Frizanta^® (Spray) Instructions for Use

Marketing Authorization Holder

Vertex, JSC (Russia)

ATC Code

R01AX08 (Framycetin)

Active Substance

Framycetin (Rec.INN registered by WHO)

Dosage Form

Frizanta®

Nasal spray 12.5 mg/mL

Dosage Form, Packaging, and Composition

Nasal spray

15 ml – bottles – carton packs – By prescription

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

An antibiotic from the aminoglycoside group with a broad spectrum of action 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 intranasally only. Use the spray in a vertical position, with the head upright.

Before initial use, prime the pump by pressing the actuator several times until a full spray is produced.

Clear nasal passages prior to administration. Insert the nozzle gently into the nostril.

For adults and children: administer one spray into each nostril.

Apply three to six times per day, ensuring equal distribution between nasal passages.

The maximum daily frequency is six applications. Do not exceed the recommended number of doses.

The standard treatment course is seven days. Do not use for more than seven consecutive days.

Discontinue use immediately upon resolution of infectious symptoms. Reevaluate the patient if symptoms persist beyond one week.

For postoperative prophylaxis, initiate use as directed by the surgeon. The duration of prophylactic use is typically shorter.

Close the bottle tightly after each use. Discard the bottle one month after first opening.

Adverse Reactions

Possible: allergic reactions.

Contraindications

Hypersensitivity to antibiotics of the aminoglycoside group; pregnancy, breastfeeding period.

Framycetin should not be used for washing 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.