Panthenol-health

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANTHENOL-ZDOROVYE (PANTHENOL-ZDOROVYE)

Composition:

Active substance: dexpanthenol;

1 g of the preparation contains 50 mg of dexpanthenol;

Excipients: Euxyl® PE 9010 containing 90% phenoxyethanol and 10% ethylhexylglycerin (calculated as phenoxyethanol), DL-pantolactone, cetyl stearyl alcohol, potassium cetyl phosphate, isopropyl myristate, propylene glycol, lanolin, purified water.

Pharmaceutical form. Topical cream.

Main physicochemical properties: cream of white to almost white color, homogeneous in consistency, with a faint odor.

Pharmacotherapeutic group. Agents promoting wound healing (scar formation).

ATC code D03AX03.

Pharmacological properties.

Pharmacodynamics.

Dexpanthenol, the active substance of the medicinal product, is rapidly converted into pantothenic acid within cells and acts as a vitamin. Dexpanthenol is more readily absorbed than pantothenic acid following topical application.

Pantothenic acid is a component of essential coenzyme A (CoA). In this form, acetyl-coenzyme A, CoA plays a central role in the metabolism of every cell. Thus, pantothenic acid is necessary for the restoration and regeneration of damaged skin and mucous membranes.

Pharmacokinetics.

Dexpanthenol is rapidly absorbed through the skin, after which it is immediately converted into pantothenic acid and incorporated into the body's internal depot of this vitamin.

In the blood, pantothenic acid binds to plasma proteins (mainly to β-globulins and albumin). In healthy adults, the concentration is approximately 500–1000 mcg/L and 100 mcg/L in whole blood and blood serum, respectively.

Pantothenic acid is not metabolized in the body and is excreted unchanged. After oral administration, 60–70% of the dose is excreted in urine, the remainder in feces. In adults, 2–7 mg of pantothenic acid is excreted daily in urine; in children, 2–3 mg.

Clinical characteristics.

Indications.

The medicinal product is used in the following cases:

• for prophylactic treatment of dry, reddened, or cracked skin;
• to accelerate healing and epithelialization of the skin in minor injuries (such as mild burns and abrasions); in skin irritations (e.g., due to radiation therapy, phototherapy, or ultraviolet irradiation); in diaper dermatitis; in chronic skin ulcers and pressure sores; in anal fissures; cervical erosions; and after skin grafting;
• for skin care of patients during and after topical application of corticosteroids;
• for prophylactic care of mammary glands in breastfeeding women, as well as for treatment of nipple irritation and cracks.

Contraindications.

Hypersensitivity to dexpanthenol or to any other component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Interactions with other medicinal products are unknown.

Special precautions for use

When using the medicinal product, avoid contact with the eyes.

Cetyl stearyl alcohol and lanolin may cause local skin reactions (e.g. contact dermatitis). Propylene glycol may cause skin irritation.

Use during pregnancy or breastfeeding

There are no grounds to consider the use of the medicinal product during pregnancy or breastfeeding as hazardous. During pregnancy, the product should be used only as prescribed by a physician.

When used for the treatment of cracked nipples during breastfeeding, the cream should be washed off before nursing.

Ability to influence reaction rate while driving or operating machinery

No effect.

Method of Administration and Dosage

Accelerating healing and epithelialization, routine skin care: apply the cream once or several times daily, depending on need.

Care of mammary glands in breastfeeding women: apply the cream to the nipples after each breastfeeding session.

Treatment of cervical mucosa defects: apply the cream once or several times daily under medical supervision.

Infant care: apply the cream after each diaper (nappy) change.

The medicinal product rapidly penetrates the skin, making it suitable for the care of weeping wounds, exposed skin surfaces (face), and hairy skin areas. It spreads easily over the surface, thus being suitable for the treatment of painful sunburns and other mild burns.

Children. The medicinal product can be used in children of all age groups, including infants.

Overdose.

Even inappropriate use of larger than recommended amounts of the medicinal product does not lead to toxic adverse reactions.

Side effects.

Immune system, skin and subcutaneous tissue disorders. Rarely (<1/10,000), allergic reactions have been reported, including skin reactions: contact dermatitis, allergic dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and vesicles.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 15 g, 30 g, or 100 g in tubes in a box.

Supply category. Over-the-counter (without prescription).

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and place of business.
Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenko Street, 22.