D-panthenol-Nizhpharm (Ointment) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

Hemofarm A.D. Vrsac Branch Plant Sabac (Serbia)

Quality Control Release

HEMOFARM, A.D. (Serbia)

ATC Code

D03AX03 (Dexpanthenol)

Active Substance

Dexpanthenol (Rec.INN registered by WHO)

Dosage Form

D-panthenol-Nizhpharm

Ointment for external use 5%: tube 30 g

Dosage Form, Packaging, and Composition

Ointment for external use homogeneous, from white to light yellow in color.

Excipients: glycerol (glycerin), petrolatum, lanolin, liquid paraffin, solid paraffin, stearyl alcohol, cetyl alcohol, water.

30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug improving trophism and tissue regeneration, for external use

Pharmacotherapeutic Group

Tissue repair stimulant

Pharmacological Action

Dexpanthenol is a derivative of pantothenic acid. Dexpanthenol is converted in the body into pantothenic acid, which is a component of coenzyme A and is involved in acetylation processes, in the synthesis of acetylcholine, corticosteroids, and porphyrins.

Furthermore, it participates in practically all metabolic processes (tricarboxylic acid cycle, metabolism of carbohydrates, fats and fatty acids, phospholipids, proteins), stimulates the regeneration of the skin and mucous membranes, normalizes cellular metabolism, accelerates mitosis and increases the strength of collagen fibers. It has a regenerating, metabolic, and weak anti-inflammatory effect.

Pharmacokinetics

When applied topically, it is rapidly absorbed by the skin and converted into pantothenic acid, binds to plasma proteins (mainly to beta-globulin and albumin). The concentration in blood is 0.5-1 mg/l, in blood serum – 100 µg/l. Pantothenic acid is not metabolized in the body (except for incorporation into CoA), and is excreted unchanged.

Indications

• Dry skin;
• Violation of the integrity of the skin and soft tissues;
• Minor injuries;
• Burns (thermal and sunburn);
• Abrasions;
• Bullous dermatitis;
• Abscess;
• Furuncle;
• Trophic leg ulcers;
• Bedsores;
• Cracks;
• Aseptic postoperative wounds;
• Poorly healing skin grafts;
• Treatment and prevention of cracks and inflammation of the mammary gland nipples during lactation;
• Care for infants;
• Prevention and treatment of diaper rash;
• Skin healing for minor injuries;
• Diaper erythema in infants.

ICD codes

Dosage Regimen

Externally. For treating wounds, diaper rash, abscesses, bedsores, dermatitis, for breast care, for infants – 5% ointment is applied 2-3 times/day to the affected surface in a thin layer and gently rubbed in depending on the indication; to the area of the mammary gland nipple, the ointment is applied as a compress after each breastfeeding.

For infants D-panthenol-Nizhpharm is applied to the back, buttocks, and groin area after each change of underwear or water procedure.

Adverse Reactions

Possible occurrence of allergic reactions; if they appear, discontinue use of the drug.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Can be used during pregnancy and the breastfeeding period.

Pediatric Use

For treating wounds, diaper rash, abscesses, bedsores, dermatitis in infants – 5% ointment is applied 2-3 times/day to the affected surface in a thin layer and gently rubbed in depending on the indication.

For infants D-panthenol-Nizhpharm is applied to the back, buttocks, and groin area after each change of underwear or water procedure.

Special Precautions

Treatment of poorly healing skin grafts and trophic ulcers should be carried out under the supervision of the attending physician.

Do not apply to weeping wounds.

Drug Interactions

Not identified.

Storage Conditions

Store at a temperature from 15°C (59°F) to 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 5 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.