Instructions for Bepanthen Plus cream tube 30 g
Composition
active ingredients: dexpanthenol, chlorhexidine dihydrochloride;
1 g of cream contains dexpanthenol 50 mg, chlorhexidine dihydrochloride 5 mg;
Excipients: DL-pantolactone, cetyl alcohol, stearyl alcohol, white soft paraffin, mineral oil, lanolin, polyethylene glycol stearate, purified water.
Dosage form
Cream.
Main physical and chemical properties: Homogeneous cream of almost white color with a faint odor.
Pharmacotherapeutic group
Dermatological preparations. Antiseptics and disinfectants. Chlorhexidine, combinations. ATX code D08A C52.
Pharmacological properties
Pharmacodynamics
Chlorhexidine dihydrochloride is a well-tolerated antiseptic with bactericidal activity against gram-positive bacteria, especially susceptible strains of Staphylococcus aureus, the organisms most commonly associated with skin infections. Chlorhexidine dihydrochloride is less active against gram-negative pathogens. Some strains 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 to pantothenic acid in 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 and healing of damaged skin and mucous membranes.
Pharmacokinetics
Absorption of chlorhexidine through intact skin has not been demonstrated. Low blood concentrations of chlorhexidine (1 μg/mL) have been observed in infants bathed in a 4% chlorhexidine gluconate solution.
Little is known about the distribution of chlorhexidine in organs and tissues, as absorption through the skin is minimal. After oral administration of 300 mg in healthy adults, peak plasma concentrations of 0.2 μg/mL can be determined after 30 minutes.
Chlorhexidine is virtually not absorbed in adults after topical application to the skin.
Dexpanthenol is rapidly absorbed by the skin. In skin cells, it is quickly converted to pantothenic acid and added to the endogenous reserves of this vitamin.
Pantothenic acid is bound 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 per day.
Indication
Superficial skin lesions of any origin, in which 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.
Minimally invasive surgery: injuries and surgical wounds.
Contraindication
Hypersensitivity to dexpanthenol and/or chlorhexidine, or to any other components of the drug.
Do not apply to a perforated eardrum.
Interaction with other medicinal products and other types of interactions
Chlorhexidine is incompatible with saponifying agents and other anionic compounds. Bepanthen® Plus is not recommended for use simultaneously with other antiseptics to prevent their mutual effects (anti-reaction or inactivation).
Application features
Contact with eyes, ears and mucous membranes should be avoided. If the cream gets into the eyes, they should be rinsed 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 and deep wounds, as well as wounds resulting from bites and punctures, require medical intervention (there is a risk of 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 sepsis). The drug should not be used to treat infected wounds with abundant purulent exudation.
If the infection persists or the condition worsens, you should consult a doctor.
Use during pregnancy or breastfeeding
Animal reproduction studies have not revealed any risk to the fetus. However, Bepanthen® Plus should not be used on large surfaces during pregnancy, as there are no data from controlled studies in pregnant women.
The drug can be used by women during breastfeeding, but application to large areas of skin should be avoided. If the drug is used to treat cracked nipples, it should be washed off before breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
Adults and children over 1 year of age should apply the drug 1 or more times a day, depending on the need, to previously cleansed affected areas of the skin.
The daily dose with multiple applications should not exceed 5 g of cream.
If necessary, bandages can be applied.
The frequency of application of the cream and the 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.
Children
The drug should be used in children over 1 year of age.
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 skin, skin irritation may occur. The drug is intended for the treatment of superficial skin lesions. Application to large areas of skin should be avoided.
Adverse reactions
Immune system, skin and subcutaneous tissue disorders: Allergic reactions, including allergic skin reactions such as contact dermatitis, allergic dermatitis, pruritus, erythema, burning sensation, 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.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
3.5 g, or 30 g, or 100 g of cream in tubes in a cardboard box.
Vacation category
Without a prescription.
Producer
GP Grenzach Produktions GmbH/GP Grenzach Produktions GmbH.
Location of the manufacturer and address of its place of business
Emil-Barell-Strasse 7, 79639 Grenzach-Wyhlen, Germany.
