Candibiotic (Drops) Instructions for Use

Marketing Authorization Holder

Glenmark Pharmaceuticals, Ltd. (India)

Contact Information

GLENMARK IMPEX LLC (Russia)

ATC Code

S02CA (Corticosteroids in combination with antimicrobial drugs)

Dosage Form

Candibiotic

Ear drops: 5 ml bottle with dropper included

Dosage Form, Packaging, and Composition

Ear drops as a clear, light yellow liquid.

Excipients: glycerol, propylene glycol.

5 ml – dark glass bottle, closed with a screw-on aluminum cap with first-opening control (1) in a carton pack complete with a dropper^×.

^× A dropper inserted into a plastic screw cap is supplied with the bottle. Each bottle, complete with a dropper placed in a sealed polyethylene bag and instructions for use, is placed in a carton pack.

Clinical-Pharmacological Group

A drug with antibacterial, antifungal, anti-inflammatory, and local anesthetic action for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of ear diseases; corticosteroids in combination with antimicrobial agents

Pharmacological Action

The drug has a local antimicrobial, antibacterial, anti-inflammatory, and local anesthetic effect.

Chloramphenicol is a broad-spectrum bacteriostatic antibiotic. It disrupts the process of protein synthesis in the microbial cell. It is active against gram-positive and gram-negative bacteria.

Beclomethasone dipropionate is a glucocorticosteroid. It has anti-inflammatory and anti-allergic effects.

Clotrimazole (an imidazole derivative) is a broad-spectrum antifungal agent for topical use. The antifungal effect of clotrimazole is associated with disruption of ergosterol synthesis, which is part of the fungal cell membrane, which changes membrane permeability and causes subsequent cell lysis.

Lidocaine is a local anesthetic agent. It causes reversible blockade of impulse conduction along nerve fibers by blocking the passage of sodium ions through the membrane.

Pharmacokinetics

Pharmacokinetic studies of the drug have not been conducted.

Indications

Allergic and inflammatory diseases of the ear, including:

• Acute diffuse external otitis;
• Acute otitis media;
• Chronic otitis in the acute stage;
• Condition after ear surgery.

ICD codes

Dosage Regimen

The drug is used topically. Instill 4-5 drops into the external auditory canal 3-4 times/day.

Improvement occurs within 3-5 days. The course of treatment is 7-10 days.

Before opening the package and first use of the drug, it is necessary to warm the bottle in the hand for 3-5 minutes, to room temperature. With further use and storage at room temperature, additional warming is not required.

Adverse Reactions

Local reactions rarely – itching, burning at the site of application of the drug; allergic reactions are possible.

From the organ of vision rarely (≥1/10000-<1/1000) – blurred vision.

Contraindications

• Hypersensitivity to the components of the drug;
• Violation of the integrity of the tympanic membrane;
• Children under 6 years of age.

Use in Pregnancy and Lactation

The issue of the advisability of prescribing the drug during pregnancy is decided by the doctor individually. Prescription of the drug is possible in cases where the intended therapeutic benefit for the mother outweighs the potential risk to the fetus.

Pediatric Use

The use of the drug is contraindicated in children under 6 years of age.

Special Precautions

Visual Impairments

Visual impairments may occur with systemic and topical use of glucocorticosteroids. If a patient has symptoms such as blurred vision or other visual disturbances, it is necessary to recommend that the patient consult an ophthalmologist to identify possible causes of visual impairment, including cataract, glaucoma, or rare diseases, such as central serous chorioretinopathy, which have been observed with systemic and topical use of glucocorticosteroids.

Overdose

Data on drug overdose are not provided.

Drug Interactions

Drug interactions of the drug have not been studied.

Storage Conditions

The drug should be stored out of the reach of children, in a light-protected place at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Do not freeze.

Shelf Life

The shelf life is 2 years. Do not use after the expiration date.

After opening the package, store at a temperature not exceeding 30°C (86°F) for no more than 1 month.

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.