Pantanol-zdorovya plus

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANTENOL-ZDOROVYA PLUS

Composition:

Active substances: dexpanthenol, benzalkonium, chlorhexidine;

1 g of the preparation contains 50 mg of dexpanthenol, 0.5 mg of benzalkonium chloride; 38.8 mg of chlorhexidine digluconate solution;

Excipients: cetostearyl alcohol; polyethylene glycol (macrogol) stearate; polyoxyl hydrogenated castor oil; DL-pantolactone; propylene glycol; mineral oil; soft white paraffin; purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: cream from white to almost white, homogeneous in consistency.

Pharmacotherapeutic group. Dermatologicals. Antiseptics and disinfectants. Chlorhexidine, combinations.

ATC Code D08AC52.

Pharmacological properties.

Pharmacodynamics.

The cream exerts wound-healing, anti-inflammatory, antibacterial, and antifungal effects.

Dexpanthenol is rapidly converted into pantothenic acid (vitamin B5) in skin cells and acts as a vitamin. Pantothenic acid is a component of the essential coenzyme A, which plays a key role in cellular metabolism. Thus, dexpanthenol promotes the formation and healing of damaged areas of the skin and mucous membranes, increases hydration of the stratum corneum, improves skin barrier function, accelerates mitosis, and enhances the strength of collagen fibers.

Chlorhexidine is a well-tolerated antiseptic with bactericidal activity against gram-positive bacteria, particularly sensitive strains of Staphylococcus aureus—microorganisms most commonly associated with skin infections. Chlorhexidine is less active against gram-negative pathogens. Some strains of Pseudomonas and Proteus are resistant to chlorhexidine. The drug is active against Candida albicans and some other fungi. When applied topically, it prevents wound surface infection.

Benzalkonium chloride is a quaternary ammonium compound with antiseptic and antimicrobial activity. Benzalkonium chloride exerts bactericidal effects against a broad spectrum of gram-positive and gram-negative bacteria. It is active against enterococci, gonococci, staphylococci, corynebacteria, Candida species, herpes simplex virus type II, cytomegalovirus, HIV, chlamydia, and trichomonads.

The original formulation of the medicinal product ensures enhanced intensity of antimicrobial action.

Pharmacokinetics.

Dexpanthenol is rapidly absorbed through the skin following topical application. In skin cells, dexpanthenol is quickly converted into pantothenic acid, thereby replenishing the body's stores of this vitamin. When entering systemic circulation, pantothenic acid binds to plasma proteins (β-globulin and albumin). Pantothenic acid undergoes no biotransformation and is excreted unchanged (60–70% is excreted in urine, the remainder in feces).

Absorption of chlorhexidine through intact skin has not been detected. In infants bathed in a 4% solution of chlorhexidine gluconate, low blood concentrations of chlorhexidine (1 mcg/mL) were observed.

Benzalkonium is not absorbed through intact skin or mucous membranes and, when used at recommended doses, does not penetrate into blood plasma or breast milk.

Clinical characteristics.

Indications.

The medicinal product is used topically for the following indications:

• for the treatment of minor abrasions, scratches, cuts, lacerations, skin fissures, minor burns, and for prevention of their infection;
• for the treatment of nipple fissures in breastfeeding women;
• for the treatment of skin infections, particularly secondarily infected eczema and neurodermatitis;
• in burn medicine for the treatment of granulating burn wounds, preparation of wounds for autodermoplasty, and after plastic surgeries to improve graft take;
• in surgery for the treatment of wounds of various localization and etiology, including postoperative wounds, trophic ulcers, and pressure sores in the regeneration phase (phase 2 of the wound healing process);
• in radiation medicine for the treatment of radiation ulcers in the regeneration phase.

Contraindications.

The drug should not be used in case of increased individual sensitivity to any of its components.

The drug is contraindicated for application on a perforated tympanic membrane.

The drug should not be used for the treatment of infected wounds with abundant purulent exudation during the first phase of wound healing. Cream application is possible only after elimination of purulent infection and transition of the inflammatory process into the regeneration phase.

The drug should not be used in allergic diseases and hemophilia.

Interaction with other medicinal products and other types of interactions.

Dexpanthenol may enhance the effect of depolarizing muscle relaxants (e.g., succinylcholine chloride, decamethonium bromide) and reduce the effect of non-depolarizing muscle relaxants (e.g., tubocurarine chloride) due to its ability to stimulate acetylcholine synthesis.

Chlorhexidine is incompatible with emulsifying agents and other anionic compounds.

Benzalkonium chloride is incompatible with soaps and other anionic surfactants, as well as with citrates, iodides, nitrates, permanganates, salicylates, silver salts, and tartrates.

Concomitant use of the drug with other antiseptics is not recommended to avoid mutual interference (antagonism or inactivation).

Special precautions for use

For external use only.

Avoid contact with eyes, ears, and mucous membranes. In case of accidental contact with eyes, rinse thoroughly with plenty of running water.

This medicinal product is not recommended for treating skin irritations with low risk of infection (e.g., sunburn). In such cases, Pantenol-Zdorovya, topical cream, is recommended. Do not use in allergic skin diseases without infectious complications.

Large, heavily contaminated or deep wounds, as well as wounds caused by bites or punctures, require medical attention (risk of tetanus). If wound size remains significant or the wound does not heal within 10–14 days, the continued use of this product should be reconsidered. Treatment should also be re-evaluated if pronounced perifocal hyperemia, swelling, severe pain, increased purulent exudation, or fever occur (risk of sepsis). If symptoms persist or worsen, consult a physician.

The product contains cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis); polyoxyl hydrogenated castor oil, which may cause skin reactions; and propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding

During pregnancy, avoid applying the cream to large areas of skin due to the lack of controlled studies in pregnant women.

Breastfeeding women should remove any residual cream with clean, soft wipes and wash the nipples and surrounding skin with warm boiled water before nursing.

Ability to affect reaction speed when driving or operating machinery

No effect.

Method of Administration and Dosage.

The cream is intended for topical use.

The frequency of cream application and duration of treatment are determined individually by a physician, depending on the course of the disease, efficacy, and tolerability of therapy.

For adults and children aged 1 year and older: apply a thin layer of cream once or several times daily, as needed, to previously cleaned affected areas of the skin. The dosage is determined individually based on the size of the affected area. Occlusive dressings may be used if necessary.

Children. The drug can be used in children aged 1 year and older.

Overdose.

There have been no reports of overdose with topical use of the drug. Hypervitaminosis has not been observed. Elevated aminotransferase levels have been reported after chlorhexidine self-poisoning. Skin irritation may frequently occur after repeated topical application to the same skin areas. The drug 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 reactions, including skin allergic reactions such as contact dermatitis, allergic dermatitis, pruritus, erythema, burning sensation, eczema, rash, urticaria, swelling, skin irritation, vesicles. Hypersensitivity, anaphylactic reactions and anaphylactic shock (life-threatening) with corresponding laboratory and clinical manifestations, including asthma syndrome, reactions ranging from mild to moderate severity, which may affect the skin, respiratory system, gastrointestinal tract, cardiovascular system, including cardiorespiratory failure.

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. 20 g, 40 g or 100 g in a tube in a box.

Supply category. Over-the-counter.

Manufacturer.

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and location of business activity.

Ukraine, 61013, Kharkiv region, Kharkiv, Shevchenka Street, 22.