Pharmacological properties
Pharmacodynamics. Chlorhexidine is a well-tolerated antiseptic that has a bactericidal effect against gram-positive bacteria, especially sensitive strains of Staphylococcus aureus - microorganisms that are most often associated with skin infections.
Chlorhexidine dihydrochloride is less active against gram-negative pathogens. Some species of Pseudomonas and Proteus are resistant to chlorhexidine. It has weak activity against fungi and is inactive against viruses.
Dexpanthenol, the active ingredient in Bepanthen ® Plus, is rapidly converted into pantothenic acid in skin cells and acts like a vitamin. However, dexpanthenol has the advantage of being absorbed more quickly than pantothenic acid when applied topically.
Pantothenic acid is a component of the vital coenzyme A (CoA). In this form, acetyl-coenzyme A (CoA) plays a leading role in the metabolism of every cell. Thus, pantothenic acid is necessary for the formation of epithelium and the healing of skin and mucous membrane injuries.
Pharmacokinetics: Absorption of chlorhexidine through intact skin has not been demonstrated. Low plasma concentrations of chlorhexidine (1 μg/mL) have been observed in infants bathed in a 4% chlorhexidine gluconate wash solution.
Little is known about the distribution of chlorhexidine in organs and tissues, since absorption through the skin is minimal. After oral administration of 300 mg in healthy adults, C max in blood plasma, which is 0.2 μg / ml, can be determined after 30 minutes.
Chlorhexidine is practically not absorbed after topical application. After oral administration, chlorhexidine is almost completely excreted in the feces.
Dexpanthenol is quickly absorbed by the skin. In skin cells, it quickly turns into pantothenic acid and replenishes endogenous reserves of this vitamin.
In the blood, pantothenic acid binds to plasma proteins (mainly β-globulin and albumin). In healthy adults, the concentration is approximately 500-1000 μg/L and 100 μg/L in blood and serum, respectively.
Pantothenic acid is not broken down in the body and is excreted unchanged. 60-70% of an oral dose is excreted in the urine, the rest in the feces. In adults, 2-7 mg is excreted in the urine, in children - 2-3 mg/day.
Indication
Superficial skin lesions of any origin, where there is a risk of infection: scratches, cuts, abrasions, skin cracks, burns, abscesses, dermatitis; chronic skin lesions, such as trophic leg ulcers and pressure sores; skin infections, such as secondarily infected eczema and secondarily infected neurodermatitis; treatment of cracked nipples in breastfeeding women; in minimally invasive surgery: injuries and surgical wounds.
Application
Adults and children from 1 year of age should apply the drug once or several times a day, depending on the need, to previously cleansed affected areas of the skin. The daily dose with repeated use should not exceed 5 g.
If necessary, bandages can be applied.
The frequency of application and duration of treatment are determined individually by the doctor, depending on the clinical signs of skin damage. Application to large areas of skin should be avoided.
Contraindication
Hypersensitivity to Dexpanthenol and/or chlorhexidine or any other components of the drug. should not be applied to a perforated eardrum.
Side effects
Immune system, skin and subcutaneous tissue disorders: allergic reactions, including allergic skin reactions such as contact dermatitis, allergic dermatitis, pruritus, erythema, burning, eczema, rash, urticaria, edema, skin irritation, blisters. Hypersensitivity, anaphylactic reactions and anaphylactic shock (potentially life-threatening) with associated laboratory and clinical manifestations including asthma syndrome, mild to moderate reactions potentially affecting the skin, respiratory system, gastrointestinal tract, cardiovascular system including cardiorespiratory failure.
Special instructions
Contact with eyes, ears and mucous membranes should be avoided. If the drug gets into the eyes, they should be rinsed thoroughly with water.
Bepanthen ® Plus is not recommended for the treatment of skin irritations with a low risk of infection (e.g. sunburn). In such cases, Bepanthen ® cream is recommended. Do not use in allergic skin diseases without infectious complications.
Large, heavily contaminated deep wounds, as well as wounds resulting from bites and punctures, require medical intervention (there is a risk of developing tetanus). If the wound size remains large within 10-14 days or the wound does not heal, the appropriateness of prescribing the drug should be reconsidered. This is also necessary if there is severe perifocal hyperemia, the wound swells, severe pain appears, purulent exudation increases or the injury is accompanied by fever (risk of developing sepsis). The drug should not be used to treat infected wounds with abundant purulent exudation.
Use during pregnancy and breastfeeding. Animal reproduction studies have not revealed any risk to the fetus. However, Bepanthen® Plus should not be used on large skin surfaces during pregnancy, as there are no data on controlled studies in pregnant women.
The drug can be used by women during breastfeeding, but should be avoided on large areas of skin. If the drug is used to treat cracked nipples, it should be washed off before breastfeeding.
Children. The drug should be used in children from 1 year of age.
The ability to influence the reaction speed when driving vehicles or working with other mechanisms. Does not affect.
Interactions
Chlorhexidine is not compatible with saponifying agents and other anionic compounds. Bepanthen® Plus is not recommended for use simultaneously with other antiseptics to prevent their mutual effects (anti-inactivation or antagonism).
Overdose
With topical application of the drug, cases of overdose are unknown.
Dexpanthenol, even in high doses, is well tolerated and considered non-toxic. Hypervitaminosis is unknown.
Elevated aminotransferase levels have been described after self-poisoning with chlorhexidine.
Often, after repeated topical application to the same areas of the skin, skin irritation may occur. The drug is intended for the treatment of superficial skin lesions. Application to large areas of the skin should be avoided.
Storage conditions
At a temperature not exceeding 25 °C.
