Izofra spray nasal solution 8000 IU/ml bottle with sprayer 15 ml

Instructions for use Izofra spray nasal solution 8000 IU/ml bottle with sprayer 15 ml

Composition

active ingredient: framycetin;

1 ml of solution contains framycetin sulfate 12.5 mg (8000 IU);

Excipients: methylparaben (E 218), sodium chloride, sodium citrate, citric acid monohydrate, purified water.

Dosage form

Nasal spray, solution.

Main physicochemical properties: clear liquid.

Pharmacotherapeutic group

Anti-edematous and other drugs for topical use in cases of nasal cavity diseases. ATX code R01A X08.

Pharmacological properties

Pharmacodynamics

Framycetin is an antibiotic from the aminoglycoside group for topical use. The concentration of framycetin achieved with topical application ensures its bactericidal activity against gram-positive and gram-negative microorganisms that cause the development of infectious processes in the upper respiratory tract.

Framycetin is active against Corynebacterium, Listeria monocytogenes, Staphylococcus meti-S, Acinetobacter (mainly Acinetobacter baumanii), Branhamella catarrhalis, Campylobacter, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenza, Klebsiella, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Salmonella, Serretia, Shigella, Yersinia.

Pasteurella species is moderately sensitive to framycetin.

Bacteria resistant to framycetin are Enterococci, Nocardia asteroides, Staphylococcus meti-R* (resistance is about 30-50%, more pronounced in hospital), Streptococcus, Alcaligenes denitrificans, Burkholderia, Flavobacterium sp., Providencia stuartii, Pseudomonas aeruginosa, Stenotrophomonas maltophilia, resistant anaerobic bacteria, Chlamydia, Mycoplasma, Rickettsia.

Pharmacokinetics

Pharmacokinetic studies of the drug were not conducted due to low systemic absorption.

Indication

As part of combination therapy for infectious and inflammatory diseases of the upper respiratory tract, including rhinitis, rhinopharyngitis, sinusitis in the absence of damage to the walls of the nasal sinuses; prevention and treatment of inflammatory processes after surgical interventions.

Contraindication

Hypersensitivity (allergy) to any of the components of the drug, including framycetin and other aminoglycoside antibiotics.

Children's age up to 1 year.

Interaction with other medicinal products and other types of interactions

Unknown.

If you are using any other topical medications, you should definitely inform your doctor.

Application features

The drug should not be used for rinsing the paranasal sinuses. With prolonged use of the drug, the emergence of resistant strains of microorganisms is possible. If there is no therapeutic effect within 7 days of treatment, the drug should be discontinued.

Use during pregnancy or breastfeeding

The effectiveness and safety of the drug during pregnancy have not been sufficiently studied.

Toxic effects on the fetal cochleovestibular apparatus are possible. Systemic penetration through the mucous membrane is possible, therefore the drug should not be prescribed to this category of patients.

The use of the drug during breastfeeding is not recommended, since aminoglycosides penetrate into breast milk.

Ability to influence reaction speed when driving vehicles or other mechanisms

No cases of impact on reaction speed when driving vehicles or working with other mechanisms were identified.

Method of administration and doses

Adults should be prescribed 1 injection into each nasal passage 4-6 times a day.

Children over 1 year of age should be given 1 spray into each nasal passage 3 times a day. The spray should be administered by pressing the bottle. When using, hold the bottle vertically and tilt your head slightly forward to inject the solution into the nasal passage as a spray, not a jet of liquid.

The duration of treatment is up to 10 days.

Children

Use as prescribed by a doctor for the treatment of children over 1 year of age.

Overdose

No cases of overdose were noted.

Adverse reactions

The following adverse reactions have been spontaneously reported with the following frequencies in patients treated with framycetin during post-marketing experience and in the scientific literature (very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (less than < 1/10,000)).

Rare: allergic skin reactions (urticaria, itching).

Expiration date

3 years.

Storage conditions

Store out of the reach of children at a temperature not exceeding 25 °C.

Packaging

15 ml in a bottle with a sprayer in a cardboard box.

Vacation category

According to the recipe.

Producer

Sofartex, France.

Location of the manufacturer and its business address

21, rue Pressoir, 28500, Vernouillet, France.

Applicant

Bouchard Recordate Laboratories, France.