Vagitsin neo

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VAGICIN NEO (VAGICIN NEO)

Composition:

Active substances: neomycin sulfate, polymyxin B sulfate, nystatin;

1 tablet contains: neomycin sulfate 35,000 IU, polymyxin B sulfate 35,000 IU, nystatin 100,000 IU;

Excipients: lactose monohydrate; microcrystalline cellulose; maize starch; sodium croscarmellose; magnesium stearate.

Pharmaceutical form. Vaginal tablets.

Main physicochemical properties: tablets from light yellow to yellow in color, oval-shaped, biconvex surface, with a score line. Minor specks on the tablet surface are permissible.

Pharmacotherapeutic group. Antibacterials and antiseptics used in gynecology. Antibiotics. Nystatin, combinations. ATC code G01AA51.

Pharmacological properties.

Pharmacodynamics.

The properties of the drug are composed of the characteristics inherent to its individual components.

Neomycin sulfate is an aminoglycoside antibiotic that exerts a bactericidal effect by inhibiting the function of bacterial ribosomes in a broad spectrum of microorganisms:

aerobic gram-positive bacteria: Corynebacterium, Listeria monocytogenes, Staphylococcus meti-S;

aerobic gram-negative bacteria: Acinetobacter (predominantly Acinetobacter baumannii), Branhamella catarrhalis, Campylobacter, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Salmonella, Serratia, Shigella, Yersinia, Pasteurella.

Polymyxin B sulfate is a polypeptide antibiotic group that exerts a bactericidal effect primarily against aerobic gram-negative bacteria: Acinetobacter, Aeromonas, Alcaligenes, Citrobacter freundii, Citrobacter koseri, Enterobacter, Escherichia coli, Klebsiella, Moraxella, Pseudomonas aeruginosa, Salmonella, Shigella, Stenotrophomonas maltophilia. Polymyxin B disrupts the osmotic resistance of bacterial membranes and is also active against pathogenic organisms in both growth and resting phases.

Nystatin is a polyene antibiotic that exerts a fungicidal effect against Candida species.

Nystatin acts fungicidally or fungistatically by binding to ergosterol in the fungal cytoplasmic membrane. It is active against Candida spp., Histoplasma spp., Coccidioides spp., Cryptococcus spp., Aspergillus, Blastomyces dermatidis.

The active substances do not interfere with the activity of lactobacilli that are part of the normal vaginal microflora.

Pharmacokinetics.

Not sufficiently studied.

Clinical characteristics.

Indications.

Local treatment of vaginitis caused by microorganisms sensitive to the components of the drug (bacterial vaginitis, vulvovaginitis caused by Candida albicans and Candida non-albicans, mixed vaginitis), and bacterial vaginosis.

Official recommendations regarding appropriate use of antibacterial agents should be taken into account.

Contraindications.

This medicinal product is contraindicated in cases of:

• hypersensitivity to the active or excipient ingredients (or hypersensitivity to the corresponding group of substances);
• use of diaphragms and latex condoms.

It is not recommended to use in combination with spermicides.

Interaction with other medicinal products and other forms of interaction.

Contraindicated combinations

Condoms and diaphragms, due to the risk of their rupture.

Not recommended combinations

Spermicides

The use of any product for intravaginal administration may likely render local contraception with spermicides ineffective.

Special precautions for use.

Warning

If local intolerance or allergic reaction occurs, treatment must be discontinued. Sensitization of the body following local administration of antibiotics may subsequently lead to allergic reactions upon systemic use of the same or structurally related antibiotic.

Precautionary measures during use

Treatment duration should be limited due to the risk of developing microbial resistance to the components of the drug or the occurrence of superinfection.

Due to the lack of data on the absorption of neomycin and polymyxin B through mucous membranes, there is a risk of systemic effects, particularly in the presence of renal impairment.

Use during pregnancy or breastfeeding.

The medicinal product contains the aminoglycoside antibiotic neomycin. Since systemic absorption of neomycin cannot be excluded, there is a potential risk of ototoxic effects. Therefore, the use of medicinal products containing neomycin should be avoided during pregnancy. In clinical studies and during long-term post-marketing surveillance, no cases of developmental abnormalities or fetotoxicity have been reported.

Due to insufficient data on the passage of the drug into breast milk, use during breastfeeding is not recommended.

Ability to affect reaction speed when driving vehicles or operating machinery.

Does not affect.

Method of Administration and Dosage.

For adults: administer 1 tablet intravaginally once daily in the evening before bedtime.

Insert one tablet deeply into the vagina, preferably while lying down.

Treatment duration: 12 days.

Practical Recommendations

• The patient should be informed about the importance of maintaining personal hygiene (wearing cotton underwear, avoiding douching and/or use of tampons during treatment) and, whenever possible, eliminating unfavorable factors that may have contributed to the disease.
• The issue of treating the partner should be decided individually in each case.
• Treatment should not be interrupted during menstruation.

Children.

This medicinal formulation is not intended for use in children.

Overdose.

Excessive and prolonged use may cause systemic effects (on the auditory organs and kidneys), especially in patients with renal insufficiency. Prolonged use is also associated with an increased risk of developing allergic eczema.

Side effects.

Side effects are classified by their impact on systems and organs. The frequency of side effects reported in spontaneous reports is unknown (cannot be estimated from available data).

Immune system disorders

Hypersensitivity: rash, itching, urticaria, and anaphylactic reaction.

Reproductive system and breast disorders

Local reactions such as burning sensation, itching, irritation, redness, and swelling.

Reporting of side effects

Reporting of side effects after drug registration is important. It enables continuous monitoring of the benefit-risk balance of the drug. Healthcare professionals and patients, or their legal representatives, should report all suspected side effects and lack of drug efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 tablets per blister in a box.

Prescription status. Prescription only.

Manufacturer.

Limited Liability Company "Pharmaceutical Company "Zdorovya".

Manufacturer's address and place of business.

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22.