Gentazone - instructions for use, dose, side effects, contraindications

Active substances: betamethasone sodium phosphate - 1.316 mg (equivalent to Betamethasone 1.0 mg), gentamicin sulfate (in terms of gentamicin) - 3.0 mg;

Excipients: disodium edetate (disodium salt of ethylenediamine-tetraacetic acid) - 0.1 mg benzalkonium chloride - 0.1 mg Sodium chloride - 4.75 mg sodium dihydrogen phosphate dihydrate (sodium phosphate aqueous odnozameschonny 2) - 1.13 mg, sodium hydrogen phosphate dodecahydrate (sodium phosphate aqueous dvuzameschonny 12) - 4.08 mg sodium tetraborate decahydrate (sodium tetraborate 10-water) - 2.0 mg, sodium citrate pentaseskvigidrat (sodium citrate trohzameschonny 5,5-aq) - 1 , 5 mg, water for injection - up to 1 ml.

Description:Transparent colorless or light yellow liquid.

Pharmacotherapeutic group:Antibiotic - aminoglycoside + glucocorticosteroid

ATX: & nbsp

D.07.X.C.01 Betamethasone in combination with other drugs

Pharmacodynamics:

Gentazone^® is a combination drug, the effect of which is due to the components that make up its composition.

Gentazone^® has anti-inflammatory and anti-allergic effect.

Gentamicin - a broad-spectrum antibiotic from the group of aminoglycosides, acts bactericidal. Effective against microorganisms: coagulase-positive and coagulase-negative staphylococci (including Staphylococcus aureus), Escherichia coli, indole-positive and indolotricative species of Proteus spp., Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Salmonella spp., Shigella spp., Moraxella spp. (including Moraxella lacunata) and Neisseria species, including Neisseria gonorrhoeae.

Resistant to gentamicin: some strains of streptococci (including Streptococcus pneumonia and strains of group D), Providencia rettgeri, Bacteroides spp., Clostridium spp., Treponema pallidum, Neisseria meningitidis.

Resistance to gentamycin is mainly due to the modification of the antibiotic by transferase enzymes (acetyltransferases, phosphotransferases and adenylyltransferases), which makes it impossible for it to bind to ribosomes. There are other mechanisms of resistance to aminoglycoside antibiotics (change in the targets of action - bacterial ribosomes, reduction or termination of antibiotic transport inside the bacterial cell).

Resistance to gentamicin develops slowly, however, strains resistant to neomycin and kanamycin may exhibit resistance to gentamicin (incomplete cross-resistance). Tormycin-resistant microorganisms are also resistant to the action of gentamicin (complete cross-resistance).

Gentamicin does not affect fungi, viruses, protozoa.

Betamethasone - Glucocorticosteroid (GCS), is a synthetic derivative of prednisolone, has a pronounced local anti-inflammatory effect. Suppressing cellular and fibrinous exudation and normalizing the increased permeability of capillaries, which is manifested by a decrease in local hyperemia, edema and effusion. In case of allergic or traumatic lesion of the cornea, SCS suppress proliferation of fibroblasts and post-inflammatory neovascularization of the cornea, thus preserving its transparency.

Pharmacokinetics:

The drug penetrates into the intraocular fluid, cornea, iris, ciliary body, retina. Can have a systemic effect only when used in large doses or with prolonged use.

Indications:

Diseases of the eyes.

Treatment of infectious and inflammatory diseases of anterior segment of the eyeball and an auxiliary apparatus of the organ of vision caused by microorganisms sensitive to gentamicin and requiring the joint use of antibacterial and anti-inflammatory drugs (dacryocystitis, barley, meibomitis, staphylococcal blepharoconjunctivitis, secondarily infected allergic keratoconjunctivitis, keratitis postoperative period, in the absence of damage to the corneal epithelium).

Diseases of the ear.

Acute and chronic otitis externa; Secondarily infected diseases of the external auditory canal: eczema, seborrheic and contact dermatitis.

Contraindications:

- Hypersensitivity to the components of the drug;

- keratitis caused by the herpes simplex virus (treelike keratitis);

- viral diseases of the cornea and conjunctiva (for example, with chicken pox);

- mycobacterial or fungal infections of the eye or ear;

- trachoma;

- Vaccination (dermatosis, which occurs as a complication of acute vaccination);

- conditions accompanied by thinning of the cornea and sclera (for example, after removal of the foreign body from the cornea);

- absence or perforation of the tympanic membrane;

- lactation period;

- Children's age till 8 years.

Pregnancy and lactation:

Pregnancy.

There is no information on the efficacy and safety of Gentazone^® pregnant women. The use of the drug in pregnancy is possible only if the intended use of the drug by the mother exceeds the possible risk of using the drug for the fetus.

Breastfeeding period.

It is not known whether gentamicin and betamethasone in breast milk. For the duration of therapy, the drug should stop breastfeeding.

Dosing and Administration:

It is used in adults and children older than 8 years in the conjunctival sac or external auditory meatus.

With eye diseases

Dosage should be determined for each patient individually. Usually 1-2 drops are injected into the conjunctival sac of the affected eye 3-4 times a day. In the acute phase, the frequency of application of the drug can be increased to 2 drops per hour or every 2 hours. Later, when the course of the disease becomes controlled, the frequency of application decreases.The duration of treatment depends on the nature and severity of the disease. In the absence of therapeutic effect within 14 days after the start of treatment, further use of the drug appears to be inexpedient.

In case of ear diseases

Before applying the drug, the external ear canal should be cleaned. The recommended initial dose is 3-4 drops from 2 to 4 times a day. The patient should lie on his side so that the affected ear is turned upwards; After instillation should remain in this position for a few more minutes to ensure the penetration of the drug inside the auditory canal.

