DECAZOLE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DEKASOL

Composition:

Active substance: decamethoxine;

1 can contains decamethoxine (calculated as dry substance) 52 mg;

Excipients: ethanol (96 %), glycerol, cetyl stearyl alcohol, polysorbate 80, purified water, propellant 134a.

Pharmaceutical form. Aerosol.

Main physicochemical properties: the medicinal product forms a white foam upon release from the can.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology. Other antimicrobial and antiseptic agents. ATC code G01AX.

Pharmacological properties.

Pharmacodynamics.

Decamethoxine exerts an antimicrobial effect on the pathogenic flora of the vagina, most pronounced against gram-positive cocci and rod-shaped microorganisms (S. aureus and B. subtilis). The effect of the medicinal product on gram-negative flora (E. coli, P. aeruginosa, P. vulgaris, K. pneumonie) and Candida species is weaker. Decamethoxine exhibits antitrichomonas activity, which is inferior to that of metronidazole and trichomonacid.

Pharmacokinetics.

The medicinal product is not absorbed into the systemic circulation and acts locally.

Clinical characteristics.

Indications.

For the prevention and treatment of non-specific, trichomonal, and candidal colpitis.

Contraindications.

Hypersensitivity to the components of the medicinal product.

Interaction with other medicinal products and other types of interactions.

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

Pharmacodynamic: decamethoxine increases the sensitivity of antibiotic-resistant microorganisms to antibiotics.

Special precautions for use.

The medicinal product contains cetostearyl alcohol, which may cause local reactions (e.g., contact dermatitis).

External vaginal hygiene may be performed using clean water without soap applied 2 hours before or 2 hours after the application of Decazole, since soap may destroy the active substance of the medicinal product.

Use during pregnancy or breastfeeding.

The medicinal product should not be used during pregnancy or breastfeeding due to lack of clinical data.

Ability to affect reaction speed when driving or operating machinery.

The use of the medicinal product does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

For use in adult women. Before using Decazol, shake the canister, remove the protective cap, attach the applicator to the valve stem, insert the free end of the applicator deeply into the vagina (in the lying position), as close as possible to the cervix, and press the base of the applicator. The dosage of the aerosol-foam is determined by the duration of pressing – 1 second.

For prophylaxis and treatment of nonspecific colpitis in women, Decazol should be used as monotherapy or in combination with conventional antibacterial agents 2–4 times daily for 5–7 days. For treatment of trichomonal and candidal colpitis, Decazol should be administered in courses (2–3 courses of 7–10 days each).

Children.

The medicinal product is not intended for use in children.

Overdose.

Unlikely, since Decazol acts locally and does not enter the systemic circulation.

Side effects.

Immune system side effects: allergic reactions, including skin itching, rash.

Local effects: with prolonged use, a slight disturbance of the natural pH level and normal vaginal flora is possible, as well as mild local irritation (itching of external genital organs, burning sensation, increased vaginal discharge).

Shelf life. 2 years.

Storage conditions.

Keep out of reach of children. Store in the original packaging at a temperature not exceeding 25 °C. Protect from falls, impacts, and direct sunlight.

Packaging.

60 g in an aluminum aerosol can with a continuous-action valve, equipped with an applicator and protective cap; 1 can per carton.

Category of release. Over-the-counter.

Manufacturer. JSC "STOMA".

Manufacturer's address and place of business. 3, Newton Street, Kharkiv, Ukraine, 61105.