Gyterna (Tablets) Instructions for Use

Marketing Authorization Holder

Veropharm, JSC (Russia)

ATC Code

G01BA (Antibacterial agents in combination with corticosteroids)

Dosage Form

Gyterna

Vaginal tablets: 6 or 10 pcs.

Dosage Form, Packaging, and Composition

Vaginal tablets are round, flat-cylindrical, light yellow or yellow in color, marbled, with a specific odor.

Excipients: potato starch, lactose (milk sugar), polyvinylpyrrolidone (povidone), colloidal silicon dioxide (aerosil), talc, magnesium stearate, polyplasdone XL-10 (croscarmellose sodium), chocolate-scented flavoring composition.

6 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with antibacterial, antiprotozoal, antifungal, and anti-inflammatory action for topical use in gynecology

Pharmacotherapeutic Group

Combined antimicrobial agent (antibiotic+antimicrobial and antiprotozoal agent+antifungal agent+glucocorticosteroid)

Pharmacological Action

A combined medicinal product with antiprotozoal, antibacterial, and antifungal action for topical use in gynecology.

It also has an anti-inflammatory effect; ensures the integrity of the vaginal mucosa and constant pH.

Metronidazole (a nitroimidazole derivative) is an antiprotozoal agent that inhibits the synthesis of nucleic acids in the DNA of microorganism cells.

Active against Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis, Mobiluncus spp., as well as against obligate anaerobes: Bacteroides spp., Fusobacterium spp.

Neomycin is a broad-spectrum antibiotic from the aminoglycoside group.

It acts bactericidally.

Active against gram-positive (Staphylococcus spp., Streptococcus pneumoniae) and gram-negative (Escherichia coli, Shigella dysenteria, Shigella flexneri, Shigella boydii, Shigella sonnei, Proteus spp.) microorganisms.

Nystatin is active against yeast-like fungi of the genus Candida, changes the permeability of cell membranes and slows their growth.

Prednisolone is a glucocorticosteroid that has a pronounced anti-inflammatory, anti-allergic, and anti-exudative effect.

Indications

Treatment of vaginitis caused by microorganisms sensitive to the drug, including: bacterial vaginitis; vaginal trichomoniasis; vaginitis caused by fungi of the genus Candida; mixed vaginitis.

Prevention of vaginitis, including: before gynecological operations; before childbirth and abortion; before and after insertion of intrauterine devices; before and after diathermocoagulation of the cervix; before hysterosalpingography.

ICD codes

Dosage Regimen

Administer one vaginal tablet intravaginally, once daily, preferably at bedtime.

Moisten the tablet with a small amount of water immediately prior to insertion to initiate dissolution.

For therapeutic treatment of vaginitis, the average duration is 10 consecutive days.

In cases of confirmed mycosis (fungal infection), the treatment course can be extended up to 20 days based on physician assessment.

For prophylactic use prior to gynecological procedures, the course is typically 6 days; follow specific medical instructions.

Continue treatment throughout the menstrual period; do not interrupt the regimen.

For infectious vaginitis and trichomoniasis, ensure simultaneous treatment of the sexual partner to prevent reinfection.

Complete the full prescribed course even if symptoms improve earlier to ensure eradication and prevent recurrence.

Adverse Reactions

Allergic reactions burning sensation, itching, hyperemia of the vaginal mucosa (especially at the beginning of treatment).

Contraindications

Hypersensitivity to the components of the combination.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is possible only if the potential benefit to the mother outweighs the risk to the fetus or infant.

Special Precautions

For vaginitis and trichomoniasis, simultaneous treatment of sexual partners is recommended.

Use should not be discontinued during menstruation.

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.