Combinil®

Brand Sentiss Pharma

In stock 1107 Items

Available since: 2019-09-19

All payments are SSL encrypted
Full Refund if you haven't received your order
International shipping to the USA, UK and Europe

Clinical Pharmacology

Combined intended for local use in ophthalmic and otorhinolaryngological practice. The therapeutic effect of the drug Combine is due to the antimicrobial effect of ciprofloxacin and the anti-inflammatory effect of dexamethasone.

Ciprofloxacin - an antimicrobial drug from the group of fluoroquinolones, has a broad spectrum of antibacterial 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 impaired. Ciprofloxacin acts both on reproducing microorganisms and on those at rest.

The spectrum of antibacterial action of ciprofloxacin includes:

Gram-negative microorganisms:

Esherichia coli.
Salmonella spp.
Shigella spp.
Proteus spp. (indolent 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.
Chlamidia 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 anti-inflammatory, anti-allergic and anti-proliferative effects.

It reduces the permeability and proliferation of capillaries, local exudation, cellular infiltration, phagocytic activity, collagen deposition and fibroblast activity, inhibits the formation of scar tissue. Thus, dexamethasone reduces the main symptoms of inflammation.

Pharmacokinetics

Absorption and metabolism

When used in ophthalmology, ciprofloxacin penetrates well into various tissues of the eye, with the exception of the lens. WITH _max occurs within 30 minutes, the greatest concentration is observed in the moisture of the anterior chamber. Observed systemic reabsorption. However, the drug concentration 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 therapeutic concentrations are achieved in the aqueous humor; 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 in the ear canal, the maximum serum concentration for ciprofloxacin is 1.55 ng / l, and for dexamethasone, 0.86. ng / l.

Removal

The half-life of drugs - 2.9 hours and 2.8 hours, respectively.

Part of the preparation as an auxiliary component of hydroxypropyl beta cyclodextrin contributes to the long-term preservation 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 injuries of the eye and its appendages and during operations on the eyeball.

Bacterial inflammatory diseases of the ear:

Acute otitis externa.
Acute otitis media with shunt eardrum.
Acute otitis media with granulations and otorrhea in the presence of an eardrum shunt.

Composition

1 ml contains:

Active substances: dexamethasone 1 mg, ciprofloxacin (in the form of hydrochloride) 3 mg;

Excipients: benzalkonium chloride, hydroxypropylbetadex, disodium edetate, mannitol, hydrochloric acid (up to pH 4.0), water d / i.

No customer reviews for the moment.

Write your review

Dosage and Administration

In bacterial inflammatory diseases of the eye and its appendages

1-2 drops instilled into the conjunctival sac every four to six hours. The first 24 to 48 hours of installation can be made every two hours.

In 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 the head for 60 seconds to fully penetrate the drug into the auditory canal.

The 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 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.

Adverse reactions

By the organs of vision

Corneal infiltrates, burning, redness, itchy eyes, conjunctivitis, keratitis, periocular edema, swelling of the face, foreign body sensation in the eye, photophobia, blurred vision, dry eye, eyelid edema, conjunctival hyperemia, glaucoma and damage to the optic nerve, loss of visual acuity and hyperemia of the conjunctiva, glaucoma and damage to the optic nerve, loss of visual acuity and hyperemia of the conjunctiva, glaucoma and damage to the optic nerve narrowing of the visual fields, cataract formation, secondary infection (fungal and bacterial), thinning of the cornea and / or perforation of the eyeball, slow wound healing.

On the part of the hearing

Discomfort and pain in the ear, itching in the ear, ear congestion, taste perversions, skin rash.

Contraindications

Hypersensitivity to the active substance of the drug or to any auxiliary ingredients that are part of this dosage form of the drug.
Herpetic keratitis and other viral lesions of the cornea and conjunctiva.
Tuberculosis of the eye.
Fungal lesions of the eye.
Viral infections of the ear canal.
Perforation of the eardrum.
Children's age up to 18 years.
Pregnancy.
Lactation period.

Drug interactions

Systemic absorption with local use is insignificant, so the likelihood of drug interactions is extremely small.

Inductors, inhibitors and substrates of hepatic enzymes

Drugs that induce the activity of cytochrome P450 ZA4 (CYP ZA4) (barbiturates, phenytoin, carbamazepine, rifampicin) can enhance the metabolism of corticosteroids.

Drugs that induce CYP3A4 activity (ketoconazole, macrolides) can potentially cause an increase in plasma corticosteroids.

Dexamethasone is a moderate inducer of CYP3A4. Co-administration with drugs metabolized by CYP3A4 (erythromycin) can increase their clearance, reducing their concentration in plasma.

The 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.

It 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.

Pregnancy and Lactation

Contraindicated in pregnancy and lactation.

Special instructions

In bacterial inflammatory diseases of the ear

Before using the ear drops, you should reorganize the external auditory canal (rinse and dry the external auditory canal).

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

It is necessary to lie on one side or tilt the head back to facilitate burying. To drip into the external auditory canal a specified number of drops. Let the drops flow into the ear canal, pulling the earlobe down and back.Keep your head in the upturned position for about 2 minutes. Can be placed in the external auditory canal cotton wool.

In bacterial inflammatory diseases of the eye and its appendages

Prolonged use can lead to an increase in intraocular pressure, followed by damage to the optic nerve, a decrease in acuity and visual fields, and the formation of posterior subcapsular cataracts.

When using the drug Combine-Duo for more than 10 days, it is necessary to control intraocular pressure.

In acute purulent eye infections, corticosteroids may worsen or mask the symptoms of the disease.

Prolonged 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 instillation of the drug and put it on again only after 20 minutes, since the preservative contained in the preparation may have an adverse effect on eye tissue.

The bottle must be closed after each use.

Do not touch the eye with a pipette tip.

Impact on the ability to drive vehicles and mechanisms

After use of the drug may decrease the clarity of visual perception, so immediately after instillation is not recommended to drive a car and engage in activities that require increased attention and speed of psychomotor reactions.

Overdosage

Symptoms: the occurrence of point keratitis, erythema, increased tearing, swelling and itching of the eyelids.

Treatment: there is no specific antidote. You should wash your eyes with water, discontinue the drug and prescribe symptomatic therapy. Data on systemic manifestations of overdose is not.