Instructions Bepanten Plus cream tube 100 g
Warehouse
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.
Pharmacological group
Dermatological preparations. Antiseptics and disinfectants. Chlorhexidine, combination. 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 wash 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 to healthy adults, the maximum plasma concentration is 0.2 μg/ml, detectable after 30 minutes.
Chlorhexidine is practically not absorbed from 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, which pose a risk of infection: scratches, cuts, scratching, skin cracks, burns, abscesses, dermatitis.
Chronic skin lesions, such as trophic ulcers and bedsores.
Skin infections, such as secondarily infected eczema and secondarily infected neurodermatitis.
Treatment of cracked nipples in breastfeeding women.
Minimally invasive surgery: injuries and wounds.
Contraindication
Hypersensitivity to dexpanthenol and/or chlorhexidine or to 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 influence (anti-action or inactivation).
Application features
Avoid contact with eyes, ears and mucous membranes. If the cream gets into your eyes, rinse them 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 for 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 larger 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 worsens, you should consult a doctor.
Use during pregnancy or breastfeeding
Animal reproduction studies have not revealed any risk to the fetus. However, Bepanthen® 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
Does not affect.
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 repeated use should exceed 5 g of cream.
Bandages can be applied if necessary.
The frequency of application of the cream and the duration of treatment are determined by the doctor's recommendation individually 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 at 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.
Side effects
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;
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.
Address
Emil-Barell-Strasse 7, 79639 Grenzach-Wyhlen, Germany/Emil-Barell-Strasse 7, 79639 Grenzach-Wyhlen, Germany.
