Panthenol plus

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANTHENOL PLUS (PANTHENOLO PLUS)

Composition:

Active substances: dexpanthenol, chlorhexidine digluconate;

1 ml of the preparation contains dexpanthenol 50 mg; chlorhexidine digluconate 5 mg;

Excipients: DL-pantolactone, macrogol lauryl ether, ethanol 96%, purified water.

Pharmaceutical form. Topical spray, solution.

Main physicochemical properties: clear, colorless liquid with a weak characteristic odor.

Pharmacotherapeutic group. Dermatologicals. Antiseptics and disinfectants. Chlorhexidine combinations. ATC code D08AC52.

Pharmacological properties.

Pharmacodynamics.

Dexpanthenol is rapidly converted within cells into pantothenic acid, which, as part of one of the most important coenzymes—coenzyme A—plays a key role in the metabolism of every cell. Pantothenic acid is essential for the formation of epithelium of the skin and mucous membranes. It promotes increased mitotic activity and enhances collagen fiber strength during wound healing.

Chlorhexidine digluconate belongs to well-known antiseptics that are well tolerated and exhibit bactericidal activity against gram-positive bacteria, particularly sensitive strains of Staphylococcus aureus (golden staphylococcus), which are most commonly associated with skin infections. It shows somewhat lower activity against gram-negative microorganisms. Certain species of Pseudomonas and Proteus are insensitive. It has weak effects on fungi and is ineffective against viruses.

Pharmacokinetics.

Dexpanthenol is rapidly absorbed through the skin, immediately converted into pantothenic acid (vitamin B5), and added to the body's endogenous stores of this vitamin.

In the blood, pantothenic acid binds to plasma proteins (particularly to beta-globulin and albumin). In healthy adults, blood concentrations are approximately 500–1000 µg/L, and serum concentrations are about 100 µg/L.

Pantothenic acid is not metabolized in the body and is excreted unchanged. 60–70% of an oral dose is excreted in urine, the remainder in feces. In adults, approximately 2–7 mg/day is excreted in urine; in children, 2–3 mg/day.

Absorption of chlorhexidine through intact skin in adults has not been detected. In infants bathed in a 4% cleansing solution of chlorhexidine digluconate, low blood concentrations of chlorhexidine (≤ 1 µg/mL) have been observed.

Clinical characteristics.

Indications.

Superficial skin lesions of any origin where there is a risk of infection: scratches, abrasions, cuts, skin fissures, burns, boils, dermatitis (inflammation of the skin).

Chronic skin lesions such as leg ulcers and pressure sores.

Skin infections, for example, secondarily infected eczema and secondarily infected neurodermatitis.

Treatment of nipple fissures in breastfeeding women.

Minor surgical procedures: injuries and surgical wounds.

Contraindications.

Hypersensitivity to the components of the medicinal product. Do not apply to a perforated eardrum.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with other antiseptics is not recommended to avoid mutual interference (antagonism or inactivation). Chlorhexidine is incompatible with emulsifying agents and other anionic compounds.

Special precautions for use

Avoid contact with ears and mucous membranes. The medicinal product must not enter the eyes. Serious cases of persistent corneal damage, potentially requiring corneal transplantation, have been reported following accidental exposure to chlorhexidine-containing preparations in the eyes—even when eye protection measures were taken—due to solution spread beyond the intended surgical site. Extreme caution must be exercised during application to ensure that the product does not migrate beyond the intended application site into the eyes. Particular care should be taken in anesthetized patients, who may not be able to immediately report exposure of the eyes to the solution. If the medicinal product enters the eyes, they should be immediately and thoroughly rinsed with water. An ophthalmologist should be consulted promptly.

The product is not recommended for use on skin irritations with low risk of infection (e.g., sunburn). In such cases, products without disinfectants are recommended.

Rarely, when using antiseptic agents containing chlorhexidine, mild to moderate allergic reactions may occur, affecting the skin (e.g., itching, urticaria), face (e.g., angioneurotic edema), respiratory tract (e.g., asthma, wheezing, or other breathing difficulties), gastrointestinal tract, or cardiovascular system. If symptoms of a severe allergic reaction occur, use of the medicinal product should be discontinued immediately and medical advice should be sought to prevent further progression.

If infection persists or the condition worsens, consult a physician.

Use during pregnancy or breastfeeding

Reproductive toxicity studies in animals have not shown any risk to the fetus. However, during pregnancy, the medicinal product should not be applied to large areas of skin, as there are no controlled studies in pregnant women.

The product may be used by women during breastfeeding, but application to large skin surfaces should be avoided. If the product is used to treat cracked nipples, it should be washed off prior to breastfeeding.

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

Dosage and Administration.

Apply the medicinal product to adults, adolescents, and children: apply once or several times daily to previously cleaned wounds or inflamed areas of the skin. Dressings may be used if necessary.

Children.

For use in children aged 1 year and older.

Overdose.

Dexpanthenol is well tolerated even at high doses and is considered non-toxic. Cases of hypervitaminosis have not been reported.

Elevated levels of aminotransferase after self-poisoning with chlorhexidine have been described. Repeated frequent topical application to the same skin areas may cause skin irritation. The product is intended for the treatment of superficial skin injuries. Application to large skin areas should be avoided.

Side effects.

Immune system, skin and subcutaneous tissue disorders. Allergic skin reactions and burning sensation may rarely occur. Cases of contact dermatitis, allergic dermatitis, pruritus, erythema, eczema, rash, urticaria, swelling, skin irritation, and vesicles have been reported. Hypersensitivity, allergic reactions, and anaphylactic shock (potentially life-threatening) with corresponding laboratory and clinical manifestations, including asthma syndrome, and mild to moderate reactions potentially affecting the skin, respiratory system, gastrointestinal tract, and cardiovascular system, including cardiopulmonary failure, have been reported.

Eye disorders: Corneal erosion, epithelial defect/corneal injury, severe irreversible visual impairment. During the post-marketing period, cases of severe corneal erosion and irreversible severe visual impairment of unknown frequency have been reported following accidental exposure to eyes of *products containing chlorhexidine*, resulting in some patients requiring corneal transplantation (see section "Dosage and administration").

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

30 ml in a bottle equipped with a spray pump, spray nozzle, and protective cap, in a carton.

Availability.

Over-the-counter (without prescription).

Manufacturer.

Limited liability company "Pharmaceutical Company "Zdorovia".

Manufacturer's address and location of business activity.

22 Shevchenko Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.