Translation of the instructions can be
PANTHENOL PLUS cream
Instruction
For medical use of the medicinal product
Panthenol plus
Composition:
Active ingredient: chlorhexidine dihydrochloride, dexpanthenol;
1 g of cream contains chlorhexidine dihydrochloride 5 mg, dexpanthenol 50 mg;
Excipients: DL-pantolactone, cetyl alcohol, stearyl alcohol, white soft paraffin, mineral oil, lanolin, polyethylene glycol stearate, purified water.
Dosage form.
Cream.
Main physicochemical properties: homogeneous cream from almost white to pale yellow in color.
Pharmacotherapeutic group.
Dermatological agents. antiseptics and disinfectants. chlorhexidine, combinations.
PBX code D08A C52.
Pharmacological properties.
Pharmacodynamics.
Chlorhexidine dihydrochloride is an antiseptic that has a bactericidal effect on gram-positive bacteria, especially sensitive strains of Staphylococcus aureus - microorganisms that are most often associated with skin infections. To a lesser extent, chlorhexidine dihydrochloride is active against gram-negative pathogenic microorganisms. 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 of Panthenol Plus, is rapidly converted into pantothenic acid in cells and acts as a vitamin. But dexpanthenol has the advantage that it is absorbed more quickly 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 each cell. Thus, pantothenic acid is necessary for the formation and healing of skin and mucous membrane injuries.
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 to healthy adults, Cmax in plasma of 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.
Clinical characteristics.
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 neurodermatitis. Treatment of cracked nipples in breastfeeding women. In minimally invasive surgery: injuries and surgical wounds.
Contraindication.
Hypersensitivity to Dexpanthenol and/or chlorhexidine or any other components of the drug. should not be applied to a perforated eardrum.
Interaction with other drugs and other types of interactions.
Chlorhexidine is not compatible with soaps and other anionic compounds. Panthenol Plus is not recommended for use simultaneously with other antiseptics to prevent their mutual influence (anti-action or inactivation).
Application features.
Contact with eyes, ears and mucous membranes should be avoided. If the drug gets into the eyes, they should be rinsed thoroughly with water.
Panthenol Plus is not recommended for the treatment of skin irritations with a low risk of infection (e.g. sunburn). 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 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.
If symptoms persist or worsen, you should consult a doctor.
Use during pregnancy or breastfeeding.
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.
The ability to influence the 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 once or several times a day, depending on the need, to previously cleansed affected areas of the skin.
The daily dose for multiple 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.
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, 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.
2 years.
Storage conditions.
Store at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging.
30 g in a tube, in a cardboard pack.
Vacation category.
Without a prescription.
Manufacturer/applicant.
"Ternofarm" LLC.
Location of production and its address of place of business / location of the applicant.
Ukraine, 46010, Ternopil, Fabrychna St., 4.
Tel. / Fax: (0352) 521-444, www.ternopharm.com.ua
