Rhinobact^® (Spray) Instructions for Use

Marketing Authorization Holder

Sintez PJSC (Russia)

ATC Code

R01AX08 (Framycetin)

Active Substance

Framycetin (Rec.INN WHO registered)

Dosage Form

Rhinobact®

Nasal spray 1.25%: 10 ml, 15 ml, or 20 ml bottle with spray nozzle

Dosage Form, Packaging, and Composition

Nasal spray as a clear, colorless or slightly yellowish solution.

Excipients: methylparahydroxybenzoate (methylparaben, methylhydroxybenzoate, nipagin), sodium chloride, sodium citrate pentasesquihydrate (trisodium citrate 5.5-hydrate), citric acid monohydrate, water for injections.

10 ml – bottles with a capacity of 10 ml with a spray nozzle (1) – cardboard packs.
15 ml – bottles with a capacity of 20 ml with a spray nozzle (1) – cardboard packs.
20 ml – bottles with a capacity of 20 ml with a spray nozzle (1) – cardboard packs.

10 ml in polyethylene bottles with a capacity of 10 ml, 15 ml or 20 ml in polyethylene bottles with a capacity of 20 ml with a spray nozzle

Clinical-Pharmacological Group

Antibacterial drug for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other preparations for topical use; other drugs for the treatment of nasal diseases

Pharmacological Action

Broad-spectrum aminoglycoside antibiotic for topical use in otorhinolaryngology. It acts bactericidally, damages the cytoplasmic membrane, disrupts the flow of metabolites inside the cell and causes rapid death of microorganisms.

It is active against most gram-positive and gram-negative bacteria: Staphylococcus aureus, Staphylococcus spp. (including strains resistant to other antibiotics), some strains of Streptococcus spp., Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Klebsiella spp., Haemophilus influenzae, Salmonella spp., Shigella spp., Enterobacter spp., Proteus spp., Serratia marcescens, Pasteurella spp., Vibrio spp., Borrelia, Leptospira spp., Mycobacterium tuberculosis (including strains resistant to streptomycin), causing the development of infectious processes in the upper respiratory tract.

Treponema spp., some strains of Streptococcus spp., and anaerobic microorganisms are resistant to framycetin.

Pharmacokinetics

When applied topically, it has low systemic absorption.

Indications

As part of combination therapy for infectious and inflammatory diseases of the upper respiratory tract, including: rhinitis, rhinopharyngitis, sinusitis (in the absence of septal damage). Prevention and treatment of inflammatory processes after surgical interventions.

ICD codes

Dosage Regimen

Administer Rhinobact^® nasal spray topically only. Do not use for sinus irrigation.

For adults and children, administer one spray into each nostril. Repeat this administration three to six times per day.

The maximum duration of treatment is seven days. Do not exceed this treatment period.

For post-surgical prophylaxis and treatment of inflammation, follow the specific regimen prescribed by the physician.

Discontinue use immediately upon resolution of infectious and inflammatory symptoms.

If no clinical improvement is observed within several days, re-evaluate the diagnosis and treatment plan.

Adverse Reactions

Possible: allergic reactions.

Contraindications

Hypersensitivity to aminoglycoside antibiotics; pregnancy, breastfeeding period.

Framycetin should not be used for irrigation of the paranasal sinuses.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Can be used in children according to indications, in recommended doses.

Special Precautions

During treatment, the appearance of resistant strains of microorganisms is possible.

Aminoglycoside antibiotics can cause reversible, partial or complete deafness and have a nephrotoxic effect when used systemically and when applied topically to open wounds or damaged skin. These effects are dose-dependent and are enhanced in cases of impaired liver or kidney function. The risk of their occurrence should be taken into account in case of topical application of high doses of the drug in children. Therapy should not be continued after the symptoms disappear.

Framycetin should not be used simultaneously with other antibiotics that have ototoxic and nephrotoxic effects (streptomycin, monomycin, kanamycin, gentamicin).

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.