Pharmacodynamics. Chlorhexidine is an antiseptic that is well tolerated and bactericidal against gram-positive bacteria, especially sensitive strains of staphylococcus aureus, microorganisms most often associated with skin infections.
To a lesser extent, chlorhexidine dihydrochloride is active against gram-negative pathogenic microorganisms. Some Pseudomonas and Proteus species are resistant to chlorhexidine. It has weak activity against fungi and is inactive against viruses.
Dexpanthenol, the active ingredient in Bepanten® Plus, is rapidly converted into pantothenic acid in skin cells and acts as a vitamin. But dexpanthenol has the advantage of being absorbed faster than pantothenic acid when applied topically.
Pantothenic acid is a component of the vital coenzyme A (CoA). In this form, acetylcoenzyme A (CoA) plays a leading role in the metabolism of every cell. Thus, pantothenic acid is essential for the formation of epithelium and the healing of skin and mucous membrane lesions.
Pharmacokinetics. Absorption of chlorhexidine through intact skin has not been detected. In infants who were bathed in a 4% chlorhexidine gluconate detergent solution, low plasma concentrations of chlorhexidine were observed (1 μg / ml).
Little is known about the distribution of chlorhexidine in organs and tissues, since absorption through the skin is minimal. For oral administration of 300 mg in healthy adults, Cmax in blood plasma of 0.2 μg / ml can be determined after 30 minutes.
Chlorhexidine is practically not absorbed after topical cutaneous application. After oral administration, chlorhexidine is almost completely excreted in the feces.
Dexpanthenol is rapidly absorbed by the skin. In skin cells, it quickly converts 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 about 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.
Superficial skin lesions of any origin, in which there is a risk of infection: scratches, cuts, scratches, 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 women who are breastfeeding; in minimally invasive surgery: trauma and surgical wounds.
For adults and children from 1 year old, apply the preparation once or several times a day, depending on the need, on previously cleansed affected skin areas. the daily dose for repeated use should not exceed 5 g.
Bandages can be applied as needed.
The frequency of application of the preparation and the duration of treatment are determined individually on the recommendation of a doctor, depending on the clinical signs of skin damage. Use on large areas of skin should be avoided.
Hypersensitivity to dexpanthenol and / or chlorhexidine or any other components of the preparation. can not be applied to a perforated eardrum.
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 corresponding laboratory and clinical manifestations, including asthma syndrome, mild to moderate reactions that potentially affect the skin, respiratory system, gastrointestinal tract, cardiovascular system, including cardiovascular failure.
Contact with eyes, ears and mucous membranes should be avoided. if the preparation gets into the eyes, they must be thoroughly rinsed with water.
Bepanten® Plus is not recommended for treatment of skin irritations, the probability of infection of which is low (for example, in case of sunburn). In such cases, it is recommended to use Bepanten® cream. Do not use for allergic skin diseases without infectious complications.
Large, highly contaminated deep wounds, as well as wounds resulting from bites and punctures, require medical intervention (there is a risk of tetanus development). If the size of the wound remains large within 10-14 days or the wound does not heal, the advisability of prescribing the preparation should be reconsidered. It is also necessary if there is severe perifocal hyperemia, the wound swells, severe pain appears, purulent exudation intensifies, or damage is accompanied by fever (risk of sepsis). The preparation should not be used to treat infected wounds with profuse purulent exudation.
If symptoms persist or the condition worsens, you should see a doctor.
Use during pregnancy and lactation. In the study of reproductive function in animals, no risk to the fetus was identified. However, during pregnancy, Bepanten® Plus should not be used on large skin surfaces, since there are no data on controlled studies in pregnant women.
The preparation can be used by women during breastfeeding, but should refrain from using on large skin surfaces. If the preparation is used to treat cracked nipples, it should be washed off before breastfeeding.
Children. The preparation should be used in children from 1 year of age.
The ability to influence the reaction rate when driving or working with other mechanisms. Does not affect.
Chlorhexidine is incompatible with saponifying agents and other anionic compounds. bepanten® plus is not recommended to be used simultaneously with other antiseptics to prevent their mutual influence (counteraction or inactivation).
With local application of the preparation, cases of overdose are unknown.
Dexpanthenol, even at high doses, is well tolerated and considered non-toxic. Hypervitaminosis is unknown.
An increase in the level of aminotransferase after self-poisoning with chlorhexidine has been described.
Often, after repeated topical application, irritation may occur on the same areas of the skin. The preparation is intended for the treatment of superficial skin lesions. Use on large areas of skin should be avoided.
At a temperature not higher than 25 ° C.