Panthenolspray (Aerosol) Instructions for Use

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

ASM Aerosol-Service, AG (Switzerland)

Quality Control Release

Dr. GERHARD MANN Chem.-Pharm. Fabrik, GmbH (Germany)

Contact Information

BAUSH HEALTH LLC (Russia)

ATC Code

D03AX03 (Dexpanthenol)

Active Substance

Dexpanthenol (Rec.INN registered with WHO)

Dosage Form

Panthenolspray

Aerosol for external use 4.63%: bottle 130 g 1 pc.

Dosage Form, Packaging, and Composition

Aerosol for external use in the form of a white foam with a faint sourish odor.

Excipients: cetearyl alcohol (emulsifying type A), liquid wax, liquid paraffin, peracetic acid, propellant (propane, n-butane, isobutane), purified water.

130 g – aluminum aerosol cans (1) with a valve and spray nozzle – cardboard packs.

Clinical-Pharmacological Group

Drug improving tissue regeneration, for external use

Pharmacotherapeutic Group

Drugs for the treatment of wounds and ulcers; drugs promoting normal scarring; other drugs promoting normal scarring

Pharmacological Action

The active substance of the drug – Dexpanthenol – is converted in the body into pantothenic acid, which, being a component of coenzyme A (CoA), plays an important role in acetylation and oxidation processes, participates in carbohydrate and fat metabolism, and in the synthesis of acetylcholine. It has a weak anti-inflammatory effect and improves tissue regeneration.

Pharmacokinetics

Absorption

When applied topically, it is rapidly absorbed by the skin and converted into pantothenic acid, binds to plasma proteins (mainly beta-globulin and albumin). Its concentration in blood is 0.5-1 mg/L, in blood serum – 100 µg/L.

Elimination

Pantothenic acid is not metabolized in the body (except for incorporation into CoA) and is excreted unchanged.

Indications

• Dry skin;
• Wounds and burns (sunburn and thermal);
• Dermatitis; bedsores; diaper rash; aseptic postoperative wounds; poorly healing skin grafts;
• Treatment and prevention of fissures and inflammation of the mammary gland nipples during lactation;
• Care for infants; prevention and treatment of diaper rash in infants; activation of the skin healing process in minor injuries, diaper erythema.

ICD codes

Dosage Regimen

Externally. One or several times/day by spraying from a distance of 10-20 cm so that the damaged surface is covered with the drug.

The duration of treatment depends on the severity of the disease.

The course of treatment depending on the type of pathology can range from 2-3 days to 3-4 weeks.

For sunburn and dermatological diseases

The foam is rubbed into the affected surface with light movements until the drug is absorbed into the skin. The drug is applied 3-4 times/day.

For the treatment of granulating burns, wounds and trophic ulcers with weak exudation

Before using the drug, the wound surface is cleaned of exudate and necrotic tissues, washed with a solution of hydrogen peroxide, furacilin 1:5000 or chlorhexidine digluconate 0.05% and dried. The foam is applied in an even layer 1.0-1.5 cm thick so that the entire affected surface is covered with foam, and a sterile gauze bandage is applied. Dressings are changed once every 1-2 days when treating burns and once/day when treating wounds and trophic ulcers. With the open method of burn treatment, the foam is applied 1-2 times/day. The duration of treatment is determined by the dynamics of wound epithelialization.

Care for the mammary glands of nursing mothers

The foam is applied to the nipples of nursing mothers after each feeding and rubbed in with massaging movements.

Care for infants

The foam is applied with each diaper change.

If improvement does not occur after treatment, or symptoms worsen, or new symptoms appear, it is necessary to consult a doctor.

The drug should be used only according to the method of application and in the doses indicated in the instructions.

Adverse Reactions

The frequency of adverse reactions is classified in accordance with WHO recommendations, side effects are classified by frequency: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10000 and <1/1000), frequency unknown (cannot be estimated from the available data).

If skin allergic reactions occur, the use of the drug should be discontinued.

If the patient experiences side effects listed in the instructions, or they worsen, or the patient notices any other side effects not listed in the instructions, a doctor should be informed.

Contraindications

• Hypersensitivity to dexpanthenol or excipients of the drug;
• In case of severe, deep or heavily contaminated wounds (such injuries require medical intervention).

With caution

Patients suffering from bronchial asthma or bronchopulmonary diseases should not inhale the spray vapors, as this may cause irritation of the mucous membranes and provoke an attack of bronchial asthma.

Use in Pregnancy and Lactation

Panthenolspray can be used during pregnancy and breastfeeding. However, its application to large skin areas should be avoided.

If the drug is used to treat nipples during lactation, it must be washed off before breastfeeding.

In case of suspected, planned or established pregnancy, it is necessary to consult a doctor.

Pediatric Use

Used according to indications.

Special Precautions

The bottle must be shaken thoroughly before each use.

The can is under pressure. Protect from direct sunlight and temperatures above 50°C (122°F). After use, do not force open the can and do not burn it. Do not spray near an open flame or on hot objects. Store away from sources of ignition, protect the can from impacts and falls.

Avoid getting the foam (aerosol) into the eyes. If foam accidentally gets into the eyes, they should be rinsed with water.

Avoid contact with ears and mucous membranes, do not take orally (if large amounts are accidentally ingested, a doctor should be consulted immediately).

When applying to the face area, do not spray directly onto the face; it is recommended to first apply to the hand, then spread over the damaged area of facial skin.

Large area, heavily contaminated and deep wounds, as well as bite and puncture wounds require medical intervention (danger of tetanus). If the wound size remains consistently large for some time, or the wound does not heal within 10-14 days, then a doctor should be consulted in this case. This is also necessary if the wound edges are severely hyperemic, the wound suddenly swells and severe pain appears, or the injury is accompanied by fever (danger of sepsis). Frequent application to the same area of skin may lead to irritation. The drug is intended for the treatment of small wounds; application in large quantities should be avoided.

The drug should not be applied to wounds with abundant purulent exudation.

Treatment of poorly healing skin grafts and trophic ulcers is carried out under medical supervision.

Patients suffering from bronchial asthma or bronchopulmonary diseases should not inhale the spray vapors, as this may cause irritation of the mucous membranes and provoke an attack of bronchial asthma.

The cetearyl alcohol contained in the drug may cause local skin reactions (e.g., contact dermatitis).

Effect on ability to drive vehicles and operate machinery

The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.

Overdose

Overdose is unlikely when using the drug in accordance with the instructions for use. In case of accidental ingestion, symptomatic therapy is indicated.

Drug Interactions

No interaction of Panthenolspray with other drugs has been identified.

Concurrent use of condoms and Panthenolspray foam applied in the genital or anal area may reduce the effectiveness of condoms, as their tensile strength may decrease due to the paraffin content.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.