Combinil-duo eye and ear drops 5 ml

Pharmacological properties

Combinil-Duo solution is used in ophthalmic practice as a local antimicrobial and anti-inflammatory agent. Its therapeutic effect is due to the presence of the fluoroquinolone antibiotic ciprofloxacin and the glucocorticosteroid dexamethasone.

Ciprofloxacin has an antibacterial effect and has a bactericidal effect. The effect of the substance inhibits the enzyme DNA gyrase of bacterial microflora, as a result of which DNA replication is disrupted and the synthesis of bacterial cellular proteins stops. Ciprofloxacin is active against reproducing microorganisms, as well as those in the dormant stage. Its antibacterial effect extends to Esherichia coli, Shigella spp., Salmonella spp., most species of Proteus spp., Morganella morganii, Klebsiella spp., Citrobacter spp., Enterobacter spp., Campylobacter spp., Vibrio spp., Hafnia spp., Haemophilus influenzae, Providencia stuartii, Pasteurella multocida, Gardnerella spp., Pseudomonas spp., Legionella pneumophila, Moraxella catarrhalis, Neisseria spp., Acinetobacter spp., Chlamidia spp., Brucella spp. (Gram-negative bacteria). And also: Staphylococcus spp., St. agalactiae, Streptococcus pyogenes, Corynebacterium diphtheria. The toxicity of the substance is negligible.

Dexamethasone is a synthetic glucocorticosteroid commonly used as an anti-inflammatory and immunosuppressive agent. When applied topically, its therapeutic activity is due to its anti-inflammatory, antiallergic, and antiproliferative properties. It reduces the permeability of capillary walls, local exudation, phagocytic activity, and cellular infiltration. Prevents collagen deposition and fibroblast activity, prevents the formation of scar tissue.

The auxiliary component hydroxypropyl betacyclodextrin contained in Combinil-Duo promotes long-term preservation of active substances on the surface of the eye, which increases the effectiveness of the solution.

Combinil-duo 5ml eye/ear drops

Release form

Eye and ear drops.

Package

There is 5 ml of the drug in a plastic dropper bottle. In a cardboard package there is 1 dropper bottle. 5 ml

pharmachologic effect

Combinil is intended for local use in ophthalmological and otorhinolaryngological practice. The therapeutic effect of the drug Combinilo is due to the antimicrobial effect of ciprofloxacin and the anti-inflammatory effect of dexamethasone. Ciprofloxacin is an antimicrobial drug from the fluoroquinolone group, has a wide spectrum of antibacterial action and 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 microorganisms that are reproducing and those in the dormant stage. The spectrum of antibacterial action of ciprofloxacin includes: Gram-negative microorganisms: Escherichia 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 catarrhalis. Acinetobacter spp. Brucella spp. Chlamydia spp. Gram-positive microorganisms: Staphylococcus spp. Streptococcus pyogenes. St. agalactiae. Corynebacterium diphtheriae. Listeria monocitogenes. The drug is low toxic. Dexamethasone is a synthetic glucocorticosteroid primarily used as an anti-inflammatory and immunosuppressive agent. When applied topically, the therapeutic activity of dexamethasone is due to its anti-inflammatory, antiallergic and antiproliferative effects. It reduces capillary permeability and proliferation, local exudation, cellular infiltration, phagocytic activity, collagen deposition and fibroblast activity, and inhibits the formation of scar tissue. Thus, dexamethasone reduces the main symptoms of inflammation.

Pharmakinetics

Absorption and metabolism When used in ophthalmology, ciprofloxacin penetrates well into various tissues of the eye, with the exception of the lens. C max 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 has no clinical significance. Dexamethasone, after instillation into the conjunctival sac, penetrates well into the corneal epithelium and conjunctiva; at the same time, therapeutic concentrations are achieved in the aqueous humor of the eye; with inflammation or damage to the mucous membrane, the penetration rate increases. When used in otorhinolaryngological practice, when a fixed combination of ciprofloxacin and dexamethasone is administered into the ear canal, the maximum serum concentration for ciprofloxacin is 1.55 ng/l, and for dexamethasone 0.86. ng/l. Elimination The half-life of the drugs is 2.9 hours and 2.8 hours, respectively. Hydroxypropylbetacyclodextrin, which is part of the drug as an auxiliary component, promotes long-term preservation of the active substance on the front surface of the eye, thereby increasing the effectiveness and duration of action 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 injuries to the eye and its appendages and during operations on the eyeball. Bacterial inflammatory diseases of the ear: Acute external otitis. Acute otitis media with eardrum shunt. Acute otitis media with granulations and otorrhea in the presence of an eardrum shunt.

Contraindications

Hypersensitivity to the active substance of the drug or to any auxiliary ingredients included in this dosage form of the drug. Herpetic keratitis and other viral lesions of the cornea and conjunctiva. Tuberculosis of the eye. Fungal infections of the eyes. Viral infections of the ear canal. Perforation of the eardrum. Children under 18 years of age. Pregnancy. Breastfeeding period.

