Garasone (Drops) Instructions for Use

Marketing Authorization Holder

Schering-Plough Labo N.V. (Belgium)

ATC Code

S02CA (Corticosteroids in combination with antimicrobial drugs)

Active Substances

Betamethasone sodium phosphate

Gentamicin

Dosage Form

Garasone

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

Dosage Form, Packaging, and Composition

5 ml – polyethylene dropper bottles (1) – cardboard packs.

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

A combined drug, the action of which is due to the components included in its composition.

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 penicillinase-producing strains), 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), it has a local anti-inflammatory effect, 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 lesions of the cornea, GCS 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

For eye diseases: the dosage should be determined individually for each patient. Usually, instill 1-2 drops into the conjunctival sac of the affected eye 3-4 times/day. In the acute stage, the frequency of application of the drug can be increased to 2 drops every hour or every 2 hours; subsequently, when the course of the disease becomes controlled, the frequency of application is reduced. The total duration of local treatment depends on the nature and severity of the disease. If there is no therapeutic effect within 14 days after the start of treatment, further use of the drug is considered inappropriate.

For ear diseases: before using the drug, the external auditory canal should be cleaned. The recommended initial dose is 3-4 drops from 2 to 4 times/day. The patient should lie on their side so that the affected ear is facing upwards; after instilling the solution, one should remain in this position for a few more minutes to ensure the penetration of the drug into the auditory canal.

When inflammatory phenomena decrease, the dosage should be gradually reduced and the application of the drug should be discontinued after the symptoms of the disease disappear.

If necessary, a cotton swab soaked with Garasone can be inserted into the external auditory canal. The swab must be kept moist by wetting it with the drug every 4 hours. Every 24 hours the swab should be replaced.

For chronic diseases of the eyes and ears, discontinuation of treatment with Garasone should be carried out gradually, by reducing the frequency of application.

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, damage to the optic nerve, 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

• Hypersensitivity to any of the components of the drug;
• 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 (due to lack of information);

During treatment, it is not recommended to wear soft contact lenses (due to the presence of benzalkonium chloride in the composition of the drug).

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

Garasone should not be prescribed during pregnancy unless the potential benefit from its use for the mother justifies the potential risk to the fetus.

It is not known whether the components of Garasone are excreted in breast milk. Therefore, during the use of the drug, it may be necessary to refrain from breastfeeding.

Pediatric Use

The safety and efficacy of Garasone in children under 6 years of age have not been established.

Special Precautions

Garasone is intended for topical use only. It must not be administered subconjunctivally or directly into the anterior chamber of the eye.

The absence of a rapid clinical effect after application of the drug is a reason for 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.

When prescribing Garasone for a period of 10 days or more, it is necessary to measure intraocular pressure. 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 bacterial corneal ulcers, which may be caused by Pseudomonas aeruginosa, with a combination of an antibiotic and 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, one should be aware of the possibility of its ototoxicity.

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 the blood serum and urine after such application.

Long-term topical use 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.

To avoid contamination and cross-infection, one bottle of the drug should not be used for simultaneous treatment of eye and ear infection. If the open end of the dropper bottle touches any surface, the solution may become contaminated. Using the dropper bottle by more than one person may lead to the spread of infection.

With long-term treatment with the drug, its discontinuation is recommended to be carried out gradually.

Use in pediatrics

The safety and efficacy of Garasone in children under 6 years of age have not been established.

Overdose

Symptoms: with long-term use of high doses of GCS – suppression of the function of the hypothalamic-pituitary-adrenal system, hypercortisolism; of aminoglycosides – ototoxic effect.

Treatment: gradual withdrawal of the drug, if necessary – symptomatic therapy, including correction of water-electrolyte balance.

Storage Conditions

Store in a place inaccessible to children, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use the drug after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

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.