Betagenot^® (Drops) Instructions for Use

Marketing Authorization Holder

Masterlek, CJS (Russia)

Manufactured By

Pharmaceutical Firm LECKO, CJS (Russia)

ATC Code

S02CA (Corticosteroids in combination with antimicrobial drugs)

Active Substances

Gentamicin (Rec.INN registered by WHO)

Betamethasone sodium phosphate (BAN adopted for use in the United Kingdom)

Dosage Form

Betagenot®

Eye/ear drops 1.316 mg+3 mg/1 ml: bottle 5 ml with dropper cap included

Dosage Form, Packaging, and Composition

Eye/ear drops as a transparent, colorless or slightly yellowish liquid.

Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium tetraborate, sodium citrate, sodium chloride, disodium edetate (Trilon B), benzalkonium chloride, water for injections.

5 ml – dark glass bottles (1) complete with a dropper cap – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

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, it has 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, glucocorticosteroids suppress the proliferation of fibroblasts 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 part 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 for ophthalmic use or into the external auditory canal for otologic use.

For acute conditions, instill 1-2 drops into the affected eye or ear every 1-2 hours during the initial treatment phase.

As inflammation and infection subside, reduce the frequency of application to 1 drop 3-4 times daily.

For chronic conditions, the standard regimen is 1-2 drops applied 2-4 times daily.

Do not use the preparation for more than 7-10 days without re-evaluation by a physician.

Monitor intraocular pressure if treatment extends beyond 10 days, especially in patients with a history of glaucoma.

For ear infections, ensure the tympanic membrane is intact prior to application.

Do not allow the dropper tip to contact any surface, including the eye, ear, or fingers, to prevent contamination.

If using other topical ophthalmic agents, administer them at least 5 minutes apart from this preparation.

Shake the bottle well before each use if the solution appears cloudy or contains particles.

Discard the bottle 28 days after first opening to prevent microbial contamination.

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 glucocorticosteroids 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 eardrum; 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 during the lactation (breastfeeding) period.

Special Precautions

The recommended method of application must be strictly observed.

The absence of a rapid clinical effect after the use of preparations 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 it is necessary to use for 10 days or more, intraocular pressure should be monitored.

It is recommended to perform eye tonometry using a slit lamp.

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 glucocorticosteroids.

It is known that in diseases causing 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 treatment of corneal ulcers of bacterial etiology, which may be caused by Pseudomonas aeruginosa, with the combination of an antibiotic and a glucocorticosteroid.

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, glucocorticosteroids can mask an already existing infection or potentiate it.

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

In the case of topical administration of an antibiotic from the aminoglycoside group, 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 use of antibiotics or glucocorticosteroids can lead to an increase in the growth of non-susceptible microorganisms, including fungi.

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

With long-term treatment with preparations 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.