INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DecaLor (DecaLor)

Composition:

Active ingredient: decamethoxine;

1 tablet contains 0.2 mg of decamethoxine;

Excipients: calcium stearate, povidone, potato starch, sucrose (sucrose).

Pharmaceutical form. Tablets.

Main physicochemical characteristics: round-shaped tablets with a biconvex surface and a score line, white or almost white in color.

Pharmacotherapeutic group. Preparations used for throat disorders. Miscellaneous antiseptics.
ATC Code
R02A A20.

Pharmacological Properties

Pharmacodynamics

Decamethoxine is a quaternary ammonium compound and belongs to the group of cationic surfactants. Decamethoxine binds to the phosphate groups of lipids in the microbial cell cytoplasmic membrane, leading to disruption of its permeability and subsequent destruction.

Decamethoxine has a broad spectrum of antimicrobial activity. It is active against Staphylococcus spp. (including penicillin-resistant strains of S. aureus), Streptococcus spp., Stomatococcus spp., and Corynebacterium spp. (including C. diphtheriae). It also demonstrates activity against protozoa, yeast-like fungi, particularly Candida albicans, and dermatophytes.

Decamethoxine exerts bactericidal, fungicidal, and sporicidal effects and also inactivates diphtheria exotoxin.

Decamethoxine does not suppress the specific and non-specific immune reactivity of the human body.

Pharmacokinetics

Not studied.

Clinical Characteristics

Indications

For local use as part of complex therapy of diseases of the oral cavity, pharynx, and larynx (gingivitis, periodontitis, stomatitis, oral mucosal candidiasis, pharyngitis, laryngitis, tonsillitis, early stage of angina);
for sanitation of the oral cavity, pharynx, and nasopharynx in carriers of pathogenic staphylococcus, diphtheria bacillus, or Candida;
for antimicrobial prophylaxis following surgical interventions in the oral cavity, pharynx, or larynx.

Contraindications. Hypersensitivity to decamethoxine or to any other component of the medicinal product.

Interaction with other medicinal products and other forms of interaction. When used concomitantly with antibiotics and systemic antimicrobial agents, the antibacterial effect of the medicinal product is enhanced.

Special precautions for use.

The medicinal product contains sucrose; therefore, it should be used with caution in patients with diabetes mellitus. Do not use in patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

If used for more than 7 days, disturbances in the pharyngeal microflora balance may occur.

To increase the concentration of the active substance in saliva, avoid frequent swallowing of saliva during tablet dissolution.

Concomitant use of this medicinal product with various types of mouth and throat rinses is not recommended.

Use during pregnancy or breastfeeding.
There are no clinical data on the use of DecaLOR during pregnancy or lactation. The drug should not be used during pregnancy. If it is necessary to use the medicinal product, breastfeeding should be discontinued.

Ability to influence reaction rate when driving vehicles or operating machinery.
No effect.

Method of administration and dosage.

Rinse the mouth and place the tablet in the oral cavity. Hold until completely dissolved. For adults, DecaLOR should be used at a dose of 1 tablet 4–6 times daily. The duration of treatment should not exceed 7 days. The medicinal product should be used after eating; for 1 hour afterwards, eating and drinking should be avoided.

Children.
There are no clinical data on the safety and efficacy of using the medicinal product DecaLOR in children.

Overdose.
No cases of overdose with the medicinal product DecaLOR have been reported.

Side effects

Allergic reactions, including skin rashes and pruritus.

Hypersalivation is possible, which disappears after dissolving the tablets.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after registration of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the use of this medicinal product. Healthcare professionals and pharmacists, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.
3 years.

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

Keep out of reach of children.

Packaging.
10 tablets in a blister; 2 blisters in a cardboard box.

Supply category.
Over-the-counter (without prescription).

Manufacturer.
ASTRAFARM LLC.

Manufacturer's address and location of its business activity.
6, Kyivska Street, m. Vyshneve, Buchanskyi district, Kyiv region, 08132, Ukraine.