Celista®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CELESTA® (CELISTA)

Composition:

Active substance: miramistin;

1 ml of solution contains miramistin 0.1 mg;

Excipient: purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: a clear colorless or slightly yellowish liquid, which foams when shaken.

Pharmacotherapeutic group. Antiseptics and disinfectants. ATC code D08A J.

Pharmacological Properties.

Pharmacodynamics.

The action of miramistin is due to the direct hydrophobic interaction of its molecules with the lipids of microbial cell membranes, leading to their fragmentation and destruction. In this process, part of the miramistin molecule penetrates into the hydrophobic region of the membrane, disrupts the supramembrane layer, loosens the membrane structure, increases its permeability for high-molecular-weight substances, alters the enzymatic activity of the microbial cell by inhibiting enzymatic systems, which results in suppression of microbial viability and their subsequent cytolysis.

Unlike other antiseptics, miramistin exhibits high selectivity of action against microorganisms, as it has almost no effect on human cell membranes. This effect is associated with the different structure of human cell membranes (which have significantly longer lipid radicals, sharply limiting the possibility of hydrophobic interaction between miramistin and human cells).

Miramistin exerts a pronounced antimicrobial effect against Gram-positive (including Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae, etc.) and Gram-negative (particularly Pseudomonas aeruginosa, Escherichia coli, Klebsiella spp., etc.) bacteria, as well as against aerobic and anaerobic, spore-forming and non-spore-forming bacteria, both as monocultures and microbial associations, including hospital strains. It also demonstrates antiviral activity against herpes viruses and human immunodeficiency virus (HIV), among others.

Miramistin exerts antifungal activity against ascomycetes of the genus Aspergillus and Penicillium, yeasts (Rhodotorula rubra, Torulopsis gabrata), yeast-like fungi (Candida albicans, Candida tropicalis, Candida krusei), dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton schoenleini, Trichophyton violaceum, Epidermophyton Kaufman-Wolf, Epidermophyton floccosum, Microsporum gypseum, Microsporum canis), and other pathogenic fungi (e.g., Pityrosporum orbiculare (Malassezia furfur)) as monocultures and microbial associations, including fungal microflora resistant to chemotherapeutic agents. Under the influence of miramistin, microbial resistance to antibiotics is reduced. It has no allergenic properties and does not produce local irritant effects.

Pharmacokinetics.

When applied topically, it is not absorbed through the skin and mucous membranes.

Clinical characteristics.

Indications.

• Complex treatment of acute and chronic tonsillitis, pharyngitis, and laryngitis.
• Treatment and prevention of infectious-inflammatory diseases of the oral cavity: stomatitis, gingivitis, periodontitis.
• Prevention of microbial complications following surgical procedures on the oral mucosa.
• Treatment and prevention of candidiasis of the oral mucosa.

Contraindications.

Individual hypersensitivity to miramistin.

Children under 3 years of age.

Interaction with other medicinal products and other types of interactions.

When antibiotics are used concomitantly with miramistin, a decrease in microbial resistance to antibiotics is observed.

Special precautions for use.

To minimize the risk of infection transmission, the medicinal product should not be used by more than one person.

Use during pregnancy or breastfeeding.

Since systemic absorption of the medicinal product Celistar® is negligible, its use is permitted during pregnancy or breastfeeding.

Effect on ability to drive or operate machinery.

The medicinal product Celistar® does not affect the ability to drive or engage in other potentially hazardous activities requiring increased attention and psychomotor reaction speed.

Method of Administration and Dosage.

Celistat®, spray is intended for topical use, administered into the oral cavity and/or pharynx using the spray nozzle. The duration of therapy ranges from 4 to 10 days, depending on the clinical response and time to remission.

For tonsillitis, pharyngitis, laryngitis:

Children aged 3–6 years – one press of the spray nozzle, 3–4 times daily;

Children aged 7–14 years – two presses of the spray nozzle, 3–4 times daily;

Adolescents aged 14 years and older, and adults – three to four presses of the spray nozzle, 3–4 times daily.

For stomatitis, gingivitis, periodontitis:
The medication should be sprayed within the oral cavity 3–4 times daily. If spraying is not feasible, the solution may be applied locally using compresses or gauze pads soaked in the medication, placed into the oral cavity.

For prevention of microbial complications after surgical procedures:
The wound surface should be irrigated with miramistin or moistened gauze pads soaked in the medication should be applied to the wound surface.

For oral mucosal candidiasis:
The medication should be sprayed or applied using a sterile gauze pad soaked in the medication, placed into the oral cavity 3 times daily.

Children.

The medication may be used in children aged 3 years and older.

Overdose.

Symptoms of overdose have not been observed.

Side effects.

Immune system disorders: hypersensitivity reactions.

Other: in individual cases, a transient burning sensation may occur, which resolves spontaneously within 15–20 seconds after administration of the medicinal product and does not require discontinuation.

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after marketing authorization of the medicinal product is an important procedure. It enables continuous 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. 3 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.

50 ml in a bottle, 1 bottle with spray nozzle in a carton.

Supply category. Over-the-counter.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and location of operations.

13, Boryspylska Street, Kyiv, 02093, Ukraine.