TERGYNAN® (Ternidazole, Neomycin, Nystatin) 10 tablets

Ingredients

Each tablet is composed of the following components:

Active Ingredients:

• Ternidazole: 200 mg


• Neomycin Sulfate: 100 mg (equivalent to 65,000 IU)


• Nystatin: 100,000 IU


• Prednisolone Sodium Metasulfobenzoate (equivalent to prednisolone): 4.7 mg (3 mg)

Excipients:

• Starch


• Colloidal Anhydrous Silicon Dioxide


• Sodium Starch Glycolate (Type A)


• Magnesium Stearate


• Lactose Monohydrate


• Purified Water

 

Pharmacological Characteristics

Pharmacokinetics

No studies have been conducted due to minimal systemic absorption.

Pharmacodynamics: This combined drug is intended for local use in gynecology and exhibits several beneficial properties, including antimicrobial, anti-inflammatory, antiprotozoal, and antifungal effects.

Ternidazole, an antifungal agent belonging to the imidazole derivative group, exerts its action by inhibiting the synthesis of enzymes like squalene epoxidase and ergosterol, which are crucial components of fungal cell membranes. This inhibition leads to the accumulation of squalene within the fungal cell wall, resulting in structural and functional changes in the cell membrane. Ternidazole also demonstrates trichomonacid effects and is effective against anaerobic bacteria, particularly gardnerella.

Neomycin sulfate, a broad-spectrum antibiotic from the aminoglycoside group, exhibits bactericidal activity against both gram-positive (e.g., Staphylococcus spp., Streptococcus pneumoniae) and gram-negative (e.g., Escherichia coli, various Shigella spp., Proteus spp.) microorganisms. Its bactericidal action is attributed to its interference with ribosomes, which leads to the inhibition of protein synthesis within bacterial cells. Neomycin is generally inactive against Streptococcus spp., and the development of resistance in microorganisms against neomycin occurs gradually and to a limited extent.

Nystatin, an antifungal antibiotic in the polyene group, is effective against yeast-like fungi, specifically those of the Candida genus. Nystatin exerts its antifungal effects by binding to sterols in the fungal cell membrane, disrupting membrane permeability and slowing down fungal cell growth.

Prednisolone, a dehydrated analogue of hydrocortisone, possesses anti-inflammatory, anti-allergic, and anti-exudative properties. It works by suppressing the functions of leukocytes and limiting their migration to inflamed areas. Additionally, prednisolone interferes with macrophage activity, inhibiting phagocytosis and interleukin-1 production. It reduces capillary permeability by blocking histamine release and also suppresses fibroblast activity and collagen formation. Moreover, prednisolone inhibits phospholipase A2 activity, leading to the suppression of prostaglandin and leukotriene synthesis.

 

Indications for Use

This medication is indicated for the treatment of vaginitis caused by microorganisms sensitive to the drug, including bacterial vaginitis (including that caused by Trichomonas vaginalis), fungal vaginitis (caused by yeast-like fungi of the Candida genus), mixed infections, and for the prevention of vaginitis in various gynecological scenarios, such as before gynecological operations, childbirth and abortion, the installation of intrauterine devices, diathermocoagulation of the cervix, and hysterography.

 

Usage Instructions and Dosage

Insert one tablet deeply into the vagina while lying down before bedtime. Prior to vaginal insertion, soak the tablet in water for 20-30 seconds. Following administration, remain in a reclined position for 10-15 minutes. Typically, the treatment course spans 10 days.

 

Side Effects

Possible side effects include vaginal burning, itching, and irritation, especially at the start of treatment. In some instances, allergic reactions like skin rash and itching may occur.

 

Contraindications

Do not use if you are hypersensitive to any components of the medication.

 

Special Considerations

For vaginitis and trichomoniasis treatment, consider simultaneous treatment for sexual partners. Continue treatment during menstruation. This medication is not intended for use in pediatric patients.

Pregnancy and Nursing: Use during pregnancy and lactation is only advisable when the potential benefits to the mother outweigh potential risks to the fetus or infant.

Effects on Driving or Machinery Operation: This medication does not affect your ability to drive or operate potentially dangerous machinery.

Overdose: An overdose is unlikely due to minimal systemic absorption.