Use during pregnancy and breastfeeding

Contraindicated during pregnancy and breastfeeding.

special instructions

For bacterial inflammatory diseases of the ear Before using ear drops, the external auditory canal should be sanitized (rinse and dry the external auditory canal). Before instilling the drug into the external auditory canal, you should warm it to body temperature by holding it in your hands for 1-2 minutes. It is necessary to lie on your side or tilt your head back to facilitate instillation. Place the indicated number of drops into the external auditory canal. Allow the drops to drain into the external auditory canal, pulling the earlobe down and back. Keep your head tilted back for about 2 minutes. You can place a cotton wool pad in the external auditory canal. For bacterial inflammatory diseases of the eye and its appendages, long-term use 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 posterior subcapsular cataracts. When using the drug Combinil-Duo for more than 10 days, it is necessary to monitor intraocular pressure. For acute purulent eye infections, corticosteroids may worsen or mask symptoms. Long-term use of the drug may reduce the immune response and lead to the development of secondary eye infections. Patients using contact lenses should remove them before instillation of the drug and put them back on only after 20 minutes, since the preservative contained in the drug may have an adverse effect on the eye tissue. The bottle must be closed after each use. Do not touch the tip of the pipette to your eye. Effect on the ability to drive vehicles and machinery After using the drug, the clarity of visual perception may decrease; therefore, immediately after instillation, it is not recommended to drive a car or engage in activities that require increased attention and speed of psychomotor reactions.

Compound

1 ml contains: Active substances: dexamethasone 1 mg, ciprofloxacin (in the form of hydrochloride) 3 mg; Excipients: benzalkonium chloride, hydroxypropyl betadex, disodium edetate, mannitol, hydrochloric acid (up to pH 4.0), water for injection.

Directions for use and doses

For bacterial inflammatory diseases of the eye and its appendages, 1-2 drops are instilled into the conjunctival sac every four to six hours. The first 24-48 hours of installation can be done every two hours. For bacterial inflammatory diseases of the ear, 4 drops into the external auditory canal of the affected ear twice a day for 7 days. You should not change the position of your head for 60 seconds to ensure complete penetration of the drug into the ear canal. Course of treatment: for acute bacterial conjunctivitis, blepharitis - from 5 to 14 days. For keratitis - 2-4 weeks. For the prevention of inflammatory diseases after surgical interventions 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.

Side effects

On the part of the visual organs: Corneal infiltrates, burning, redness, itching of the eyes, conjunctivitis, keratitis, periocular edema, facial edema, foreign body sensation in the eye, photophobia, blurred vision, dry eye, eyelid edema, conjunctival hyperemia, glaucoma and optic nerve damage, decreased visual acuity and narrowing of visual fields, cataract formation, secondary infection (fungal and bacterial), thinning of the cornea and/or perforation of the eyeball, delayed wound healing. On the part of the hearing organs: Discomfort and pain in the ear, itching in the ear, ear congestion, taste perversions, skin rash.

Drug interactions

Systemic absorption when applied topically is negligible, so the likelihood of drug interactions is extremely low. Inducers, inhibitors and substrates of liver enzymes Drugs that induce the activity of cytochrome P450 3A4 (CYP 3A4) (barbiturates, phenytoin, carbamazepine, rifampicin) can enhance the metabolism of corticosteroids. Drugs that induce CYP3A4 activity (ketoconazole, macrolides) can potentially cause an increase in plasma corticosteroid levels. Dexamethasone is a moderate CYP3A4 inducer. Co-administration with drugs metabolized by CYP3A4 (erythromycin) may increase their clearance, reducing their plasma concentrations. Combination of ciprofloxacin with other antimicrobial drugs 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.

Overdose

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

Storage conditions

In a place protected from light, at a temperature not exceeding 25°C. Do not freeze. Shelf life: 2 years.

Conditions for dispensing from pharmacies

Dispensed with a doctor's prescription

Directions for use and doses

The standard regimen for using the Combinil-Duo solution involves the conjunctival application of 1-2 drops of the drug every 4 or 6 hours. During the first two days, installations are prescribed every 2 hours.

Duration of treatment:

• Acute bacterial conjunctivitis and blepharitis - course 5 - 14 days.
• Keratitis - course 2 - 4 weeks.
• Prevention of surgical infections - course 5 - 30 days.

When using Combinil-Duo for more than 10 days, monitoring of intraocular pressure is mandatory.

