Universal reference book for medicines
Name of the drug: DEXA-GENENTAMINE (DEXA-GENTAMICIN)

Active substance: dexamethasone, gentamicin

Type: The drug with antibacterial and anti-inflammatory action for topical application in ophthalmology

Manufacturer: URSAPHARM Arzneimittel (Germany)
Composition, form of production and packaging
Eye drops are
colorless, transparent.

1 ml

dexamethasone sodium phosphate 1 mg

gentamicin sulfate 5 mg,

which corresponds to the content of gentamicin 3 mg

Excipients: benzalkonium chloride (preservative) - 0.05 mg, potassium hydrophosphate - 1.88 mg, potassium dihydrogen phosphate - 5.86 mg, sodium chloride - 5 mg, water d / and - up to 1 ml.

5 ml - a bottle-droppers polymer (1) - packs cardboard.

Eye ointment is white with a yellowish tinge, translucent.

1 g

dexamethasone 300 μg

gentamicin sulfate 5 mg,

which corresponds to the content of gentamicin 3 mg

Excipients: Vaseline white - 775.98 mg, paraffin liquid - 149.13 mg, lanolin - 69.9 mg.

2.5 g - aluminum tubes (1) with a polyethylene tip - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Combination drug for topical application in ophthalmology.
Has anti-allergic, anti-inflammatory and antibacterial action.
Dexamethasone - GCS, has an anti-allergic and pronounced anti-inflammatory effect.
The index of its relative anti-inflammatory activity is 30.
Gentamicin is an antibiotic of the aminoglycoside group, characterized by a wide spectrum of action.
Active in relation to the majority of gram-positive and gram-negative microorganisms, incl. Pseudomonas aeruginosa, Escherichia coli, Klebsiella spp., Salmonella spp., Proteus spp., Serratia spp. Moderately active against Staphylococcus spp.
PHARMACOKINETICS

With topical application, dexamethasone 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 penetration rate increases.
Gentamicin sulfate, when applied topically, is found in the therapeutic concentration in the corneal stroma, in the anterior chamber, vitreous humor for 6 hours. Gentamicin sulfate does not enter the systemic bloodstream through intact epithelium of the cornea



INDICATIONS

- infections of the anterior part of the eye caused by the microflora sensitive to gentamicin (conjunctivitis, keratitis, blepharitis, barley);

- allergic processes of the anterior part of the eye, accompanied by bacterial infection;

- prevention and treatment of inflammatory phenomena in the postoperative period (after cataract removal and antiglaucoma operations).

DOSING MODE

Eye drops Dexa-Gentamycin is instilled into the conjunctival sac by 1-2 drops 4-6 times / day.

A strip of ointment 1 cm long is placed in the conjunctival sac 2-3 times / day.
During the application of ophthalmic ointment, contact with the skin surface or conjunctiva should be avoided.
The duration of Dex-Gentamicin treatment usually does not exceed 2-3 weeks.
The duration of therapy is determined by the effectiveness of the drug, the severity of the symptoms and the likelihood of developing side effects.
With the simultaneous use of several ophthalmic drugs, it is recommended that Dexa-Gentamicin be formulated in the form of an ophthalmic ointment no earlier than 15 minutes after the use of eye drops.

SIDE EFFECT

Rarely: allergic reactions, a burning sensation in the eye after applying the drug.

Possible: contact dermatitis, herpetic keratitis, corneal perforation in the presence of keratitis, fungal infection, increased manifestation of bacterial infection of the cornea, ptosis, mydriasis.
The use of a cornea after injury can lead to a slowing of its healing. With prolonged use - the development of secondary glaucoma, steroid cataracts.
CONTRAINDICATIONS

- keratitis caused by viruses Herpes simplex and Varicella zoster (dendritic keratitis);

- viral diseases of the cornea and conjunctiva (including chicken pox);

- fungal diseases of the eyes;

- mycobacterial infections of the eyes;

- acute purulent diseases of the eyes with epithelial lesions of the cornea;

- corneal epitheliopathy;

- trauma and ulceration of the cornea;

- increased intraocular pressure;

- I trimester of pregnancy;

- children and adolescents under 18 years of age (due to lack of data on effectiveness and safety);

- wearing contact lenses;

- Hypersensitivity to the components of the drug.

During the use of the drug is not recommended to use contact lenses.

PREGNANCY AND LACTATION

Adequate and strictly controlled clinical studies of the safety of the use of the drug Dexa-Gentamicin during pregnancy and lactation were not conducted.
In the II and III trimesters of pregnancy and during breastfeeding, the drug can be used when the intended benefit of therapy for the mother exceeds the potential risk to the fetus or child. Contraindicated in the first trimester of pregnancy.
APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

SPECIAL INSTRUCTIONS

If the duration of the drug is more than 2 weeks, as well as in patients with a history of glaucoma, it is recommended that the intraocular pressure be monitored regularly.

If the use of contact lenses is necessary, then they should be removed before using Dexa-Gentamicin in the form of eye drops and set again not earlier than 20 minutes.

The patient should be informed that if side effects occur, the treatment should be stopped immediately and referred to the ophthalmologist.

Use in Pediatrics

To date, clinical trials of the safety and efficacy of the use of the Dexa-Gentamicin drug in children are not available.
The use of the drug in pediatrics is possible if the expected therapeutic effect exceeds the potential risk of adverse reactions.
Impact on the ability to drive vehicles and manage mechanisms

Immediately after the use of the drug Dexa-Gentamycin, a short-term disturbance of visual acuity may occur, leading to a slowing down of psychomotor reactions.Therefore, it is not recommended to apply the drug directly before working with mechanisms and driving vehicles.
Within 30 minutes after instillation, it is necessary to refrain from occupations that require increased attention.
OVERDOSE

When using Dexa-Gentamicin, an overdose is unlikely.

DRUG INTERACTION

When combined with atropine, other cholinergic drugs, medications causing mydriasis, an increase in intraocular pressure is possible.

With topical application, gentamicin is incompatible with amphotericin B, heparin, sulfadiazine, cephalothin and cloxacillin.
Local application of these drugs together with gentamicin can lead to the deposition of precipitates in the conjunctival cavity.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. Eye drops should be stored in a dark place at a temperature of no higher than 25 ° C.
Shelf life - 3 years. After opening the bottle, eye drops should be used within 6 weeks.
Eye ointment should be stored at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
After opening the tube, ophthalmic ointment should be used within 4 weeks.

Do not use after the expiration date printed on the package.

The drug should be stored out of the reach of children.

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