TAMISOL®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT TAMISTOL® (TAMISTOL®)

Composition:

Active substance: benzyl dimethyl[3-(myristoylamino)propyl]ammonium chloride monohydrate;

1 suppository contains benzyl dimethyl[3-(myristoylamino)propyl]ammonium chloride monohydrate 0.015 g;

Excipients: polyethylene glycol 1500, polyethylene glycol 400, hard fat, cetyl alcohol, titanium dioxide (E 171), colloidal anhydrous silicon dioxide.

Pharmaceutical form. Suppositories 0.015 g for rectal and vaginal use.

Main physicochemical properties: white, bullet-shaped suppositories. A surface film on the suppository is permissible.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology, excluding combinations with corticosteroids. ATC Code G01A.

Anti-inflammatory agents used in intestinal diseases. ATC Code A07E.

Pharmacological Properties.

Pharmacodynamics.

Tamistol® is an antimicrobial medicinal product (antiseptic). The active ingredient, benzyl dimethyl [3-(myristoylamino)propyl] ammonium chloride monohydrate, is a cationic surfactant with antimicrobial (antiseptic) activity.

The mechanism of action of Tamistol® is based on direct hydrophobic interaction of the molecule with microbial membrane lipids, leading to their fragmentation and destruction.

Unlike other antiseptics, Tamistol® exhibits high selectivity of action against microorganisms, as it practically does not affect human cell membranes. This effect is due to the different structure of human cell membranes (significantly longer lipid radicals, which greatly limit the possibility of hydrophobic interaction between the active substance and human cells).

Tamistol® has pronounced antimicrobial activity against Gram-positive and Gram-negative, aerobic and anaerobic, spore-forming and non-spore-forming bacteria, both as monocultures and microbial associations, including hospital strains with multidrug resistance to antibiotics. It exerts a destructive effect on pathogens of sexually transmitted infections (gonococci, Treponema pallidum, trichomonads, chlamydia), as well as on herpes viruses, human immunodeficiency virus, etc. It also has antifungal activity against ascomycetes of the genus Aspergillus and the genus Penicillium, yeasts (Rhodotorula rubra, Torulopsis gabrata, and others), yeast-like fungi (Candida albicans, Candida krusei, and others), dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, T. schoenleini, T. violaceum, Epidermophyton Kaufman-Wolf, E. floccosum, Microsporum gypseum, Microsporum canis, and others), as well as other pathogenic fungi [e.g., Pityrosporum orbiculare (Malassezia furfur)], both as monocultures and microbial associations, including fungal microflora resistant to chemotherapeutic agents. Under the influence of Tamistol®, microbial resistance to antibiotics decreases.

Tamistol® has anti-inflammatory effects, enhances local defense reactions and regenerative processes, and activates immune defense mechanisms. It does not affect hormonal status.

Pharmacokinetics.

Tamistol® exerts a local effect. Data on the potential penetration of the drug into systemic circulation are lacking.

Clinical characteristics.

Indications.

In gynecology: acute and chronic bacterial or fungal vaginitis. Prevention of inflammatory complications prior to gynecological procedures (artificial termination of pregnancy, insertion and removal of intrauterine devices, diathermocoagulation of the cervix, hysterosalpingography, and others).

In venereology: prevention of sexually transmitted infections.

In proctology: proctitis, proctosigmoiditis, postoperative infections of the rectum.

Contraindications.

Hypersensitivity to the components of the drug. Intravaginal use is contraindicated during pregnancy (safety of use has not been studied).

Precautionary measures.

Consult a physician before starting treatment!

The effectiveness of the drug depends on strict adherence to the application instructions:

• insert the suppository as deeply as possible into the vagina or rectum;
• do not use soap or other soap-based products for genital hygiene within 2 hours before and 2 hours after intravaginal administration of Tamistol® (use only clean water for this purpose).

Interaction with other medicinal products and other forms of interaction.

When used concomitantly, Tamistol® may enhance the effectiveness of antibiotics.

Special precautions for use.

Use during pregnancy or breastfeeding.

The safety of use during pregnancy has not been studied.

There are no data on the negative effects of the drug during breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

The drug does not affect reaction speed when driving or operating machinery.

Method of Administration and Dosage.

In gynecology: intravaginally. Before use, remove the suppository from its protective packaging and insert deeply into the vagina.
For acute vaginitis: 1 suppository twice daily for 7 days.
For subacute and chronic vaginitis: 1 suppository once daily at bedtime for 14 days (regardless of the phase of the menstrual cycle).
If necessary, the treatment course may be prolonged.
For prophylactic purposes: 1 suppository once daily for 2–3 days.

In venereology: intravaginally, 1 suppository 10–15 minutes before sexual intercourse.

In proctology:

• For chronic proctitis, proctosigmoiditis: rectally, 1 suppository daily after a water micro-enema, for 1–2 weeks;
• After surgical intervention: rectally, 1 suppository daily for 1 week.

Children.
The medicinal product is not intended for use in pediatrics.

Overdose.
Not observed.

Side effects.

In individual cases, a transient burning sensation is possible, which disappears within 15–20 seconds and does not require discontinuation of treatment.

Shelf life. 3 years.

The product must not be used after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 5 suppositories in a blister; 1 or 2 blisters per carton.

Supply category. Over-the-counter.

Manufacturer.

JSC "Lekhim-Kharkiv".

Manufacturer's address and place of business.

36 Severina Pototskogo Street, Kharkiv, 61115, Ukraine.

Marketing Authorization Holder.

Collective Scientific and Implementation Small Enterprise "ISNA".

Address of the Marketing Authorization Holder.

8 Dubrovitska Street, Office 160, Kyiv, 04114, Ukraine.