tilt the head back to facilitate instillation. Instill the specified number of drops into the external auditory canal. Allow the drops to drain into the external auditory canal by pulling the earlobe down and back. Keep your head tilted back for about 2 minutes. Can be placed in the external auditory canal with cotton wool.Before instilling the drug into the external auditory canal, you should warm it up to body temperature by holding it in your hands for 1-2 minutes. It is necessary to lie on one side or tilt the head back to facilitate instillation. Instill the specified number of drops into the external auditory canal. Allow the drops to drain into the external auditory canal by pulling the earlobe down and back. Keep your head tilted back for about 2 minutes. Can be placed in the external auditory canal with cotton wool.Before instilling the drug into the external auditory canal, you should warm it up to body temperature by holding it in your hands for 1-2 minutes. It is necessary to lie on one side or tilt the head back to facilitate instillation. Instill the specified number of drops into the external auditory canal. Allow the drops to drain into the external auditory canal by pulling the earlobe down and back. Keep your head tilted back for about 2 minutes. Can be placed in the external auditory canal with cotton wool.Can be placed in the external auditory canal with cotton wool.Can be placed in the external auditory canal with cotton wool.

Influence on the ability to drive vehicles and use mechanisms

After using eye drops, a decrease in the clarity of visual perception is possible, therefore, immediately after instillation, it is not recommended to drive a car and engage in activities that require increased attention and speed of psychomotor reactions.

Overdose

Symptoms: local - the occurrence of punctate keratitis, erythema, increased lacrimation, edema and itching of the eyelids. There are no data on systemic manifestations of overdose. Treatment: there is no specific antidote. You should rinse your eyes with water, cancel the drug and prescribe symptomatic therapy.

Drug interactions

Systemic absorption when applied topically is negligible, so the likelihood of drug interactions is extremely small. Drugs that induce the activity of the isoenzyme CYP 3A4 (barbiturates, phenytoin, carbamazepine, rifampicin) can increase the metabolism of GCS. Drugs that inhibit the activity of CYP 3A4 (ketoconazole, macrolides) can potentially cause an increase in plasma corticosteroid levels. Dexamethasone is a moderate inducer of CYP3A4. Co-administration with drugs metabolized by CYP3A4 (erythromycin) can increase their clearance, reducing their plasma concentration. When ciprofloxacin is combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergism is usually observed;can be successfully used in combination with azlocillin and ceftazidime for infections caused by Pseudomonas spp .; with mezlocillin and other beta-lactam antibiotics - for streptococcal infections; with isoxazolylpenicillins and vancomycin - for staphylococcal infections; with metronidazole and clindamycin - for anaerobic infections.