Gentason^® (Drops) Instructions for Use

Marketing Authorization Holder

Sintez PJSC (Russia)

ATC Code

S01CA05 (Betamethasone and antimicrobial drugs)

Active Substances

Betamethasone sodium phosphate

Gentamicin

Dosage Form

Gentason®

Eye and ear drops 1 mg+3 mg/ml: bottle 5 ml

Dosage Form, Packaging, and Composition

5 ml – polyethylene dropper bottles (1) – cardboard packs.
5 ml – polyethylene dropper bottles (50) – cardboard boxes (for hospitals).

Clinical-Pharmacological Group

A drug with antibacterial and anti-inflammatory action for topical application in ophthalmology and ENT practice

Pharmacotherapeutic Group

Topical glucocorticosteroid + aminoglycoside antibiotic

Pharmacological Action

Combined medicinal product for topical use.

Gentamicin is a broad-spectrum antibiotic from the aminoglycoside group, it acts bactericidally.

It is effective against microorganisms: Staphylococcus aureus (coagulase-positive, coagulase-negative, as well as some strains producing penicillinase), Pseudomonas aeruginosa, indole-positive and indole-negative species of Proteus, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Haemophilus aegyptius, Enterobacter aerogenes, Moraxella lacunata (Morax-Axenfeld bacillus) and species of Neisseria, including Neisseria gonorrhoeae.

Betamethasone sodium phosphate is a glucocorticosteroid (GCS) that exerts a local anti-inflammatory effect by suppressing cellular and fibrinous exudation and normalizing increased capillary permeability, which is manifested by a reduction in local hyperemia, edema, and effusion.

In allergic or traumatic corneal lesions, GCS suppress fibroblast proliferation and post-inflammatory neovascularization of the cornea, thus preserving its transparency.

Indications

Staphylococcal blepharoconjunctivitis; keratoconjunctivitis, secondarily infected conjunctivitis; blepharitis; keratitis; episcleritis; dacryocystitis; hordeolum (meibomitis); injuries of the anterior segment of the eye resulting from foreign body entry, exposure to radiation, thermal and chemical burns, as well as in the postoperative period; acute and chronic external otitis, eczema of the external auditory canal.

ICD codes

Dosage Regimen

Instill the drops topically into the conjunctival sac of the eye or into the external auditory canal of the ear.

For acute ophthalmic conditions, instill one to two drops into the affected eye(s) every one to two hours during the initial 24-48 hours.

As inflammation subsides, reduce application frequency to one drop three to four times daily.

For chronic ophthalmic conditions, the standard regimen is one drop two to four times daily.

For acute otitis externa, instill three to four drops into the affected ear three to four times daily.

For chronic otitis externa, the typical dose is three to four drops into the affected ear two to three times daily.

Gently press on the lacrimal sac for one to two minutes after ophthalmic administration to minimize systemic absorption.

Lie with the affected ear upward for several minutes after aural instillation.

Do not allow the dropper tip to contact the eye, ear, or any other surface to avoid contamination.

The maximum treatment duration should generally not exceed 14 days for ophthalmic use or 7-10 days for aural use unless directed by a physician.

Discontinue treatment if no clinical improvement is observed after three to five days and re-evaluate the diagnosis.

Monitor intraocular pressure if ophthalmic treatment continues for more than 10 days, particularly in at-risk patients.

Adverse Reactions

After application, short-term appearance of a burning sensation, itching, or dryness of the skin at the application site is possible.

Adverse events associated with the effect of GCS on the eyes: increased intraocular pressure, glaucoma, optic nerve damage, decreased visual acuity and narrowing of visual fields, development of posterior subcapsular cataract, delayed wound healing, penetration of air bubbles after surgical treatment of cataract, development of secondary eye infection (for example, Herpes Zoster), acute anterior uveitis, perforation of the cornea and sclera, mydriasis, accommodation disturbance, and ptosis.

When using antibiotics to treat the eyes, allergic reactions may develop.

Transient eye irritation has been reported in connection with the use of gentamicin sulfate.

Contraindications

Keratitis caused by the herpes simplex virus (dendritic keratitis); viral diseases of the cornea and conjunctiva (for example, in chickenpox); mycobacterial or fungal infections of the eye or ear; trachoma; conditions accompanied by thinning of the cornea and sclera (for example, after removal of a foreign body from the cornea); absence or perforation of the tympanic membrane; children under 6 years of age; pregnancy; lactation period; hypersensitivity to the components of the combination.

With caution

Open-angle glaucoma, high degree of myopia or diabetes mellitus in family history; infection caused by the herpes simplex virus.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and lactation (breastfeeding).

Special Precautions

The recommended method of application must be strictly observed.

The absence of a rapid clinical effect after the use of drugs containing this combination is a reason for conducting an additional examination to clarify the diagnosis.

If signs of the disease persist or in case of its recurrence, it is necessary to conduct a bacteriological study to determine the sensitivity of the pathogen to antibiotics.

If use for 10 days or more is necessary, intraocular pressure should be monitored.

Tonometry of the eyes using a slit lamp is recommended.

Patients with a family history of open-angle glaucoma, high myopia, or diabetes mellitus are at risk of increased intraocular pressure as a result of topical application of GCS.

It is known that in diseases causing thinning of the cornea or sclera, topical application of GCS can lead to perforation of the eyeball.

In this regard, it is not recommended to start treatment of corneal ulcers of bacterial etiology, which may be caused by Pseudomonas aeruginosa, with a combination of an antibiotic and a GCS.

It is advisable to use only an antibacterial agent at the beginning of treatment.

If there is a response to antibacterial therapy, then an anti-inflammatory agent may be recommended to be added to the treatment to minimize the fibrotic reaction and prevent the formation of a corneal scar.

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

When treating an infection caused by the herpes simplex virus, GCS should be used with extreme caution.

When an antibiotic from the aminoglycoside group is prescribed topically, the possibility of its ototoxicity should be taken into account.

Animal studies have shown that Gentamicin, when applied topically to the external auditory canal, can be absorbed into the blood, as it was detected in blood serum and urine after such application.

Long-term topical application of antibiotics or GCS can lead to an increase in the growth of non-susceptible microorganisms, including fungi.

Cross-allergic reactions between various aminoglycosides and GCS have been noted.

With long-term treatment with drugs containing this combination, therapy is recommended to be discontinued gradually.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.