HEPIDERM-HEALTH

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEPIDERM-ZDOROV'YA

Composition:

Active substance: dexpanthenol;

1 g of the preparation contains dexpanthenol 50 mg;

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

Pharmaceutical form. Topical cream.

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

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

ATC code D03A X03.

Pharmacological Properties.

Pharmacodynamics. Dexpanthenol, the active ingredient of HepiDerm-Zdorov'ya, a cream for external use, 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. It is then immediately converted into pantothenic acid and incorporated into the body's internal pool of this vitamin.

In the blood, pantothenic acid binds to plasma proteins (mainly to β-globulins and albumin). In healthy adults, concentrations are approximately 500–1000 μg/L in whole blood and 100 μg/L in 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. Adults excrete 2–7 mg of pantothenic acid per day in urine, children excrete 2–3 mg.

Clinical characteristics.

Indications. Hepiderm-Health, a topical cream, is used in the following cases:

• prophylactic treatment of dry, reddened skin or skin with cracks;
• to accelerate healing and epithelialization of the skin in minor skin injuries (mild burns and abrasions); in skin irritations (e.g., due to radiotherapy, phototherapy, or ultraviolet radiation exposure); diaper dermatitis; chronic skin ulcers and pressure sores; anal fissures; cervical erosions and after skin grafting;
• skin care in patients during and after local application of corticosteroids;
• prophylactic care of mammary glands in breastfeeding women and for treatment of irritations and cracks of nipples.

Contraindications. Hypersensitivity to dexpanthenol or to any of the other components of the product.

Interaction with other medicinal products and other forms of interaction. Cases of interaction with other medicinal products are unknown.

Instructions for use.

When using the product, avoid contact with the eyes.

Cetostearyl 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 product during pregnancy or breastfeeding as risky. During pregnancy, the product should be used only as directed by a physician.

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

Ability to affect reaction speed when driving or operating machinery. No effect.

Method of Administration and Dosage

Accelerating healing and epithelialization, regular skin care: apply the cream once or several times daily, as needed.

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 preparation rapidly penetrates the skin, making it suitable for care of weeping wounds, exposed skin surfaces (face), and hairy skin. It spreads easily over the surface and is therefore suitable for treatment of painful sunburns and other mild burns.

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

Overdose. The active ingredient of the preparation, dexpanthenol, is well tolerated and considered non-toxic in the literature. Hypervitaminosis has not been reported.

Side effects.

Immune system, skin and subcutaneous tissue disorders. 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. 5 % cream for external use, 15 g, 30 g or 100 g in tubes in a box.

Supply category. Over-the-counter.

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorovya".

Manufacturer's location and address of business activity. Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22.