With a reduction in inflammatory phenomena, the dosage should be gradually reduced, and the drug should be discontinued after the symptoms disappear.

If necessary, inside the external ear canal, you can insert a cotton swab impregnated with the drug. The tampon should be kept moist, moistened with a drug every 4 hours. Every 24 hours, the tampon should be replaced.

For chronic diseases of the eyes and ears, the cessation of drug treatment should be gradual, by reducing the frequency of use.

Side effects:

Undesirable reactions noted with the use of the drug Gentazone^®: increased intraocular pressure, the development of reactions of eye hypersensitivity (conjunctival injection, conjunctival edema, burning).

Undesirable reactions associated with the use of combinations of corticosteroid and antibacterial drug: sensitization due to the presence of an antibacterial component in the drug, increased intraocular pressure with possible development of the glaucoma symptom complex and, in rare cases, damage to the optic nerve; posterior subcapsular cataract formation, bullous keratopathy development of postoperative cataract extraction, the development of secondary infections of the eye, including those caused by Herpes simplex, slow wound healing of anterior segment of eyeball.

When using drugs containing corticosteroids as an active substance, it is possible to develop acute iridocyclitis and perforation of the sclera, mydriasis, decreased visual acuity, the appearance of visual field defects, ptosis, and accommodation disorders.

Transient eye irritation, including burning after instillation, was noted with ophthalmic forms of gentamicin.

Overdose:

Symptoms.

Long-term use of corticosteroids or their use in high doses can lead to suppression of the hypothalamic-pituitary-adrenal system and lead to secondary adrenal insufficiency, including Cushing's disease. Symptoms of acute overdose with corticosteroids are reversible. It is unlikely that the symptoms of overdose will develop if the recommended doses of gentamicin are exceeded once.

Treatment.

If necessary, it is possible to remove gentamicin from the body through peritoneal dialysis or hemodialysis. By hemodialysis 80-90% of the drug is excreted from the body within 12 hours, peritoneal dialysis is less effective. Overdose of corticosteroids requires symptomatic treatment and correction of electrolyte balance. Chronic overdosage of corticosteroids requires a gradual dose reduction.

Interaction:

The drug interaction with other drugs has not been recorded.

Special instructions:

It is intended for local use only.

The drug should not be injected subconjunctivalally or directly into the anterior chamber of the eye.

The absence of a rapid clinical effect after the use of the drug may serve as an excuse for conducting an additional examination with a view to clarifying the diagnosis.

If the signs of the disease persist or if it recurs, despite the complete course of treatment with the drug, it is desirable to carry out a bacteriological study of smears from the conjunctiva to determine the sensitivity of the pathogen to the antibiotic.

When prescribing the drug for a period of 10 days or more, monitoring of intraocular pressure is necessary. It is recommended to perform tonometry of the eyes and study using a slit lamp. Patients who have a family history of patients with open-angle glaucoma, high degree myopia, or diabetes mellitus are at risk of increasing intraocular pressure as a result of topical treatment with glucocorticosteroids. The drug should be used with caution in open-angle glaucoma, high-grade myopia, or diabetes mellitus in a family history.

It is known that with diseases that cause thinning of the cornea or sclera, topical application of glucocorticosteroids can lead to perforation of the eyeball.In this regard, it is not recommended to start with the combination "antibiotic-anti-inflammatory agent" treatment of corneal ulcers of bacterial etiology, which can be caused by Pseudomonas aeruginosa. It is advisable at first to use only an antibacterial agent. If there is an answer to antibacterial therapy, it may be recommended to add anti-inflammatory medication to the treatment to minimize fibrotic reaction and to prevent scarring of the cornea.

In acute purulent processes in the eye, glucocorticosteroids can mask an existing infection or potentiate it.

In the treatment of infection caused by the herpes simplex virus, the drug should be used extremely cautiously.

In the case of a local antibiotic from the aminoglycoside group, one should bear in mind the possibility of its ototoxicity.

Gentamicin in local application in the area of the external auditory canal can be absorbed into the blood.

Long-term local use of antibiotics or GCS can lead to an increase in the growth of insensitive microorganisms, including fungi.

Between the various aminoglycosides and GCS, cross-allergic reactions were noted.

In order to avoid contamination and cross infection, one bottle of the drug should not be used to simultaneously treat infection of the eye and ear.

If the open end of the vial touches a surface, contamination of the solution may occur. The use of a vial by more than one person can lead to the spread of infection.

With prolonged treatment with the drug, it is recommended to cancel it gradually.

The drug contains a preservative benzalkonium chloride, which can be absorbed by soft contact lenses, causing a change in their color and adversely affecting the eyes' tissue (prolonged use may result in the development of acute keratitis and / or toxic corneal ulcer). If you need to use contact lenses during treatment with Gentazone^®, they should be removed before using the drug and, if necessary, put on again not earlier than 15 minutes after instillation.

Effect on the ability to drive transp. cf. and fur:

During treatment, care should be taken when driving vehicles and engaging in other potentially hazardous activities,as within a few minutes after instillation, visual acuity reduction is possible.

Form release / dosage:Eye and ear drops 0.1316% + 0.3%.

Packaging:

To 5 ml in bottles for eye drops from plastic with a nozzle-dispenser and a cap screwed from plastic. Each bottle with instructions for use in a pack of cardboard.

For 50 bottles with an equal number of instructions for use in a cardboard box (for delivery to hospitals).

Storage conditions:In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:2 years. After opening the vial, the drug should be used within 1 month. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003331

Date of registration:24.11.2015

Expiration Date:24.11.2020

The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp19.06.2017

Illustrated instructions

Instructions

Gentazone® (Gentasone)