Sanidar®

INSTRUCTIONS for medical use of the medicinal product Sanidar® (Sanidar)

Composition:

active substance: decamethoxine;

1 ml of solution contains decamethoxine 0.2 mg;

excipients: sodium chloride, water for injections.

Pharmaceutical form. Solution for external use.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Antiseptics and disinfectants. Quaternary ammonium compounds. Decamethoxine. ATC code D08AJ10.

Pharmacological properties.

Pharmacodynamics.

Decamethoxine exerts antimicrobial and antifungal effects by accumulating at the cytoplasmic membrane (CM) of microbial cells and binding to phosphatidyl groups of membrane lipids, thereby disrupting the permeability of the microbial cytoplasmic membrane. Decamethoxine has a pronounced bactericidal effect against staphylococci, streptococci, Corynebacterium diphtheriae, encapsulated bacteria, and fungicidal activity against yeasts, yeast-like fungi, causative agents of epidermophytia, trichophytia, microsporia, erythrasma, as well as some species of molds (Aspergilli, Penicilli), a protistocidal effect against trichomonads and Giardia, and a virucidal effect against lipophilic viruses. It is highly active against microorganisms resistant to antibiotics. Resistant strains to decamethoxine develop slowly and to a minor extent during prolonged use. Bacteriostatic (fungistatic) concentrations are similar to its bactericidal (fungicidal), virucidal, and protistocidal concentrations. During the use of the medicinal product, the sensitivity of antibiotic-resistant microorganisms to antibiotics increases.

Pharmacokinetics.

The medicinal product is practically not absorbed through mucous membranes, intact skin, or wound surfaces.

Clinical characteristics.

Indications.

For the treatment of bacterial and fungal skin infections, microbial eczema, and purulent-inflammatory lesions of soft tissues (abscesses, carbuncles, phlegmons, furuncles, purulent wounds, panaritium); stomatological diseases (stomatitis, ulcerative-necrotic gingivitis, dystrophic-inflammatory form of periodontosis grade I–II in the acute stage).

The medicinal product is also indicated in chronic tonsillitis, angina, carriage of staphylococci and diphtheria bacilli, ulcerative colitis, and periproctitis.

In gynecological practice, for the treatment of candidiasis of the vaginal mucosa, microbial origin inflammatory genital diseases, pre-delivery sanitation of birth canals, and postpartum endometritis.

For the treatment of purulent-inflammatory diseases of the abdominal and pleural cavities.

For hygienic disinfection of medical personnel hands and rubber gloves during patient examination and performance of medical manipulations and minor surgical procedures, and for pre-sterilization disinfection of medical instruments and diagnostic equipment made of metals, rubber, polymer materials, and glass.

Contraindications.

Individual hypersensitivity to the components of the medicinal product.

Interaction with other medicinal products and other types of interactions.

Decamethoxine is a cationic surfactant; therefore, it is incompatible with soap and other anionic compounds.

Decamethoxine increases the sensitivity of antibiotic-resistant microorganisms to antibiotics.

Instructions for use.

Decamethoxine at the concentration used in the medicinal product has no toxic effect. Prolonged use of the medicinal product does not cause any toxic reactions. Warming the solution to 38 °C prior to application increases its effectiveness. In cases of inflammatory conditions and skin irritation, the medicinal product should be diluted with distilled water in a ratio of 1:1 or 1:2.

Use during pregnancy or breastfeeding.

Animal studies have demonstrated embryotoxic and teratogenic effects of decamethoxine. There is insufficient data on the safety of using the medicinal product in pregnant women. The medicinal product should not be used during pregnancy, except in individual cases where the benefit to the mother outweighs the potential risk to the fetus.

Ability to influence reaction rate when driving or operating machinery.

There are no warnings regarding the influence on reaction speed when driving or operating machinery.

Method of Administration and Dosage.

Do not swallow the solution when using the medicinal product.

For purulent and fungal skin lesions, and purulent wounds, apply the solution as washes or compresses. For the treatment of proctitis and ulcerative colitis, administer warm solution as enemas, 50–100 mL twice daily until complete disappearance of acute inflammatory signs. In cases of fistulas in chronic paraproctitis, irrigate the fistulous tracts daily with the medicinal product for 3–4 days. For urinary bladder irrigation in adult patients, use decamethoxine solution diluted 1:7 with purified water at a dose of 500–600 mL (7–20 irrigations per treatment course).

Treat oral mucosal lesions by application of 25–50 mL for 10–15 minutes or by rinsing (100–150 mL). Treat acute-stage I–II degree dystrophic-inflammatory periodontosis by irrigation of pathological periodontal pockets with warm solution (50–70 mL) or by application to the gums until inflammatory symptoms subside. For patients with oral candidiasis or ulcerative-necrotic gingivitis, prescribe mouth rinsing (100–150 mL) four times daily for 5–10 days.

Treat candidal tonsillitis and chronic tonsillitis by lavage of the palatine tonsil crypts (50–75 mL per irrigation).

Eradicate carriership of Staphylococcus and Corynebacterium diphtheriae by rinsing the pharynx, lavage of tonsillar crypts, and irrigation of the nasopharynx and tonsils. Perform lavage of crypts 3–5 times every other day.

In the treatment of purulent-inflammatory diseases of the peritoneal and pleural cavities, fill the affected area completely with the medicinal product, leaving it in place for at least 10 minutes. If necessary, especially when closing the wound "blindly" (without drainage), repeatedly fill the surgical cavity and then remove the solution until the washings are clear. Perform continuous irrigation and drainage of the cavity using drainage tubes or by puncture technique.

For the treatment of microbial, fungal, and trichomonas mucosal vaginal infections, use the medicinal product as douching (50–100 mL of solution warmed to 38°C, three times daily). In the same manner, perform single pre-delivery sanitation of the birth canal. Treat postpartum endometritis by irrigating the uterine cavity with warm medicinal solution (150–200 mL) twice daily.

Disinfect hands and rubber gloves by applying 5–10 mL of the medicinal product to the previously washed surface for 5 minutes.

Disinfect cleaned medical instruments, mouthpieces, tubes, and equipment by immersing them in the solution for 30 minutes.

Children.

Experience of use in children is lacking.

Overdose.

Due to the absence of systemic absorption, overdose is unlikely.

Adverse reactions.

In rare cases, some patients may experience increased individual sensitivity. In such individuals, skin rashes, burning, dryness, itching, and other local allergic reactions may occur after application of the medicinal product.

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after medicinal product registration is an important procedure. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging. 100 ml, 200 ml or 400 ml in bottles.

100 ml, 200 ml or 400 ml in bottles with protective cap.

Supply classification. Over-the-counter.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and location of its business operations.

13, Borysplilska Street, Kyiv, 02093, Ukraine.