Terzhinan

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TERGYNAN® (TERGYNAN®)

Composition:

Active substances: ternidazole, neomycin sulfate, nystatin, sodium prednisolone metasulfobenzoate;

Each vaginal tablet contains: ternidazole 200 mg; neomycin sulfate 100 mg (65,000 IU); nystatin 100,000 IU; sodium prednisolone metasulfobenzoate 4.7 mg, equivalent to 3.0 mg of prednisolone.

Excipients: wheat starch, colloidal anhydrous silicon dioxide, sodium starch glycolate (type A), magnesium stearate, lactose monohydrate.

Pharmaceutical form. Vaginal tablets.

Main physicochemical characteristics: elongated cream-colored tablets with the letter "T".

Pharmacotherapeutic group.
Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives and corticosteroids.
ATC code: G01AF.

Pharmacological properties.

Pharmacodynamics.

The pharmacological properties are determined by the characteristics of the drug's components. Tergynan, with its polyvalent formulation, is suitable for comprehensive local treatment of vaginitis of various origins: infectious, parasitic, or mixed. It combines the following active ingredients:

• tinidazole, which exerts trichomonacidal activity and is effective against anaerobic bacteria, including Gardnerella;
• neomycin sulfate, a broad-spectrum antibiotic active against vaginal pyogenic organisms;

microorganisms sensitive to neomycin sulfate include:

Corynebacterium, Listeria monocytogenes, Staphylococcus Meti-S, Acinetobacter baumannii, Brahamella 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;

• nystatin, a polyene antifungal antibiotic active against Candida species;
• prednisolone, a glucocorticoid with pronounced anti-inflammatory effects.

The excipient composition helps maintain the integrity of the vaginal mucosa and a stable pH.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Treatment of vaginitis caused by microorganisms sensitive to the drug, such as:

• bacterial vaginitis caused by common pyogenic microflora;
• nonspecific vaginitis accompanied by desquamative discharge;
• trichomonal vaginitis;
• vaginitis caused by Candida fungi;
• vaginitis caused by mixed infections (trichomonads, anaerobic infection, and yeast-like fungi).

Contraindications.

Hypersensitivity to the components of the drug. This medicinal product is not recommended for use in combination with certain doses of acetylsalicylic acid (see "Interaction with other medicinal products and other forms of interaction").

Interaction with other medicinal products and other forms of interaction.

Interaction related to prednisolone

Undesirable combinations:

• with acetylsalicylic acid: increased risk of bleeding when used concurrently with anti-inflammatory doses of acetylsalicylic acid (≥ 1 g per dose or ≥ 3 g daily).

Combinations requiring caution:

• with anticonvulsants, enzyme inducers: reduced plasma concentration and efficacy of corticosteroids due to enhanced hepatic metabolism. The consequences are particularly severe (or significant) in patients with Addison's disease treated with hydrocortisone and in organ transplantation. Clinical and laboratory monitoring is required, along with dose adjustment of corticosteroids during and after treatment with enzyme-inducing agents;
• with isoniazid: reduced plasma concentration of isoniazid due to enhanced hepatic metabolism, and reduced hepatic metabolism of glucocorticoids;
• with rifampicin: reduced plasma concentration and efficacy of corticosteroids due to enhanced hepatic metabolism following interaction with rifampicin. The consequences are particularly severe (or significant) in patients with Addison's disease treated with hydrocortisone and in organ transplantation. Clinical and laboratory monitoring is required, along with dose adjustment of corticosteroids during and after treatment with rifampicin;
• with other hypokalemic agents: increased risk of hypokalemia. Serum potassium levels should be monitored and corrected if necessary;
• with cardiac glycosides: hypokalemia exacerbates the toxic effects of cardiac glycosides. Before initiating treatment, assess for hypokalemia, determine serum potassium levels, and perform electrocardiography;
• with medicinal products that may cause polymorphic ventricular tachycardia of the "torsades de pointes" type: increased risk of ventricular arrhythmia, including polymorphic ventricular tachycardia of the "torsades de pointes" type. Before initiating treatment, assess for hypokalemia, determine serum potassium levels, and perform electrocardiography.

Combinations requiring attention:

• with cyclosporine: enhanced effects of prednisolone, including Cushing-like symptoms, reduced carbohydrate tolerance (decreased prednisolone clearance);
• with acetylsalicylic acid: increased risk of bleeding with antipyretic or analgesic doses of ≥ 500 mg per dose or < 3 g daily;
• with nonsteroidal anti-inflammatory drugs: increased risk of peptic ulcer and gastrointestinal bleeding;
• with fluoroquinolones: possible increased risk of tendinitis or even tendon rupture (rare), particularly in patients receiving long-term corticosteroid therapy.

Special precautions for use.

Simultaneous treatment of the sexual partner is required to prevent the risk of reinfection.

Despite topical application, minor absorption of various components may occur (see "Adverse reactions").

Increased sensitivity following local application may indicate contraindication to use of this or related antibiotics.

Precautions during use.

The duration of treatment should be limited in order to reduce the risk of development of resistant microorganisms or superinfection caused by such microorganisms.

Use during pregnancy or breastfeeding.

Use is possible only as prescribed and under medical supervision according to the indicated conditions for use of the drug.

Ability to influence reaction rate while driving or operating machinery.

No special warnings required.

Method of Administration and Dosage.

The dosage and duration of treatment are determined individually by a physician.

The medication is intended for adult use. It is administered vaginally, 1 vaginal tablet 1–2 times daily. The average duration of treatment is 10 consecutive days. In cases of confirmed fungal infection (mycosis), treatment lasts 20 days.

Patients are advised to wash their hands thoroughly before handling the tablets. Prior to insertion, immerse the tablet in water for 2–3 seconds, then insert it to the most comfortable depth into the vagina (this is easiest when the patient is lying on her back with knees bent). After insertion, it is recommended to remain lying down for approximately 15 minutes.

Practical advice.

Treatment should be accompanied by adherence to personal hygiene (wear cotton underwear, avoid douching, and use sanitary pads instead of tampons during treatment) and, whenever possible, avoidance of unfavorable factors.

The treatment course should not be interrupted during menstruation.

Children.

The medication is not used in children.

Overdose.

Data not available.

Side effects.

Immune system: hypersensitivity.

Skin and subcutaneous tissue disorders: allergic dermatitis, rash, pruritus, urticaria.

Reproductive system and breast: application site reactions such as paresthesia or irritation, erosion, vaginal edema, burning sensation in the vagina, vulvovaginal erythema, vulvovaginal pain, vulvovaginal pruritus.

Shelf life. 3 years.

Storage conditions.

Keep out of reach of children.

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

Packaging.

6 or 10 tablets per strip; 1 strip per cardboard box labeled in Ukrainian and English.

Prescription status. Prescription only.

Manufacturer.

Sofartex / Sophartex.

Manufacturer's address.

21 rue du Pressoir, 28500 Vernouillet, France / 21 Pressoir Street, 28500, Vernouillet, France.

Marketing Authorization Holder.

Laboratories Bouchara Recordati, France / Laboratories Bouchara Recordati, France.