Side effects

• Infiltrates in the cornea, burning, itching, redness of the eye.
• Conjunctivitis, keratitis.
• Swelling of the face, periocular edema, sensation of a foreign body in the eye.
• Photophobia, blurred vision, dry eye syndrome.
• Redness of the conjunctiva, swelling of the eyelids.
• Glaucoma, cataracts, optic nerve damage.
• Thinning of the cornea, narrowing of the fields and decreased visual acuity, perforation of the eyeball.
• Secondary infection (bacteria, fungi).
• Distortion of taste.
• Skin rash.

Indications for use

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 to the eye and its appendages and during operations on the eyeball.

Infectious and inflammatory diseases of the ear:

• acute external otitis media;
• acute otitis media with eardrum shunt;
• acute otitis media with granulations and otorrhea in the presence of an eardrum shunt.

special instructions

Unreasonably long-term use of Combinil-Duo solution can lead to an increase in intraocular pressure, which leads to damage to the optic nerve, the formation of cataracts and a decrease in visual acuity.

When acute purulent eye infections are treated with corticosteroids, the symptoms of the disease may worsen or be masked.

Patients using contact lenses should remove them before each instillation of Combnil-Duo. They can be put on again only 20 minutes after the procedure, since the preservative in the solution can have a negative effect on contact correction devices.

After using the drug, you should not immediately get behind the wheel or start working with complex mechanisms due to the resulting temporary visual impairment.

The bottle should be tightly closed after each use. Do not touch the dispenser to any surfaces.

Store the Combinil-Duo solution at room temperature in a dark place. Not given to children.

The shelf life of the unopened solution is 2 years. The opened solution is good for one month.

COMBINIL-DUO (drops)

wow."
After seeing the doctor, I immediately went to the nearest pharmacy to buy drops. Like all drops, “Combinil-Duo” is sold in a small cardboard box, which protects the drug from bright light. On the front side of the package: the name of the drug and the company that produces it; active and excipients of the composition in percentage.

These drops are made in India, but the barcode costs the USA and Canada. All information about the manufacturer can be found on the back of the box. The price is written next to the barcode; to put it mildly, it is not at all affordable. In general, it is better to purchase domestically produced medicines - they are much cheaper and, as practice shows, they are not at all inferior in quality to imported ones. A list of active and auxiliary components in milligrams is also printed here.

How and under what conditions to store the drops is written on one of the ends of the package. By the way, when you buy a bottle, there is no dispenser. Before use, you must turn the cap clockwise until it stops and a small hole will appear in place of the dispenser. This nuance is also written on the packaging.

The date of manufacture and expiration date of the medicinal product are located on the bottom of the package. The shelf life after opening the drug is short - only 45 days.

The bottle is small in size, it fits well in the hand, does not slip and is easy to use. It is made of transparent plastic, thanks to which you can see how much of the drug remains in the bottle. I like that the plastic is soft, it makes dispensing the drops very easy. The drug itself resembles ordinary water - a clear liquid that does not have a distinct odor. All information on the bottle is duplicated from the packaging.

The box with drops also contains detailed instructions for the medical use of the drug.

Pharmacological actions of the drug.

This drug is quite multifunctional, and from the name of the drops it is clear that they are suitable for treating diseases of both the eyes and ears. It’s interesting, but my disease is not on the list of indications for use, but the doctor prescribed it and, as they say, she knows best. The drug has a lot of contraindications.

Both methods of using drops and doses are described. As I wrote above, there are many contraindications, so during the course of treatment, the manufacturer recommends seeing a doctor, which is what I do.

The drug also has quite a lot of side effects - I personally experienced redness, dryness and itching of the eye.

I mentioned above that my treatment is complex - drops + tetracycline ointment. As such, there is no contact between these two medications, since the interval between their use is several hours, so I did not experience any allergic reactions or other unpleasant incidents.

Well, now about my impressions after using this drug. After instilling eye drops, a very unpleasant burning sensation is felt, fortunately it goes away quickly - after 15-20 seconds. In the first minutes, the eye feels discomfort - as if a small foreign body has entered it, visibility becomes unclear. After about 10 minutes, the discomfort disappears, and the image before your eyes regains clarity.

I can only judge the effectiveness of the drug based on the treatment of eye diseases. I used them 4-5 times a day in combination with tetracycline ointment (at night). The drops did not completely cope with my disease, but at the initial stage they helped a lot - they relieved redness and reduced the size of the tumor. Let me note, in my opinion, an important nuance: after use, the drops flow down the throat and they taste bitter.

I will summarize and highlight all the pros and cons of the medical drug “Combinil-Duo”.

Pros: + drops are suitable for treating eyes and ears; + easy-to-use and dosage bottle;

Cons: - many contraindications and side effects; - after using drops to treat eye diseases, they flow down the throat; — the price could be more affordable.

? +/- partially helped with mild chalazion.

Of course, it’s up to you to decide whether to buy this drug or not; I just shared my experience. If you decide to purchase, be sure to consult with your doctor; after all, the drug has a number of side effects. And I, in turn, wish that you don’t need these drops!

Thank you for your attention!